Daylette - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life

Active ingredients: Drospirenone, Ethinylestradiol

DAYLETTE 3 mg / 0.02 mg film-coated tablets

Indications Why is Daylette used? What is it for?

Important things to know about combined hormonal contraceptives (COCs):

• They are one of the most reliable reversible methods of contraception when used correctly
• They slightly increase the risk of having blood clots in the veins and arteries, especially during the first year of taking or when restarting a combined hormonal contraceptive after a break of 4 or more weeks
• Take care and see your doctor if you think you have symptoms of a blood clot (see section 2 "Blood clots")

• Daylette is a contraceptive pill and is used to prevent pregnancy.
• Each of the 24 white active tablets contains a small amount of two different female hormones, called drospirenone and ethinyl estradiol.
• The 4 green colored tablets do not contain active ingredients and are also called placebo tablets.
• Contraceptive pills that contain two hormones are called "combination" pills.

General warnings

Before you start using Daylette you should read the information on blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before you can start taking Daylette, your doctor will ask you a few questions about your health history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may also carry out other tests.

In this leaflet, several situations are described under which you must stop taking Daylette, or conditions under which the reliability of Daylette may be reduced. In such situations, either you must not have sexual intercourse or you must use other non-hormonal methods of birth control such as, for example, the use of a condom or another type of barrier.

Do not use methods based on the rhythmic contraceptive method or on the measurement of body temperature. These methods can be unreliable as Daylette modifies the monthly changes in body temperature and cervical mucus.

Daylette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease. Do not use Daylette

Contraindications When Daylette should not be used

Do not use Daylette if you have any of the conditions listed below. If you have any of the conditions listed below, please contact your doctor. Your doctor will discuss with you other birth control methods that may be more suitable for you.

• If you are allergic to ethinyl estradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). This can cause itching, rash or swelling
• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE) or other organs
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden or antiphospholipid antibodies;
• if you are due to have an "operation or if you are going to lie down for a long time (see section" Blood clots ");
• if you have ever had a heart attack or stroke
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischemic attack (TIA - temporary stroke symptoms);
• if you have any of the following diseases, which may increase the risk of blood clots in the arteries:
• severe diabetes with blood vessel injury
• very high blood pressure
• very high level of fat (cholesterol or triglycerides) in the blood
• a disease known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called 'migraine with aura';
• if you have (or have ever suffered) from liver disease and your liver function has not yet returned to normal
• if your kidneys are not working well (kidney failure)
• if you have (or have ever had) liver cancer
• if you have (or have ever had) or if you suspect that you may have breast or genital cancer
• if you experience vaginal bleeding for no reason
• DAYLETTE contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

Precautions for use What you need to know before you take Daylette

Talk to your doctor or pharmacist before taking Daylette.

When should you see a doctor?

Contact a doctor urgently

• if you notice possible signs of a blood clot which may indicate that you are suffering from a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack or a stroke (see section below " Blood clot (thrombosis) ").

For a description of the symptoms of these serious side effects go to the section "How to recognize a blood clot

Tell your doctor if any of the following apply to you.

In some situations you need to be especially careful while using Daylette or any other combination pill, and your doctor may need to have you checked regularly. If any of the following apply to you, you must tell your doctor before you start taking Daylette.

If this condition appears or worsens while you are using Daylette you should tell your doctor

• if a close relative has or has ever had breast cancer
• if you have liver or gallbladder disease
• if you have diabetes
• if you suffer from depression
• if you are epileptic (see "Other medicines and Daylette")
• if you have a disease that first appeared during pregnancy or with previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, a "rash characterized by blisters during pregnancy (herpes gravidarum), a disease of the nervous system that causes sudden movements of the body (Sydendam's chorea)
• if you have or have ever experienced golden brown pigment spots (chloasma), also called "pregnancy spots", which especially affect the face. In this case, avoid direct exposure to sunlight or ultraviolet rays
• if you have hereditary angioedema, products containing estrogen can cause or aggravate symptoms. You should contact a doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue and / or pharynx and / or difficulty in swallowing or the appearance of hives accompanied by breathing difficulties.
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease that affects the natural defense system);
• if you have haemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited disease of the red blood cells);
• if you have high levels of fat in the blood (hypertriglyceridaemia) or a "positive family history of this condition." Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have an "operation or if you are going to lie down for a long time (see section 2" Blood clots ");
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after having a baby you can start taking Daylette;
• if you have "inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins.

Blood clots

Using a combined hormonal contraceptive such as Daylette increases your risk of developing a blood clot compared with not using one. In rare cases, a blood clot can block blood vessels and cause serious problems

Blood clots can develop

• in veins (called "venous thrombosis", "venous thromboembolism" or VTE)
• in the arteries (referred to as 'arterial thrombosis', 'arterial thromboembolism' or ATE).

Recovery from blood clots is not always complete. Rarely, long-lasting severe effects can occur or, very rarely, they can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Daylette is low

HOW TO RECOGNIZE A BLOOD CLOT

See a doctor immediately if you notice any of the following signs or symptoms.

Do you have any of these signs? What are you probably suffering from?

• swelling in one leg or along a vein in the leg or foot, especially when accompanied by:
• pain or tenderness in the leg that may only be felt when standing or walking;
• increased sensation of heat in the affected leg;
• change in color of the skin on the leg, such as turning pale, reddish or bluish;

Deep vein thrombosis

• sudden and unexplained shortness of breath or rapid breathing;
• sudden cough with no obvious cause, possibly causing blood to be emitted;
• sharp chest pain which may increase with deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in the stomach

If you are unsure, tell your doctor as some of these symptoms, such as coughing or shortness of breath, may be mistaken for a milder condition such as a "respiratory infection (eg a" common cold "). Pulmonary embolism Symptoms that occur most frequently in one eye:

• immediate loss of vision or
• painless blurring of vision which can progress to loss of vision

Retinal vein thrombosis (blood clot in the eye)

• chest pain, discomfort, feeling of pressure or heaviness;
• sensation of squeezing or fullness in the chest, arm or below the breastbone;
• feeling of fullness, indigestion or choking;
• upper body discomfort radiating to the back, jaw, throat, arms and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeats

Heart attack

• sudden numbness or weakness of the face, arm or leg, especially on one side of the body;
• sudden confusion, difficulty speaking or understanding;
• sudden difficulty seeing in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden, severe or prolonged migraine with no known cause;
• loss of consciousness or fainting with or without seizures.

Stroke symptoms can sometimes be brief, with almost immediate and complete recovery, but you still need to see a doctor urgently as you may be at risk for another stroke. Stroke

• swelling and pale blue discoloration of one extremity;
• severe stomach pain (acute abdomen)

Blood clots that block other blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been linked to an increased risk of blood clots forming in the veins (venous thrombosis). However, these side effects are rare. In most cases they occur in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause a deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can cause a "pulmonary embolism."
• Very rarely, a clot can form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?

The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may be even higher if you restart taking a combined hormonal contraceptive (the same drug or a different drug) after a break of 4 or more weeks.

After the first year, the risk is reduced but is always slightly higher than if you were not using a combined hormonal contraceptive.

When you stop taking Daylette your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Daylette is low.

• Out of 10,000 women who are not using any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal contraceptive containing drospirenone, such as Daylette, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see under "Factors that increase the risk of a blood clot forming").

Women who are not using a combined hormone pill / patch / ring and who are not pregnant Risk of developing a blood clot in a year About 2 out of 10,000 women Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate About 5-7 out of 10,000 women Women who use Daylette About 9-12 out of 10,000 women

Factors that increase the risk of developing a blood clot in a vein

The risk of developing a blood clot with Daylette is low but some conditions increase the risk. Its risk is greater:

• if you are severely overweight (body mass index or BMI over 30 kg / m2);
• if a member of your immediate family has had a blood clot in the leg, lung or other organ at a young age (less than about 50 years). In this case you could have an inherited blood clotting disorder;
• if you are going to have an operation or if you have to lie down for a long time because of an injury or illness or if you have a leg in a cast. You may need to stop taking Daylette a few weeks before the surgery or during the period where you are less mobile. If you have to stop taking Daylette, ask your doctor when you can start taking it again;
• as you get older (especially over the age of 35);
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases the more conditions you have of this type

Air travel (lasting> 4 hours) may temporarily increase the risk of a blood clot, especially if you have some of the other risk factors listed.

