SECURGIN - PACKAGE LEAFLET - LEAFLETS

Home / leaflets / 2021

Securgin - Package Leaflet

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

Active ingredients: Desogestrel, Ethinylestradiol

SECURGIN 0.15 mg + 0.02 mg tablets

Why is Securgin used? What is it for?

Before you start using SECURGIN you should read the information on blood clots in section 2. It is especially important that you read the symptoms of a blood clot.

In this leaflet, some situations are described in which the pill should be stopped or in which a reduction in the effectiveness of the pill may occur. In these situations, you should not have sexual intercourse or you should take additional non-hormonal contraceptive precautions, such as using a condom or other barrier method. Do not use rhythm or basal temperature methods. These methods may be unreliable because the pill it alters the normal changes in temperature and cervical mucus that occur during the menstrual cycle. SECURGIN, like all contraceptive pills, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

SECURGIN should not normally be used to postpone a period. However, if in exceptional cases it is necessary to delay a period, please contact your doctor.

Contraindications When Securgin should not be used

If you are allergic to the active substances or any of the other ingredients of this medicine

Do not use SECURGIN 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 (or have ever had) a blood clot in a vessel of the leg (deep vein thrombosis, DVT), of the lung (pulmonary embolism , EP) or other bodies;

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 have to undergo an operation or if you will lie down for a long time;
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 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 suffered in the past from pancreatitis (inflammation of the pancreas) associated with high levels of fat in the blood;
If you have jaundice (yellowing of the skin) or have severe liver disease;
If you have or have suffered in the past from a type of cancer that grows under the influence of sex hormones (such as breast and genital cancer);
If you have or have suffered in the past from liver cancer;
If you have vaginal bleeding of unknown origin;
If you have endometrial hyperplasia (abnormal growth of the lining of the uterus);
If you are pregnant or suspect that you are pregnant.

If any of these conditions appear for the first time while taking the pill, stop taking it immediately and tell your doctor. In the meantime, use non-hormonal methods of contraception.

Precautions for use What you need to know before taking Securgin

Talk to your doctor or pharmacist before taking Securgin.

When should you see a doctor?

Periodic check-ups During the use of the pill, your doctor will ask you to come to periodic check-ups. You usually have to undergo a check-up at least every year.

See a doctor urgently if:

observe 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 "Clot blood (thrombosis) ").
observe any changes in your health, particularly in relation to what is reported in this leaflet
you feel a lump in your breast;
you experience symptoms of angioedema such as swelling of the face, tongue and / or throat and / or difficulty swallowing or hives with difficulty breathing;
you need to use other medicines (see also "Pill and other medicines");
you have intense and unusual vaginal bleeding;
she forgot to take the tablets during the first week of the pack and had sex in the previous seven days;
have severe diarrhea;
have not had a period for two consecutive cycles or suspect pregnancy (do not start a new pack without first checking with your doctor).
has sudden changes in hearing, smell and taste;

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 SECURGIN you should tell your doctor:

If you smoke;
If you have diabetes
If you are overweight;
If you suffer from high blood pressure;
If you suffer from heart valve disorders or certain heart rhythm disorders;
If a first degree family member has had a thrombosis, heart attack or stroke;
If you suffer from migraines;
If you suffer from depression;
If you suffer from epilepsy;
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 or a first-degree family member have or have had high cholesterol levels
if you are going to have an operation or if you are going to lie down for a long time
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 SECURGIN;
if you have "inflammation of the veins under the skin (superficial thrombophlebitis);
if you have varicose veins;
If a first degree family member has or has ever had breast cancer;
If you suffer from liver or gallbladder problems;
If you have disorders that first appeared or worsened during pregnancy or during treatment with sex hormones (e.g. hearing loss, a disorder called porphyria; skin disease called herpes gravidarum; neurological disease called Sydenham's chorea );
If you have had or have chloasma (pigmentation of the skin in brown-yellow patches, especially on the face); in this case avoid prolonged exposure to sunlight or ultraviolet rays.

In case of first appearance, relapse or worsening of any of the above conditions while using the pill, consult your doctor.

Blood clots

Using a combined hormonal contraceptive such as SECURGIN 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)

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 SECURGIN 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 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

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 SECURGIN, the 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 SECURGIN 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 that contains desogestrel, such as SECURGIN, about 9-12 will develop a blood clot in a year.

The risk of a blood clot forming depends on your medical history.

Risk of developing a blood clot in one year Women who are not using a combined hormone pill / patch / ring and who are not pregnant 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 SECURGIN About 9-12 out of 10,000 women

Very rarely, blood clots can form in an artery (arterial thrombosis), for example in the blood vessels of the heart (causing a heart attack) or in the brain (causing a stroke). Very rarely, blood clots can form in the liver, intestines. , kidney or eye Very occasionally a thrombosis can cause serious permanent disability or can be fatal.

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

The risk of developing a blood clot with SECURGIN 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 close relative 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 SECURGIN a few weeks before surgery or during the period in which you are less mobile. If you have to stop taking SECURGIN, 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 SECURGIN needs to be stopped.

