Kontracept

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: Information for the user

Contracept, 0.02 mg + 0.075 mg, film-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 resuming use after a break of 4 weeks or more
• Vigilance should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots")
• The Contracept drug does not protect against sexually transmitted diseases.
• The Contracept drug may increase the risk of blood clots and breast cancer.
• The Contracept drug should not be used in some women due to their current medical problems or diseases. The leaflet content should be reviewed to ensure that the Contracept drug can be used by the patient.
• For effective pregnancy prevention, it is essential to take the Contracept drug as recommended and start each package of the drug at the right time. The patient should be informed about what to do in case of a missed tablet or if she suspects she is pregnant.

The leaflet content should be carefully reviewed before using the drug, as it contains important information for the patient.

• The leaflet should be kept to be re-read if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Contracept and what is it used for
• 2. Important information before using Contracept
• 3. How to use Contracept
• 4. Possible side effects
• 5. How to store Contracept
• 6. Package contents and other information

1. What is Contracept and what is it used for

• Contracept is an oral contraceptive tablet used to prevent pregnancy.
• Each tablet contains small amounts of two different female sex hormones, ethinylestradiol and gestodene.
• Contraceptive tablets like Contracept, containing two hormones, are called combined tablets.

2. IMPORTANT INFORMATION BEFORE USING CONTRACEPT

General notes.

Before starting to take Contracept, the patient should review the information about blood clots (thrombosis) in section 2. It is especially important to review the symptoms of blood clots (see section 2 "Blood clots").
Before starting to use Contracept, the doctor should take a medical history of the patient or her family members. The doctor should measure the patient's blood pressure and, depending on the patient's health, perform other examinations.
The leaflet describes situations in which Contracept should be discontinued or its effectiveness may be reduced. In such situations, the patient should abstain from sexual intercourse or use additional non-hormonal contraceptive methods, e.g., a condom or another barrier method. The patient should not use the cervical mucus observation method or the temperature method. These methods may be ineffective because Contracept disrupts temperature and cervical mucus changes during the menstrual cycle.

Contracept, like other combined hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

When not to use Contracept

Contracept should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, she should inform her doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable:

• 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 she has blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases that 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).
• hyperhomocysteinemia
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) pancreatitis;
• if the patient has (or has had in the past) severe liver failure, and liver function is still not normal;
• if the patient has (or has had in the past) liver tumors;
• if the patient has (or has had in the past) or suspects breast cancer or genital organ cancer;
• if the patient has any unexplained vaginal bleeding;
• if the patient is hypersensitive to ethinylestradiol or gestodene or any of the other ingredients of this drug (listed in section 6), diagnosed as itching, rash, or swelling;
• if the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Contracept and other medicines").

Warnings and precautions

When should the patient contact a doctor?
The patient should contact a doctor immediately

• if the patient notices any symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

To get a description of the serious side effects listed, see "How to recognize a blood clot".
Psychiatric disorders:
Some women using hormonal contraceptives, including Contracept, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should contact a doctor as soon as possible for further medical advice.
If the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing, the patient should contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
Some of the conditions listed below may worsen after taking Contracept. They may also mean that Contracept is not suitable for the patient. In such a case, the patient may still take Contracept, but she should be particularly cautious and have more frequent check-ups.

The patient should tell the doctor if she has any of the following conditions.

If these symptoms occur or worsen while taking Contracept, the patient should also tell her doctor.
In some cases, the patient should be particularly cautious when taking Contracept or other combined oral contraceptives, and regular check-ups with a doctor may be necessary. If any of the following risk factors occur, the patient should inform her doctor before starting to use Contracept.

• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• 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 anemia (a genetic disease of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient is immediately postpartum, she is at higher risk of blood clots. The patient should consult a doctor to find out how soon she can start taking Contracept after giving birth;
• if the patient has superficial thrombophlebitis (inflammation of veins under the skin);
• if the patient has varicose veins;
• if there is a history of breast cancer in the patient's family;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient or someone in her immediate family has been diagnosed with heart or circulatory disorders, e.g., high blood pressure;
• if the patient or someone in her immediate family has been diagnosed with blood clotting disorders;
• if the patient has a genetic disease called porphyria;
• if the patient is overweight (obese);
• if the patient has migraines;
• if the patient has epilepsy (see "Using other medicines");
• if the patient has had a disease that first appeared during pregnancy or while using sex hormones, e.g., hearing loss, porphyria (a blood disease), herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a neurological disease characterized by sudden movements of the body);
• if the patient has (or has had) chloasma (brown patches, so-called "pregnancy patches", especially on the face). In this case, the patient should avoid exposure to sunlight or ultraviolet radiation;

Contracept and blood clots

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Contracept, is associated with an increased risk of blood clots compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thrombosis")
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thrombosis").

Not all patients recover fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the overall risk of serious blood clots caused by Contracept is small.

HOW TO RECOGNIZE A BLOOD CLOT

The patient should contact a doctor immediately if she notices any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from
these symptoms?

The patient should contact a doctor as soon as possible. The patient should discontinue Contracept until she has consulted a doctor and received information about the possibility of continuing treatment.

In the meantime, the patient should use another contraceptive method, e.g., condoms.

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges in 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 highest?

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

What factors increase the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Contracept is small.

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

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Contracept 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/m2);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• with age (especially over 35 years of age);
• if the patient has recently given birth;

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these factors apply to the patient, even if the patient is not sure. The doctor may decide to discontinue Contracept.
The patient should inform the doctor if any of the above conditions change while using Contracept, e.g., if someone in the patient's immediate family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

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

Like blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with Contracept is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes. If the patient uses a hormonal contraceptive like Contracept, she should stop smoking. 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 someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years of age). In this case, the patient may also be at higher risk of having a heart attack or stroke;
• if the patient or someone in her immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia called atrial fibrillation)
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should inform the doctor if any of the above conditions change while using Contracept, e.g., if the patient starts smoking, someone in the patient's immediate family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

Contracept and cancer

There are reports that oral contraceptives slightly increase the risk of cervical cancer, but this relationship may not be related to their use, but rather to the patient's sexual behavior (e.g., unprotected sex). All women should have regular Pap smears.
If the patient has or has had breast cancer, she should not use Contracept. Contracept slightly increases the risk of breast cancer. This risk increases with the duration of Contracept use but decreases within 10 years after stopping the drug. Breast cancer rarely occurs in women under 40 years of age, so the risk of additional breast cancer cases in women currently or recently using Contracept is small. For example:

• Among 10,000 women who have never used oral contraceptives, about 16 will develop breast cancer before the age of 35
• Among 10,000 women who used oral contraceptives for 5 years after the age of 20, about 17-18 will develop breast cancer before the age of 35
• Among 10,000 women who have never used oral contraceptives, about 100 will develop breast cancer before the age of 45
• Among 10,000 women who used oral contraceptives for 5 years after the age of 30, about 110 will develop breast cancer before the age of 45

The risk of breast cancer is higher:

• if the patient has a close relative with breast cancer,
• if the patient is severely overweight

The patient should contact a doctor as soon as possible if she notices any changes in her

breasts, such as indentations on the skin, changes in the nipples, or lumps that can be seen or felt.
Contracept has also been associated with liver diseases, such as jaundice and non-cancerous liver tumors. Very rarely, the use of Contracept has also been associated with certain types of liver cancer in women who have taken the drug for a long time.

If the patient experiences severe abdominal pain or yellowing of the skin or eyes (jaundice), she should contact a doctor immediately.

This may mean that the patient needs to discontinue Contracept.

