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Package leaflet: Information for the user

Gestodette 0.075 mg / 0.02 mg coated tablets and

Important things to know about combined hormonal contraceptives (CHCs):  They are one of the most reliable reversible methods of contraception if used correctly  They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks  Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)

Read all of this leaflet carefully before you start taking this because it contains important information for you.  Keep this leaflet. You may need to read it again.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet 1. What Gestodette is and what it is used for 2. What you need to know before you take Gestodette 3. How to take Gestodette 4. Possible side effects 5. How to store Gestodette 6. Contents of the pack and other information

1. What Gestodette is and what it is used for

Gestodette 0.075 mg / 0.02 mg coated (also referred to shortly as Gestodette) is an oral contraceptive containing a combination of two female sex . It can be used to prevent unwanted .

The two types of hormones are ethinylestradiol (it has -like effects) and gestodene (it has effects like the natural luteal , progesteron). Because of the two kinds of hormones it belongs to the so called ‘combined’ products and because of the identical tablets to the ‘monophasic’ tablets.

The oral contraceptives are very effective tools of family planning. If taken precisely according to the guidance (without missed pills), it provides almost full protection against unwanted pregnancy.

2. What you need to know before you take Gestodette

General notes

Before you start using Gestodette you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”.

In this Patient Information Leaflet we outlined several scenarios when you have to stop taking Gestodette or its contraceptive potential is decreased. In these cases you have to avoid sexual intercourse or you should use a non-hormonal method (e.g. ) or an extra barrier method of contraception. Don't use calendar or temperature methods since oral contraceptives make these methods unreliable.

As with other combined oral contraceptives taking Gestodette does not protect you against HIV- (AIDS) or other sexually transmitted diseases

Do not take Gestodette

You should not use Gestodette if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of would be more appropriate.

 if you are allergic to ethinylestradiol, gestodene or any of the other ingredients of this medicine (listed in section 6)  if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;  if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, or antiphospholipid antibodies;  if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’)  if you have ever had a heart attack or a 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 ischaemic attack [TIA – temporary stroke symptoms]);  if you have any of the following diseases that may increase your risk of a clot in the arteries: – severe with blood vessel damage – very high blood pressure – a very high level of fat in the blood ( or triglycerides) – a condition known as hyperhomocysteinaemia  if you have (or have ever had) a type of called ‘migraine with aura’  have or have had inflammation of the pancreas with high blood levels of certain lipids;  have active severe disease or positive patient history for it with laboratory parameters of the liver not yet normalized;  have known or suspected tumors of genital organs or breasts;  have active liver tumor (benign or malignant) or a positive patient history for it;  notice vaginal bleeding of unknown origin;  are or might be pregnant.  if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ and dasabuvir or glecaprevir/pibrentasvir (see also in section Other and Gestodette).

If you experience any of the disorders listed above while taking Gestodette, immediately stop taking the pill and contact your doctor. In the meantime non-hormonal methods of contraception should be employed.

Warnings and precautions

When should you contact your doctor? Seek urgent medical attention - if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (ie deep vein thrombosis), a blood clot in the lung (ie ), a heart attack or a stroke (see ‘Blood clots section below). For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.

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

In some conditions combined contraceptives can be taken only under close medical supervision. If the condition already exists, develops, or gets worse while you are using Gestodette, you should tell your doctor.

- if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease); - if you have systemic lupus erythematosus (SLE –; a disease affecting your natural defence system); - if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys); - if you have sickle cell anaemia (an inherited disease of the red blood cells); - if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas); - if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’); - if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Gestodette; - if you have an inflammation in the veins under the skin (superficial thrombophlebitis); - if you have varicose veins; - if you smoke; - if you have diabetes mellitus; - if you have (body mass index is above 30 kg/m2); - if you have hypertension; - if you have valvular heart disease or cardiac rhythm disorders; - if any of your closest relatives had thrombosis, heart attack, or stroke; - if you have migraine; - if you have seizures (epilepsy); - if you have or bilious complaints; - if you have a desease, which occurred during your pregnancy or during use of sex hormones (e.g. hard of hearing; a red pigment production disorder in the blood with sensitivity of the skin to light between others (); blister like rash in later stages of your pregnancy (herpes gestationis); nerve desease with sudden, unwanted movements of the body (Sydenham chorea); - if you have or previously had yellowish-brown patches on the skin, especially on the face (chloasma); if this applies to you, you should avoid direct sunshine or ultraviolet light.

