Silvie 30

Patient Information Leaflet: User Information

Sylvie 20,20 µg + 75 µg, sugar-coated tablets
Sylvie 30,30 µg + 75 µg, sugar-coated tablets
Ethinylestradiol + Gestodene

Important Information About Combined Hormonal Contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after restarting use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood Clots").

It is Essential to Carefully Read the Leaflet Before Taking the Medication, as it Contains Important Information for the Patient

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Sylvie 20, Sylvie 30 and what is it used for
• 2. Important information before taking Sylvie 20, Sylvie 30
• 3. How to take Sylvie 20, Sylvie 30
• 4. Possible side effects
• 5. How to store Sylvie 20, Sylvie 30
• 6. Contents of the pack and other information

1. What is Sylvie 20, Sylvie 30 and what is it used for

Sylvie 20, Sylvie 30 is a combined oral contraceptive.
Each tablet contains a small amount of two different female hormones. These are: ethinylestradiol
(estrogen) and gestodene (progestogen). Due to the low hormone content, Sylvie 20, Sylvie 30
is classified as a low-dose contraceptive.
Indications for use
Prevention of pregnancy.
Oral contraception is a very effective method of preventing pregnancy. During correct use of oral hormonal contraceptives, the likelihood of becoming pregnant is very low.

2. Important information before taking Sylvie 20, Sylvie 30

General Notes

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Before starting to take Sylvie 20, Sylvie 30, the information about blood clots (thrombosis) in section 2 should be read.
It is especially important to read about the symptoms of blood clots (see section 2 "Blood Clots").
Sylvie 20, Sylvie 30 should not be taken if the patient has any of the conditions listed below. If the patient has any of these conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method would be more suitable.

When Not to Take Sylvie 20, Sylvie 30

• if the patient is allergic to ethinylestradiol or gestodene or any of the other ingredients of this medication (listed in section 6);
• if the patient currently has (or has ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have a blood clotting disorder - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section "Blood Clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (temporary stroke-like symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if the patient has (or has ever had) a type of migraine called "migraine with aura";
• if the patient has (or has ever had) pancreatitis (inflammation of the pancreas) with high levels of fats in the blood (severe hypertriglyceridemia);
• if the patient has (or has ever had) severe liver disease (until liver function tests have returned to normal);
• if the patient has (or has ever had) liver tumors, either benign or malignant;
• if the patient has (or has ever had) hormone-dependent tumors, such as breast cancer or cancer of the genital organs;
• if the patient has undiagnosed vaginal bleeding;
• if the patient is pregnant or suspects they may be pregnant;
• if the patient has hepatitis C and is taking antiviral medications containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section 2 "Sylvie 20, Sylvie 30 and other medications").

Warnings and Precautions

When to Exercise Particular Caution When Taking Sylvie 20, Sylvie 30:

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When should a doctor be contacted?
A doctor should be contacted immediately

• -if the patient notices any of the symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood Clots"). To get a description of these serious side effects, see "How to recognize a blood clot".

If Sylvie 20, Sylvie 30 is taken in any of the following situations, close medical supervision is necessary.

Tell a Doctor if the Patient Has Any of the Following Conditions.

A doctor should also be told if these conditions first occur, get worse, or come back while taking Sylvie 20, Sylvie 30.

• If the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system).
• If the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure).
• If the patient has sickle cell disease (an inherited disease of the red blood cells).
• If the patient has high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis.
• If the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with difficulty breathing, they should contact a doctor immediately. Estrogen-containing products may cause or worsen symptoms of hereditary and acquired angioedema.
• If the patient needs to have surgery or will be immobilized for a long time (see section "Blood Clots").
• If the patient has recently given birth, as they are at a higher risk of blood clots. A doctor should be consulted to determine how soon after giving birth they can start taking Sylvie 20, Sylvie 30.
• If the patient has superficial thrombophlebitis (blood clots in the veins under the skin).
• If the patient has varicose veins.

If any of the above conditions occur for the first time, come back, or get worse while taking Sylvie 20, Sylvie 30, a doctor should be contacted.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Sylvie 20, Sylvie 30, is associated with an increased risk of blood clots, compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also known as "arterial thromboembolism").

