Active ingredients: Gestodene, Ethinylestradiol
MINESSE 60 micrograms / 15 micrograms, film-coated tablets
Indications Why is Minesse used? What is it for?
- MINESSE is an oral contraceptive pill, used to prevent pregnancy.
- Each of the 24 pale yellow tablets contains a small amount of two different female hormones, called gestodene and ethinyl estradiol.
- The 4 white tablets do not contain active substances and are called "placebo tablets".
- Contraceptive pills that contain two hormones are called "combination" pills.
Contraindications When Minesse should not be used
Do not use MINESSE 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 have an allergy (hypersensitivity) to one of the active substances (gestodene or ethinyl estradiol) or to any of the other ingredients of this medicine (the list of excipients is given in section 6).
- 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 could increase the risk of clots in the arteries: o severe diabetes with blood vessel damage o very high blood pressure o very high level of fat (cholesterol or triglycerides) in the blood o 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 had) a benign tumor (called focal nodular hyperplasia or hepatic adenoma) or liver malignancy or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking the tablets until your liver functions normally;
- if you have vaginal bleeding of unknown cause;
- if you have breast cancer or cancer of the uterus or cancer that is sensitive to female sex hormones or if you suspect that you may have any of these cancers.
Precautions for use What you need to know before taking Minesse
General notes
Before you start taking MINESSE, your doctor will ask you a few questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your personal situation, may also carry out other tests.
Before you start using MINESSE 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").
This leaflet describes various situations which require the suspension of MINESSE or in which the reliability of MINESSE may be reduced. In such situations it is necessary to refrain from sexual intercourse or to adopt non-hormonal contraceptive measures, such as the use of condoms or other methods. barrier. Do not use the rhythm or basal temperature method. In fact, these methods can be unreliable, because MINESSE alters the monthly changes in body temperature and cervical mucus.
MINESSE, like all hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
When should you see a doctor?
See 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 stroke (see "Blood clot (thrombosis)" section below). 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.
If this condition appears or worsens while you are using MINESSE you should tell your doctor.
- if your blood tests have shown that you have a high level of sugar, a high level of cholesterol and fat or a high level of prolactin (hormone that stimulates milk production);
- if you are obese;
- if you have benign breast cancer or a close relative who has had breast cancer
- if you have uterine disease (uterine dystrophy);
- if you suffer from epilepsy (see also "Taking other medicines");
- if you suffer from migraines;
- if you have hearing loss due to a disease known as otosclerosis;
- if you suffer from asthma;
- 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 soon after having a baby you can start taking MINESSE;
- if you have "inflammation of the veins under the skin (superficial thrombophlebitis);
- if you have varicose veins.
- if you or a close relative (parents, grandparents, brothers, sisters ...) have ever suffered from a disease with a tendency to develop blood clots (in the legs, lungs or elsewhere; heart attack; stroke);
- if during pregnancy, or while using another contraceptive pill, you have had a skin disease which caused itching, red spots and blisters (herpes gestationis);
- if you have had spots on your face (chloasma) during pregnancy or while using another contraceptive pill. If so, avoid direct exposure to sunlight while using MINESSE;
- if you suffer from gallstones;
- if you have heart, liver or kidney disease;
- if you suffer from depression;
- if you have high blood pressure;
- if you suffer from a disease known as 'chorea' characterized by involuntary, irregular and sudden movements.
If you have hereditary angioedema, products containing estrogen can induce or worsen the symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and / or pharynx and / or difficulty in swallowing or hives accompanied by breathing difficulties.
Do not hesitate to ask your doctor or pharmacist for advice if you have any questions about using MINESSE.
BLOOD CLOTS
Using a combined hormonal contraceptive such as MINESSE increases the risk of developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
- in veins (referred to as 'venous thrombosis', 'venous thromboembolism' or VTE)
- in the arteries (a condition called '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 MINESSE is low.
HOW TO RECOGNIZE A BLOOD CLOT
See a doctor immediately if you notice any of the following signs or symptoms.
- swelling of one leg or along a vein in the leg or foot, especially when accompanied by:
- pain or tenderness in the leg which 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, red or blue
- 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 stomach pain 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" ).
- immediate loss of vision or
- painless blurring of vision which can progress to loss of vision
- 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
- 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.
- swelling and pale blue discoloration of one extremity;
- severe stomach pain (acute abdomen)
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
- The use of combined hormonal contraceptives has been related to an increased risk of blood clot formation 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, the 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 MINESSE, the risk of developing a blood clot returns to normal levels 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 MINESSE 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 MINESSE, about 9-12 will develop a blood clot in a year.
- The risk of having a blood clot depends on your medical history (see under “Factors that increase the risk of a blood clot”).
Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with MINESSE is low but some conditions cause it to increase. Its risk is greater:
- if you are severely overweight (body mass index or BMI above 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 have to undergo an operation or if you have to lie down for a long time due to an injury or illness or if you have a leg in a cast. It may be necessary to stop taking MINESSE a few weeks before surgery or during the period when you are less mobile. If you have to stop taking MINESSE, 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 to stop taking MINESSE.
If any of the above conditions change while you are using MINESSE, 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 MINESSE is very low but can increase:
- with increasing age (over 35 years);
- if you smoke. When using a combined hormonal contraceptive such as MINESSE 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 MINESSE, 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.