If you experience any of the disorders listed above while taking Gestodette, contact your doctor.

Psychiatric disorders: Some women using hormonal contraceptives including Gestodette have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Gestodette 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 (referred to as a ‘’, ‘venous thromboembolism’ or VTE) . in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE). Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.

It is important to remember that the overall risk of having a harmful blood clot due to any Gestodette is small.

HOW TO RECOGNISE A BLOOD CLOT Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs? What are you possibly suffering from?  swelling of one leg or along a vein in the leg or foot Deep vein thrombosis especially when accompanied by:  pain or tenderness in the leg which may be felt only when standing or walking  increased warmth in the affected leg  change in colour of the skin on the leg e.g. turning pale, red or blue

 sudden unexplained breathlessness or rapid breathing; Pulmonary embolism  sudden cough without an obvious cause, which may bring up blood;  sharp chest pain which may increase with deep breathing;  severe light headedness or dizziness;  rapid or irregular heartbeat  severe pain in your ;

If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (eg a

‘common cold’). Symptoms most commonly occur in one eye: Retinal vein thrombosis  immediate loss of vision or (blood clot in the eye)  painless blurring of vision which can progress to loss of vision

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

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

Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke..  swelling and slight blue discolouration of an extremity; Blood clots blocking other  severe pain in your stomach (acute abdomen) 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 connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of 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 may form in a vein 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 also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more. After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive. When you stop Gestodette your risk of 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 a blood clot in the leg or lung (DVT or PE) with Gestodette is small. - Out of 10,000 women who are using a combined hormonal contraceptive that contains , , or 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 gestodene such as Gestodette between about 9 and 12 women will develop a blood clot in a year. - The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below)

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

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot with Gestodette is small but some conditions will increase the risk. Your risk is higher:  if you are very overweight (body mass index or BMI over 30kg/m2);  if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (eg. below the age of about 50). In this case you could have a hereditary blood clotting disorder;  if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of Gestodette may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Gestodette ask your doctor when you can start using it again.  as you get older (particularly above about 35 years);  if you gave birth less than a few weeks ago The risk of developing a blood clot increases the more conditions you have. Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed. It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Gestodette needs to be stopped.

If any of the above conditions change while you are using Gestodette, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke from using Gestodette is very small but can increase:  with increasing age (beyond about 35 years);  if you smoke. When using a combined hormonal contraceptive like Gestodette you are advised to stop smoking. If you are unable to stop smoking and are older than 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 then about 50). In this case you could also have a higher risk of having a heart attack or stroke;  if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);  if you get , especially migraines with aura;  if you have a problem with your heart (valve disorder, disturbance of the rhythm 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 increased even more. If any of the above conditions change while you are using Gestodette, for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

Stop taking the pill and contact your doctor if you notice probable signs of thromboembolism (see “When should you visit your doctor?”)

Gestodette and the risk of cancer

Breast cancer has been found slightly more often in women who use the pill than in those not using it. 10 years after stopping the pill this small difference disappears. It is not certain whether it is caused by the pill. Women using the pill are examined more often, so that between others is noticed in an earlier stage.

In rare cases benign liver tumors – and even more rarely malignant liver tumors – have been reported in users of the pill. These tumors may lead to internal (abdominal) bleeding. You should contact your doctor immediately, if you have severe pain in your stomach.

The most important risk factor of the cancer is the active human papilloma virus (HPV) infection. Some studies have shown that there are more cases of cervix cancer among women using the pill for a long time. However, it is not at all certain whether this is caused by the pill, because the incidence of

cervix cancer is affected by many other factors, e.g. by the sexual behavior (e.g. changing partners frequently).

Other medicines and Gestodette

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Gestodette. They can tell you if you need to take additional contraceptive precautions (for example ) and if so, for how long, or, whether the use of another medicine you need must be changed.

Some medicines can have an influence on the blood levels of Gestodette and can make it less effictive in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for the treatment of:: - epilepsy (e.g. primidon, , , carbamazepin, oxcarbazepin, topiramat and felbamat); - tuberculosis (e.g. ); - HIV and Hepatitis C Virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such asritonavir, , ) - fungal (e.g. , ) - arthritis, arthrosis (etoricoxib) - high blood pressure in the blood vessels in the lungs () - containing the herbal remedy St John's wort (), used mainly for treatment of depressive mood.

