Sylvie 20

Sylvie 20, 20 µg + 75 µg, film-coated tablets
Sylvie 30, 30 µg + 75 µg, film-coated tablets
Ethinylestradiolum + Gestodenum
Important information about combined hormonal contraceptives

• When used correctly, they are among the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient

• Keep this leaflet, so you can read it again if needed.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms appear identical.
• If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

Sylvie 20 and Sylvie 30 are combined oral hormonal contraceptives.
Each tablet contains a small amount of two different female hormones: ethinylestradiol (an estrogen) and gestodene (a progestogen). Due to their low hormone content, Sylvie 20 and Sylvie 30 are classified as low-dose oral contraceptives.

Indications
Prevention of pregnancy.
Oral hormonal contraception is a highly effective method of preventing pregnancy. When used correctly, the likelihood of becoming pregnant while taking oral hormonal contraceptives is very low.

2. Important information before using Sylvie 20, Sylvie 30

General notes
Before starting treatment with Sylvie 20, Sylvie 30, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Do not use Sylvie 20, Sylvie 30 if any of the following conditions apply to you. If any of the conditions listed below apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

When not to use Sylvie 20, Sylvie 30

• if you are allergic to ethinylestradiol or gestodene or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following diseases which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you have previously had or currently have pancreatitis associated with markedly increased triglyceride (fat) levels in the blood (severe hypertriglyceridaemia);
• if you have previously had or currently have severe liver disease (until liver function tests return to normal);
• if you have previously had or currently have benign or malignant liver tumours;
• if you have previously had or currently have hormone-dependent cancers (e.g. breast or genital organ cancer);
• if you have vaginal bleeding of unknown cause;
• if pregnancy has been confirmed or is suspected;
• if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section 2 "Sylvie 20, Sylvie 30 and other medicines").

Warnings and precautions
When to exercise special caution when using Sylvie 20, Sylvie 30:
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or stroke (see section below "Blood clots"). For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

If you use Sylvie 20, Sylvie 30 under any of the following circumstances, careful and regular medical monitoring is required.
Tell your doctor if you have any of the following conditions.
Also inform your doctor if any of these conditions develop or worsen during treatment with Sylvie 20, Sylvie 30.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (a disease affecting the body's natural immune system).
• If you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure).
• If you have sickle cell anaemia (an inherited disorder of red blood cells).
• If you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis.
• If you develop symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, potentially with breathing difficulties, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• If you are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots").
• If you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Sylvie 20, Sylvie 30.
• If you have inflammation of the superficial veins (superficial thrombophlebitis).
• If you have varicose veins.

If any of the symptoms listed above occur for the first time, recur, or worsen during treatment with Sylvie 20, Sylvie 30, contact your doctor.
BLOOD CLOTS
Using combined hormonal contraceptives such as Sylvie 20, Sylvie 30 is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious problems.
Blood clots can occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Sylvie 20, Sylvie 30 is small.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What is the likely cause?

• Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, e.g. pallor, redness, or blueness;
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden coughing without an obvious cause, possibly accompanied by coughing up blood;
• sudden chest pain, which may worsen on deep breathing;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).
Symptoms most commonly affecting one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless visual disturbances, which may progress to vision loss;
• chest pain, discomfort, pressure, heaviness; Myocardial infarction
• sensation of tightness or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, or stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat;
• sudden weakness or numbness of the face, arms, or legs, Stroke especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding speech;

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis), although these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a blood clot in a vein may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be increased 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, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Sylvie 20 or Sylvie 30, the risk of blood clot formation returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on individual risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Sylvie 20 or Sylvie 30 is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing gestodene, such as Sylvie 20 or Sylvie 30, will develop blood clots.
• The risk of developing blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Sylvie 20, Sylvie 30 is low; however, certain factors may increase this risk.
The risk is higher:

• if the patient is significantly overweight [body mass index (BMI) above 30 kg/m²];
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In such cases, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue the use of Sylvie 20, Sylvie 30 several weeks before surgery or immobilization. If the patient must stop taking Sylvie 20, Sylvie 30, they should consult their doctor about when it is safe to resume;
• with increasing age (particularly over 35 years of age);
• if the patient has recently given birth (within the past few weeks).

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if the patient has other risk factors listed above.
It is important to inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Sylvie 20, Sylvie 30.
The patient should inform the doctor if the status of any of the above conditions changes during treatment with Sylvie 20, Sylvie 30, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It should be noted that the risk of heart attack or stroke associated with the use of Sylvie 20, Sylvie 30 is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Sylvie 20, Sylvie 30, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood fats (cholesterol or triglycerides);
• if the patient suffers from migraine, particularly migraine with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be further increased.
The patient should inform the doctor if the status of any of the above conditions changes during treatment with Sylvie 20, Sylvie 30, for example, if the patient starts smoking, if a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.
If symptoms suggestive of thrombosis occur, the patient should stop taking the tablets and consult a doctor immediately (see also “When to contact the doctor”).