MINESSE and cancer
Breast cancer has been observed slightly more frequently in women using combination pills, but it is not known whether this is caused by the pill. It may be that these women were simply seen more thoroughly and more often and that breast cancer was detected earlier.
In women who use combination pills for a relatively long period of time, studies have reported cases of cervical cancer. It is currently unknown whether this is caused by the pill or is attributable to sexual behavior (eg more frequent changes in partners) and other factors. In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using the Pill. If you have unusually severe abdominal pain, please contact your doctor.
Intermenstrual bleeding
Unexpected bleeding (bleeding outside the days you take the placebo tablets) may occur during the first few months of taking MINESSE. If this bleeding occurs for more than a few months, or begins after a few months, the doctor must investigate the cause.
What to do if menstruation does not appear during the placebo days
If you have taken all the active pale yellow tablets correctly, have not had severe vomiting or diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.
If your period does not appear twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure you are not pregnant.
Interactions Which drugs or foods can modify the effect of Minesse
Always tell your doctor what medicines or herbal products you are already taking, including medicines bought without a prescription. Also tell any other doctor or dentist prescribing medicine (or pharmacist) that you are using MINESSE. They can tell you if you need to use extra contraceptive precautions (such as a condom) and, if so, for how long.
Some medicines can affect the blood levels of MINESSE, can make MINESSE less effective in preventing pregnancy, and can cause unexpected bleeding.
These include medicines used to treat:
- HIV and hepatitis C virus infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
- epilepsy (e.g. phenobarbital, phenytoin, primidone, carbamazepine or topiramate)
- tuberculosis (rifabutin, rifampicin)
- fungal infections (griseofulvin, azole antifungals e.g. itraconazole, voriconazole, fluconazole)
- bacterial infections (macrolide antibiotics e.g. clarithromycin, erythromycin)
- certain heart problems, high blood pressure (calcium channel blockers e.g. verapamil, diltiazem)
- arthritis, osteoarthritis (etoricoxib)
- sleep disturbances (modafinil)
- St. John's wort remedy, which is used to treat some types of depression
- grapefruit juice
Troleandomycin may increase the risk of intrahepatic cholestasis (retention of bile in the liver) when administered concomitantly with Combined Oral Contraceptives (COCs).
Minesse may influence the effect of other medicines, eg:
- lamotrigine
- cyclosporine
- theophylline
- tizanidine
Ask your doctor or pharmacist for advice before taking any medicine.
Warnings It is important to know that:
Pregnancy
If you are pregnant, your doctor has no reason to prescribe contraception.
If you discover that you are pregnant while taking MINESSE, stop taking this pill and consult your doctor.
If you are planning to become pregnant, tell your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Feeding time
It is not recommended to use MINESSE if you are breastfeeding.
If you wish to breastfeed, your doctor will recommend a suitable form of contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
MINESSE contains lactose.
If you suffer from intolerance to some sugars, consult your doctor before taking MINESSE.
Dose, Method and Time of Administration How to use Minesse: Posology
Dosage
- Always start taking MINESSE from the tablet marked with the number 1 next to the word "START".
- Pierce the empty cell in the center of the blister corresponding to the day of the week on which you took the first tablet. This will be the start day for each new blister. It will also be the day of the week when you take tablets number 8, 15 and 22 marked with a different colored border. This will help you check that you are taking the tablets correctly.
- Each blister contains 28 tablets. Take one pill at the same time every day, for 28 consecutive days, following the direction indicated by the arrows, without ever making a mistake, as follows: take one pale yellow active tablet a day, for the first 24 days; then a white placebo pill every day for the last 4 days.
- After taking the last tablet, continue taking MINESSE the next day starting another strip with no free interval between each strip. You will always have to start a new strip on the same day of the week. As there are no intervals, it is important that you have already got yourself a new blister before you run out of one.
- Menstruation usually starts two to three days after taking the last pale yellow tablet in the strip and may not have finished before starting the next strip.
Method and route of administration
Take each tablet with a large glass of water.
If you have not used a hormonal contraceptive in the previous month
Take the first tablet on the first day of your period.
If she was using another "contraceptive pill."
Use up the blister pack you are taking (if the pack of pills you are taking also contains hormone-free (inactive) tablets, do not take them). Then you start the MINESSE blister the next day, leaving no pill-free interval.
If you were using a progestogen-only method (progestogen-only pill, injectable method, or implant)
- Switching from a progestogen-only pill: You can start MINESSE at any time during your period, the day after you stopped the progestogen-only pill.
- Transition from an implant: You start MINESSE on the day the implant is removed.
In any case, you must use a barrier method of contraception (such as a condom) for the first 7 days of taking the pill.
If you start MINESSE after a first trimester miscarriage
You can start taking MINESSE immediately, but you must follow your doctor's advice before starting.
If you start MINESSE after giving birth or after an abortion in the second trimester
As with any other contraceptive pill, MINESSE should not be started earlier than 21-28 days after delivery or abortion, as the risk of blood clots is higher. If you start later, we recommend that you use a barrier method of contraception during the first 7 days of taking the pill If you have had sex before starting MINESSE make sure you are not pregnant or wait for the next cycle.
Always ask your doctor for advice.
Duration of use
Your doctor will tell you how long to take this pill.