If any of the above conditions change while you are using SECURGIN, 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 SECURGIN is very low but can increase:

with increasing age (over 35 years);
if you smoke. When using a combined hormonal contraceptive such as SECURGIN 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 SECURGIN, 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.

Pill and cancer

Breast cancer is diagnosed slightly more often in women who use the pill than in women who do not. This slight increased risk gradually disappears over 10 years after stopping the use of the pill. It is not known whether the pill is the cause of this difference. This may be due to the fact that women are seen much more often. and therefore breast cancer is likely to be diagnosed earlier.

Benign liver tumors and, even more rarely, malignant liver tumors have been observed in rare cases in women using the Pill. These tumors can cause internal bleeding. Contact your doctor immediately if you experience any severe abdominal pain.

Cervical cancer is caused by a "human papillomavirus (HPV) infection. It is more common in women who use the pill for a long time. It is not known whether this is due to" use of hormonal contraceptives, sexual behavior or to other factors (such as better cervical screening).

Interactions Which drugs or foods may change the effect of Securgin

Some medicines may reduce the effectiveness of the pill. These include medicines for the treatment of epilepsy and narcolepsy (eg primidone, phenytoins, hydantoins, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, modafinil); tuberculosis (eg. rifampicin, rifabutin) and HIV infection (eg ritonavir, nelfinavir, nevirapine, efavirenz); antibiotics for other infections (eg ampicillin, tetracyclines, griseofulvin); for high blood pressure lungs (bosental) and preparations based on St. John's wort (Hypericum perforatum, used mainly for the treatment of depression). The pill can also interfere with the work of other medicines (eg cyclosporine and lamotrigine).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Also tell any other doctors or dentist who may prescribe other medicines (or the pharmacist) that you are using SECURGIN. This way they can tell you if and for how long you need to use additional contraceptive methods.

Warnings It is important to know that:

Laboratory analysis

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

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 and pharmacist for advice before taking this medicine.

Pregnancy

SECURGIN should not be used by women who are pregnant or suspect pregnancy. If you suspect that you are pregnant while taking SECURGIN, you must stop treatment immediately and contact your doctor as soon as possible.

Feeding time

The use of SECURGIN is not recommended during breastfeeding. If you want to take the pill while breastfeeding, you will need to contact your doctor.

Driving and using machines

SECURGIN DOES NOT AFFECT THE ABILITY TO DRIVE VEHICLES OR USE MACHINERY. IMPORTANT INFORMATION ABOUT SOME EXCIPIENTS OF SECURGIN.

SECURGIN contains lactose monohydrate. If your doctor has diagnosed you with "intolerance to some sugars, contact your doctor before you start using SECURGIN.

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

When and how to take the tablets Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

The SECURGIN pack contains 21 tablets, all marked with the day of the week on which each should be taken. Take the tablet at about the same time every day, with a little water if necessary. Follow the direction of the arrows until all 21 tablets have been used up.

Do not take pills for the next 7 days. Menstruation should appear during these 7 days (withdrawal bleeding). They usually start 2-3 days after taking the last SECURGIN tablet. Start the new pack on the eighth day, even if your period has not finished yet. By doing this you will always start the new pack on the same day of the week and the withdrawal bleeding will always occur on approximately the same days of the week, every month. .

How to start the first pack of SECURGIN

If you have not used any hormonal contraceptive pills in the previous month.

Start taking SECURGIN on the first day of your period, ie the first day of your period, taking the tablet marked with that day of the week. Then continue in the order indicated by the arrows. SECURGIN is effective immediately. He therefore does not need additional contraceptive methods.

It can also be started between the second and fifth day of the cycle, but in this case an additional contraceptive method (barrier method) must be used for the first 7 days of taking the tablets in the first cycle.

Changing from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal contraceptive ring, or transdermal patch)

You can start taking SECURGIN the day after the last pill of the previous contraceptive (ie without observing any tablet-free break). If your previous contraceptive pack also contains inactive tablets, you can take SECURGIN the day after taking the last one. active tablet (if in doubt, ask your doctor or pharmacist). It can also start later, but never later than the day after the pill-free interval (or the day after the last inactive tablet) of the previous contraceptive. use a vaginal ring or a transdermal patch, it is preferable to start taking SECURGIN on the day of the removal of the ring or patch. or the patch.

If you have used the pill, patch or ring consistently and correctly and if you are sure you are not pregnant, you can also stop taking the pill or remove the ring or patch on any day and start using SECURGIN immediately. If you follow these instructions, you do not need to resort to the use of additional contraceptive methods.

Switching from progestogen-only pill (minipill)

You can stop taking the minipill on any day and start taking SECURGIN the next day at the same time. However, if you have sex, use an additional method of contraception (barrier method) for the first 7 days of taking SECURGIN.