Oral contraception and cancer
Women using oral contraceptives have a slightly higher incidence of breast cancer compared to women of the same age who do not use them. It is not known whether this difference is solely due to the use of hormonal contraceptives. It may also be due to the fact that women using hormonal contraception undergo more frequent medical examinations, leading to earlier detection of breast cancer. This difference in breast cancer incidence gradually decreases and, 10 years after stopping oral contraceptives, the risk is the same as in women who have never used them.
Rare cases of benign and, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives. These tumors may lead to life-threatening intra-abdominal bleeding. If severe abdominal pain occurs, the patient should contact a doctor immediately.
There are reports of a higher incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be related to the use of the pills but rather to differences in sexual behavior.

Psychiatric disorders
Some women using hormonal contraceptives, including Sylvie 20, Sylvie 30, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact a doctor as soon as possible for further medical advice.

Sylvie 20, Sylvie 30 and other medicines
Some medicines may affect the action of Sylvie 20, Sylvie 30 and reduce its effectiveness. These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV/HCV infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors), other infectious diseases (e.g., griseofulvin), as well as herbal products containing St. John's wort (Hypericum perforatum), mainly used for treating depressive moods.

Combined oral contraceptives may affect the metabolism of other medicines, leading to increased (e.g., cyclosporine) or decreased (e.g., lamotrigine) plasma and tissue concentrations.
The patient should inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Sylvie 20, Sylvie 30 should not be used if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may cause elevated liver function tests (increased levels of liver enzyme ALT).
The doctor will recommend an appropriate method of contraception before starting treatment with these medicines. Sylvie 20, Sylvie 30 may be resumed approximately 2 weeks after stopping these medicines. See section 2 “When not to use Sylvie 20, Sylvie 30”.
Note: The patient should read the information regarding concomitant use of medicines to recognize possible interactions.

Pregnancy and breastfeeding
Before taking any medicine, consult a doctor.
Sylvie 20, Sylvie 30 should not be taken during pregnancy or if pregnancy is suspected.
If pregnancy is suspected, the patient should consult a doctor immediately.
The use of 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 mechanical vehicles or operate machinery has been observed.

When to contact the doctor
The patient should contact the doctor immediately if:

• they notice concerning changes in their health status, particularly any of the conditions listed in this leaflet (see also: “Important information before using Sylvie 20, Sylvie 30” and “How to use Sylvie 20, Sylvie 30”; also remember the points regarding close relatives);
• they detect a lump in the breast;
• they plan to take other medicines (see also “Sylvie 20, Sylvie 30 and other medicines”);
• immobilization is expected or surgical procedure is planned (inform the doctor at least 4 weeks in advance);
• they experience heavy vaginal bleeding;
• they miss tablets in the first week of the cycle (each first week of subsequent cycles of Sylvie 20, Sylvie 30) and had intercourse in the previous 7 days;
• they experience acute diarrhea;
• they do not have withdrawal bleeding in two consecutive cycles or suspect pregnancy (do not start the next pack without consulting a doctor).

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

Sylvie 20, Sylvie 30 contains monohydrate lactose and sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Sylvie 20, Sylvie 30 contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered “sodium-free”.

3. How to use Sylvie 20, Sylvie 30

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This leaflet describes many situations in which you should stop taking Sylvie 20, Sylvie 30 or in which the effectiveness of the medicine may be reduced. It also specifies circumstances when sexual intercourse should be avoided or additional contraceptive methods (e.g. condoms or other mechanical methods) should be used. The calendar method and temperature measurement method cannot be used, as Sylvie 20, Sylvie 30 affects changes in body temperature and cervical mucus characteristics typical of the menstrual cycle.
Sylvie 20, Sylvie 30, like other oral contraceptives, does not protect against HIV infection (AIDS) or sexually transmitted diseases.

How to take Sylvie 20, Sylvie 30

• When and how should the tablets be taken?

The blister pack contains 21 tablets. Each tablet is marked on the packaging with the day of the week on which it should be taken. Take one tablet daily in the order indicated by the arrows on the pack, every day at approximately the same time, swallowing with a small amount of liquid if necessary. One tablet should be taken each day for 21 consecutive days. After this, no tablets should be taken for 7 days. During this 7-day break (when no tablets are taken), withdrawal bleeding usually occurs. This so-called "withdrawal bleeding" typically begins 2–3 days after the last tablet and may continue into the start of the next pack. This means that each new pack should always be started on the same day of the week, and bleeding will generally occur around the same days in each cycle.