Overdose What to do if you have taken too much Minesse
If you take more MINESSE than you should
An overdose can cause gastrointestinal problems (e.g. nausea, vomiting, abdominal pain), breast tenderness, dizziness, sleepiness / fatigue and irregular menstruation (bleeding). Ask your doctor for advice.
If you forget to take MINESSE
If you forget to take the pill there is a risk of getting pregnant. If you realize that you have not taken a pale yellow tablet within 12 hours of the time you normally take your tablet, take the forgotten tablet immediately and continue as normal, taking the tablet. next tablet at the usual time until the end of the blister. If you find that you have not taken a pale yellow tablet more than 12 hours after the time you normally take it, there is a risk that you will become pregnant. Then:
- take the forgotten tablet immediately, even if that means taking 2 tablets on the same day;
- continue to take the contraceptive until the end of the strip;
- in addition, use a barrier method of contraception (condom, spermicide…) for the next 7 days;
- if this 7-day period goes beyond the last pale yellow tablet, throw away the remaining tablets and start the next blister.
If you have forgotten some pale yellow tablets in a blister pack and you do not have your expected period, which should start while taking the white tablets, you may be pregnant. If you have forgotten one or more white tablets, you are still protected as long as there are no more than 4 days between the last pale yellow tablet in the current strip and the first pale yellow tablet in the next strip. Ask your doctor for advice.
If you experience severe vomiting or diarrhea within 4 hours of taking the pill, the situation is similar to when you forget a tablet. After vomiting or diarrhea, you should take another tablet from a reserve strip as soon as possible. . If possible, take it within 12 hours of your usual time of taking the pill. If this is not possible, or 12 hours have already passed, you should follow the instructions given in "If you forget to take MINESSE".
If these episodes of severe vomiting or diarrhea recur for several days, you must use a barrier method of contraception (condom, spermicide ...) until the next blister begins.
Ask your doctor for advice.
Side Effects What are the side effects of Minesse
Like all medicines, MINESSE 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 MINESSE, 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 take MINESSE '.
Common side effects (may affect 1 to 10 in 100 women):
- vaginal infection, including vaginal candidiasis
- mood changes, including depression or altered sexual desire
- nervousness or dizziness
- nausea, vomiting or abdominal pain
- acne
- breast problems, such as pain, tenderness, swelling or discharge
- painful menstruation or change in menstrual flow
- changes in vaginal discharge or a change in the cervix (ectropion)
- fluid retention in tissues or edema (marked fluid retention)
- weight loss or gain
Uncommon side effects (may affect 1 to 10 in 1,000 women):
- changes in appetite
- abdominal cramps or flatulence
- skin rash, excessive hair growth, hair loss or facial blemishes (chloasma)
- changes in laboratory test results: increased cholesterol, triglyceride levels or increased blood pressure
Rare side effects (may affect 1 to 10 in 10,000 women):
- allergic reactions (very rare cases of hives, angioedema or severe respiratory or circulatory disorders)
- harmful blood clots in a vein or artery, for example: in a leg or foot (DVT); in a lung (PE); heart attack; stroke or mini-stroke or temporary stroke-like symptoms , known as transient ischemic attack (TIA); or 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).
- glucose intolerance
- intolerance to contact lenses
- jaundice
- a type of skin reaction called 'erythema nodosum'.
Very rare side effects (may affect less than 1 in 10,000 women):
- benign liver tumor (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumor
- worsening of an immune system disease (lupus), liver disease (porphyria) or a disease known as 'chorea' characterized by irregular, sudden and involuntary movements
- some types of eye diseases, such as inflammation of the optic nerve, which can lead to partial or total loss of vision
- pancreatic diseases
- increased risk of gallstones or obstruction of the flow of bile
- liver or biliary disease (such as hepatitis or abnormal liver function)
- blood and urinary tract disease (haemolytic and uremic syndrome)
- a type of skin reaction called "erythema multiforme".
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 use this medicine after the expiry date which is stated on the carton and blister.
No special storage conditions are required.
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.
Composition and pharmaceutical form
What MINESSE contains
Pale yellow tablet
The active ingredients are: 60 micrograms of gestodene and 15 micrograms of ethinylestradiol.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, polacrilin potassium, Aqua Polish P Yellow [hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 1500].
White tablet
It does not contain active ingredients.
The other ingredients are: lactose monohydrate, maize starch, magnesium stearate, Aqua Polish P White [hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol 400, macrogol 1500].
Description of the appearance of MINESSE and contents of the pack
MINESSE is available in the form of film-coated tablets.
Each pack contains 1, 3 or 6 blisters, each containing 28 tablets (24 pale yellow active tablets with "60" stamped on one side and "15" on the other side of the tablet and 4 white placebo tablets).
Each blister is packaged in a foil pouch containing a silica gel desiccant pouch.
The silica gel desiccant pouch can be discarded after opening the pouch containing the blister.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
MINESSE 60/15 MCG TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gestodene: ........ 60 mcg
Ethinylestradiol: ........ 15 mcg
for each pale yellow film-coated tablet (active tablet).
Excipients: lactose.
The white film-coated tablets do not contain any active ingredients (placebo)
Excipients: lactose.
For a complete list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
The active tablet is pale yellow, film-coated, round with convex faces, stamped with "60" on one side and "15" on the other.
