Silvie 20

Patient 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.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming 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 the symptoms of their illness 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, you should read the information about blood clots (thrombosis) in section 2. 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 veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have a blood clotting disorder - for example, 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 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) benign or malignant liver tumors;
• if the patient has (or has ever had) hormone-dependent tumors (breast or genital tumors);
• if the patient has unexplained vaginal bleeding;
• if the patient is pregnant or suspects they are 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 you contact your doctor?
You should see your doctor immediately

• -if you notice any of the symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood Clots"). To find out about the symptoms of these serious side effects, see "How to recognize a blood clot".

If you are taking Sylvie 20, Sylvie 30 in any of the situations listed below, close medical supervision is necessary.

Tell Your Doctor if You Have Any of the Following Conditions.

Tell your doctor if you have any of these conditions or if they get worse while taking Sylvie 20, Sylvie 30.

• If you have Crohn's disease or ulcerative colitis (a chronic inflammatory disease of the intestines).
• If you have systemic lupus erythematosus (a disease that affects the body's natural defense system).
• If you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure).
• If you have sickle cell disease (a genetic disorder of red blood cells).
• If you have 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 you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with difficulty breathing, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.
• If you need to have surgery or will be immobilized for a long time (see section "Blood Clots").
• If you have recently given birth, you are at a higher risk of blood clots. You should ask your doctor how soon after delivery you can start taking Sylvie 20, Sylvie 30.
• If you have superficial thrombophlebitis (inflammation of the veins just under the skin).
• If you have varicose veins.

If any of the above conditions occur for the first time or worsen while taking Sylvie 20, Sylvie 30, you should contact your doctor.

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 completely. 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

You should see your doctor immediately if you notice any of the following symptoms.
Are you 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, such as pallor, redness, or cyanosis; 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 abdominal pain.

If you are unsure, you should see your 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 lead to loss of vision; Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, tightness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating 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 the 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 deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot 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 blood clots in veins 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 medication) 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 you stop 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 you are severely overweight (body mass index (BMI) over 30 kg/m^2);
• if someone in your immediate family has had a blood clot in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness, or have a leg in a cast. You may need to stop taking Sylvie 20, Sylvie 30 for a few weeks before surgery or immobilization. If you need to stop taking Sylvie 20, Sylvie 30, ask your doctor when you can start taking it again;
• with increasing age (especially over 35 years of age);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present.
Long-distance air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if you have other risk factors.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop 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 if you gain weight significantly, you should inform your doctor.

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 (over 35 years of age);
• if you smoke.While taking a hormonal contraceptive like Sylvie 20, Sylvie 30, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years of age, your doctor may advise using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years of age). In this case, you may also be at a higher risk of having a heart attack or stroke;
• if you or a family member have high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraine, especially migraine with aura;
• if you have heart disease (valve damage, arrhythmia 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 a blood clot may be even higher.
You should inform your doctor if there is a change in the status of any of the above conditions while taking Sylvie 20, Sylvie 30, such as starting to smoke, a family member being diagnosed with a blood clot without a known cause, or if you gain weight significantly.
In the event of symptoms suggesting a blood clot, you should stop taking the tablets and consult your doctor immediately (see also "When to contact your 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 hormonal contraceptives. The reason may be, for example, that women who use hormonal contraceptives are more likely to have regular check-ups and breast cancer is detected earlier. The described difference in the incidence of breast cancer decreases gradually, and 10 years after 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, you should see your doctor 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. However, this relationship may not be related to taking the tablets but may be due to differences in sexual practices.

Psychiatric 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 or symptoms of depression occur, you should see your doctor 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. These include 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).
You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Sylvie 20, Sylvie 30 should not be taken if you have hepatitis C and are 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 tests (increased levels of the liver enzyme ALT).
Your doctor will recommend a suitable contraceptive method before starting these medications. You can restart Sylvie 20, Sylvie 30 about 2 weeks after finishing these medications. See section 2 "When not to take Sylvie 20, Sylvie 30".
Note: You should read the information about concomitant use of medications to recognize possible interactions.