Irregular bleeding

Some women may experience minor, unexpected bleeding or spotting while taking Contracept, especially during the first few months. This bleeding is usually not a cause for concern and will stop after a day or two. The patient should continue to take Contracept as usual. Bleeding or spotting should stop after taking a few initial blisters of the drug.
Unexpected bleeding may also occur if the patient does not take the tablets regularly, so the patient should try to take the tablets at the same time every day. Unexpected bleeding may also be caused by taking other medicines.
The patient should contact a doctorif irregular bleeding or spotting:

• continues for longer than the first few months
• starts after some time (e.g., several months) after starting to take Contracept
• continues even after stopping Contracept.

What to do if bleeding does not occur during the Contracept-free interval

If all tablets were taken correctly, there was no vomiting or severe diarrhea, and no other medicines were used, the likelihood of pregnancy is small. If the expected withdrawal bleeding does not occur within the next two months, there is a possibility of pregnancy. The patient should contact a doctor immediately. The patient should not start the next blister until the doctor has confirmed that she is not pregnant.

Contracept and other medicines

The patient should inform the doctor who prescribed Contracept about all medicines or herbal products taken recently. The patient should also inform other doctors or dentists who prescribe other medicines (or the pharmacist dispensing the medicines) about the use of Contracept.
The patient will receive information on whether it is necessary to use additional contraceptive methods (e.g., condoms) and, if so, for how long.

• Certain medicines may reduce the effectiveness of Contracept or cause unexpected bleeding. These include medicines used to treat epilepsy (e.g., hydantoin, topiramate, felbamate, lamotrigine, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (e.g., rifampicin), immunomodulating agents (cyclosporine), medicines used to treat HIV (e.g., ritonavir) or other infectious diseases (e.g., griseofulvin), and products containing St. John's wort (Hypericum perforatum).
• The patient should contact a doctor if she plans to use products containing St. John's wort (Hypericum perforatum) while taking Contracept.
• Contracept may affect the effectiveness of certain medicines, such as cyclosporine (medicines used to treat infectious diseases) or antiepileptic drugs containing lamotrigine (may increase the frequency of seizures),
• The patient should not take Contracept if she has severe liver disease and is taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as this may increase liver function test results (increase in liver enzyme activity ALT).
  The doctor will prescribe a different type of contraception before starting treatment with these medicines.
  Contracept can be taken again about 2 weeks after completing treatment with antiviral medicines (see section "When not to use Contracept").
  The patient should tell her doctor or pharmacist about all medicines she is currently taking or has recently taken, as well as any medicines she plans to take.
  The patient should also tell her doctor or pharmacist if she is taking any other medicines.

  Laboratory tests

  Because combined oral contraceptives may affect the results of certain laboratory tests, the patient should inform her doctor or laboratory staff about their use.

  Pregnancy and breastfeeding

  Contracept should not be used during pregnancy. If the patient becomes pregnant while taking Contracept, she should stop taking the drug immediately and contact a doctor.
  Before taking any medicine, the patient should consult a doctor or pharmacist.
  Contracept is not recommended during breastfeeding.
  If the patient plans to use Contracept during breastfeeding, she should contact a doctor.

  Driving and using machines

  There is no information suggesting that Contracept affects the ability to drive or operate machines.
  Contracept contains lactose and sucrose.
  If the patient has an intolerance to some sugars, she should contact a doctor before taking Contracept.

  3. How to use Contracept

  The patient should take one Contracept tablet every day, if necessary with a small amount of water. The tablets can be taken with or without food, but every day at the same time.
  The blister pack contains 21 tablets. On the blister pack, each subsequent tablet is marked with the day of the week on which it should be taken. If the patient starts taking Contracept on a Wednesday, she should take the tablet marked "Wed". The next tablets should be taken in the order indicated on the packaging by an arrow, until all 21 tablets have been taken.
  Then, the patient should not take any tablets for the next 7 days. During the 7-day tablet-free interval (also called the weekly break), withdrawal bleeding will occur. This "withdrawal bleeding" usually starts on the second or third day of the weekly break.
  On the eighth day, counting from the last tablet taken (i.e., after the 7-day weekly break), the patient should start taking tablets from the next blister pack, even if the bleeding has not stopped. This means that the patient should start the next blister pack on the same day of the week, and the withdrawal bleeding will occur on the same days of the month.
  If the patient uses Contracept according to these rules, the contraceptive effect also covers the 7-day period during which no tablets are taken.