• Starting to take Sylvie 20, Sylvie 30 for the first time
• If no hormonal contraception was used in the previous month

Start taking the tablets on the first day of your natural menstrual cycle (i.e. the first day of menstrual bleeding). You may also start between days 2 and 5 of the cycle; in this case, during the first cycle, additional mechanical contraception is recommended for the first 7 days of tablet intake.

• If previously using another combined hormonal contraceptive (pill, vaginal ring, or transdermal patch)

Start taking Sylvie 20, Sylvie 30 the day after taking the last active tablet of the previously used contraceptive (meaning no break between tablets). If the previous contraceptive also includes placebo tablets (without active ingredients), you may start Sylvie 20, Sylvie 30 the day after the last active tablet (if unsure which tablet this is, consult your doctor or pharmacist). You may also start later, but never later than the day when the next tablet of the previous contraceptive would have been taken (or the day after the last placebo tablet of the previous contraceptive).
If using a vaginal ring or transdermal patch, start taking Sylvie 20, Sylvie 30 on the day of removal, but no later than the day the next ring or patch would have been applied.
If following the above recommendations, additional contraceptive methods are not required.

• If previously using a progestogen-only pill (mini-pill)

You may stop taking the mini-pill on any day and start taking Sylvie 20, Sylvie 30 at the same time instead. If sexual intercourse occurs during the first 7 days of taking Sylvie 20, Sylvie 30, use additional contraceptive methods (mechanical methods) simultaneously.

• If previously using a progestogen-only contraceptive in the form of injections, implant, or intrauterine system releasing progestogen

Start taking Sylvie 20, Sylvie 30 on the day the next injection was due or on the day of implant or system removal. If sexual intercourse occurs during the first 7 days of tablet intake, use mechanical contraceptive methods simultaneously.

• After childbirth, miscarriage, or induced abortion

• After first-trimester miscarriage

Sylvie 20, Sylvie 30 may be started immediately. In this case, additional contraceptive methods are not required.

• After childbirth or second-trimester miscarriage

Your doctor will advise starting tablet intake between 21 and 28 days after childbirth or second-trimester miscarriage. If starting later, your doctor will advise using additional mechanical contraception for the first 7 days of tablet intake. If sexual intercourse occurred before starting the combined oral contraceptive, ensure you are not pregnant or wait until the first natural menstrual bleeding occurs.

Taking more than the recommended dose of Sylvie 20, Sylvie 30
Nausea, vomiting, or vaginal bleeding (especially in young girls) may occur. There are no reports of severe adverse effects after taking multiple tablets of Sylvie 20, Sylvie 30 at once.
If you have taken more than the recommended dose of Sylvie 20, Sylvie 30 or if a child has taken the medicine, consult your doctor or pharmacist for advice.

Stopping Sylvie 20, Sylvie 30
Sylvie 20, Sylvie 30 may be discontinued at any time. Your doctor will suggest alternative contraceptive methods if you do not wish to become pregnant. If you stop taking the medicine because you wish to become pregnant, wait until your natural period occurs. This will help determine the expected date of delivery.

Missed dose of Sylvie 20, Sylvie 30
If less than 12 hours have passed since the missed tablet, contraceptive effectiveness is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.
If more than 12 hours have passed since the missed tablet, contraceptive effectiveness may be reduced. The more consecutive tablets missed, the greater the risk of reduced contraceptive effect.
The risk of pregnancy is particularly high if tablets are missed at the beginning or end of the pack. In such cases, follow the rules below (see also the chart below).

• More than 1 tablet missed from the pack

Consult your doctor.

• One tablet missed in the first week of taking the medicine

Take the missed tablet as soon as possible, even if this means taking two tablets at once, and continue taking the following tablets at the usual time. Use additional contraceptive methods (e.g. condoms) for the next 7 days.
If sexual intercourse occurred in the week before the missed tablet, pregnancy may have occurred. Inform your doctor immediately.

• One tablet missed in the second week of taking the medicine

Take the missed tablet as soon as possible, even if this means taking two tablets at once, and continue taking the following tablets at the usual time. Contraceptive effectiveness is not reduced, and additional contraceptive methods are not required. However, if previous dosing errors occurred or more than one tablet was missed, use additional (mechanical) contraception for 7 days.

• One tablet missed in the third week of taking the medicine

You may choose one of the following options without needing additional contraceptive methods, provided correct dosing was followed during the 7 days preceding the missed dose. Otherwise, follow the first of the two options below and use additional contraception for the next 7 days.

1. Take the missed tablet as soon as possible, even if this means taking two tablets at once, 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 spotting or bleeding may occur during tablet intake.
2. Alternatively, stop taking tablets from the current pack, take a 7-day break (including the day the tablet was missed), and then continue with the next pack.

If you forget to take tablets and no expected bleeding occurs during the first tablet-free break, you may be pregnant. Contact your doctor before starting the next pack.