Do not use Gestodette if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir as this may cause increases in liver function blood test results (increase in ALT liver ). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Gestodette can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Gestodette”.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, if you think you might be pregnant, or are planning to have a baby do not take Gestodette. If you suspect that you became pregnant while taking Gestodette, contact your doctor immediately. The use of combined oral contraceptives during lactation may lead to a reduction in the volume of milk produced and to a change in its composition. Mothers who are breast-feeding are advised not to take Gestodette.

Driving and using machines

Gestodette does not affect driving and operating machinery.

When should you visit your doctor?

Your doctor might tell you to return for regular check-ups while you are on the pill, in most cases this is needed once a year.

Contact your doctor as soon as possible if you experience any of the followings:

- if you experience any change in your health status (see especially symptoms described in this leaflet), or the disorders mentioned in the leaflet develop in your close family; - if you can palpate a node in your breast; - if you have to take other medicines; - before a planned major operation or immobilization (ask your doctor at least 4 weeks before); - if you experience unusually strong vaginal bleeding; - if you forgot to take one or more pills during the first week of the treatment or you had sexual intercourse in the preceding 7 days; - if you did not have withdrawal bleeding for two occasions in a row, or you suspect that you are pregnant (the next pack of Gestodette can only be started if your doctor considers this safe).

Stop taking Gestodette and contact your doctor with no delay if you experience the following symptoms and conditions suspect to be signs of thrombosis: - if you have sudden, persistent coughing; - if you have sudden severe pain in the chest, whether or not reaching to the left arm; - if you have sudden breathlessness; - if you have unusual severe, prolonged headache or migraine attackes on one side of your head; - in the case of sudden partial or complete loss of vision or diplopia; - if your speech becomes blurred or it is difficult to speech; - if you notice sudden changes to your hearing, sense of smell or taste; - if you feel dizziness or collapse with or without focal epilepsy; - if you notice weakness or very marked numbness suddenly affecting one side or one part of the body; - if you have severe pain in your belly; - if you have severe pain or swelling in your leg(s). More details on the above listed conditions can be read in other parts of this leaflet.

Gestodette contains lactose and saccharose. If you know that you have hypersensitivity to some types of sugars, ask your doctor before taking Gestodette.

3. How to take Gestodette

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Every package of Gestodette contains 21 or 3x21 coated tablets. The day of the week when each coated tablet should be taken is indicated on the blister pack.

You should try to take the pill at the same time every day, with some fluid if necessary. Take one pill each day, following the direction of the arrows, until you have finished the pack. You have 7 days when you take no pill. During this "pill-free" 7 days you should have a withdrawal bleeding, usually 2-3 days after you have taken the last pill.

Start taking your next pack of Gestodette on the 8th day after you took the last pill. You should start taking your next pack of Gestodette even if you are still bleeding. Each new pack will begin on the same day of the week as the one before, so it is easy to remember when to start again, moreover your cycle will always be on the same days of the month.

If you follow the instructions the pill protects you from unwanted pregnancy from the first day of treatment.

Taking your first pack of Gestodette

No previous application of in the last month: Take one coated tablet each day, starting on the first day of the To help you track your doses take the pill marked with the correct day of the week.

Changing to Gestodette from a combined contraceptive: The first coated tablet should be taken on the first day immediately after the last coated tablet (without a “pill-free” period). If there were inactive (hormone free) coated tablets in your previous products as well, Gestodette should be started after the last active (hormone containing) coated tablet. If you are not sure which coated tablets are the active ones, ask your doctor or pharmacist.

Changing from a monocomponent -only product (minipill): Women taking progestogen-only minipills can change at any time to Gestodette and it can be taken on the next day (in the usual time). In this case additional contraceptive precautions (e.g. barrier methods) will be required for the first 7 days of pill-taking.

If you had contraceptive injection or used a or an containing levonorgestrel (IUS): Those using implants or IUS can start on the day when the implant or IUS is removed. Women receiving injections can start taking coated tablets when the next injection is due. In all of these cases additional contraceptive precautions (e.g. barrier methods) will be required for the first 7 days of pill-taking.

After having a baby: If you have just had a baby, your doctor may advise you to start taking Gestodette after your first period. However in some cases you can start hormonal contraception earlier, please ask your doctor. You must not breastfeed if you take Gestodette, unless it was ordered by your doctor.

After or miscarriage: Follow the instructions of your doctor.

Ask your doctor or pharmacist if you think that Gestodette is too strong or too week for you.