  When to start using Contracept from the first package

  • If the patient has not used oral contraceptives in the last monthThe patient should start taking the tablets on the first day of her natural menstrual cycle (i.e., the first day of menstrual bleeding). If the patient starts taking Contracept on the first day of menstrual bleeding, the contraceptive effect starts immediately. The patient can also start taking the tablets between the 2nd and 5th day of the cycle, but in this case, she should use additional contraceptive methods (e.g., condoms) for the first 7 days.
  • Switching from a previously used combined oral contraceptive or vaginal ring or patchThe patient should start taking Contracept the next day after the end of the period without taking tablets from the previous contraceptive or after taking the last placebo tablet from the previous contraceptive. When switching from a combined contraceptive vaginal ring or patch, the patient should follow the doctor's instructions.
  • Switching from a progestogen-only contraceptive (progestogen-only pill, injection, implant, or intrauterine system - IUS)When switching from injections, the switch should be made on the day the next injection is scheduled. When switching from a progestogen-only pill, the switch should be made on the day the next pill is scheduled. When switching from an implant or IUS, the switch should be made on the day the implant is removed. However, in all these cases, it is recommended to use additional contraceptive methods (e.g., condoms) for the first 7 days.
  • After a miscarriageThe patient should follow the doctor's instructions.
  • After childbirthThe patient should start taking the tablets within 21-28 days after giving birth. If the patient starts taking Contracept after 28 days, it is recommended to use barrier methods (e.g., condoms) for the first 7 days. If the patient has had sexual intercourse after giving birth before starting to take Contracept, she should ensure that she is not pregnant or wait for her first menstrual period.

  If the patient is unsure when to start taking Contracept, she should consult a doctor.

  • If the patient is breastfeeding and wants to start taking ContraceptContracept should not be used during breastfeeding. See section "Breastfeeding".

  Using more than the recommended dose of Contracept

  No serious side effects have been reported after taking too many Contracept tablets.
  If the patient takes several tablets, she may experience nausea or vomiting. In young girls, vaginal bleeding may occur.
  If the patient has taken too much Contracept or suspects that a child has taken some tablets, she should contact a doctor or pharmacist.

  Missing a dose of Contracept

  • If the delay in taking a tablet is less than 12 hours, the contraceptive effect is maintained. The missed tablet should be taken as soon as possible, and the remaining tablets should be taken at the usual time.
  • If the delay in taking a tablet is more than 12 hours, the contraceptive effect may be reduced. The more tablets missed, the higher the risk of reduced contraceptive effect.

  The risk of reduced contraceptive effect is higher if the missed tablet occurs at the beginning or end of the blister pack. In such a situation, the patient should follow the rules presented below (see the scheme below).

  • Missing more than one tablet from the blister packThe patient should contact a doctor.
  • Missing a tablet in the 1st weekThe missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. From that moment on, the patient should take the remaining tablets at the usual time. At the same time, for the next 7 days, the patient should use additional contraceptive methods, e.g., condoms. If the patient had sexual intercourse in the past week or forgot to start taking tablets from a new blister pack after the weekly break, she should consider the possibility of pregnancy. The patient should contact a doctor.
  • Missing a tablet in the 2nd weekThe missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. From that moment on, the patient should take the remaining tablets at the usual time. The contraceptive effect has not been reduced, and there is no need to use additional contraceptive methods.
  • Missing a tablet in the 3rd weekThe patient can follow one of the following recommendations:
  • 1. The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. From that moment on, the patient should take the remaining tablets at the usual time. After taking the last tablet from the current blister pack, the patient should start the next blister pack immediately, without taking the usual 7-day break. It is likely that withdrawal bleeding will occur at the end of the tablets from the second blister pack, but the patient may experience spotting or breakthrough bleeding during the second blister pack.
  • 2. The patient can also stop taking the tablets from the current blister pack. The patient should take a break of 7 days (including the days of missed tablets), and then start taking the tablets from a new blister pack. If the patient wants to start the next blister pack on the scheduled day, she should take a shorter break than 7 days. If the patient chooses one of these options, there is no need to use additional contraceptive methods. If the patient does not experience withdrawal bleeding after missing a tablet and during the first regular break after taking the tablets, she should consider the possibility of pregnancy. The patient should contact a doctor before starting the next blister pack.