Missed tablet management chart
Missed more than
1 tablet from current pack → Consult doctor
Sexual intercourse occurred
in the week preceding
Week 1. missed tablet
No intercourse occurred

• Take missed tablet
• Use additional contraception for 7 days
• Finish tablets in pack
• Take missed tablet
  Missed only 1 tablet Week 2. - Finish tablets in pack (delay >12 hours but <24 hours)
• Take missed tablet
• Finish pack
• Do not take 7-day break
• Continue with next pack

or
Week 3.

• Discontinue remaining tablets in pack
• Take break (no more than 7 days, including day of missed tablet)
• Continue with next pack

Management in the following situations:

• Gastrointestinal disturbances (vomiting)

If vomiting occurs, the active ingredients of Sylvie 20, Sylvie 30 may not be fully absorbed. If vomiting occurs within 3 to 4 hours of taking a tablet, follow the advice under "Missed dose of Sylvie 20, Sylvie 30". In case of severe gastrointestinal disturbances, use additional contraceptive methods.

• Intention to delay withdrawal bleeding

To delay the onset of withdrawal bleeding, start the next pack of Sylvie 20, Sylvie 30 immediately after finishing the current one, without a 7-day break. The delay may last as long as needed, even until the end of the second pack. During the extended cycle, light breakthrough bleeding or spotting may occur. After a normal 7-day break, resume regular intake of Sylvie 20, Sylvie 30.

• Intention to change the day of withdrawal bleeding

To change the day of withdrawal bleeding to another day of the week than indicated by the tablet schedule, shorten the next tablet-free break by the number of days you wish to shift the bleeding. For example, if the tablet-free break usually starts on Fridays but you want it to start on Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. If the tablet-free break is very short (e.g. 3 days or less), withdrawal bleeding may not occur during the break. Light bleeding or spotting may occur during the next pack.

• Unexpected bleeding

During the first few months of taking Sylvie 20, Sylvie 30, some women may experience irregular vaginal bleeding (spotting or breakthrough bleeding). Despite this, continue taking the tablets as directed. This usually resolves after 3 cycles. If bleeding recurs, becomes bothersome, or lasts too long, inform your doctor.

• Absence of withdrawal bleeding

If all tablets were taken correctly, there were no vomiting or severe diarrhea, and no other medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking Sylvie 20, Sylvie 30.
If withdrawal bleeding does not occur in two consecutive months, pregnancy is possible. Inform your doctor immediately. Do not start the next pack of Sylvie 20, Sylvie 30 until your doctor has ruled out pregnancy.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes
in health status that the patient considers related to the use of Sylvie 20, Sylvie 30,
a doctor should be consulted.
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, “Important information before taking Sylvie 20, Sylvie 30”.
Serious adverse reactions
Serious adverse reactions associated with the use of Sylvie 20, Sylvie 30, and their accompanying symptoms are described in the following sections of the leaflet: “Oral contraception and cancer”, “Blood clots”. Please read these sections for additional information and consult a doctor immediately if necessary.
Contact a doctor immediately 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 accompanied by breathing difficulties (see also section “Warnings and precautions”).
Other possible adverse reactions
Below are symptoms reported by women taking Sylvie 20, Sylvie 30, although they may not have been caused by the medicine.
Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity,
• intolerance to contact lenses,
• weight loss,
• increased libido,
• flushing, breast discharge,
• nodular erythema, erythema multiforme,
• harmful blood clots in veins or arteries, 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 ischaemic attack, known as transient ischaemic attack,
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).
In women with hereditary angioedema, exogenous estrogens (such as those contained in this medicine) may cause the onset or worsening of symptoms.
Other adverse reactions may occur in some individuals during the use of Sylvie 20, Sylvie 30.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sylvie 20, Sylvie 30

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sylvie 20, Sylvie 30 contains
The active substances are:
ethinylestradiol: 20 micrograms and gestodene: 75 micrograms (Sylvie 20)
or
ethinylestradiol: 30 micrograms and gestodene: 75 micrograms (Sylvie 30)
The other ingredients are:
Tablet core:
Calcium sodium edetate
Monohydrate lactose
Corn starch
Magnesium stearate
Povidone 25
Coating:
Sucrose
Povidone 90 F
Calcium carbonate
Macrogol 6000
Talc
Glycol wax Montana

What Sylvie 20, Sylvie 30 looks like and contents of the pack
Sylvie 20, Sylvie 30 are round sugar-coated tablets. Each pack of Sylvie 20, Sylvie 30 contains one (three or six) calendar blister pack(s) with 21 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa Street 65
00-667 Warsaw
Poland

Manufacturer:
Farmak International Sp. z o.o.
Chełmżyńska Street 249
04-458 Warsaw
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Sylvie 20, Sylvie 30