Changing from an injection contraceptive or progestogen-only implant or progestogen-releasing intrauterine device (IUS)

You can start taking SECURGIN when your next injection is due or on the day of removal of the implant or IUS. However, if you have sex, use an additional method of contraception (barrier method) for the first 7 days of taking SECURGIN. .

After giving birth

After having a baby, your doctor may tell you to wait until your first normal menstrual period before you start using SECURGIN. Sometimes it is possible to start even earlier. Your doctor will give you instructions.If you are breastfeeding and want to use SECURGIN, talk to your doctor first.

After a spontaneous or induced abortion

Your doctor will give you instructions.

WHAT TO DO IF ...

… You forget to take Securgin

If less than 12 hours have passed since the time of usual intake, the reliability of the pill is maintained. Take the forgotten tablet as soon as you remember and then take the next tablets as usual.

If more than 12 hours have passed since the time of usual intake, the reliability of the pill may be reduced. The greater the number of consecutively forgotten tablets, the greater the risk that the contraceptive effect will be reduced. The risk of pregnancy is particularly high if pills are forgotten at the beginning and at the end of the pack. Then you will have to follow the instructions below (see also the diagram below).

If you have forgotten to take more than one tablet in a pack.

Ask your doctor for instructions.

If you forgot 1 tablet in the first week

Take the tablet as soon as you remember (even if that means taking two tablets at the same time) and continue as usual. Use additional contraceptive methods (barrier method) for the next 7 days. If you have had sexual intercourse in the week preceding the forgetfulness, there is a possibility that you have become pregnant.

Contact your doctor immediately.

If you forgot 1 tablet in the second week

Take the forgotten tablet as soon as you remember (even if that means taking two tablets at the same time) and continue as usual. The contraceptive safety of the pill is maintained. No other additional contraceptive measures need to be used.

If you forgot 1 tablet in the third week

You can choose one of the following alternatives, without the need for additional contraceptive precautions.

Take the forgotten tablet as soon as you remember (even if that means taking two tablets at the same time) and continue as usual. Start the new pack as soon as you finish the current one, with no gap between the two packs. Withdrawal bleeding may not occur until the second pack is finished, but breakthrough bleeding (spotting) or breakthrough bleeding may occur during the second pack. or
Discontinue tablets from the current pack, observe an interval of 7 days or less (include the day of the missed pill) and continue with a new pack. If you choose this alternative, you can always start the new pack on the same day of the week on which you usually start.

If you have forgotten to take one or more tablets from a pack and you do not have a period in the first pill-free interval, it is possible that you are pregnant. In this case, you should contact your doctor before starting the new pack.

...... if you suffer from gastrointestinal disorders (such as vomiting or severe diarrhea)

If you vomit or have severe diarrhea, the active substances in the SECURGIN tablet may not be fully absorbed. If you vomit within 3-4 hours of taking the tablet, the situation is similar to that of a forgotten tablet. You should follow the directions given for forgetting tablets. In case of severe diarrhea, contact your doctor.

....... in case you want to postpone the day of the start of menstruation

You can delay the start of your period if you start taking the tablets of a new pack of SECURGIN immediately after finishing the current pack. You can continue with the new pack as long as you wish, until the end of the second pack. When you want your period to start, stop taking the tablets. While using the second pack you may experience breakthrough bleeding or spotting while taking the tablets. Start the next pack after the usual 7-day tablet-free break.

....... in case you want to change the day of the start of your period

If you take the tablets correctly, you will have your period on about the same day every 4 weeks. If you want to change this day, you just need to shorten (never lengthen) the next pill-free interval. For example, if your periods usually appear on a Friday and you want them to appear on a Tuesday in the future (3 days earlier), you should start the next pack 3 days earlier than usual. If you shorten your tablet-free interval by a lot (eg 3 days or less) you may not have vaginal bleeding during that interval. You may have breakthrough bleeding or spotting while using the next pack.

...... if you have unexpected bleeding With all oral contraceptives, in the first months of taking, you may have irregular vaginal bleeding (spotting or breakthrough bleeding) between periods. You may need to use sanitary pads, but you must continue to take the tablets as normal. The irregular bleeding usually disappears once the body gets used to the pill (usually after about 3 months). Consult your doctor if bleeding persists, becomes intense or recurs at intervals.

… ..If you have missed your period If you have taken all the tablets correctly and have not vomited and have not had severe diarrhea or other medicines, it is very unlikely that you are pregnant. Continue to take SECURGIN as usual.

If your period does not occur twice in a row, it is possible that you are pregnant. Contact your doctor immediately. Do not start the new pack of SECURGIN until your doctor has ruled out that you are pregnant.

If you stop taking SECURGIN

You can stop taking SECURGIN at any time.

If you still want to avoid becoming pregnant, ask your doctor for advice on other methods of birth control. If you want to stop taking SECURGIN to become pregnant, you should wait for a natural period before you start trying to conceive. This will help you determine when your baby will be born.