It is important that you tell your doctor if any of these apply to you, even if you are not sure. Your doctor may decide that Daylette needs to be stopped.

If any of the above conditions change while you are using Daylette, for example if a close relative has a thrombosis for no known reason or if you gain a lot of weight, contact your doctor

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an "artery?"

Like blood clots in a vein, clots in an artery can cause serious problems, for example, they can cause a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery

It is important to note that the risk of heart attack or stroke associated with the use of Daylette is very low but can increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Daylette you are advised to stop smoking. If you are unable to stop smoking and are over the age of 35, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at high risk of having a heart attack or stroke;
• if you or a close relative have a high level of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraines, especially migraines with aura;
• if you have any heart problems (valve defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes

If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be even higher.

If any of the above conditions change while you are using Daylette, for example if you start smoking, if a close relative has a thrombosis for no known reason, or if you gain a lot of weight, contact your doctor.

Daylette and tumors

Breast cancer has been detected slightly more frequently in women using combination pills, but it is not known whether this is due to the treatment. For example, it may be that more cancers are diagnosed in women on combination pills as they undergo medical tests more frequently.

The incidence of breast cancer gradually decreases after discontinuation of combination hormonal contraceptives. It is important that you regularly check your breasts and that you contact your doctor if you feel any lumps.

Benign liver tumors and even more rarely malignant liver tumors have been reported rarely in women taking the Pill. Contact your doctor if you experience unusually severe abdominal pain.

Bleeding in the interval between menstrual periods

During the first few months of using Daylette, you may experience unexpected bleeding (bleeding that does not coincide with the days you took the placebo). If this bleeding occurs for more than a few months, or if it begins after a few months, the doctor must determine the nature of the problem.

What to do if no bleeding occurs during the placebo days

If you have taken all the white active tablets correctly, have not vomited or had severe diarrhea and have not taken any other medicines, it is very unlikely that you are pregnant.

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately. Only start the next strip if you are sure that you are not pregnant.

Interactions Which drugs or foods can change the effect of Daylette

Always tell your doctor about any medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes other medicines (or the pharmacist) that you are using Daylette. They can tell you if you need to take other contraceptive precautions (e.g. condoms) and if so, for how long.

Some medicines can make Daylette less effective in preventing pregnancy, or can cause unexpected bleeding. Among them are:

medicines used to treat

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g. rifampicin)
• HIV infections (ritonavir, nevirapine)
• other infections (antibiotics such as griseofulvin, penicillin, tetracycline)
• high blood pressure in the blood vessels in the lungs (bosentan)
• the pesticide called St. John's wort.

Daylette may affect the effect of other medicines, such as

• medicines containing cyclosporine
• the anti-epileptic lamotrigine (this can increase the frequency of seizures).

Daylette with food and drink

Daylette can be taken with or without food, if needed with a small amount of water.

Laboratory tests

If you need to have a blood test, tell your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives can affect the results of some tests.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant, you should not take Daylette. If you become pregnant while taking Daylette you must stop taking the drug immediately and contact your doctor.

If you are planning to become pregnant, you can stop taking Daylette at any time (see also "If you want to stop" Daylette ").

Ask your doctor or pharmacist for advice before taking any medicine.

Feeding time

The use of Daylette is not recommended when a woman is breastfeeding. If you wish to take the pill while breastfeeding, you should contact your doctor. Ask your doctor or pharmacist for advice before taking any medicine.

Feeding time

The use of Daylette is not recommended when a woman is breastfeeding. If you wish to take the pill while breastfeeding, you should contact your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There is no information to suggest that the use of Daylette affects driving or use of machines.

Daylette contains lactose, sunset yellow and soy lecithin

In Daylette, the white film-coated active tablets contain 48.53 mg of lactose monohydrate and the green inactive tablets contain 37.26 mg of anhydrous lactose. If you have been told by your doctor that you have an "intolerance to some sugars, contact your doctor before taking this medicine.

The film-coated tablets that do not contain hormones (placebo) contain the dye "sunset yellow", which can cause an allergic reaction.

Daylette also contains 0.070 mg of soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Dose, Method and Time of Administration How to use Daylette: Posology

Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

Each blister contains 24 white active tablets and 4 green placebo tablets.

Daylette tablets of two different colors are arranged in order. One blister contains 28 tablets.

Take one Daylette tablet every day with a small amount of water as needed. You can take the tablets with or without food, but the tablets should be taken at about the same time each day.

Be careful not to confuse the tablets: take one white tablet every day for the first 24 days, then one green tablet for the last 4 days. Then, you must start a new pack immediately (24 white tablets and 4 green tablets). Therefore, there is no break between one pack and another.

Due to the different composition of the tablets it is necessary that you start with the first tablet positioned in the upper left and then take the tablets each day.

For the correct order, please follow the direction indicated by the arrows on the package.

Preparation of the package

To check your daily contraceptive intake, use the arrows on the package.

The arrows indicate the order in which you should take the tablets. During the 4 days of taking the green placebo tablets (the placebo days), your menstrual period (also called withdrawal bleeding) usually begins. Your menstrual period will normally begin during the second or third day after taking the last active, white tablet of Daylette. After taking the last green tablet, you must start the next pack even if the bleeding has not stopped. This means that you will start each new pack on the same day of the week, and that your menstrual period usually occurs on the same days as every month.

If you use Daylette in this way, you are also protected against pregnancy during the 4 days that you take a placebo tablet.

When can the first pack start?

• If you have not used a hormonal contraceptive in the previous month

Start taking Daylette on the first day of your period (i.e. the first day of your period). If you start using Daylette on the first day of your period you are immediately protected from pregnancy. He can also start on days 2 to 5 of the cycle, but in this case he must use additional protective methods (for example, a condom) for the first 7 days.

• If you switch to Daylette from another combination hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch)

Start Daylette preferably the day after taking the last active tablet (the last tablet containing the active ingredients) of your previous pill, but no later than the day after the end of the previous pill withdrawal period (or after the last pill). inactive tablet of the previous pill) When changing from a vaginal ring or a patch with a combined hormonal contraceptive, follow the advice of your doctor.

• If you switch to Daylette from a progesterone-only method of birth control (progesterone-only pill, injection, implant, progesterone-releasing intrauterine system IUD)

You can change on any day from the progesterone-only pill (from an implant or IUD on the day of removal, from an injectable contraceptive on the day the next injection would be given) but in all these cases you need to take measures additional protection (for example, a condom) for the first 7 days of taking the tablets.

• After a miscarriage

Follow your doctor's instructions.

• After giving birth

You can start Daylette between 21 and 28 days after giving birth. If it starts after 28 days, you must use a so-called barrier method (for example, a condom) during the first 7 days of using Daylette. If, after giving birth, you have had sex before starting Daylette (again), you must first make sure that you are not pregnant or wait for your next period.

• If you are breast-feeding after having a baby and want to restart Daylette

Read the section on "Breastfeeding".

Ask your doctor for advice if you are not sure when to start.

Overdose What to do if you have taken too much Daylette

If you take more Daylette than you should

No serious consequences have been reported with taking too many Daylette tablets.

If you take several tablets all at once, symptoms such as nausea or vomiting may occur. Young girls can experience vaginal bleeding.

If you have swallowed too many Daylette tablets, or if you notice that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Daylette

The last 4 tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these tablets, it has no effect on the reliability of Daylette.

Throw away the forgotten placebo tablet.

• if you are less than 12 hours late in taking a tablet, contraceptive protection is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.
• If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. The more tablets you forget, the higher the risk of becoming pregnant.