Pregnancy and Breastfeeding

Before taking any medication, you should consult your doctor.
Sylvie 20, Sylvie 30 should not be taken during pregnancy or if pregnancy is suspected.
If pregnancy is suspected, you should see your doctor as soon as possible.
Sylvie 20, Sylvie 30 is not recommended 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 Your Doctor

You should see your doctor immediately if:

• you notice any changes in your 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"; you should also remember the points about your relatives);
• a breast lump is found;
• you plan to take other medications (see also "Sylvie 20, Sylvie 30 and other medications");
• you are going to have surgery or will be immobilized (you should inform your doctor at least 4 weeks in advance);
• you experience heavy vaginal bleeding;

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• you miss tablets in the first week of the cycle (every first week of Sylvie 20, Sylvie 30) and have had sexual intercourse during the previous 7 days;
• you experience severe diarrhea;
• you do not have withdrawal bleeding during two consecutive cycles or suspect pregnancy (do not start the next pack without consulting your 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 you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking Sylvie 20, Sylvie 30.

Sylvie 20, Sylvie 30 Contains Sodium.

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

3. How to Take Sylvie 20, Sylvie 30

This medication should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
The leaflet describes many situations in which you should not take Sylvie 20, Sylvie 30 or in which the effectiveness of the medication may be reduced. It also lists circumstances in which you should not have sexual intercourse or should use additional contraceptive methods, such as condoms or other barrier methods. The calendar method and temperature measurement method cannot be used, as Sylvie 20, Sylvie 30 affects temperature changes and cervical mucus properties characteristic 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. You should take one tablet of Sylvie 20, Sylvie 30 every day, in the order indicated by the arrows on the packaging, every day, at about the same time, with a small amount of liquid if necessary. For 21 consecutive days, take one tablet per day. Then, do not take any tablets for 7 days. During this 7-day break, during which you do not take tablets ("tablet-free interval"), you will usually start withdrawal bleeding. 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 you will always start each new pack on the same day of the week, and your bleeding will occur at about the same time each cycle.

• Starting Sylvie 20, Sylvie 30 for the First Time
• If you have not taken hormonal contraception in the last month

Take the first tablet in the pack on the first day of your period (the first day of menstrual bleeding). You can also start taking the tablets between the 2nd and 5th day of your period, but during the first cycle, you should use additional mechanical contraception (e.g., condoms) for the first 7 days.

• If you have been taking another combined hormonal contraceptive (tablet, vaginal ring, or patch)

Start taking Sylvie 20, Sylvie 30 the next day after taking the last active tablet of your previous contraceptive (this means no break in taking tablets). If your previous contraceptive also contains inactive tablets (placebo), you can start taking Sylvie 20, Sylvie 30 the next day after taking the last active tablet (if you are unsure which tablet is which, ask your doctor or pharmacist). You can also start taking Sylvie 20, Sylvie 30 later, but no later than the day you would have taken the next active tablet (or the next placebo tablet of your previous contraceptive).
In the case of a vaginal ring or transdermal patch, you should start taking Sylvie 20, Sylvie 30 on the day the ring or patch is removed, but no later than the day you would have applied a new ring or patch. If you follow these recommendations, you do not need to use additional contraceptive methods.

• If you have been taking a progestogen-only tablet (mini-pill)

You can stop taking the mini-pill at any time and start taking Sylvie 20, Sylvie 30 at the same time. If you have sexual intercourse during the first 7 days of taking Sylvie 20, Sylvie 30, you should use additional mechanical contraception.

• If you have been taking a progestogen-only injection, implant, or intrauterine system

Start taking Sylvie 20, Sylvie 30 on the day you would have had your next injection or on the day the implant or intrauterine system is removed. If you have sexual intercourse during the first 7 days of taking the tablets, you should use additional mechanical contraception.
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy

You can start taking Sylvie 20, Sylvie 30 immediately. In this case, you do not need to use additional contraceptive methods.