Not everyone who gets a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.
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Remember that the Overall Risk of a Blood Clot Due to Sylvie 20, Sylvie 30 is Small.

HOW TO RECOGNIZE A BLOOD CLOT

A doctor should be contacted immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
Why might the patient be suffering from
these symptoms?

• Swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in the color of the leg skin, such as pallor, redness, or purple discoloration; Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain.

If the patient is unsure, they should contact a doctor,
as some of these symptoms, such as coughing or shortness of breath, can be mistaken for less serious conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may progress to loss of vision; Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, or heaviness;
• feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body that radiates to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat; Heart attack
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, difficulty speaking or understanding; Stroke

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BLOOD CLOTS IN VEINS

What Can Happen if a Blood Clot Forms in a Vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism), although these side effects are rare. They usually occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot in a vein can form in another organ, such as the eye (retinal vein thrombosis).

When is the Risk of Blood Clots in Veins the Highest?

The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher than when not taking combined hormonal contraceptives.
If the patient stops taking Sylvie 20, Sylvie 30, the risk of blood clots returns to normal within a few weeks.

What Factors Increase the Risk of Blood Clots in Veins?

The risk of blood clots associated with Sylvie 20, Sylvie 30 is small, but some factors can increase this risk.
The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m^2);
• if someone in the patient's close family has had a blood clot in the leg, lung, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have an inherited blood clotting disorder;
• if the patient needs to have surgery, is immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Sylvie 20, Sylvie 30 for a few weeks before surgery or immobilization. If the patient needs to stop taking Sylvie 20, Sylvie 30, they should ask their doctor when they can restart the medication;
• with increasing age (especially above 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (over 4 hours) may temporarily increase the risk of blood clots, especially if the patient has other risk factors.
It is essential to inform a doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop the patient from taking Sylvie 20, Sylvie 30.
If there is a change in the status of any of the above conditions while taking Sylvie 20, Sylvie 30, such as a family member being diagnosed with a blood clot without a known cause or the patient gaining significant weight, the doctor should be informed.

BLOOD CLOTS IN ARTERIES

What Can Happen if a Blood Clot Forms in an Artery?

Similar to blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.
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Factors that Increase the Risk of Blood Clots in Arteries

It is worth noting that the risk of a heart attack or stroke associated with Sylvie 20, Sylvie 30 is very small, but it may increase:

• with age (above approximately 35 years old);
• if the patient smokes.While taking a hormonal contraceptive like Sylvie 20, Sylvie 30, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at a higher risk of having a heart attack or stroke;
• if the patient or someone in their close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraine, especially migraine with aura;
• if the patient has heart disease (valve damage, irregular heartbeat called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of these conditions or if any of them are particularly severe, the risk of a blood clot may be even higher.
If there is a change in the status of any of the above conditions while taking Sylvie 20, Sylvie 30, such as the patient starting to smoke, someone in their close family being diagnosed with a blood clot without a known cause, or the patient gaining significant weight, the doctor should be informed.
In the event of symptoms suggesting a blood clot, the patient should stop taking the tablets and consult a doctor immediately (see also "When to contact a doctor").

Oral Contraceptives and Cancer

In women who take oral contraceptives, breast cancer is slightly more common than in women of the same age who do not take them. It is not known whether this difference is caused solely by the use of oral contraceptives. The reason may be, for example, that women who use hormonal contraception are more likely to have regular check-ups and breast cancer is detected earlier. This difference in breast cancer incidence decreases gradually and after 10 years of stopping oral contraceptives, the risk is the same as for women who have never taken them .
Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women taking combined oral contraceptives. If severe abdominal pain occurs, a doctor should be consulted as soon as possible.
There are reports of a higher incidence of cervical cancer in women who have taken oral contraceptives for a long time. This association may not be related to the use of the pill but may be due to differences in sexual behavior.

Mental Health Disorders

Some women who take hormonal contraceptives, including Sylvie 20, Sylvie 30, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, a doctor should be contacted as soon as possible for further medical advice.
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Sylvie 20, Sylvie 30 and Other Medications

Some medications may affect the action of Sylvie 20, Sylvie 30 and may reduce its effectiveness. This applies to medications used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
• tuberculosis (e.g., rifampicin),
• HIV/HCV infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors), other infectious diseases (e.g., griseofulvin), as well as medications containing St. John's Wort (mainly used to treat depressive moods).