The risk of incomplete contraceptive protection is greatest if you forget a white tablet placed at the beginning or end of week 3. Therefore, you must observe the following rules (see also diagram):

• More than one tablet forgotten in this pack

Consult your doctor.

• One tablet forgotten between days 1-7 (first row)

Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue to take the tablets at the usual time and take extra precautions for the next 7 days, for example a condom.

If you have had sexual intercourse in the week before forgetting the tablet, you should be aware that there is a risk of pregnancy. If so, consult your doctor.

• One tablet between days 8-14 (second row)

Take the tablet as soon as you remember, even if that means taking two tablets at the same time. Continue to take the tablets at the usual time. The protection against pregnancy is not reduced and you do not need to take additional precautions.

• One tablet forgotten between days 15-24 (third row)

You can choose between two alternatives:

1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the green placebo tablets in this pack, throw them away and start the next pack (the starting day will be different). Your period will likely occur at the end of the second pack while you are taking the green placebo tablets, but you may experience light or menstruation-like bleeding while using the second pack.

2. Alternatively, you can discontinue the white active tablets and switch directly to the 4 green placebo tablets (before taking the placebo tablets, note the day you forgot the tablet). If you want to start a new pack on the day you always start, take the placebo tablets for less than 4 days.

By following one of these two recommended options, you are protected against pregnancy

• If you have forgotten to take any tablet in a pack, and no bleeding occurs during the placebo days, this may mean that you are pregnant. Consult your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours of taking an active white tablet, or if you experience severe diarrheal discharges, there is a risk that the active ingredients contained in the pill are not fully absorbed by your body.

The situation is almost identical to that of forgetting to take a tablet. After episodes of vomiting or diarrhea, you should take another white tablet from a reserve strip as soon as possible. If possible, take this tablet within 12 hours of your usual pill-taking time. If this is not possible or if 12 hours have passed, you should follow the instructions given under "If you forget to take Daylette".

Delay of the menstrual period: what you need to know

Although it is not recommended, it is possible to delay your menstrual period by not taking the green placebo tablets from the fourth row of the pack, by switching directly to a new pack of Daylette and taking all the tablets from the new pack. You may notice light or menstruation-like bleeding while using the second pack.

Finish this second pack by taking the 4 green tablets from the fourth row.At this point, you start the next pack.

Ask your doctor for advice before deciding to delay your menstrual period

Change of the first day of the menstrual period: what you need to know

If you take the tablets as directed, your menstrual period will start during the placebo days. If you need to change this day, reduce the number of days you take the green placebo tablets (but never lengthen it: 4 days is the maximum!). For example, if you start taking the placebo tablets on a Friday and you want to start on a Tuesday instead (3 days earlier), you should start a new strip of tablets 3 days earlier than usual. There may be no bleeding during this time. Later, you may notice light or menstruation-like bleeding.

If in doubt, consult your doctor.

If you want to stop taking Daylette

You can stop taking Daylette at any time. If you do not want to get pregnant, ask your doctor for other reliable methods of contraception. If you want to become pregnant, stop taking Daylette and wait for a period before trying This will make it easier to calculate the expected delivery date.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Daylette

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, especially if they are severe or persistent, or if there is any change in your health that you think might be due to Daylette, please tell your doctor.

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women taking combined hormonal contraceptives. For more detailed information on the different risks from "taking combined hormonal contraceptives, see section 2" What you need to know before you use Daylette ".

The following is a list of side effects that have been associated with the use of drospirenone / ethinylestradiol:

Common side effects (may affect up to 1 in 10 people):

• mood changes
• headache
• nausea
• chest pain, menstrual problems such as irregular or absent menstrual cycles.

Uncommon side effects (may affect up to 1 in 100 people):

• depression, decreased sexual interest, nervousness, sleepiness
• dizziness, pins and needles
• migraine, varicose veins, hypertension
• stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhea
• acne, itching, rash
• states of suffering and pain, eg. back pain, pain in the limbs, muscle cramps
• vaginal mycosis, pelvic pain, breast enlargement, benign breast lumps, uterine / vaginal bleeding (which usually decreases with continued treatment), vaginal discharge, flushing, inflammation of the vagina (vaginitis), irregular periods, painful menstruation, reduced menstruation, too heavy menstrual bleeding, vaginal dryness, abnormal vaginal smear
• weakness, increased sweating, fluid retention
• weight gain.

Rare side effects (may affect up to 1 in 1,000 people):

• harmful blood clots in a vein or artery, for example: in a leg or foot (DVT), lung (PE), heart attack, stroke, mini stroke or temporary stroke-like symptoms, known such as transient ischemic attack (TIA), blood clots in the liver, stomach / intestines, kidneys or eye. (The chance of developing a blood clot may be higher if you have any other conditions that increase this risk (see section 2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot))
• candida (fungal infection)
• decrease in the number of white blood cells in the blood (anemia), increase in the number of platelets in the blood (thrombocythemia)
• allergic reaction
• hormonal (endocrine) disorder
• increased appetite, loss of appetite, too high a concentration of potassium in the blood, too low a concentration of sodium in the blood
• inability to reach orgasm, insomnia
• dizziness, trembling
• visual disturbances e.g. inflammation of the eyelid, dry eyes
• too rapid heartbeat
• inflammation of a vein, nosebleed, fainting
• abdominal bloating, intestinal upset, bloated feeling, stomach hernia, fungal infection of the mouth, constipation, dry mouth
• localized pain in the bile ducts or gallbladder, inflammation of the gallbladder
• golden brown skin spots, eczema, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair growth, skin disorders, skin stretch marks, skin inflammation, skin inflammation sensitive to light, skin nodules
• Difficult or painful sexual intercourse, inflammation of the vagina (vulvovaginitis), post-sexual intercourse bleeding, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the mucosal surface of the neck of the "uterus, contraction or wear of the endometrium, ovarian cysts, enlargement of the uterus
• feeling of general malaise
• weight loss.

The following undesirable effects have also been reported, but based on the available data their frequency cannot be estimated:

• hypersensitivity
• skin rash with redness or disc-shaped ulcerations (erythema multiforme).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

Do not store above 25ºC. Store in the original package to protect the medicine from light.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.

The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

What Daylette contains

• The active substances are 3 mg of drospirenone and 0.02 mg of ethinylestradiol in each white tablet.
• The excipients are:

white active film-coated tablets:

Tablet core:

lactose monohydrate

cornstarch

cornstarch

pregelatinized

macrogol graft copolymer of poly (vinyl alcohol)

magnesium stearate.

Coating film:

poly (vinyl alcohol)

titanium dioxide (E171)

talc

macrogol 3350

lecithin (soy).

Green placebo film-coated tablets:

Tablet core:

microcrystalline cellulose

anhydrous lactose

pregelatinised maize starch

magnesium stearate

anhydrous colloidal silica.

Coating film:

poly (vinyl alcohol)

titanium dioxide (E171)

macrogol 3350

talc

carmine d "indigo (E132)

quinoline yellow (E104)

black iron oxide (E172)

sunset yellow FCF (E110).

What Daylette looks like and contents of the pack

The active film-coated tablet is a white to off-white, round, biconvex film-coated tablet approximately 6 mm in diameter. On one side there is the engraving: "G73", on the other side there are no engravings.

The film-coated placebo tablet is green, round, film-coated biconvex approximately 6 mm in diameter, unmarked.

Daylette 3 mg / 0.02 mg film-coated tablets are contained in PVC / PE / PVDC-Al blister packs. The blisters are placed in folding boxes containing the patient information leaflet; A storage case is included in each box.

Pack sizes:

1x28 film-coated tablets

3x28 film-coated tablets

6x28 film-coated tablets

13x28 film-coated tablets

Not all pack sizes may be marketed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information about Daylette can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 AUTHORIZATION NUMBER" PLACING ON MARKET09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIOPharmaceuticals, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORAN PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

DAYLETTE 3 MG / 0.02 MG TABLETS COATED WITH FILM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

24 white or almost white tablets (active) film coated:

each film-coated tablet contains 3 mg of drospirenone and 0.02 mg of ethinylestradiol.