The placebo tablet is white, round with convex faces.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Oral hormonal contraception.
04.2 Posology and method of administration
Take one tablet regularly and without interruption a day, at the same time, for 28 consecutive days (one pale yellow tablet active in the first 24 days and one white inactive tablet in the following 4 days), with no interval between one pack and the next. . Withdrawal bleeding normally begins 2-3 days after taking the last active tablet and may persist beyond the start of the new pack.
How to start Minesse
- No hormonal contraceptive treatment in the previous month: take the first tablet on the 1st day of menstruation.
- Changing from another combined oral contraceptive:
The woman should start MINESSE the day after the last active tablet of her previous combined oral contraceptive.
- Changing from a progestogen-only contraceptive (minipill, injectable preparations, implant):
The woman can change at any time if she is coming from the minipill, and she must start taking MINESSE the next day. of an injectable, on the day the next injection should be given. In all these cases the woman should also be advised to also use a supportive non-hormonal method of contraception for the first seven days of tablet-taking.
- After a first trimester abortion:
The woman can start MINESSE immediately. No additional contraceptive measures are necessary.
- After delivery or second-trimester abortion:
Since the immediate postpartum period is associated with an increased risk of thromboembolism, the use of COCs should not commence before the 21st-28th day after delivery or after a second trimester abortion. The woman should be warned. to also use a non-hormonal supportive method of contraception in the first 7 days of taking the tablets. However, if intercourse has taken place in the meantime, pregnancy must be ruled out or the first menstruation should be awaited before actually starting the COC.
For women who are breastfeeding, see section 4.6.
Missing of one or more tablets
Contraceptive safety may decrease if pale yellow tablets are missed, particularly if the forgotten occurs during the first few days of the treatment cycle.
• If you notice that you have forgotten to take a pale yellow tablet within 12 hours of the usual time, you should take it immediately and continue treatment as normal, taking the next tablet at the usual time.
• If you notice that you have forgotten to take a pale yellow tablet more than 12 hours after the usual time, contraceptive protection is no longer ensured. The last missed tablet should be taken immediately, even if it meant taking two tablets anyway. day and the oral contraceptive treatment continued until the end of the calendar pack, using at the same time also an alternative non-hormonal method of contraception (condoms, spermicides, etc.) for the next 7 days. If the 7 days, in which an alternative contraceptive method is required, go beyond the last active tablet of the pack you are using, you will need to start the new pack the day after taking the last active tablet of the pack that you are using and all inactive tablets should be discarded. The user is unlikely to have a withdrawal bleed until the interval during which the second pack placebo tablets are taken, but may have spotting or breakthrough bleeding. If, at the end of the second pack, no withdrawal bleeding occurs, the possibility of pregnancy must be excluded before restarting taking the tablets.
Mistakes in taking one or more white tablets have no consequences, as long as the interval between the last pale yellow tablet in the current calendar pack and the first pale yellow tablet in the next calendar pack is no more than 4 days.
In case of onset of gastrointestinal disorders:
The onset of intercurrent digestive disturbances, such as vomiting or intense diarrhea, within four hours of taking the tablet may render the method temporarily ineffective and such occurrences must be dealt with in the same way as forgetting the tablet for less than 12 hours. Supplemental tablets must be taken from the reserve pack. If these episodes recur for several days, an alternative non-hormonal method of contraception (condom, spermicide, etc.) should be used until the next calendar pack is started.
04.3 Contraindications
This medicine is contraindicated in the following cases:
• hypersensitivity to any of the active substances or to any of the excipients
• arterial thromboembolic accidents or arterial thromboembolic disease in medical history
• venous thromboembolic accidents or venous thromboembolic disease in history such as deep vein thrombosis and pulmonary embolism
• hereditary or acquired predisposition for venous or arterial thrombosis
• cerebrovascular disease or arterial coronary artery disease
• uncontrolled hypertension
• valvulopathy
• thrombogenic rhythm disturbances
• history of migraine with focal neurological symptoms, such as aura
• diabetes complicated by micro- or macroangiopathy
• Known or suspected breast cancer;
• cancer of the endometrium or other known or suspected estrogen-dependent neoplasm.
• liver adenoma or carcinoma or liver disease in progress until liver function tests have returned to normal.
• undiagnosed genital bleeding.
04.4 Special warnings and appropriate precautions for use
Risk of arterial and venous thromboembolic disease
Before prescribing oral contraceptive combinations, it is necessary to systematically exclude the presence of risk factors for arterial and venous thromboembolic disease taking into account contraindications and precautions for use.
Therapy should be discontinued if warning symptoms of impending complications occur: intense and unusual headaches, visual disturbances, elevated blood pressure, clinical signs of phlebitis and pulmonary embolism.
1. Risk of venous thromboembolism
The use of any combined oral contraceptive carries an increased risk of venous thromboembolism (VTE) compared with no use. The excess risk of VTE is highest during the first year of use in a woman starting a contraceptive. combined oral for the first time. This increased risk is lower than the risk of VTE associated with pregnancy which is estimated to be 60 cases per 100,000 pregnancies. VTE is fatal in 1-2% of cases.