Combined oral contraceptives may affect the metabolism of other medications, whose levels in the blood and tissues may increase (e.g., cyclosporin) or decrease (e.g., lamotrigine).
A doctor or pharmacist should be informed about all medications the patient is currently taking or has recently taken, as well as any medications they plan to take.
Sylvie 20, Sylvie 30 should not be taken if the patient has hepatitis C and is taking antiviral medications containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause elevated liver function test results (increased levels of the liver enzyme ALT).
A doctor will recommend a suitable type of contraception before starting these medications. Sylvie 20, Sylvie 30 can be restarted about 2 weeks after finishing treatment with these medications. See section 2 "When not to take Sylvie 20, Sylvie 30".
Note: The patient should read the information about concomitant use of medications to recognize possible interactions.

Pregnancy and Breastfeeding

A doctor should be consulted before taking any medication.
Sylvie 20, Sylvie 30 should not be taken during pregnancy or if pregnancy is suspected.
If pregnancy is suspected, a doctor should be consulted as soon as possible.
It is not recommended to take Sylvie 20, Sylvie 30 during breastfeeding.

Driving and Operating Machinery

No effect of Sylvie 20, Sylvie 30 on the ability to drive and use machines has been observed.

When to Contact a Doctor

A doctor should be contacted immediately if:

• the patient notices any worrying changes in their health, especially any of the conditions listed in this leaflet (see also "Important information before taking Sylvie 20, Sylvie 30" and "How to take Sylvie 20, Sylvie 30"; also remember the points about close relatives);
• a breast lump is found;
• the patient plans to take other medications (see also "Sylvie 20, Sylvie 30 and other medications");
• the patient will be immobilized or is scheduled for surgery (the doctor should be informed at least 4 weeks in advance);
• there is heavy vaginal bleeding;

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• a tablet is missed in the first week of the cycle (every first week of the Sylvie 20, Sylvie 30 cycle), and there was sexual intercourse during the previous 7 days;
• there is severe diarrhea;
• there is no withdrawal bleeding during two consecutive cycles or the patient suspects they may be pregnant (a new pack should not be started without consulting a doctor).

The situations and symptoms listed above are described in more detail in other parts of this leaflet.

Sylvie 20, Sylvie 30 Contains Lactose Monohydrate and Sucrose.

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medication.

Sylvie 20, Sylvie 30 Contains Sodium.

The medication contains less than 1 mmol (23 mg) of sodium per sugar-coated tablet, which means it is considered "sodium-free".

3. How to Take Sylvie 20, Sylvie 30

This medication should always be taken as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
The leaflet describes many situations in which the patient should stop taking Sylvie 20, Sylvie 30 or in which the effectiveness of the medication may be reduced. It also lists circumstances in which sexual intercourse should not take place or in which additional contraceptive methods should be used, such as condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used, as Sylvie 20, Sylvie 30 affects the changes in temperature and cervical mucus characteristics that are typical of the menstrual cycle.

Sylvie 20, Sylvie 30, Like Other Oral Contraceptives, Does Not Protect Against HIV (AIDS) or Sexually Transmitted Diseases.

How to Take Sylvie 20, Sylvie 30

• When and how to take the tablets?

The blister pack contains 21 tablets. On the packaging, each tablet is marked with the day of the week on which it should be taken. One tablet of Sylvie 20, Sylvie 30 should be taken every day, in the order indicated by the arrows on the packaging, at the same time, with a small amount of liquid if necessary. For 21 consecutive days, take 1 tablet per day. Then, do not take any tablets for 7 days. During this 7-day tablet-free period, withdrawal bleeding usually begins. This so-called "withdrawal bleeding" usually starts 2-3 days after taking the last tablet and may last until the next pack is started. This means that the patient will always start a new pack on the same day of the week and that the bleeding will occur at approximately the same time every cycle.

• Taking Sylvie 20, Sylvie 30 for the First Time
• If the Patient Has Not Taken Hormonal Contraception in the Last Month

Tablet-taking should begin on the 1st day of the natural menstrual cycle (i.e., on the 1st day of menstrual bleeding). Tablet-taking can also begin between the 2nd and 5th day of the menstrual cycle; in this case, during the first cycle, additional mechanical contraception should be used for the first 7 days.