If you take more Gestodette than you should

No severe harm caused by overdose of Gestodette has been observed. Overdose may cause nausea, vomiting and, in young girls, withdrawal bleeding. If you notice that a child has probably taken several coated tablets, contact your doctor with no delay.

What to do if you want to stop Gestodette?

You can stop taking Gestodette at any time. If you do not want to be pregnant, ask your physician about other, reliable contraceptive methods. If you have any further questions on the use of this medicine, ask your doctor, or pharmacist.

If you forget to take Gestodette

If the forgotten coated tablet is taken within 12 hours, no further precautions are necessary; the product should be taken as soon as possible and further coated tablets should be taken at the usual time. Contraceptive protection of Gestodette should not be affected.

If a coated tablet is forgotten for more than 12 hours, contraceptive protection will be reduced. The risk for an unwanted pregnancy is extremely high if you forgot to take the pill at the start or at the end of the package. In this case the following rules have to be applied.

- If you forgot to take one coated tablet on the first week: You should take the last forgotten coated tablet even if this means taking two coated tablets in one day and then continue to take coated tablets at the normal time. Additional contraceptive precautions (e.g. condom) should be taken for the next seven days. However, if sexual intercourse has already preceded in the previous seven days, pregnancy cannot be excluded. In this case inform your doctor with no delay. - If you forgot to take one coated tablet on the second week: You should take the last forgotten coated tablet even if this means taking two coated tablets in one day and then continue to take coated tablets at the normal time. If you have taken the coated tablets regularly on the preceding 7 days, no additional contraceptive precautions should be taken. - If you forgot to take one coated tablet on the third week: By using the next protocols, no additional contraceptive precautions should be taken, given that you have taken the coated tablets regularly on the preceding 7 days.

You have two choices: 1. You should take the last forgotten coated tablet even if this means taking two coated tablets in one day and then continue to take coated tablets at the normal time. The next pack must be started as soon as the current one is finished, i.e. no gap should be left between packs. You will not have a withdrawal bleeding until the end of the second pack and you might experience some spotting or break-through bleeding on tablet taking days.

2. The second option is that you do not continue the pack already in use, but observe a maximum seven-day-long tablet free period (days when the coated tablet were missed should be counted), then you carry on with a new pack. If you want to start your new package on the usual day of the week, the “pill-free” period can be shorter than 7 days!

- If you forgot to take more than one coated tablet: Ask your doctor. Do not forget that there is no effective contraception in this case!

If several coated tablets were missed from the current package and there is no withdrawal bleeding in the first tablet-free period, there is a high possibility of a pregnancy. You are adviced to contact your doctor before starting a new package of Gestodette.

Gastro-intestinal upset

If vomiting or severe diarrhea occurs within 3-4 hours after coated tablet intake, a coated tablet may not be absorbed properly from the gastrointestinal truct. The situation is similar as if you had forgotten to take a coated tablet. In this case a coated tablet should be taken as soon as possible, possibly within 12 hours. After more than 12 hours, directions in section „ If you forget to take Gestodette” should be followed to take missed coated tablets.

Delaying the time of menstrual bleeding

You can delay the time point of bleeding if after having finished the previous package, you continue taking Gestodette without a drug-free interval. bleeding can be delayed until the end of the second pack, or if it is necessary, for a shorter period. During the application of the second pack you might

experience some spotting or break-through bleeding on tablet taking days. After finishing the second pack 7 tablet-free days have to elapse, then application of Gestodette can recommence.

If you want to have the start of the menstrual cycle on a different day

If you followed the instructions while taking the coated tablets, your cycle will be approximately on the same day every four weeks. If you want to have the start of the menstrual cycle on a different day of the week, length of the tablet-free interval should be decreased as necessary. Never elongate the tablet-free interval! Let’s say that you usually have your cycle on Friday, but you would like to have it on Tuesday (thus, three days earlier). To achieve this start to take coated tablets from the next package three days earlier. However, if the tablet-free period is too short (3 days or shorter) there is no withdrawal bleeding but spotting or break-through bleeding during the application of the second pack can occur.

What if you have bleeding between periods?

In some cases women taking combined oral contraceptives may have a little break-through bleeding or spotting, especially during the first few months. It might be necessary to use tampons or hygienic pads; but you should keep taking the pills. When your body becomes adapted to the effects of the coated tablets, irregular bleeding will disappear; usually this takes three cycles. If the bleeding keeps on, is more intense or is returning, talk to your doctor.

What to do if withdrawal bleeding did not occur?