  What to do in case of vomiting or severe diarrhea

  If vomiting or severe diarrhea occur within 3-4 hours after taking a tablet, there is a risk that the active substances of the tablet may not be fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhea, the patient should take another tablet from the next blister pack as soon as possible. If possible, the patient should take the tablet within 12 hours of the usual time of taking the tablet. If this is not possible or 12 hours have already passed, the patient should follow the instructions in the section "Missing a dose of Contracept".

  4. Possible side effects

  Like all medicines, this medicine can cause side effects, although not everybody gets them.
  If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Contracept, you should consult a doctor.
  In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before taking Contracept".
  You should immediately consult a doctor if any of the following symptoms of angioedema occur:
  Swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing (see also section "Warnings and precautions").

  Severe side effects - seek medical attention immediately

  Rarely(occur in fewer than 1 in 1,000 women)

  • 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-like symptoms, known as a transient ischemic attack blood clots in the liver, stomach/intestine, kidneys, or eye

  The likelihood of blood clots may be higher if the patient has other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).
  Symptoms of blood clots(see section 2 "Blood clots")

  Symptoms of severe allergic reaction or exacerbation of hereditary angioedema

  o swelling of the hands, face, lips, mouth, tongueor throat. Swelling of the tongue and/or throat can cause difficulty swallowing and breathing.
  o red, blotchy rash (hives) and itching.

  • Liver cancer

  Symptoms of breast cancer include:

  • dimplingof the skin
  • changes in the nipple
  • any visible or palpable lumps.

  Symptoms of cervical cancer include:

  • abnormal vaginal dischargewith an unpleasant smell and/or containing blood
  • unexplained vaginal bleeding
  • pelvic pain
  • pain during intercourse

  Symptoms of severe liver failure include:

  • severe upper abdominal pain
  • yellowing of the skin or eyes(jaundice)
  • liver inflammation
  • itchingall over the body

  If the patient suspects that any of the above symptoms have occurred, she should

  immediately consult a doctor.It may be necessary to discontinue Contracept.

  Less serious side effects

  Very common(occur in more than 1 in 10 women)

  • headaches
  • nervousness

  Common(occur in fewer than 1 in 10 women)

  • nausea
  • abdominal pain
  • weight gain
  • depression or mood changes
  • breast pain or tenderness vaginal inflammation, including candidiasis
  • fluid retention
  • migraine
  • increased or decreased libido
  • dizziness
  • visual disturbances
  • acne
  • irregular bleeding
  • amenorrhea
  • scanty periods

  Uncommon(occur in fewer than 1 in 100 women)

  • nausea and vomiting, including vomiting
  • skin rash (may be itchy)
  • increased blood lipid levels (hyperlipidemia)
  • hypertension
  • hirsutism (excessive hair growth)
  • excessive hair loss
  • changes in blood lipid levels, including hypertriglyceridemia

  Rare(occur in fewer than 1 in 1,000 women)

  • reduced tolerance to contact lenses
  • vaginal discharge
  • systemic lupus erythematosus (an autoimmune disease)
  • glucose intolerance
  • otosclerosis (a hereditary condition)
  • gallstones (cholelithiasis)
  • jaundice
  • painful red lumps (erythema nodosum)
  • reduced folate levels in the blood