• If the Patient Has Previously Taken Another Combined Hormonal Contraceptive (Tablet, Vaginal Ring, or Transdermal Patch)

Taking Sylvie 20, Sylvie 30 should begin the next day after taking the last tablet containing active substances from the previously used medication (this means no break in tablet-taking). If the previously used medication also contains placebo tablets (without active substances), taking Sylvie 20, Sylvie 30 can begin the next day after taking the last tablet containing active substances (if there is any doubt, the patient should ask their doctor or pharmacist). Taking can also begin later, but no later than the day on which the next tablet from the previous medication would have been taken (or the next placebo tablet from the previous medication).
In the case of a vaginal ring or transdermal patch, taking Sylvie 20, Sylvie 30 is recommended to begin on the day the ring or patch is removed, but no later than the day the next ring or patch would have been applied. If these recommendations are followed, there is no need to use additional contraceptive methods.

• If the Patient Has Previously Taken a Progestogen-Only Tablet (Minipill)

The minipill can be stopped at any time, and Sylvie 20, Sylvie 30 can be started at the same time. If sexual intercourse takes place during the first 7 days of taking Sylvie 20, Sylvie 30, additional mechanical contraception should be used.

• If the Patient Has Previously Taken a Progestogen-Only Injection, Implant, or Intrauterine System

Taking Sylvie 20, Sylvie 30 should begin on the day the next injection would have been given or on the day the implant or intrauterine system is removed. If sexual intercourse takes place during the first 7 days of taking the tablets, additional mechanical contraception should be used.
After Childbirth, Miscarriage, or Abortion

• After a Miscarriage in the First Trimester of Pregnancy

Taking Sylvie 20, Sylvie 30 can begin immediately. In this case, there is no need to use additional contraceptive methods.

• After Childbirth or Miscarriage in the Second Trimester of Pregnancy

A doctor should inform the patient that tablet-taking should begin 21 to 28 days after childbirth or miscarriage in the second trimester. If tablet-taking is started later, the doctor should inform the patient about the need to use additional mechanical contraception for the first 7 days of tablet-taking. If sexual intercourse has taken place before starting the combined oral contraceptive, the doctor should ensure that the patient is not pregnant or wait for the first menstrual period.

Overdose of Sylvie 20, Sylvie 30

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Nausea, vomiting, or vaginal bleeding (especially in young girls) may occur.
There have been no reports of serious side effects after taking multiple tablets of Sylvie 20, Sylvie 30 at the same time.
If more tablets than recommended have been taken, or if a child has taken the medication, a doctor or pharmacist should be consulted for advice.

Stopping Sylvie 20, Sylvie 30

Sylvie 20, Sylvie 30 can be stopped at any time. A doctor will then recommend other contraceptive methods if the patient does not want to become pregnant. If the patient stops taking the medication because they want to become pregnant, they should wait until they have had a natural menstrual period. This will help determine the expected date of delivery.

Missing a Dose of Sylvie 20, Sylvie 30

If it has been less than 12 hourssince the missed tablet, the contraceptive effectiveness of the medication is maintained. The missed tablet should be taken as soon as possible, and the next tablet should be taken at the usual time.
If it has been more than 12 hourssince the missed tablet, the effectiveness of the medication may be reduced. The more tablets that are missed, the higher the risk of reduced contraceptive effectiveness.
There is a particularly high risk of pregnancy if tablets are missed at the beginning or end of the pack. In this case, the patient should follow the rules below (see also the scheme below).

• More Than One Tablet Missed from the Pack

The patient should contact their doctor.

• One Tablet Missed in the First Week of Taking the Medication

The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time, and the next tablets should be taken at the usual time. For the next 7 days, additional contraceptive methods (e.g., a condom) should be used.
If sexual intercourse took place during the week before the missed tablet, it is possible that the patient may become pregnant. A doctor should be contacted immediately.

• One Tablet Missed in the Second Week of Taking the Medication

The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time, and the next tablets should be taken at the usual time. The contraceptive effectiveness of the medication is not reduced, and there is no need to use additional contraceptive methods. However, if there were previous errors in dosing or if more than one tablet was missed, additional mechanical contraception should be used for 7 days.