Excipients with known effects:

each film-coated tablet contains 48.53 mg of lactose monohydrate and 0.070 mg of soy lecithin.

4 green placebo tablets (inactive) film coated:

the tablet does not contain active ingredients.

Excipients with known effects: 37.26 mg of anhydrous lactose, 0.003 mg of sunset yellow (E110).

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Film-coated tablet.

The active tablet is a white or almost white, round, biconvex, film-coated tablet with a diameter of approximately 6 mm. On one side there is the inscription: "G73", the other side has no engravings.

The placebo tablet is a green, round, biconvex, film-coated tablet with a diameter of approximately 6 mm, without incisions.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Oral contraception.

The decision to prescribe DAYLETTE must take into account the individual woman's current risk factors, particularly those related to venous thromboembolism (VTE) and the comparison between the risk of VTE associated with DAYLETTE and that associated with other combined hormonal contraceptives (COCs). (see sections 4.3 and 4.4).

04.2 Posology and method of administration

Dosage

Route of administration: oral use.

How to take DAYLETTE

The tablets should be taken every day at about the same time, if necessary with a small amount of liquid, in the order indicated on the blister pack. Tablet-taking should be continuous. One tablet should be taken daily for 28 consecutive days. Each subsequent pack will be started the day after taking the last tablet from the previous pack. Withdrawal bleeding usually starts on the second or third day after you start taking the placebo tablets (Last row) and it may not have ceased before the next pack is started.

How to start DAYLETTE

• No previous use of a hormonal contraceptive (within the last month).

Taking the tablets should start on the first day of the woman's natural cycle (ie the first day of her menstruation).

• Changing from a combination hormonal contraceptive (combination oral contraceptive (COC), vaginal ring or transdermal patch).

The patient should start DAYLETTE preferably the day after taking the last active tablet (the last tablet containing the active ingredients) of her previous combination oral contraceptive, but at the latest the following day at the usual tablet-free interval or "Placebo tablet range relative to her previous combined oral contraceptive. If a vaginal ring or transdermal patch has been used, the patient should start using DAYLETTE preferably on the day of removal, but at the latest when the next application should have taken place. .

• Changing from a progesterone-only method of contraception (pill, injection, implant containing only progesterone) or from a progesterone-releasing intrauterine device (IUS).

The patient can switch from the progesterone-only pill at any time (from an implant or IUS on the day of removal, from an injectable contraceptive on the day the next injection would be given) but in all these cases it must be advised to use an additional barrier method for the first 7 days of tablet-taking.

• After an abortion occurred in the first three months of pregnancy.

The patient can start therapy immediately. In doing so, you do not need to take additional contraceptive measures.

• After giving birth or having an abortion in the second trimester of pregnancy.

Patients should be advised to start 21 to 28 days after delivery or second trimester abortion. If starting later, the patient should be advised to use an additional barrier method for the first 7 days. However, if she has already had intercourse, pregnancy must be ruled out before the actual start of use of the combination oral contraceptive or the patient must wait for her first menstrual period.

For breastfeeding women, see section 4.6.

What to do if you forget to take the tablets

It is possible to skip the placebo tablets from the last (fourth) row of the blister. However, they must be discarded to avoid unknowingly prolonging the placebo tablet phase. The following recommendation refers only to forgetting active tablets:

If she is less than 12 hours late in taking the tablet, contraceptive protection is not reduced. The patient should take the tablet as soon as she remembers and should take the following tablets at the usual time.

If the delay in taking the tablet is more than 12 hours, contraceptive protection may be reduced. The behavior to be adopted in case of forgotten tablets can follow the following two basic rules:

1. Tablet-taking must never be interrupted for more than 4 days

2. 7 days of uninterrupted tablet-taking is required to achieve suppression

of the hypothalamic-pituitary-ovarian axis.

In accordance with the above, the following can be recommended in daily practice:

• Day 1 - 7

The patient will take the last missed tablet as soon as she remembers, even if this will involve taking two tablets at the same time. She will then continue to take the tablets at the usual time. In addition, you must use a barrier method such as a condom for the following 7 days. If there has been intercourse within the previous 7 days, the possibility of pregnancy should be considered. The more tablets are forgotten and the closer they are to the placebo tablet phase, the greater the risk of pregnancy.

• Day 8 - 14

The patient should take the last missed tablet as soon as she remembers, even if this will involve taking two tablets at the same time. She will then continue to take the tablets at the usual time. Provided the patient has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use additional birth control precautions. However, if you have forgotten more than one tablet, you will need to be advised to take extra precautions for 7 days.

• Day 15 - 24

The risk of decreased reliability is considerable due to the upcoming placebo tablet phase. However, by changing the tablet-taking schedule, the reduction in contraceptive protection can still be prevented. By adhering to one of the following two options, there is no need to resort to additional contraceptive precautions, provided that in the 7 days preceding the first forgetfulness the patient has taken all the tablets correctly.If not, the patient should follow the first of these two options and then take additional precautions for the next 7 days as well.

1. The patient should take the last missed tablet as soon as she remembers, even if this will involve taking two tablets at the same time. She will then continue to take the tablets at the usual time until the active tablets are used up. The 4 placebo tablets from the fourth row of the pack should be discarded. The next blister pack should be started immediately. The patient is unlikely to have a withdrawal period before completing the active tablet section of the second pack, but she may experience some spotting or loss of control bleeding on tablet-taking days.

2. The patient may also be advised to stop taking the active tablets from the current blister pack. She must then take the placebo tablets from the last row of the pack for a maximum period of 4 days, including the days when she has forgotten the tablets, and then she must continue with the next blister pack.

If the patient has forgotten to take tablets and subsequently does not experience withdrawal bleeding during the placebo tablet phase, the possibility of pregnancy should be considered.

Warnings in case of gastro-intestinal disorders

In case of severe gastro-intestinal disturbances (eg vomiting or diarrhea), absorption may not be complete and additional contraceptive measures must be taken. If vomiting occurs within 3-4 hours after taking an active tablet, a new (replacement) tablet should be taken as soon as possible. The new tablet should be swallowed if possible within 12 hours of the usual time of taking the drug. If more than 12 hours have passed, the warning regarding missed tablets, as communicated in section 4.2 "Management of forgotten tablets, is applicable. ". If the woman does not wish to change her normal tablet-taking schedule, she must take the extra tablet (s) from another blister pack.

How to postpone a withdrawal bleed

To delay a menstruation the woman must continue with another blister pack of DAYLETTE avoiding taking the placebo tablets belonging to her current pack. The duration of the delay can be extended as desired until the complete use of the active tablets belonging to the second pack. During the duration of the delay the woman may experience loss of control bleeding or spotting. The regular intake of DAYLETTE will then be resumed after the placebo tablet phase.

To shift her period to a different day of the week than the woman is used to under her current schedule, she may be advised to shorten her next placebo tablet phase by as many days as she wishes. The shorter the interval, the higher the likelihood that she will not have a withdrawal bleed but instead experience loss of control bleeding and spotting during the next pack (just like when delaying a period. ).

04.3 Contraindications

COCs should not be used in the presence of any of the conditions listed below. If any of these conditions occur for the first time during COC use, the product should be discontinued immediately.

Combined hormonal contraceptives (COCs) should not be used in the following conditions:

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

• Hypersensitivity to peanuts or soy.

• Presence or risk of venous thromboembolism (VTE)

- Venous thromboembolism - VTE (with anticoagulants) or a history of VTE (eg deep vein thrombosis [DVT] or pulmonary embolism [PE])

- Known hereditary or acquired predisposition to venous thromboembolism, such as resistance to activated protein C (including factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency

- Major surgery with prolonged immobilization (see section 4.4)

- High risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4)

• Presence or risk of arterial thromboembolism (ATE)

- Arterial thromboembolism - current or previous arterial thromboembolism (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris)

- Cerebrovascular disease - current or previous stroke or prodromal conditions (e.g. transient ischaemic attack (TIA))

- Known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)

- History of migraine with focal neurological symptoms

- High risk of arterial thromboembolism due to the presence of multiple risk factors (see section 4.4) or the presence of a serious risk factor such as:

• diabetes mellitus with vascular symptoms

• severe hypertension

• severe dyslipoproteinemia.