• After childbirth or miscarriage in the second trimester of pregnancy

Your doctor should inform you that you should start taking the tablets 21 to 28 days after childbirth or miscarriage in the second trimester. If you start taking the tablets later, your doctor should advise you to use additional mechanical contraception for the first 7 days of taking the tablets. If you have had sexual intercourse before starting Sylvie 20, Sylvie 30, you should make sure you are not pregnant or wait for your 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 you have taken more than the recommended dose of Sylvie 20, Sylvie 30 or if a child has taken some, you should ask your doctor or pharmacist for advice.

Stopping Sylvie 20, Sylvie 30

Sylvie 20, Sylvie 30 can be stopped at any time. Your doctor will recommend another contraceptive method if you do not want to become pregnant. If you stop taking Sylvie 20, Sylvie 30 because you want to become pregnant, you should wait until you have had a natural menstrual period. This will help you determine the expected date of delivery.

Missing a Dose of Sylvie 20, Sylvie 30

If it has been less than 12 hourssince you missed a tablet, the contraceptive effectiveness of Sylvie 20, Sylvie 30 is maintained. You should take the missed tablet as soon as possible and take the next tablet at the usual time.
If it has been more than 12 hourssince you missed a tablet, the effectiveness of Sylvie 20, Sylvie 30 may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness.
There is a particularly high risk of pregnancy if you miss tablets at the beginning or end of the pack. In this case, you should follow the rules below (see also the diagram below).

• Missing more than one tablet from the pack

You should consult your doctor.

• Missing one tablet in the first week of taking Sylvie 20, Sylvie 30

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and continue taking the tablets at the usual time. Use additional mechanical contraception for the next 7 days.
If you had sexual intercourse during the week before missing the tablet, it is possible that you may become pregnant. You should see your doctor as soon as possible.

• Missing one tablet in the second week of taking Sylvie 20, Sylvie 30

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and continue taking the tablets at the usual time. The contraceptive effectiveness of Sylvie 20, Sylvie 30 is not reduced, and you do not need to use additional contraceptive methods. However, if you made a mistake when taking the tablets earlier or missed more than one tablet, you should use additional mechanical contraception for 7 days.

• Missing one tablet in the third week of taking Sylvie 20, Sylvie 30

You can choose one of the following options without the need for additional contraceptive methods, provided you have taken the tablets correctly for the preceding 7 days. If not, you should follow the first of the two options below and use additional mechanical contraception for 7 days.
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• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and continue taking the tablets at the usual time. Start the next pack immediately after finishing the current one, without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but you may experience spotting or bleeding during tablet-taking.
• 2. You can also stop taking the tablets from the current pack, take a break (not more than 7 days, counting from the day you missed the tablet), and then continue taking the tablets from the next pack.

If you miss a tablet and do not have withdrawal bleeding during the tablet-free interval, you may be pregnant. You should see your doctor before starting the next pack.

Diagram for Missing a Tablet

Missed more than
1 tablet from the pack
consult your doctor
had sexual intercourse
in the week before missing
the tablet
Tydzień 1.
did not have sexual intercourse

• take the missed tablet
• use additional contraception for 7 days
• finish the pack
• take the missed tablet
• finish the pack
• take the missed tablet
• finish the pack
• do not take a 7-day break
• continue with the next pack

or
Tydzień 3.

• stop taking the pack
• take a break (not more than 7 days, counting from the day you missed the tablet)
• continue with 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, you should consult a doctor.
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In all women using combined hormonal contraceptives, there is an increased risk of 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 related to the intake of the Sylvie 20, Sylvie 30 drug and their symptoms are described in the following parts of the leaflet: "Oral contraception and cancer", "Blood clots". You should read these sections to obtain additional information and, if necessary, immediately consult a doctor.
You should immediately contact a doctor if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria, potentially with breathing difficulties (see also the "Warnings and precautions" section).

Other possible side effects

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

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

Not very often(may occur in less than 1 in 100 people):

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

Rarely(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),
• myocardial infarction,
• 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 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 (e.g., in the form of this drug) may cause the occurrence or exacerbation of its symptoms.
In some people, 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, you should tell your doctor or pharmacist about them. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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.
By reporting side effects, more information can be gathered 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. You should 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 of the tablet:
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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