• One Tablet Missed in the Third Week of Taking the Medication

The patient can choose one of the following options, without the need for additional contraceptive methods, provided that the correct dosing has been followed for the 7 days preceding the missed tablet. If not, the patient should follow the first of the two options below and use an additional contraceptive method for 7 days.

• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and take the next tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but while taking the tablets, spotting or breakthrough bleeding may occur.
• 2. Stop taking the tablets from the current pack, take a break (not more than 7 days, counting from the day the tablet was missed), and then continue taking the tablets from the next pack.

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Scheme for Missed Tablets

Missed more than
1 tablet from the pack
contact a doctor
had sexual intercourse in the week before missing the tablet
Tell the doctor

• Missed 1 tablet in the 1st week of taking the medication

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and take the next tablets at the usual time. Use additional contraceptive methods for the next 7 days.

• Missed 1 tablet in the 2nd week of taking the medication

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and take the next tablets at the usual time. The contraceptive effectiveness of the medication is not reduced, and there is no need to use additional contraceptive methods.

• Missed 1 tablet in the 3rd week of taking the medication

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and take the next tablets at the usual time. Take the tablets from the next pack without a 7-day break, or stop taking the tablets from the current pack, take a break, and then continue taking the tablets from the next pack.

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4. Possible side effects

Like any drug, this drug can cause side effects, although they may not occur in everyone. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of the Sylvie 20, Sylvie 30 drug, consult a doctor.
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All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disease). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using the Sylvie 20, Sylvie 30 drug".

Severe side effects

Severe side effects associated with the use of the Sylvie 20, Sylvie 30 drug and their symptoms are described in the following sections of the leaflet: "Oral contraception and cancer", "Blood clots". Read these sections to obtain additional information and, if necessary, consult a doctor immediately.
Immediately consult a doctor if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives, potentially with breathing difficulties (see also the "Warnings and precautions" section).

Other possible side effects

Below are symptoms reported by patients taking the Sylvie 20, Sylvie 30 drug, although they may not have been caused by the drug's action.
Frequent(may occur in less than 1 in 10 people):

• nausea, abdominal pain,
• weight gain,
• headache,
• mood changes, depressive mood,
• breast pain, breast tenderness.

Infrequent(may occur in less than 1 in 100 people):

• vomiting, diarrhea,
• fluid retention,
• migraine,
• decreased libido,
• breast enlargement,
• rash, hives.

Rare(may occur in less than 1 in 1,000 people):

• hypersensitivity,
• intolerance to contact lenses,
• weight loss,
• increased libido,
• discharge, breast secretion,
• erythema nodosum, erythema multiforme,
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis),
• in the lungs (e.g., pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient stroke symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach/intestine, kidneys, or eye.

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The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).
In women with hereditary angioedema, exogenous estrogens (administered, for example, in the form of this drug) may cause the occurrence or exacerbation of its symptoms.
In some individuals, during the use of the Sylvie 20, Sylvie 30 drug, other side effects may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the drug.

5. How to store the Sylvie 20, Sylvie 30 drug

The drug should be stored out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging.
Do not use this drug after the expiration date stated on the box and blister pack after: EXP.
The expiration date means the last day of the given month.
Drugs should not be disposed of in the sewage system or household waste containers. Ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What the Sylvie 20, Sylvie 30 drug contains

The active substances are:
ethinylestradiol: 20 micrograms and gestodene: 75 micrograms (Sylvie 20)
or
ethinylestradiol: 30 micrograms and gestodene: 75 micrograms (Sylvie 30)
Other ingredients are:
Core:
Sodium calcium versenate
Lactose monohydrate
Corn starch
Magnesium stearate
Povidone 25
Coating:
Sucrose
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Povidone 90 F
Calcium carbonate
Macrogol 6000
Talc
Montan glycol wax

What Sylvie 20, Sylvie 30 looks like and what the package contains

Sylvie 20, Sylvie 30 are round sugar-coated tablets. Each package of Sylvie 20, Sylvie 30 contains one (three or six) calendar package of 21 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Manufacturer:

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

This medicinal product is authorized for sale in the Member States of the European

Economic Area under the following names:

Poland: Sylvie 20, Sylvie 30
Date of last revision of the leaflet:May 2025
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