• Current or previous severe liver disease until liver function test values ​​have returned to normal.

• Severe renal failure or acute renal failure.

• Current or previous liver tumors (benign or malignant).

• Known or suspected cancers caused by sex steroids (eg of the genital organs or breasts).

• Undiagnosed vaginal bleeding.

04.4 Special warnings and appropriate precautions for use

Warnings

If any of the conditions or risk factors mentioned below are present, the suitability of DAYLETTE should be discussed with the woman. In the event of worsening or first appearance of any of these risk factors or conditions, the woman should contact her physician to determine whether use of DAYLETTE should be discontinued.

• Disturbances in circulation

Risk of venous thromboembolism (VTE)

The use of any combined hormonal contraceptive results in an increased risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with a lower risk of VTE. The risk associated with other products such as DAYLETTE The decision to use a product other than those associated with a lower risk of VTE should only be made after discussions with the woman to ensure that she understands the risk of VTE associated with DAYLETTE, how the your current risk factors influence that risk and the fact that the risk of developing VTE is highest in the first year of use. There is also some evidence that the risk increases when taking a COC is resumed after a 4-ounce break. several weeks.

About 2 in 10,000 women who do not use a CHC and who are not pregnant will develop a VTE over a period of one year. In a single woman, however, the risk can be much higher, depending on her underlying risk factors (see below).

It is estimated [1] that out of 10,000 women who use a CHC containing drospirenone, between 9 and 12 will develop a VTE in one year; this compares with approximately 6 [2] women using a COC containing levonorgestrel.

[1] These incidences were estimated from the totality of epidemiological study data, using the relative risks of the different products compared to COCs containing levonorgestrel

[2] Median value of the range 5-7 per 10,000 women / years, based on a relative risk of approximately 2.3-3.6 of levonorgestrel-containing COCs compared with non-use.

In both cases, the number of VTEs per year is less than the number expected in pregnancy or in the postpartum period.

VTE can be fatal in 1-2% of cases.

Very rarely, thrombosis in other blood vessels, e.g. hepatic, mesenteric, renal, or retinal veins and arteries, has been reported in women using combined hormonal contraceptives.

Risk factors for VTE

The risk of venous thromboembolic complications in women using combined hormonal contraceptives may increase substantially if additional risk factors are present, especially if there are more than one risk factors (see table).

DAYLETTE is contraindicated if a woman has several risk factors that increase her risk of venous thrombosis (see section 4.3). If a woman has more than one risk factor, it is possible that the increased risk is greater than the sum of the individual factors; in this case her total risk of VTE should be considered. If the benefit-risk ratio is considered to be negative, a combined hormonal contraceptive should not be prescribed (see section 4.3).

Table: Risk factors for VTE

Risk factor Comment Obesity (body mass index (BMI) above 30 kg / m2) The risk increases considerably as the BMI increases. Especially important to consider if other risk factors are also present. Prolonged immobilization, major surgery, any type of leg and pelvis surgery, neurosurgery or major trauma. In these situations it is advisable to stop using the pill (in the case of elective surgeries at least four weeks before) and not restart it until two weeks after complete resumption of mobility. To avoid unwanted pregnancies, another contraceptive method should be used. If DAYLETTE has not been stopped earlier, antithrombotic treatment should be considered. Note: Temporary restraint, including air travel lasting> 4 hours, can also be a risk factor for VTE, especially in women with other risk factors Positive family history (venous thromboembolism in a sibling or parent, especially at a relatively young age, i.e. before age 50). If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding to take any combined hormonal contraceptive. Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, haemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia. Old age Particularly above the age of 35

There is no agreement on the possible role of varicose veins and superficial thrombophlebitis in the onset and progression of venous thrombosis.

The increased risk of thromboembolism in pregnancy and particularly in the 6-week period of the puerperium must be considered (for information on "Pregnancy and lactation" see section 4.6).

Symptoms of VTE (deep vein thrombosis and pulmonary embolism)

If symptoms of this type occur, women should seek immediate medical attention and inform them that they are taking a CHC.

Symptoms of deep vein thrombosis (DVT) can include:

- unilateral swelling of the leg and / or foot or along a vein in the leg;

- pain or tenderness in the leg which may only be felt when standing or walking;

- increased sensation of heat in the affected leg; skin on the leg that is red or discolored.

Symptoms of pulmonary embolism (PE) can include:

- sudden and unexplained onset of shortness of breath and rapid breathing;

- sudden cough which may be associated with hemoptysis;

- sharp pain in the chest;

- severe light headedness or dizziness;

- rapid or irregular heartbeat.

Some of these symptoms (such as "shortness of breath" and "cough") are non-specific and may be misinterpreted as more common or less serious events (eg respiratory tract infections).

Other signs of vascular occlusion may include: sudden pain, swelling or a pale blue discoloration of one "extremity.

If the occlusion takes place in the eye, symptoms can range from painless blurring of vision to loss of vision. Sometimes vision loss occurs almost immediately.

Risk of arterial thromboembolism (ATE)

Epidemiological studies have associated the use of CHCs with an increased risk of arterial thromboembolism (myocardial infarction) or of cerebrovascular accidents (eg transient ischemic attack, stroke). Arterial thromboembolic events can be fatal.

Risk factors of ATE

The risk of arterial thromboembolic complications or a cerebrovascular accident in CHC users increases in the presence of risk factors (see table). DAYLETTE is contraindicated if a woman has one serious risk factor or multiple risk factors for ATE that increase her risk of arterial thrombosis (see section 4.3). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors; in this case her total risk should be considered. If the benefit-risk balance is believed to be negative, a CHC should not be prescribed (see section 4.3).

Table: Risk factors of ATE

Risk factor Comment Old age Particularly above the age of 35 Smoke Women should be advised not to smoke if they wish to use a CHC. Women over the age of 35 who continue to smoke should be strongly advised to use a different method of contraception. Hypertension Obesity (body mass index (BMI) above 30 kg / m2) The risk increases considerably as the BMI increases. Especially important in women with other risk factors. Positive family history (arterial thromboembolism in a sibling or parent, especially at a relatively young age, i.e. before age 50). If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding to take any COCs. Migraine An increase in migraine frequency or severity during CHC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation. Other medical conditions associated with adverse vascular events Diabetes mellitus, hyperhomocysteinemia, atrial valvulopathy and fibrillation, dyslipoproteinemia and systemic lupus erythematosus.

Symptoms of ATE

If symptoms of this type occur, women should contact a healthcare professional immediately and inform them that they are taking a CHC.

Symptoms of cerebrovascular accident can include:

- sudden numbness or weakness of the face, arm or leg, especially on one side of the body;

- sudden difficulty walking, dizziness, loss of balance or coordination;

- sudden confusion, difficulty in elocution or understanding;

- sudden difficulty seeing in one or both eyes;

- sudden, severe or prolonged migraine with no known cause;

- loss of consciousness or fainting with or without convulsions.

Temporary symptoms suggest it is a transient ischemic attack (TIA).

Symptoms of myocardial infarction (MI) can include:

- pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm or below the breastbone;

- discomfort radiating to the back, jaw, throat, arms, stomach;

- feeling of fullness, indigestion or choking;

- sweating, nausea, vomiting or dizziness;

- extreme weakness, anxiety or shortness of breath;

- rapid or irregular heartbeats.

The presence of a single serious risk factor or multiple risk factors, respectively, for venous or arterial disease may also constitute a contraindication. The possibility of implementing anticoagulant therapy must also be considered. COC users should be specifically advised to contact their doctor in case of possible symptoms of thrombosis. In the event of a suspected or known thrombosis, the use of the COC should be discontinued. An adequate contraceptive alternative should be undertaken given the teratogenicity of anticoagulant therapy (coumarins).