If the coated tablets have been taken correctly, according to the instructions and vomiting or diarrhea did not occur, pregnancy is very unlikely. You should take Gestodette as usual. If you miss your period twice in a row, you might be pregnant. Contact your doctor with no delay. You can continue taking Gestodette after pregnancy test was performed and your doctor suggested doing so.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any , particularly if severe and persistent, or have any change to your health that you think may be due to Gestodette, please talk to your doctor. An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use Gestodette”.

Severe side effects

For the most severe side effects in women taking combined oral contraceptives see section „ Warnings and precautions“. If necessary, turn to immediate medical help.

Other possible side effects

The side effects listed in the table were observed in women taking combined oral contraceptives. The following classification was used to specify the frequency of side effects:

Very common in more than 1 case of 10 treated women Common: between 1 and 10 cases of 100 treated women Uncommon: between 1 and 10 cases of 1000 treated women Rare: between 1 and 10 cases of 10000 treated women Very rare: in less than 1 case of 10000 treated women, including sporadic cases

Organ system Frequency of undesirable effects Common Uncommon Rare Very rare Cardiac disorders arterial hypertension

Vascular harmful blood clots disorders in a vein or artery. (please see the examples after the table) Infections and vaginitis, including infestations vaginal Immune system anaphylactic exacerbation of disorders reactions with very systemic lupus rare cases of erythematosus urticaria, angioneurotic edema, circulatory and respiratory disorders and change in weight change in plasma glucose intolerance exacerbation of nutrition disorders lipids, including porphyria hypertriglyceridemia; change in appetite (increase or decrease) Psychiatric change in mood, disorders including depression, change in Nervous system nervousness, exacerbation of disorders dizziness chorea Eye disorders irritation by contact retinal vascular lenses thrombosis, optic neuritis Gastrointestinal abdominal pain, abdominal cramps, pancreatitis, disorders nausea, vomiting bloating Hepatobiliary cholestatic icterus hepatocellular disorders carcinoma, hepatic adenoma, biliary lithiasis, cholestasis Skin and rash, chloasma erythema nodosum erythema subcutaneous (melasma) with risk multiforme tissue disorders of persistence, , alopecia Renal and urinary uremic hemolytic disorders syndrome

Reproductive and system and breast tension, , disorders , change in vaginal and menstruation General disorders fluid retention, and edema administration site conditions

 Examples for harmful blood clots in a vein: o in a leg or foot (ie DVT) o in a lung (ie PE) o heart attack o stroke o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA) o blood clots in the liver, stomach/intestine, kidneys or eye.

The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).

The pill and breast cancer

The risk of breast cancer is slightly increased in women taking combined oral contraceptives. However since the risk for the development of breast cancer below the age of 40 is small, the risk of breast cancer is small compared to the total risk. Sexual hormones influence mammary glands. Changes in the hormonal milieu (e.g. because of hormonal contraceptive use) may lead to a hormonal environment where susceptibility of the mammary glands to other factors promoting cancer development is enhanced, thus probability of cancer development is increased. Some studies acknowledge that the risk of development of breast cancer in middle age women is related to the early start and extended application of combined oral contraceptives.

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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

5. How to store Gestodette

Keep this medicine out of the sight and of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 30 °C. Keep the blister in the outer carton in order to protect from light.

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

6. Contents of the pack and other information

What Gestodette contains

The active substances are 0.075 mg gestodene and 0.02 mg ethinylestradiol.

The other ingredients are: Tablet core: sodium edetate lactose-monohydrate maize starch povidone K25 stearate

Coating sucrose povidone K90F macrogol 6000 calcium carbonate talc wax montan glycol.

What Gestodette looks like and the contents of the pack

Gestodette is a white, round, biconvex, shiny coated tablet. Gestodette is available in packages containing 21 or 3x21 coated tablets.

Marketing Authorisation Holder

<[To be completed nationally]>

Manufacturer

Haupt Pharma Münster GmbH Schleebrüggenkamp 15, 48159 Münster Germany

Pharma Pack Hungary Kft Vasút u. 13. 2040 Budaörs Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic Stodette coated tablets Bulgaria Gestodette 0.075 mg / 0.02 mg coated tablets

Hungary Stodette 0.075 mg / 0.02 mg coated tablets

Romania Stodette 0.075 mg / 0.02 mg coated tablets

Gestodette coated tablets Slovak Republic

This leaflet was last revised in: 12/2018