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

Overdose What to do if you have taken too much Securgin

After taking several SECURGIN tablets at once, no serious adverse effects have been reported. If you have taken several tablets at the same time, you may have nausea, vomiting or vaginal bleeding. If you find that a child has taken SECURGIN, ask your doctor for instructions.

Side Effects What are the side effects of Securgin

Like all medicines, SECURGIN 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 could be due to SECURGIN, 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 of taking it. for combined hormonal contraceptives, see section 2 "What you need to know before you take SECURGIN".

Common (occurring in more than 1 in 100 female users):

depressed mood, mood change
headache
nausea, abdominal pain
breast pain, breast tension
weight gain.

Uncommon (occurring in more than 1 in 1000 female users but less than 1 in 100 female users):

fluid retention
decreased sexual desire
migraine
vomiting, diarrhea
skin reactions, hives
breast enlargement.

Rare (occurring in less than 1 in 1000 users):

hypersensitivity reactions
increased sexual desire
intolerance to contact lenses
erythema nodosum, erythema multiforme (skin diseases)
breast discharge, vaginal discharge
decrease in body weight.
harmful blood clots in a vein or artery, for example:
in a leg or foot (DVT)
in one lung (PE)
heart attack
stroke
mini-stroke or temporary stroke-like symptoms, known as a 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 condition that increases this risk. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

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 "www.agenziafarmaco.it/it/responsabili". By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Do not store above 30 ° C.

Store in the original package to protect from light and moisture.

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 label.

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

Do not use this medicine if you notice changes in the color of the tablets, crumbling of the tablets or any other visible signs of deterioration.

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.

Other Information

WHAT SECURGIN CONTAINS

The active ingredients are: desogestrel (0.150 mg) and ethinyl estradiol (0.020 mg).

The other ingredients are: anhydrous colloidal silica, lactose monohydrate, potato starch, povidone, stearic acid, d / l alpha-tocopherol.

Description of what SECURGIN looks like and contents of the pack

SECURGIN is available in packs of 1, 3 or 6 calendar blisters of 21 tablets contained in a cardboard box.

The tablets are biconvex, round, 6 mm in diameter and encoded with TR4 on one side.

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.

Further information on Securgin 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 ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 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 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST 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 RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

SECURGIN 0.15 MG + 0.02 MG TABLETS

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active ingredients: 0.15 mg of desogestrel and 0.02 mg of ethinylestradiol.

Excipient with known effect: lactose

For the full list of excipients see section 6.1

03.0 PHARMACEUTICAL FORM

Tablets.

White, round, biconvex tablets with a diameter of 6 mm. The tablets are labeled "TR4" on one side and "Organon *" on the other side.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Contraception.

The decision to prescribe SECURGIN 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 SECURGIN and that associated with other Combined Hormonal Contraceptives (COCs). (see sections 4.3 and 4.4).

04.2 Posology and method of administration

Method of taking SECURGIN

The tablets should be taken in the order indicated on the blister, every day at approximately the same time, if necessary with some liquid. The tablets should be taken every day for 21 consecutive days. Subsequent packs should be started after a 7-day tablet-free interval, during which withdrawal bleeding usually occurs. Such bleeding usually occurs 2-3 days after taking the last tablet and may still be present when the next pack is started .

Pediatric population

The safety and efficacy of desogestrel in adolescents below 18 years of age have not been established. There are no data available.

How to start treatment with SECURGIN

No hormonal contraceptive treatment (in the previous month)

The intake of the tablets must begin on the first day of the natural menstrual cycle (ie the first day of menstruation). It is also possible to start between the second and fifth day of the cycle but, in this case, during the first cycle it is recommended to use also a barrier method in the first seven days of taking the tablets.

Changing from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or transdermal patch)

The first tablet of SECURGIN should preferably be taken the day after the last active tablet of the previous COC (ie the last tablet containing the active substance) or at the latest on the day after the usual tablet-free break or the day after. the last placebo tablet of the previous combined oral contraceptive. In the case of previous use of a vaginal ring or transdermal patch, SECURGIN should preferably be started on the same day as the removal of this device, or at the latest on the day intended for subsequent application.

If the woman has used the previous contraceptive method consistently and correctly and is reasonably certain that she is not pregnant, she can also switch from the previous combined hormonal contraceptive treatment to the new one, on any day of the cycle.

The hormone-free interval of the previous method should never be extended beyond the recommended time period.

Changing from a progestogen-only contraceptive (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS)

The woman can change at any time if she is from the minipill (from an implant or an IUS on the day of its removal, from an injectable on the day the next injection should be given), but in any case she should be advised to also use a barrier method of contraception for the first 7 days of tablet-taking.

After a first trimester abortion

It is possible to start immediately without the need for additional contraceptive measures.

After a birth or second-trimester abortion

For breastfeeding women see section 4.6.

The contraceptive should not be started until the 21st-28th day after delivery or after a second trimester abortion. If the intake is postponed, the woman should be advised to also use a barrier method in the first 7 days taking the tablets. However, if intercourse has occurred in the meantime, pregnancy must be ruled out or the first menstruation should be awaited before actually starting the COC.