• Tumors

An increased risk of developing cervical cancer in long-term users of COCs (> 5 years) has been reported in some epidemiological studies, but controversy continues as to whether this finding relates to effects. confounders of sexual behavior and other factors, such as human papilloma virus (HPV).

A meta-analysis from 54 epidemiological studies found that there is a slight increased relative risk (RR = 1.24) of being diagnosed with breast cancer in women who normally use COCs. The increased risk gradually disappears over the 10 years following discontinuation of oral use of COCs. Since breast cancer is rare in women under 40 years of age, the over-number of diagnoses of breast cancer in current and recent COC users, is small in relation to the overall risk of developing breast cancer. These studies do not provide an obvious cause. The trend in increased risk that has been observed it may depend on an earlier diagnosis in COC users, the biological effects of COCs, or a combination of the two.Breast cancers diagnosed in women who always use the pill tend to be less clinically advanced than cancers diagnosed in women who have never used it.

In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been observed in women using COCs. In isolated cases, these tumors have produced life-threatening intra-abdominal haemorrhages. The presence of liver cancer should be considered as part of a differential diagnosis when severe pain in the upper abdominal quadrants, liver enlargement or signs of intra-abdominal haemorrhage occur in women taking COCs.

The risk of endometrial and ovarian carcinomas is reduced with the use of higher-dose combined oral contraceptives (50 mcg ethinylestradiol). Whether this is also the case for lower-dose combined oral contraceptives is a fact that still awaits confirmation.

• Other conditions

The progestogen component in this product is a potassium-sparing aldosterone antagonist. In most cases, no increase in potassium levels is to be expected. In a clinical study, however, in some patients with renal impairment. mild or moderate and concomitant use of potassium-sparing medicinal products, serum potassium levels increased slightly, but not significantly, while taking drospirenone. Therefore, it is recommended to check, during the first course of treatment, the serum potassium of patients with renal insufficiency and serum potassium levels before treatment at the upper limits of the reference values ​​and especially during concomitant use of medicinal products. potassium sparing See also section 4.5.

Women with hypertriglyceridaemia or for whom it appears in a family history may be at increased risk of pancreatitis when using COCs.

Although modest increases in blood pressure have been reported in many women taking COCs, clinically significant increases are rare. An "immediate discontinuation" of the combined oral contraceptive is justified only in these rare cases. If, during the use of COCs in a previously hypertensive woman, constant high blood pressure or a significant increase in blood pressure does not respond adequately to antihypertensive treatment, the COC should be discontinued. Where considered appropriate, the COC should be discontinued. "COC use can be resumed if normal blood pressure values ​​are achieved with antihypertensive therapy.

It has been noted that the following conditions may occur or worsen with both pregnancy and COC use, but evidence of an association with COC use is not convincing: jaundice and / or pruritus due to cholestasis; gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea; herpes gravidarum; hearing loss linked to otosclerosis.

In women with hereditary angioedema, exogenous estrogens can induce or worsen the symptoms of angioedema.

Acute or chronic disturbances of liver function may require discontinuation of COCs until indices of liver function return to normal reference values. A recurrence of colostatic jaundice and / or cholestasis-related pruritus that occurred earlier in a pregnancy or during previous use of sex steroids requires discontinuation of the COC.

Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for the need to change the treatment regimen in diabetics using a low-dose combined oral contraceptive (containing

Worsening of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis has been reported during use of a combined oral contraceptive.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet rays while using a combined oral contraceptive.

Active film-coated tablets contain 48.53 mg lactose monohydrate, while inactive tablets contain 37.26 mg anhydrous lactose per film-coated tablet. Patients with the rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Placebo film-coated tablets contain the dye 'sunset yellow' which may cause allergic reactions.

This medicine contains 0.070 mg of soy lecithin per tablet. Patients with hypersensitivity to peanut or soy should not take this medicine.

Medical examinations / visits

Before initiating or resuming use of DAYLETTE a complete medical history (including family history) must be taken and pregnancy must be ruled out. Blood pressure should be measured and clinical examination performed, guided by contraindications (see section 4.3) and warnings (see section 4.4). It is important to draw a woman's attention to information relating to venous or arterial thrombosis, including the risk associated with DAYLETTE compared to other CHCs, symptoms of VTE and ATE, known risk factors and what to do in the event of a suspected thrombosis.

The woman should also be advised of the need to read the package leaflet carefully and to follow its advice. The frequency and type of examinations should be based on established guidelines and should be adapted to the individual woman.

Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.

Reduction of effectiveness

The efficacy of COCs may be reduced if active tablets are missed (see section 4.2), if gastrointestinal disturbances occur while taking active tablets (see section 4.2) or during concomitant therapy (see section 4.5).

Reduction of cycle control

With all COCs, irregular bleeding (the appearance of blood spots or loss of control bleeding) may occur, especially during the first months of use. Therefore, the evaluation of irregular bleeding only makes sense after an adjustment period. about three cycles.

If irregular bleeding persists or occurs after regular previous cycles, then non-hormonal causes should be considered and diagnostic investigations are indicated to rule out malignancy or pregnancy. Such measures may also include scraping.

In some women, withdrawal bleeding may not occur while taking the placebo tablets. If the COC has been taken according to the directions described in section 4.2, it is unlikely that the woman is pregnant. However, if the COC was not taken according to these directions before the first missed withdrawal bleed or if it did not occur twice in a row, pregnancy must be ruled out before continuing oral contraceptive use. combined.

04.5 Interactions with other medicinal products and other forms of interaction

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

• Influence of other medicinal products on drospirenone / ethinylestradiol

Interactions between oral contraceptives and other medicinal products may lead to bleeding from loss of control and / or contraceptive failure. The following interactions have been reported in the literature:

Hepatic metabolism

Drug interactions may occur which, by inducing liver enzymes, may lead to increased clearance of sex hormones (e.g. phenytoin, barbiturates, primidone, carbamazepine, rifampicin, bosentan, and anti-HIV medicinal products (e.g. ritonavir, nevirapine) and possibly also oxcarbazepine, topiramate, felbamato, griseofulvin and products containing the herbal medicine St. John's wort (Hypericum perforatum). Maximal enzyme induction generally occurs within approximately 10 days but is thereafter maintained for at least 4 weeks after discontinuation of drug therapy.

Interference with the enterohepatic circulation

Contraceptive failures have also been reported with antibiotics, such as penicillins and tetracyclines. The mechanism behind this effect has not been elucidated.

Management

Women on short-term treatment with any of the classes of medicines listed above or with the individual active substances (medicines that induce liver enzymes), in addition to rifampicin, must temporarily use a barrier method in addition to the combined oral contraceptive, i.e. during the concomitant administration of the medicinal product and for 7 days after its discontinuation.

For women being treated with rifampicin, a barrier method should be used in addition to the combined oral contraceptives for the duration of rifampicin administration and for 28 days after its discontinuation.

Women on long-term treatment with active substances that induce liver enzymes are recommended to use another reliable non-hormonal method of contraception.

Women being treated with antibiotics (in addition to rifampicin, see above) should use a barrier method for up to 7 days after discontinuation.

If concomitant drug administration proceeds beyond the end of the active tablets in the blister pack of the COC currently in use, the placebo tablets should be discarded and the next COC pack should be started immediately.

The major metabolites of drospirenone in human plasma are generated without the involvement of the cytochrome P450 system. Therefore, inhibitors of this enzyme system are unlikely to affect the metabolism of drospirenone.

• Influence of drospirenone / ethinylestradiol on other medicinal products

Oral contraceptives can affect the metabolism of other active ingredients. Therefore, plasma and tissue concentrations may increase (e.g. cyclosporine) or decrease (e.g. lamotrigine).

Based on inhibition studies in vitro and interaction studies in vivo In volunteers receiving omeprazole, simvastatin and midazolam as index substrates, an interaction of drospirenone at doses of 3 mg with the metabolism of other active substances is unlikely.