In several epidemiological studies it has been observed that women using combined oral contraceptives containing ethinylestradiol, mostly at a dose of 30mcg, and a progestin such as gestodene have an increased risk of VTE compared to women using combined oral contraceptives containing less than 50 mcg of ethinyl estradiol and the progestin levonorgestrel.
For products containing 30 micrograms of ethinylestradiol in combination with desogestrel or gestodene compared to those containing less than 50 micrograms of ethinylestradiol and levonorgestrel, the overall relative risk of VTE has been estimated to be between 1.5 and 2.0. The incidence of VTE for combined oral contraceptives containing desogestrel or gestodene is approximately 30-40 cases per 100,000 woman-years of use, ie an additional 10-20 cases per 100,000 woman-years of use compared to levonorgestrel. L " Relative risk impact on the number of additional cases would be greatest during the first year a woman uses a COC for the first time, when the risk of VTE is highest for all COCs.
For COCs containing less than 20 micrograms of ethinylestradiol in combination with desogestrel or gestodene, such as Minesse, no data are available on the risk of venous thromboembolism compared to other COCs.
o The risk factors for venous thromboembolism are:
- Obesity (body mass index ≥ 30 Kg / m2);
- Surgery, prolonged immobilization, postpartum period and after abortion in the second trimester: in case of planned surgery, treatment with combined oral contraceptive combinations should be interrupted one month before surgery and until mobility is fully resumed. Treatment must also be suspended in case of prolonged immobilization.
- Some inherited or acquired thrombophilias: in case of family history of venous thromboembolic disease (which has affected one or more relatives before the age of 50) or with a positive history of acquired thrombophilia, it may be useful to search for any abnormalities that may favor venous thrombosis before prescribing an estrogen-progestogen contraceptive.
- Old age
There is no consensus on the role of varicose veins and superficial thrombophlebitis in venous thromboembolism.
2. Risk of arterial thromboembolism
Epidemiological studies have associated the use of COCs with an increased risk of arterial thromboembolism (myocardial infarction and cerebrovascular accidents, including transient ischemic attack).
- The available data on the risk of myocardial infarction do not allow to conclude that this risk differs between users of second and third generation COCs.
- The arterial thromboembolic risk associated with the use of COCs increases with age and with smoking; therefore, women using oral contraceptives should be advised not to smoke, especially women over the age of 35 and using COCs should stop smoking.
- Other risk factors for arterial thromboembolism are:
* some cardiovascular disorders: hypertension, coronary heart disease, valvular disease, thrombogenic arrhythmias, diabetes; factors that constitute contraindications (see "Contraindications"); dyslipidemias.
* migraine: an increase in the frequency and intensity of migraine, which may be a prodrome of cerebrovascular events, justifies an immediate discontinuation of the COC.
* age: the risk of arterial thrombosis increases with age; after 35 years the risk / benefit ratio of this contraception must be re-evaluated patient by patient.
* some inherited or acquired thrombophilias: positive family history (arterial thrombosis in relatives at a relatively early age).
* obesity
Gynecological Tumors
A meta-analysis of data from 54 international studies found a slightly higher risk of breast cancer diagnosis among oral contraceptive users. This increased risk does not appear to depend on the duration of treatment. The influence of risk factors such as nullity or family history of breast cancer has not been established.
This increased risk is transient and disappears 10 years after the oral contraceptive is discontinued.
It is possible that more regular clinical monitoring of women taking oral contraceptives may play an important role in the greater number of breast cancers diagnosed, increasing the likelihood of early detection.
Since breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in women taking, or have recently taken, COCs is minimal when compared to the risk of cancer. breast throughout the life span.Breast cancers diagnosed in women who have always used COCs tend to be less clinically advanced than those diagnosed in women who have never used COCs.
Some epidemiological studies report an increased risk of cervical cancer in long-term users of COCs. However, the extent to which such data can be attributed to differences in sexual behavior or to other factors such as human papilloma virus (HPV) continues to be controversial.
Published data do not compromise the use of oral contraceptives, as the benefits clearly outweigh the potential risks.
In addition, oral contraception reduces the risk of ovarian and endometrial cancer.
Hepatic neoplasm / liver disease
In rare cases benign liver tumors (e.g. focal nodular hyperplasia, hepatic adenoma) and even more rarely malignant have been reported in COC users. In isolated cases, these tumors have produced life-threatening intra-abdominal haemorrhages.
It has been reported that cholestasis may occur or worsen with pregnancy and the use of COCs, but there is no clear evidence of an association with COCs.
Hepatic and hepatobiliary disorders have been reported with the use of COCs. Acute or chronic disturbances of liver function may require discontinuation of the COC until parameters of liver function return to normal.
Headache
The onset or exacerbation of migraine or the development of headache with a new feature, which is recurrent, persistent, and severe, requires discontinuation of the COC and evaluation of the cause.
Hypertension
Although uncommon, an increase in blood pressure has been reported in some women taking COCs.
In women with hypertension, a history of hypertension or hypertension-related conditions (including some kidney conditions), another method of contraception may be preferable.
If COCs are used in the above cases, careful monitoring is recommended and the COC should be discontinued if a significant increase in blood pressure occurs.
Other
- A complete personal and family medical history and physical examination should be carried out before starting to use a COC and, as a rule, to be repeated periodically while using COCs.