Irregular intake

If she is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The forgotten tablet should be taken as soon as she remembers and the following tablets should be taken at the usual pace.

If the delay in taking any tablet is more than 12 hours, contraceptive protection may be reduced; in this case the behavior to be followed can be guided by the two basic rules indicated below:

1. Tablet-taking must never be interrupted for more than 7 days.

2. to obtain an "adequate suppression of the hypothalamus-pituitary-ovary axis, it is necessary to take the tablets continuously for 7 days.

As a result, the following tips can be given in daily practice:

• First week

The last missed tablet should be taken as soon as the woman remembers, even if this means taking two tablets at the same time. The other tablets should be taken at the usual rhythm.In addition, a barrier method, such as a condom, should be used for the next 7 days. If intercourse took place during the previous week, the possibility of a pregnancy should be considered. The greater the number of missed tablets and the shorter the pill-free interval, the greater the risk of pregnancy.

• Second week

The last missed tablet should be taken as soon as the woman remembers, even if this means taking two tablets at the same time. The other tablets should be taken at the usual rhythm. It is not necessary to use any additional contraceptive methods, provided that, in the 7 days preceding the first missed tablet, the tablets have been taken correctly; however, if not, or if more than one forgotten tablet, the use of additional precautions for 7 days should be recommended.

• Third week

Given the imminence of the pill-free interval, the risk of reduced contraceptive reliability is greater. However, by changing the pattern of taking the pill, the reduction in contraceptive protection can still be prevented. By adopting either of the following two options, there is therefore no need to use additional contraceptive methods as long as all tablets have been taken correctly in the 7 days preceding the first missed tablet. Otherwise it should be recommended to follow the first of the two options and also to use additional precautions for the next 7 days.

1. The last missed tablet should be taken as soon as the woman remembers, even if this means taking two tablets at the same time. The other tablets should be taken at the usual rhythm. The next pack should be started immediately after finishing the previous one, i.e. without observing the tablet-free interval between the two packs. In this case, withdrawal bleeding is unlikely to occur before the end of the second pack; however, spotting or breakthrough bleeding may occur while taking the tablets.

2. You may also be advised to stop taking tablets from the current pack. You should therefore observe a pill-free interval of up to 7 days, including those in which tablets have been missed, and then continue with a new one. packaging.

If the woman has forgotten to take tablets and does not experience withdrawal bleeding in the first regular tablet-free interval, the possibility of pregnancy should be considered.

Recommendations in case of gastrointestinal disorders

In the presence of severe gastrointestinal disturbances, absorption may not be complete and additional contraceptive measures must be used.

If vomiting occurs within 3-4 hours of taking the tablet, follow the recommendations, if applicable, regarding not taking tablets in the section "Irregular intake". If the woman does not want to change her usual dosage schedule, she should take one or more more extra tablets from a new pack.

Mode for skipping or postponing a period

Postponing a menstruation is not an indication of the product. However, if in exceptional cases it is necessary to postpone a menstruation, one should continue taking SECURGIN tablets from another pack, without observing the tablet-free interval. The tablet-taking can be continued as long as desired, until the end of the second pack. During this period, breakthrough bleeding or spotting may occur. After the usual 7-day tablet-free interval, SECURGIN is regularly resumed.

To shift your period so that it starts on a different day of the week than usual, you can shorten the duration of the next pill-free interval by as many days as you like. The shorter the interval, the greater the risk of not having withdrawal bleeding but rather breakthrough bleeding or spotting while taking the second pack (such as when postponing a period).

04.3 Contraindications

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

Combined hormonal contraceptives (COCs) should not be used in the following conditions. If any of these conditions appear for the first time during the use of the COC, the intake of the product must be stopped immediately.

• Presence or risk of venous thromboembolism (VTE):

o Venous thromboembolism - current VTE (with anticoagulant intake) or history (e.g. deep vein thrombosis [DVT] or pulmonary embolism [PE])

o 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

o Major surgery with prolonged immobilization (see section 4.4)

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

• Presence or risk of arterial thromboembolism (ATE):

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

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

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

o History of migraine with focal neurological symptoms

o A 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

• Pancreatitis, current or past, associated with severe hypertriglyceridemia;

• Severe liver disease, either current or past, until liver function values have returned to normal;

• Liver tumors (benign or malignant), current or previous;

• Known or suspected, hormone-dependent malignant diseases (for example, of the genital organs or the breast);

• Endometrial hyperplasia;

• Vaginal bleeding of an undetermined nature;

• Known or suspected pregnancy.

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 SECURGIN 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 consult her physician to determine whether the use of SECURGIN should be discontinued.

Risk of venous thromboembolism (VTE) The use of any combined hormonal contraceptive (CHC) results in an increased risk of venous thromboembolism (VTE) compared with non-use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with a lower risk of VTE. The risk associated with other products such as SECURGIN can be doubled. 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. VTE associated with SECURGIN, the way its current risk factors affect this risk and the fact that the risk of developing a 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 break of 4 or more 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 estimated1 that out of 10,000 women who use a CHC containing desogestrel, between 9 and 12 will develop a VTE in one year; this compares with approximately 62 women using a levonorgestrel-containing CHC. In both cases, the number of VTEs per year is less than the number expected in pregnancy or in the postpartum period. VTE is fatal in 1-2% of cases.

1 These incidences were estimated from the totality of epidemiological study data, using the relative risks for the different products compared with levonorgestrel-containing COCs.

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

Very rarely, thrombosis has been reported in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries.

• Risk factors for VTE

The risk of venous thromboembolic complications in CHC users may increase substantially if additional risk factors are present, especially if there are more than one risk factors (see table).

SECURGIN 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 COC 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. Particularly 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 Note: Temporary immobilization, including air travel lasting> 4 hours, can also be a risk factor for VTE, especially in women with other risk factors In these situations it is advisable to stop using the patch / pill / ring (in case of elective surgery at least four weeks earlier) and not restart it until two weeks after complete resumption of mobility. To avoid unwanted pregnancy, another method of contraception must be used. If SECURGIN has not been discontinued earlier, antithrombotic treatment should be considered. 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 COCs. Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, hemolytic 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, particularly the 6-week period of the puerperium, must be considered (for information on "Pregnancy and lactation" see section 4.6).

The use of COCs has generally been associated with an increased risk of acute myocardial infarction (AMI) or stroke, which is strongly influenced by the presence of other risk factors (e.g. smoking, high blood pressure and age) (see also below.) These events occur infrequently It has not been studied how SECURGIN modifies the risk of AMI.

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 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). SECURGIN 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 must contact a healthcare professional immediately and inform them that they are taking a COC.

Symptoms of a 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, diploidy;

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

- loss of consciousness or fainting with or without convulsions;

- acute abdomen.

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.

Tumors

• Persistent human papillomavirus (HPV) infection is the most important risk factor in cervical cancer. Epidemiological studies indicate that long-term treatment with a combined oral contraceptive contributes to this increased risk, however there is still uncertainty as to whether this finding is attributable to confounding effects, such as cervical screening methodology and differences in sexual behavior, including the use of barrier contraceptives, or a causal association.

• A meta-analysis of 54 epidemiological studies found that women who are currently using COCs have a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed and that the excess risk gradually disappears over time. during the 10 years following the interruption of the treatment.Since breast cancer is rare in women under the age of 40, the number of extra cases of breast cancer diagnosed in women taking or recently taking a COC is low compared to the overall risk of breast cancer. . These studies provide no evidence of this causal relationship. The observed increased risk may be due to an earlier diagnosis of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both. Breast cancer diagnosed in oral contraceptive users tends to be less clinically advanced than that diagnosed in women who have never used an oral contraceptive.

• Benign liver tumors and, even more rarely, malignant liver tumors have been reported rarely in women taking COCs. In isolated cases, these tumors have resulted in life-threatening intra-abdominal haemorrhage. If a woman taking a combined oral contraceptive develops severe upper abdominal pain, liver enlargement, or signs suggestive of intra-abdominal haemorrhage, the possibility of liver cancer should be considered in the differential diagnosis.

Other conditions

• Women with hypertriglyceridaemia or a family history of this condition may have an increased risk of pancreatitis when taking COCs.

• Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are a rare event. A relationship between the use of COCs and the occurrence of clinically significant hypertension has not been established. However, if clinically significant and sustained hypertension occurs during the use of a COC, the physician should proceed with caution. taking the combined oral contraceptive and treating hypertension. If appropriate, COC use can be resumed if normal blood pressure values have been achieved with antihypertensive therapy.

• The onset or worsening of the conditions listed below has been reported both during pregnancy and while taking COCs; however, there is no conclusive evidence of a correlation between these conditions and the use of COCs: jaundice and / or pruritus from cholestasis; gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis hearing loss, angioedema (hereditary).

• Acute or chronic disturbances of liver function may require discontinuation of COC treatment until markers of liver function have returned to normal. Return of cholestatic jaundice that first occurred in pregnancy or during previous treatment with sex steroids requires discontinuation of the combined oral contraceptive.

• Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no evidence for the need for adjustment of the treatment regimen in diabetic patients using low-dose combined oral contraceptives (containing

• Crohn's disease and ulcerative colitis have been reported in association with the use of combined oral contraceptives.

• Chloasma may occasionally appear, especially in women with a history of chloasma gravidarum. While taking COCs, patients with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation.

• Women who become significantly depressed while taking COCs should stop treatment and use an alternative method of contraception to determine if this symptom is drug-related. Women with a history of depression should be closely monitored and treatment should be stopped if severe depression occurs.

Important information about some of the excipients

SECURGIN contains lactose monohydrate tablet. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.

When choosing a contraceptive method, all of the above information must be taken into consideration.

Medical examinations / visits

Before initiating or resuming use of SECURGIN, a complete medical history (including family history) should be taken and pregnancy should be ruled out. Blood pressure should be measured and a clinical examination, guided by contraindications, should be performed (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 SECURGIN 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 combined oral contraceptives may decrease, for example, in case of missed intake of one or more tablets (see section 4.2 section "Irregular intake"), gastrointestinal disturbances (see section 4.2 section "Recommendations in case of gastrointestinal complaints") or concomitant use of other medicinal products (see section 4.5).

Reduction of cycle control

Irregular vaginal bleeding (spotting or breakthrough bleeding) may occur while taking any COC, especially in the first months of treatment. Therefore, the evaluation of any irregular vaginal bleeding is only meaningful after a settling phase lasting 4 months. about three courses of treatment.

If irregular bleeding persists or occurs after previously regular cycles, a non-hormonal etiology should be considered and appropriate diagnostic measures should be implemented to rule out malignancy or pregnancy. These may include scraping.

In some women, withdrawal bleeding may not occur during the tablet-free interval. If the COC has been taken as described in section 4.2, it is unlikely that the woman is pregnant. COC has not been taken according to these indications or if two withdrawal bleeds have not occurred, pregnancy must be ruled out before continuing to take the COC.

04.5 Interactions with other medicinal products and other forms of interaction

Interactions

Interaction between oral contraceptives and other medicinal products may lead to breakthrough bleeding and / or failure of the oral contraceptive to work. The following interactions have been reported in the literature:

Hepatic metabolism: interactions may occur with medicinal products that induce microsomal enzymes which may lead to increased clearance of sex hormones (e.g. hydantoins, barbiturates, primidone, bosentan, carbamazepine, rifampicin, rifabutin, modafinil and possibly also oxcarbazepine, topiramate, felbamato, ritonavir, griseofulvin and products containing St. John's wort). HIV protease inhibitors with a potential inducer (e.g. ritonavir and nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine and efavirenz) may also affect hepatic metabolism.

Maximal enzyme induction usually occurs only after 2-3 weeks, but can then persist for at least 4 weeks after stopping drug treatment.

Failure of oral contraceptive efficacy has also been reported with antibiotics such as ampicillins and tetracyclines. The mechanism of this effect has not been elucidated.

Women undergoing treatment with one or more of these medicines, in addition to taking the combined oral contraceptive, must temporarily adopt a barrier method, or opt for another method of contraception. In the case of treatment with microsomal enzyme-inducing medicinal products, a barrier method should be used together with the combined oral contraceptive for the entire time of concomitant medication intake and for 28 days after discontinuing them. In case of long-term treatment with microsomal enzyme-inducing drugs, another method of contraception should be considered. Women on antibiotic therapy (with the exception of rifampicin and griseofulvin, which also act as microsomal enzyme-inducing drugs ) must use the barrier method up to 7 days after the end of antibiotic therapy. If the period during which the barrier method is used continues after the end of a COC pack, the next COC pack should be started without observing the usual tablet-free interval.

Oral contraceptives can interfere with the metabolism of other medicines. Consequently, plasma and tissue concentrations may increase (e.g. cyclosporine) or decrease (e.g. lamotrigine).

Note: The prescribing information of the medicinal products to be taken in combination should be consulted in order to identify potential interactions.

Laboratory tests

The use of contraceptive steroids can influence the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (transport) proteins, for example of corticosteroid-binding globulin and fractions lipid / lipoprotein, glucose metabolism, coagulation and fibrinolysis parameters The changes are generally within the range of normal laboratory values.

04.6 Pregnancy and breastfeeding

Pregnancy

SECURGIN is not indicated during pregnancy. If pregnancy occurs during treatment with SECURGIN, its administration should be discontinued. However, most epidemiological studies have not found an increased risk of birth defects in children born to women who had used COCs before pregnancy, nor any teratogenic effects if a contraceptive was inadvertently taken early in pregnancy. combined oral.

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

Feeding time

Breastfeeding can be influenced by COCs, as they can reduce the quantity and change the composition of breast milk. The use of COCs should therefore be discouraged until the end of breastfeeding. Small amounts of steroids. contraceptives and / or their metabolites may be excreted in milk, but there is no evidence that this adversely affects the health of the baby.

04.7 Effects on ability to drive and use machines

No effects on the ability to drive or use machines have been observed.

04.8 Undesirable effects

As with all COCs, changes in the characteristics of vaginal bleeding may occur, especially in the first months of treatment. These changes may include changes in the frequency (absent, reduced, more frequent or continuous), in the intensity (reduced or increased) or in the duration of bleeding.

Undesirable effects possibly related to the product that have been reported in users of SECURGIN or a combined oral contraceptive in general are shown in the table below3

All adverse reactions are listed by system organ class and frequency: common (≥1 / 100,

System and organ classification Common (≥ 1/100 e Uncommon (≥ 1 / 1,000 and Rare (≥1 / 10,000 e Disorders of the immune system Hypersensitivity Metabolism and nutrition disorders Fluid retention Psychiatric disorders Depressed mood, mood changes Reduction of libido Increased libido Nervous system disorders Headache Migraine Eye disorders Contact lens intolerance Gastrointestinal disorders Nausea, abdominal pain Vomiting, diarrhea Skin and subcutaneous tissue disorders Rash, hives Erythema nodosum, erythema multiforme Diseases of the reproductive system and breast Breast pain, breast tenderness Breast hypertrophy Vaginal secretions, breast secretions Diagnostic tests Weight gain Weight loss Vascular pathologies Venous thromboembolism (VTE), Arterial thromboembolism (ATE)

3 The MedDRA term best suited to describe a certain adverse reaction is reported. No synonyms or related conditions are reported; nevertheless, they too must be taken into consideration.

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 CHC users, and this risk is discussed in more detail in section 4.4.

The following have also been reported: hypertension, hormone-dependent tumors (eg liver tumors, breast cancer), chloasma.

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 www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose

No serious adverse effects from overdose have been reported.

Symptoms such as nausea, vomiting and, in girls, mild vaginal bleeding may occur in this circumstance.

There are no antidotes and any treatment must be symptomatic.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: systemic hormonal contraceptives, estrogen-progestogen fixed combinations.

ATC code: G 03 AA 09.

The effect of COCs is based on the interaction of various factors; the most important are the inhibition of ovulation and the modifications of the cervical secretion. In addition to protecting against the risk of pregnancy, COCs have several positive properties which, alongside the negative ones (see section 4.4 and section 4.8), may be useful in choosing the birth control method to be adopted. The menstrual cycle is more regular, menstruation is often less painful and bleeding is less abundant. This latter situation can determine a decrease in the incidence of iron deficiency. There is also evidence of a reduced risk of fibrocystic breast tumors, ovarian cysts, pelvic inflammatory disease, ectopic pregnancy, and endometrial and ovarian cancer with higher dose combined oral contraceptives (50 mcg ethinyl estradiol). Whether this also applies to lower-dose combined oral contraceptives remains to be confirmed.

05.2 Pharmacokinetic properties

Desogestrel

ABSORPTION

After oral administration, desogestrel is rapidly and completely absorbed and converted to etonogestrel. Peak serum levels are reached in about 1.5 hours. Bioavailability is 62-81%.

DISTRIBUTION

Etonogestrel binds to serum albumin and sex hormone binding globulin (SHBG). Only 2-4% of total serum drug concentrations are present as a free steroid, while 40-70% binds specifically to "SHBG. The" ethinylestradiol-induced increase in SHBG affects distribution relative to serum proteins, resulting in a increase of the fraction bound to SHBG and a reduction of the fraction bound to albumin. The apparent volume of distribution of desogestrel is 1.5 l / kg.

Biotransformation

Etonogestrel is completely metabolised by known metabolic pathways of steroids. The extent of metabolic clearance in serum is approximately 2 ml / min / kg. No interactions were noted with the concomitant administration of ethinylestradiol.

ELIMINATION

Serum levels of etonogestrel decrease in a biphasic manner. The final phase of elimination is characterized by a half-life of approximately 30 hours. Desogestrel and its metabolites are excreted via the urinary and biliary routes at a ratio of approximately 6: 4.

STATIONARY CONDITIONS

The pharmacokinetics of etonogestrel are influenced by SHBG levels, which are tripled by ethinylestradiol. After daily administration, serum levels of the drug increase approximately 2 to 3-fold, reaching steady state in the second half of the treatment cycle.

Ethinylestradiol

ABSORPTION

Orally administered ethinylestradiol is rapidly and completely absorbed. Peak serum levels are reached in 1-2 hours. Absolute bioavailability after presystemic conjugation and first pass metabolism is approximately 60%.

DISTRIBUTION

Ethinylestradiol is largely, but not specifically, bound to serum albumin (approximately 98.5%) and induces an increase in plasma SHBG concentrations. An apparent volume of distribution of approximately 5 l / kg has been determined. .

Biotransformation

Ethinylestradiol is subject to presystemic conjugation at the level of both the mucosa of the small intestine and the liver. The main metabolic pathway of ethinylestradiol is aromatic hydroxylation but a wide range of hydroxylated and methylated metabolites are also formed, present as free metabolites and conjugated with glucuronides and sulphates. The extent of metabolic clearance is approximately 5 ml / min / kg.

ELIMINATION

Serum levels of ethinylestradiol decrease biphasic. The final elimination phase is characterized by a half-life of approximately 24 hours. Unchanged drug is not excreted, ethinylestradiol metabolites are excreted via the urinary and biliary routes with a ratio of 4: 6. The half-life of metabolite excretion is approximately 1 day.

STATIONARY CONDITIONS

Steady state concentrations are reached after 3-4 days, when serum drug levels are 30-40% higher than single administration.

05.3 Preclinical safety data

Preclinical data did not reveal any specific risks for humans when COCs are taken as recommended. This is the finding of conventional studies on repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity. However, it should be remembered. that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.