• Other interactions

In patients with no renal insufficiency, concomitant use of drospirenone and ACE inhibitors or NSAIDs did not show a significant effect on serum potassium. However, concomitant use of drospirenone / ethinylestradiol with aldosterone antagonists or sparing diuretics potassium has not been studied. In this case, serum potassium should be measured during the first course of treatment. See also section 4.4.

• Laboratory tests

The use of contraceptive steroids can affect the results of some laboratory tests, including biochemical parameters of the liver, thyroid and adrenal glands, as well as kidney function, plasma levels of proteins (with transport functions), such as globulin to which corticosteroids and lipid / lipoprotein fractions bind, the parameters of carbohydrate metabolism and the parameters of coagulation and fibrinolysis.The alterations generally remain within the normal reference values.

Drospirenone causes an increase in the activity of renin, as well as of aldosterone, in the plasma, thanks to its modest antimineralocorticoid activity.

04.6 Pregnancy and lactation

Pregnancy

Drospirenone / ethinylestradiol is not indicated during pregnancy.

If pregnancy occurs during the use of drospirenone / ethinylestradiol, the preparation must be discontinued immediately. Extensive epidemiological studies have shown no increased risk of birth defects in children born to women who used a combined oral contraceptive before pregnancy and even a teratogenic effect when the COC was inadvertently taken during pregnancy.

Animal studies have shown undesirable effects during pregnancy and lactation (see section 5.3). Based on these animal data, undesirable effects due to the hormonal activity of the active substances cannot be excluded. However, experience in general with COCs during pregnancy did not provide evidence of an actual undesirable effect in humans.

The available data regarding the use of drospirenone / ethinylestradiol in combination during pregnancy are too limited to allow conclusions to be drawn on the adverse effects of drospirenone / ethinylestradiol on pregnancy, as well as on the health of the fetus and neonate. Currently, no data are available. relevant epidemiologicals.

The increased risk of thromboembolism in the postpartum period should be taken into account when DAYLETTE is restarted (see sections 4.2. And 4.4).

Feeding time

Breastfeeding may be affected by COCs, as they can reduce the amount of breast milk and alter its composition. Therefore, the use of COCs is not recommended until the breastfeeding mother has completely weaned the baby. . Small amounts of the contraceptive steroids and / or their metabolites may be excreted in the milk during COC use. These amounts may affect the baby.

04.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. No effects on the ability to drive and use machines have been observed in women using COCs.

04.8 Undesirable effects

For serious undesirable effects in COC users, see section 4.4.

The following adverse drug reactions have been reported during combination use of drospirenone / ethylnylestradiol:

Table 1: Drospirenone / ethinylestradiol 3 mg / 0.02 mg, 24 + 4 day regimen - adverse drug reactions associated with use as an oral contraceptive or in the treatment of moderate acne vulgaris, based on MedDRA System Organ Class and MedDRA terminology Frequencies are based on clinical trial data.

MedDRA System Organ Class (Version 14.1) Common (≥1 / 100, Uncommon (≥1 / 1,000 to Rare (≥1 / 10,000, Not known (frequency cannot be estimated from the available data) Infections and infestations Candidiasis Disorders of the blood and lymphatic system Anemia, Thrombocytopenia Disorders of the immune system Allergic reaction Hypersensitivity Endocrine pathologies Endocrine Disorder Metabolism and nutrition disorders Increased appetite, Anorexia, Hyperkalaemia Hyponatremia Psychiatric disorders Emotional lability Depression, Reduced libido, Nervousness, Somnolence Anorgasmia, Insomnia Nervous system disorders Headache Dizziness, Paresthesia Vertigo, Tremor Eye disorders Conjunctivitis, Dry eyes, Disturbed vision Cardiac pathologies Tachycardia Vascular pathologies Migraine, varicose veins, arterial hypertension Venous thromboembolism, Arterial thromboembolism, Phlebitis, Vascular disorder, Epistaxis, Syncope Gastrointestinal disorders Nausea Abdominal pain, Vomiting, Dyspepsia, Flatulence, Gastritis, Diarrhea Enlargement of the abdomen, Gastrointestinal upset, Feeling of gastrointestinal fullness, Hiatal hernia, Oral candidiasis, Constipation, Dry mouth Hepatobiliary disorders Biliary pain, Cholecystitis Skin and subcutaneous tissue disorders Acne, Itching, Rash Chloasma, Eczema, Alopecia, Acneiform dermatitis, Dry skin, Erythema nodosum, Hypertrichosis, Skin disorder, Skin streaks, Contact dermatitis, Photosensitive dermatitis, Skin nodules Erythema multiforme Musculoskeletal and connective tissue disorders Back pain, Pain in extremity, Muscle cramps Diseases of the reproductive system and breast Breast pain, Metrorrhagia *, Amenorrhea Vaginal candidiasis, Pelvic pain, Breast enlargement, Fibrocystic breast, Uterine / vaginal bleeding *, Genital discharge, Flushing, Vaginitis, Menstrual disorder, Dysmenorrhea, Hypomenorrhea, Menorrhagia, Vaginal dryness, Doubtful Papanicolaou smear Dyspareunia, Vulvovaginitis, Postcoital bleeding, Withdrawal bleeding, Breast cyst, Breast hyperplasia, Breast neoplasia, Cervical polyp, Endometrial atrophy, Ovarian cysts, Enlargement of the uterus General disorders and administration site conditions Asthenia, Sweating increased, Edema (generalized edema, peripheral edema, face edema) Malaise Diagnostic tests Weight gain Weight loss

* bleeding irregularities usually resolve during continued treatment

Description of some adverse reactions

An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism, has been observed in women using combined hormonal contraceptives (COCs), and this risk is discussed in more detail in the paragraph 4.4.

The following serious adverse reactions have been reported in women using COCs. These are discussed in section 4.4 Special warnings and precautions for use:

- hypertension;

- liver tumors;

- appearance or worsening of conditions for which an "association with the use of COCs is inconclusive: Crohn's disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, gestational herpes, Sydenham's chorea, syndrome hemolytic uremic, cholestatic jaundice;

- chloasma;

- acute or chronic disturbances of liver function may require discontinuation of COC use until indicators of liver function are within normal reference values;

- in women with hereditary angioedema, exogenous estrogens can induce or worsen the symptoms of angioedema.

The frequency of breast cancer diagnosis is slightly increased among women using oral contraceptives. Since breast cancer is rare in women under 40 years of age, the excess number is small compared to the overall risk of breast cancer. It is not known whether there is a causal relationship with the use of COCs.

For further information see sections 4.3 and 4.4.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

04.9 Overdose

There has been no experience yet with drospirenone / ethinylestradiol overdoses. Based on general experience with combination oral contraceptives, the symptoms that may occur in this case are: nausea, vomiting and, in young girls, mild vaginal bleeding. There is no antidote and subsequent treatment should be symptomatic.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: progestogens and estrogens, fixed combinations.

ATC code: G03AA12.

Pearl index for method failure: 0.41 (upper limit of the bilateral 95% confidence interval: 0.85).

Overall Pearl Index (method failure + patient failure): 0.80 (upper limit of the bilateral 95% confidence interval: 1.30).

Mechanism of action

The contraceptive effect of DAYLETTE is based on the interaction of various factors; the most important are the inhibition of ovulation and changes in the endometrium.

DAYLETTE is an oral contraceptive that contains the combination of ethinylestradiol and the progestin drospirenone. At the therapeutic dose, drospirenone also possesses antiandrogenic and mildly anti-mineralocorticoid properties. It has no estrogenic, glucocorticoid or antiglucocorticoid activity. This gives drospirenone a very pharmacological profile. similar to the natural hormone progesterone.

There are indications from clinical studies that the modest antimineralocorticoid properties result in a modest antimineralocorticoid effect.

Two placebo-controlled, randomized, double-blind, multicenter studies were performed to evaluate the efficacy and safety of drospirenone and ethinylestradiol in women with modest acne vulgaris.