- Caution must be adopted in women with:
- Metabolic disorders such as uncomplicated diabetes
- Hyperlipidemia (hypertriglyceridemia, hypercholesterolemia). Women undergoing treatment for hyperlipidaemia should be monitored constantly if they choose to take combined oral contraceptives. Persistent hypertriglyceridaemia can occur in a small percentage of COC users.
In patients with elevated triglycerides, the use of estrogen-containing preparations may be associated with rare but high increases in plasma triglycerides which can lead to pancreatitis.
- Obesity (body mass index = weight / height2 ≥ 30)
- Benign breast tumors and uterine dystrophy (hyperplasia, fibroid)
- Hyperprolactinemia with or without galactorea.
- Close monitoring should be ensured, even in the presence of conditions that have been reported to occur or worsen following pregnancy or the use of COCs, respectively in patients who have current or history of: epilepsy, migraine, otosclerosis, asthma, family history of vascular disease, varicose veins, gestational herpes, gallstones, SLE, cardiac, renal or hepatic dysfunction, depression, hypertension, chorea, hemolytic uremic syndrome.
- Exogenous estrogens can induce or exacerbate the symptoms of angioedema, particularly in women with hereditary angioedema
- In clinical studies, non-pregnancy-related amenorrhea was observed in 7% of cycles (occurring in 24% of women over the total duration of clinical studies) and 3.6% of women had consecutive amenorrhoeic cycles. In clinical studies, only 1% of women discontinued treatment due to amenorrhea.
- When MINESSE is taken according to the instructions, in case of an amenorrhoeic cycle there is no reason to stop the treatment and perform the pregnancy test. If MINESSE has not been taken according to the instructions or if amenorrhea occurs after a long period of regular menstrual bleeding, pregnancy should be excluded.
- Some women may experience post-therapeutic amenorrhea (possibly accompanied by anovulation) or oligomenorrhea, particularly if this condition was pre-existing. Normally these conditions resolve spontaneously, if they were to prolong, investigations on the possibility of pituitary disorders must be conducted before further prescriptions.
- Irregular bleeding (spotting or breakthrough bleeding) may occur with all COCs, especially during the first months of use. Therefore, the evaluation of any irregular bleeding is only meaningful after an adjustment period of approximately three cycles. If irregular bleeding persists or occurs after previous regular cycles, non-hormonal causes should be considered and appropriate diagnostic measures are indicated to rule out malignancy or pregnancy. Additional diagnostic measures may include curettage.
- Cases of depression have been reported during COC use. Women with a history of depression using COCs should be monitored carefully.
- If melasma / chloasma has developed during a previous pregnancy or previous use of combined oral contraceptives, avoid exposure to sunlight to minimize worsening of this condition.
- Diarrhea and / or vomiting may reduce hormone absorption from COCs (see section 4.2).
- Patients should be explained that oral contraceptives do not protect against HIV infection (AIDS) or other sexually transmitted diseases.
- Due to the presence of lactose, the use of this medicine is not recommended in women with lactose intolerance.
04.5 Interactions with other medicinal products and other forms of interaction
Interactions between ethinylestradiol and other substances can lead to a decrease or increase in serum concentrations of ethinylestradiol.
Decreased serum concentrations of ethinylestradiol can cause an increased incidence of breakthrough bleeding and menstrual irregularities and possibly reduce the efficacy of COCs.
Simultaneous use not recommended
- Enzyme inducers such as: anticonvulsants (phenobarbital, phenytoin, primidone, carbamazepine, topiramate), rifabutin, rifampicin, griseofulvin and sometimes St. John's wort (hypericum perforatum). Reduction of contraceptive efficacy due to increased hepatic metabolism during treatment and for the cycle following the discontinuation of treatment. A non-hormonal method of contraception should be preferred.
- Ritonavir: risk of decreased efficacy of COC due to decreased plasma estrogen levels. A non-hormonal method of contraception should be used.
- Modafinil: risk of reduced contraceptive efficacy during treatment and for the cycle following discontinuation of treatment.
- Certain antibiotic agents (eg ampicillin, tetracycline): reduction in contraceptive efficacy through a reduction in the enterohepatic circulation of estrogens. An additional non-hormonal method of contraception is recommended during treatment and for 7 days after stopping treatment.
- Flunarizine: risk of galactorrhea due to the increased sensitivity of the breast tissue to prolactin due to the action of flunarizine.
- Troleandomycin may increase the risk of intrahepatic cholestasis during co-administration with COCs.
In order to identify potential interactions, it is advisable to consult the package leaflet of concomitant drugs.
04.6 Pregnancy and lactation
Pregnancy
This medicine is not indicated during pregnancy.
So far, in clinical use, and unlike diethylstilbestrol, the results of numerous epidemiological studies allow us to consider reduced the risk of malformations with estrogens administered, at the beginning of pregnancy, alone or in combination.
Furthermore, the risks related to the sexual differentiation of the fetus (in particular female), which have been described with the first highly androgenomimetic progestogens, cannot be extrapolated to the more recent progestogens (such as that used in this medicinal product), which are markedly less, or not at all, androgenomimetics.
Consequently, the discovery of a pregnancy in a patient taking an "estrogen-progestogen association" does not justify the abortion.
Feeding time
The use of this medicine in breastfeeding mothers is not recommended, as estrogens, progestogens are found in breast milk
During breastfeeding, a different contraceptive method should be offered.
04.7 Effects on ability to drive and use machines
Not applicable
04.8 Undesirable effects
The following side effects have been reported in women using COCs:
For serious adverse events in COC users see section 4.4.
There is an increased risk of venous thromboembolism for all women using COCs. For information on the differences in risk between COCs, see section 4.4. For discussion of arterial thromboembolic events, see section 4.4.
Occurrence of amenorrhea was reported by 15% of women during the clinical trial; see section 4.4.
Some of the most frequent adverse events reported (greater than 10%) during phase III studies and post-marketing surveillance in women receiving MINESSE are headache, including migraine, breakthrough bleeding and spotting.
Other adverse reactions have been observed in women receiving MINESSE:
COCs can worsen biliary lithiasis and ongoing cholestasis
04.9 Overdose
Symptoms of oral contraceptive overdose in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, sleepiness / fatigue; vaginal bleeding may occur in women. There are no antidotes and further treatment should be symptomatic.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
PROGESTINICS AND ESTROGENS IN FIXED ASSOCIATION.
ATC code G03AA10 (genitourinary system and sex hormones).
Monophasic estrogen-progestogen association. Incorrect Pearl Index: 0.24 (21521 cycles).
The contraceptive efficacy of MINESSE derives from three complementary mechanisms of action:
- inhibit ovulation at the level of the hypothalamic-pituitary axis.
- make cervical secretions impermeable to the migration of spermatozoa
- make the endometrium unsuitable for implantation.
05.2 "Pharmacokinetic properties
Ethinylestradiol
Absorption:
Ethinylestradiol is rapidly and completely absorbed after oral administration. After administration of 15mcg, peak plasma concentrations of 30 pg / ml are reached after 1-1.5 hours. Ethinylestradiol undergoes a strong "first pass effect". entities, with large inter-individual variations. Absolute bioavailability is approximately 45%.
Distribution:
Ethinylestradiol has an apparent volume of distribution of 15 l / kg and plasma protein binding is approximately 98%.
Ethinylestradiol induces hepatic synthesis of sex hormone binding globulins (SHBG) and corticosteroids (CBG). During treatment with ethinylestradiol 15 mcg, plasma concentrations of SHBG increase from 86 to approximately 200 nmol / l.
Metabolism
Ethinylestradiol is completely metabolised (metabolic plasma clearance approximately 10 ml / min / kg).
The metabolites that are formed are excreted in the urine (40%) and faeces (60%).
Elimination
The elimination half-life of ethinylestradiol is approximately 15 hours. Ethinylestradiol is not significantly excreted in the unchanged form. The metabolites of ethinylestradiol are excreted in a urine / bile ratio of 4/6.
Steady state conditions:
Steady state conditions are achieved in the second half of each treatment cycle and serum levels of ethinylestradiol accumulate by a factor ranging from about 1.4 to 2.1.
Gestodene:
Absorption
After oral administration, gestodene is completely and rapidly absorbed. Absolute bioavailability is approximately 100%. After a single oral dose of 60 micrograms of gestodene, peak plasma concentrations of 2 ng / ml are reached in approximately 60 minutes. Plasma concentrations are highly dependent on SHBG concentrations.
Distribution:
Gestodene has an apparent volume of distribution of 1.4 L / kg after a single dose of 60 micrograms. It is 30% bound to plasma albumin and 50-70% to SHBG.
Metabolism:
Gestodene is extensively metabolised via the steroid pathway. Metabolic clearance is approximately 0.8 ml / min / kg after a single dose of 60 micrograms. The non-active metabolites that are formed are excreted in the urine (60%) and faeces (40%).
Elimination:
The apparent elimination half-life of gestodene is approximately 13 hours. The half-life is prolonged to 20 hours following coadministration of ethinylestradiol.
Steady state conditions:
After multiple doses in combination with ethinylestradiol the plasma concentration increases by approximately a factor of 2-4.
05.3 Preclinical safety data
Toxicological studies have been carried out on all components both individually and in combination with each other.
Acute toxicity studies in animals revealed no risk of acute symptoms due to accidental overdose.
Repeated dose general safety studies have shown no indicator effects of unexpected risks in humans.
Long-term and repeated dose carcinogenicity studies did not show carcinogenic properties. However, it is important to remember that sex steroids can promote the development of certain tissues in hormone-dependent tumors.
Teratogenicity studies did not reveal any particular risk if the estrogen-progestagen combinations are used correctly. However, it is essential to stop treatment immediately if taken by mistake at the beginning of pregnancy.
Mutagenicity studies did not reveal any mutagenic potential of ethinylestradiol or gestodene.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Pale yellow tablet (active): lactose monohydrate, microcrystalline cellulose, magnesium stearate, polacrylin potassium, Opadry yellow YS-1-6386-G [hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172 )], macrogol 1450, E wax (montanglycol wax).
White tablet (placebo): lactose monohydrate, microcrystalline cellulose, magnesium stearate, polacrylin potassium, white Opadry Y-5-18024-A [hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol 400] macrogol 1450, E wax (montanglycol wax) .
06.2 Incompatibility
Not applicable
06.3 Period of validity
34 months.
06.4 Special precautions for storage
No special storage instructions.
06.5 Nature of the immediate packaging and contents of the package
24 pale yellow tablets and 4 white tablets in blister packs (PVC / aluminum)
Pack sizes are 1 x 28, 3 x 28 and 6 x 28. Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special education is needed.
07.0 MARKETING AUTHORIZATION HOLDER
Wyeth Lederle S.p.A. - Via Nettunense 90, Aprilia (LT)
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 034922017 / M - 24 pale yellow and 4 white tablets in calendar pack (PVC / aluminum), carton of 1
AIC n. 034922029 / M - 24 pale yellow and 4 white tablets in calendar pack (PVC / aluminum), carton of 3
AIC n. 034922031 / M - 24 pale yellow and 4 white tablets in calendar pack (PVC / aluminum), box of 6
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
11.09.2000
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 07.03.2011
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
CHECKLIST FOR PRESCRIPTORS - COMBINED HORMONAL CONTRACEPTIVES
Please use this checklist together with the Summary of Product Characteristics during any consultation on Combined Hormonal Contraceptives (COCs).
• The thromboembolism (eg deep vein thrombosis, pulmonary embolism, heart attack and stroke) represents an important risk associated with the use of COCs.
• The risk of thromboembolism with a CHC is higher:
- during the first year d "employment;
- when you leave resume use after a break in intake of 4 or more weeks.
• COCs containing ethinylestradiol in combination with levonorgestrel, norgestimate or norethisterone have the lower risk to cause venous troembolism (VTE).
• The risk for a woman also depends on her baseline risk of thromboembolism. The decision to use a COC must therefore take into account the contraindications and individual risk factors, particularly those relating to thromboembolism - see the boxes below and the relevant Summary of Product Characteristics.
• The decision to use any CHC rather than one with the lowest risk of venous thromboembolism (VTE) should only be made after an interview with the woman to ensure she understands:
- the risk thromboembolism associated with its COC;
- the effect of any risk factor inherent in his risk of thrombosis;
- which must pay particular attention to signs and symptoms of a thrombosis.
Remember that a woman's risk factors can vary over time. It is therefore important to use this checklist at every consultation.
• You need surgery;
• It is necessary that you undergo a prolonged period of immobilization (as in the case of an accident or illness, or for a "cast in a lower limb).
→ In these cases it would be better to reconsider whether or not to use a non-hormonal contraceptive until the risk returns to normal..
• Travel for an extended period (> 4 hours);
• Develop any of the contraindications or risk factors for combined contraceptives;
• She has given birth in the last few weeks.
→ In such situations, your patient should pay particular attention to catch any signs and symptoms of thromboembolism.
Please strongly encourage women to read the Package Insert that accompanies each COC pack, including the symptoms of thrombosis which they should carefully watch out for.
Please report any suspected adverse reactions from COC to the territorially competent Pharmacovigilance Offices or to the AIFA as required by current legislation
IMPORTANT INFORMATION ABOUT COMBINED ORAL CONTRACEPTIVES (COCS) AND THE RISK OF BLOOD CLOTS
All combined contraceptives increase the risk of having a blood clot. The overall risk of a blood clot from taking a combined hormonal contraceptive (COC) is small., but clots can represent a serious condition and in very rare cases even fatal.
It is very important that you recognize when you may be at a higher risk for a blood clot, what signs and symptoms to watch out for and what actions you need to take.
In which situations is the risk of a blood clot higher?
- during the first year of use of a COC (including when resuming use after an interval of 4 or more weeks)
- if you are overweight
- if you are over 35 years of age
- if you have a family member who has had a blood clot at a relatively young age (i.e. under 50)
- if you have given birth in the last few weeks
Self smokes and over 35 years of age, she is strongly advised to stop smoking or to use a non-hormonal method of contraception.
See a doctor immediately if you experience any of the following symptoms:
• Severe pain or swelling in one of the legs which may be accompanied by flaccidity, warmth or changes in the color of the skin such as the appearance of paleness, redness or bluish color. He could have deep vein thrombosis.
• The sudden and unexplained shortness of breath or onset of rapid breathing; severe chest pain which may increase with deep breathing; a sudden cough with no obvious cause (which can produce blood). It could be a serious complication of deep vein thrombosis called pulmonary embolism. This occurs if the blood clot migrates from the leg to the lung.
• A pain in the chest, often sharp, but which sometimes occurs such as malaise, a sense of pressure, weight, upper body discomfort radiating to the back, jaw, throat, arm with a feeling of fullness associated with indigestion or choking, sweating, nausea, vomiting or dizziness . It could be a heart attack.
• A numbness or a sense of weakness in the face, arm or leg, especially on one side of the body; a difficulty in speaking or understanding; a "sudden confusion of mind, a sudden loss of vision or blurred vision; a headache / migraine intense and worse than usual. This could be a stroke.
Look out for symptoms of a blood clot, especially if:
• has just had surgery
• you have been immobilized for a long time (such as due to an accident or illness, or because you have had your leg in a cast)
• has traveled a long way (for more than 4 hours)
Remember to tell your doctor, nurse or surgeon that you are taking a combined hormonal contraceptive if:
• You have had or are due to have surgery
• There is any situation where a healthcare professional asks you what medications you are taking
For more information, please read carefully the Package Leaflet accompanying the drug and immediately report any undesirable effects associated with the use of the combined hormonal contraceptive to your doctor or pharmacist.