  Very rare(occur in fewer than 1 in 10,000 women)

  • liver tumors (benign liver tumors)
  • changes in glucose tolerance or effects on peripheral insulin resistance
  • exacerbation of porphyria (a hereditary disease)
  • optic neuritis
  • retinal vein thrombosis
  • pancreatitis
  • erythema multiforme (skin changes)
  • hemolytic-uremic syndrome (a kidney disease)

  Other reported side effects

  Very common(occur in more than 1 in 10 women)

  • During the first few months of use, bleeding and spotting in the middle of the cyclemay occur, which usually subside as the woman's body adapts to Contracept. If bleeding persists, becomes heavy, or recurs, you should consult a doctor (see section 2 "Bleeding in the middle of the cycle"). Rarely(occur in fewer than 1 in 1,000 women)
  • Chloasma(yellow or brown spots on the skin). It may occur even after several months of using Contracept. The spots can be reduced by avoiding sun exposure and sunbathing or using a sunlamp.

  Very rare(occur in fewer than 1 in 10,000 women)

  • movement disorders called chorea

  Conditions that may worsen during Contracept use during pregnancy or before pregnancy:

  • jaundice
  • persistent itching(pruritus)
  • gallstones
  • some rare diseases, e.g. systemic lupus erythematosus
  • pregnancy herpes(pemphigoid rash)
  • otosclerosis(a hereditary condition)
  • porphyria(a hereditary disease)

  You should inform your doctor, pharmacist, or nurseif you suspect that any side effect may be related to Contracept use. If any existing condition worsens while taking Contracept, you should also inform your doctor, pharmacist, or family planning advisor.

  Reporting side effects

  If any side effects occur, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
  Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
  Jerozolimskie Avenue 181C
  02-222 Warsaw,
  Phone: +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 or its representative.
  Reporting side effects will help to gather more information on the safety of the medicine.

  5. How to store Contracept

  Do not store above 30°C.
  The medicine should be stored out of sight and reach of children.
  Do not use Contracept after the expiry date stated on the packaging.
  The expiry date refers to the last day of the month.
  Medicines should not be disposed of via wastewater or household waste. You should 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 Contracept contains

  The active substances of Contracept are:
  Each sugar-coated tablet contains 0.02 mg of ethinylestradiol and 0.075 mg of gestodene.
  Other ingredients of Contracept are:
  tablet core: magnesium stearate, povidone K-25, corn starch, lactose monohydrate,
  tablet coating: povidone K-90, macrogol 6000, talc, calcium carbonate, sucrose, montan wax.

  What Contracept looks like and contents of the pack

  Contracept is available in the form of white, round, biconvex, sugar-coated tablets, without markings on both sides.
  Tablets are packaged in blisters - each blister contains 21 tablets. Blisters are placed in a cardboard box. Each cardboard box contains 1, 3, or 6 blisters.
  Not all pack sizes may be marketed.

  Marketing authorization holder

  Adamed Pharma S.A.
  Pieńków, ul. M. Adamkiewicza 6A
  05-152 Czosnów
  phone: +48 22 732 77 00

  Manufacturers

  Haupt Pharma Münster GmbH
  Schleebrüggenkamp 15
  D-48159 Münster
  Germany
  Adamed Pharma S.A.
  Pieńków, ul. M. Adamkiewicza 6A
  05-152 Czosnów

  This medicinal product is authorized in the Member States of the European Economic Area under the following names:

  Belgium, Luxembourg: Docgestradiol 20
  Ireland: Estelle 20/75
  Hungary, Spain: Gestinyl 20
  Czech Republic, Slovak Republic: Sunya
  Denmark, Finland: Gestinyl
  Italy: Gestodiol
  Netherlands: Ethinylestradiol/Gestodeen 0,02/0,075 A
  Poland: Kontracept
  United Kingdom: Sunya 20/75

  Date of approval of the leaflet 06.2023