After six months of treatment, compared to placebo, the combination of drospirenone and ethinylestradiol showed a statistically significant reduction of 15.6% (49.3% versus 33.7%) in inflammatory lesions, of 18.5% (40.6% versus 22.1%) in non-inflammatory lesions, and 16.5% (44.6% versus 28.1%) in total lesion counts. 11.8% (18.6% versus 6.8%), showed a "resolved" or "nearly resolved" judgment on the investigator's Overall Static Rating scale.

05.2 "Pharmacokinetic properties

• Drospirenone

Absorption

Administered orally, drospirenone is rapidly and almost completely absorbed. Maximum concentrations of the active ingredient in serum around 38 ng / ml are reached approximately 1-2 hours after taking a single tablet. Bioavailability varies between 76 and 85%. Concomitant food intake has no influence on the bioavailability of drospirenone.

Distribution

After oral administration, the serum levels of drospirenone decrease with a terminal half-life of 31 hours. bind corticoids (CBG). Only 3-5% of total serum concentrations of the active ingredient are present in the form of free steroids. The ethinylestradiol-induced increase in SHBG does not affect the binding of drospirenone to serum proteins. The mean apparent volume of distribution of drospirenone is 3.7 ± 1.2 L / kg.

Biotransformation

Drospirenone is extensively metabolised after oral administration. The main metabolites in plasma are the acid form of drospirenone, generated by the opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, both of which are formed without involvement of the P450 system. Drospirenone is metabolised in modest amounts by cytochrome P450 3A4 and has been shown to be able to inhibit this enzyme as well as cytochromes P450 1A1, P450 2C9 and P450 2C19 in vitro.

Elimination

The metabolic clearance rate of drospirenone in serum is 1.5 ± 0.2 ml / min / kg. Only minimal amounts of drospirenone are excreted unchanged. The metabolites of drospirenone are excreted with the faeces and urine at a ratio of approximately 1.2 to 1.4. The half-life of metabolite excretion with urine and faeces is approximately 40 hours.

Steady state conditions

During the therapeutic cycle, the maximum steady-state concentrations of drospirenone in serum of approximately 70 ng / ml are reached after approximately 8 days of treatment. Serum levels of drospirenone accumulated by a factor of approximately 3 as a consequence of the relationship between terminal half-life and dosing interval.

Special populations

- Effects of impaired renal function

Steady-state serum drospirenone levels in women with mild renal impairment (creatinine clearance CLcr, 50-80 mL / min) were similar to those in women with normal renal function. Serum levels of drospirenone were on average 37% higher in women with moderate renal impairment (CLcr, 30 - 50 ml / min) than in women with normal renal function. Drospirenone treatment was also well tolerated by women with mild to moderate renal impairment. Drospirenone treatment had no clinically significant effect on serum potassium concentration.

- Effects of impaired liver function

In a single dose study, oral clearance (CL / F) was reduced by approximately 50% in volunteers with moderate hepatic impairment compared to those with normal hepatic function. The observed decrease in drospirenone clearance in volunteers with moderate hepatic impairment resulted in no apparent difference in serum potassium concentrations. Even in the presence of diabetes and concomitant treatment with spironolactone (two factors that can predispose the patient to hyperkalaemia), no increase in serum potassium concentrations above the upper limit of normal has been detected. It can be concluded that drospirenone is well tolerated in patients with mild to moderate hepatic impairment (Child-Pugh B).

- Ethnic groups

No clinically relevant differences in the pharmacokinetics of drospirenone and ethinylestradiol were found between Japanese and Caucasian women.

• Ethinylestradiol

Absorption

Administered orally, ethinylestradiol is rapidly and completely absorbed. The peak serum concentration is approximately 33 pg / ml and is reached within 1-2 hours after a single oral administration. Absolute bioavailability, following conjugation. presystemic and first pass metabolism, is about 60%. Concomitant food intake reduced the bioavailability of ethinylestradiol in about 25% of the subjects studied, while in the others no change was observed.

Distribution

Serum levels of ethinylestradiol decrease in two phases, the terminal tendency phase is characterized by a half-life of approximately 24 hours. Ethinylestradiol is highly, but not specifically bound to serum albumin (approximately 98.5%) and induces an increase in serum concentrations of SHBG and corticoid binding globulin (CBG). An apparent volume of distribution of about 5 l / kg.

Biotransformation

Ethinylestradiol is subject to presystemic conjugation both in the mucosa of the small intestine and in the liver. Ethinylestradiol is mainly metabolised via aromatic hydroxylation, but a wide range of hydroxylated and methylated metabolites are formed. These metabolites are found both in free form and in conjugated form with glucuronides and sulphates. The metabolic clearance rate of ethinylestradiol is approximately 5 ml / min / kg.

Elimination

Ethinylestradiol is not excreted unchanged in significant amounts. Ethinylestradiol metabolites are excreted with a urine / bile ratio of 4: 6. The half-life of metabolite excretion is approximately one day.

Steady state conditions

Steady-state conditions are reached during the second half of the therapeutic cycle and serum levels of estinylestradiol accumulate by a factor of approximately 2.0 - 2.3.

05.3 Preclinical safety data

In laboratory animals, the effects of drospirenone and ethinylestradiol were limited to those associated with its recognized pharmacological action. In particular, reproductive toxicity studies have shown embryotoxic and foetotoxic effects in animals, considered specific for the species used. Effects on sexual differentiation were observed in rat fetuses, but not in monkeys, at exposures to drospirenone and ethinylestradiol exceeding therapeutic ones.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Tablet core (active) :

Lactose monohydrate

Cornstarch

Corn starch, pregelatinised

Macrogol graft copolymer of poly (vinyl alcohol)

Magnesium stearate

Film coating (active) :

Poly (vinyl alcohol)

Titanium dioxide (E171)

Talc

Macrogol 3350

Lecithin (soy)

Tablet core (placebo) :

Microcrystalline cellulose

Anhydrous lactose

Corn starch, pregelatinised

Magnesium stearate

Silica, colloidal anhydrous

Film coating (placebo) :

Poly (vinyl alcohol)

Titanium dioxide (E171)

Macrogol 3350

Talc

Indigo carmine (E132)

Quinoline yellow (E104)

Black iron oxide (E172)

Sunset Yellow FCF (E110)

06.2 Incompatibility

Not relevant.

06.3 Period of validity

2 years.

06.4 Special precautions for storage

Do not store above 25 ° C. Store in the original package in order to protect from light.

06.5 Nature of the immediate packaging and contents of the package

DAYLETTE 3 mg / 0.02 mg film-coated tablets are packed in PVC / PE / PVDC-Al blisters. The blisters are placed in a folded cardboard box along with the package leaflet and a storage pouch in each box.

Pack sizes:

1x28 film-coated tablets

3x28 film-coated tablets

6x28 film-coated tablets

13x28 film-coated tablets

Not all pack sizes may be marketed.

06.6 Instructions for use and handling

No special instructions.

Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

07.0 MARKETING AUTHORIZATION HOLDER

Gedeon Richter Plc

Gyömroiot 19-21

1103 Budapest

Hungary

08.0 MARKETING AUTHORIZATION NUMBER

AIC n. 041167014 - "3 Mg / 0.02 Mg Film Coated Tablets" 1x24 + 4 Tablets In Blister Pvc / Pe / Pvdc / Al

AIC n. 041167026 - "3 Mg / 0.02 Mg Film Coated Tablets" 3x24 + 4 Tablets In Blister Pvc / Pe / Pvdc / Al

AIC n. 041167038 - "3 Mg / 0.02 Mg Film Coated Tablets" 6x24 + 4 Tablets In Blister Pvc / Pe / Pvdc / Al

AIC n. 041167040 - "3 Mg / 0.02 Mg Film Coated Tablets" 13x24 + 4 Tablets In Blister Pvc / Pe / Pvdc / Al

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

June 2012

10.0 DATE OF REVISION OF THE TEXT

December 2014

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL