Kontracept

Package leaflet: Information for the user

Kontracept, 0,02 mg + 0,075 mg, coated tablets
Ethinylestradiolum + Gestodenum
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable forms of reversible contraception
• They slightly increase the risk of venous and arterial blood clots, especially during the first year of use or after restarting following a break of 4 weeks or more
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots")
• Kontracept does not protect against sexually transmitted diseases
• Kontracept may increase the risk of developing blood clots and breast cancer
• Kontracept should not be used in certain women due to existing medical conditions or diseases. Please read this leaflet carefully to ensure that Kontracept is suitable for you
• To effectively prevent pregnancy, it is important to take Kontracept exactly as directed and to start each pack at the correct time. Make sure you know what to do if you miss a tablet or suspect you may be pregnant

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

• Keep this leaflet, as you may need to read it again
• If you have any questions, ask your doctor or pharmacist
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of the leaflet:

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

1. What Kontracept is and what it is used for

• Kontracept 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 such as Kontracept, which contain two hormones, are called combined oral contraceptives

2. IMPORTANT INFORMATION BEFORE USING KONTRACEPT

General notes.
Before starting to take Kontracept, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 “Blood clots”).
Before starting Kontracept, your doctor should take a medical history, including any illnesses you or your family members have had. Your doctor should measure your blood pressure and, depending on your health status, may perform additional tests.
This leaflet describes situations in which you should stop taking Kontracept or when its effectiveness may be reduced. In such cases, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or another barrier method. Do not use the cervical mucus or temperature methods. These methods may be unreliable because Kontracept alters body temperature and vaginal mucus changes during the menstrual cycle.
Kontracept, like other combined hormonal contraceptives, does not protect against HIV (AIDS)
or other sexually transmitted infections.

When not to use Kontracept
Do not use Kontracept if you have any of the following conditions. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative contraceptive method may be more suitable:

• if you currently have (or have ever had) a blood clot in the 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 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 an early sign of heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that 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 (or have previously had) pancreatitis (pancreatitis);
• if you have severe liver dysfunction and liver function has not returned to normal;
• if you have (or have previously had) liver tumour;
• if you have (or have previously had) or are suspected of having breast cancer or genital organ cancer;
• if you have any unexplained vaginal bleeding;
• if you are hypersensitive to ethinylestradiol or gestodene, or to any of the other ingredients of this medicine (listed in section 6), diagnosed as itching, rash, or swelling;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also “Kontracept and other medicines”).

Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate deep vein thrombosis (blood clot in the leg), pulmonary embolism (blood clot in the lungs), heart attack, or stroke (see section below “Blood clots (thrombosis)”).

For a description of the symptoms of these serious adverse effects, see “How to recognize blood clots”.
Psychiatric disorders:
Some women using hormonal contraceptives, including Kontracept, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.
If you experience symptoms of hereditary or acquired angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with potential breathing difficulties, seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
Some of the conditions listed below may worsen after taking Kontracept. They may also indicate that Kontracept is not suitable for you. In such cases, you may continue taking Kontracept but should exercise particular caution and have more frequent check-ups.
Tell your doctor if you have any of the following conditions.
If any of these symptoms appear or worsen during treatment with Kontracept, inform your doctor.
In certain cases, special care is needed when using Kontracept or other combined oral contraceptives, and regular check-ups with your doctor may be necessary. If any of the risk factors listed below apply, inform your doctor before starting Kontracept.

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to 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 positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• 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 Kontracept;
• if you have superficial thrombophlebitis (inflammation of veins under the skin with blood clots);
• if you have varicose veins;
• if there is (or has been) breast cancer in your family;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you or a close family member has heart or circulatory problems, e.g. high blood pressure;
• if you or a close family member has blood clotting disorders;
• if you have an inherited disorder called porphyria;
• if you are overweight (obesity);
• if you suffer from migraines;
• if you have epilepsy (see: Use of other medicines);
• if you have ever had a condition that first appeared during pregnancy or previous use of sex hormones; for example: hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham’s chorea (a neurological disorder with sudden involuntary movements);
• if you have (or have previously had) chloasma (brownish patches, so-called “pregnancy mask”, especially on the face). In such cases, avoid exposure to sunlight or ultraviolet radiation.

Kontracept and thrombosis
BLOOD CLOTS
Using combined hormonal contraceptives such as Kontracept increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots may occur:

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

Complete recovery after a blood clot is not always possible. 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 associated with using Kontracept is low.
HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

You should contact a doctor as soon as possible. You must stop taking Kontracept
until you consult a doctor and receive information about whether treatment can be continued.
In the meantime, the patient should use another method of contraception, such as condoms.
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 venous blood clots (venous thromboembolism). 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.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is greatest during the first year of using combined hormonal contraceptives for the first time. 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 the patient stops taking Kontracept, the risk of blood clots returns to normal levels within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual's natural 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 Kontracept is low.

• In the course of 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 the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing gestodene, such as Kontracept, 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 venous blood clots
The risk of blood clots associated with the use of Kontracept is small, however,
some factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have inherited clotting disorders;
• 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 Kontracept several weeks before surgery or during immobilization. If the patient must stop taking Kontracept, ask the doctor when it is safe to resume the medication.
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing 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,
particularly if the patient has another risk factor.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Kontracept.
Inform the doctor if any of the above conditions change during treatment with Kontracept, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

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

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Kontracept is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Kontracept, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder such 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.
Inform the doctor if any of the above conditions change during treatment with Kontracept, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Kontracept and cancer
There are reports that oral contraceptives may slightly increase the risk of cervical cancer, although this association may not be directly related to the medication but rather to the patient's sexual behavior (e.g., unprotected intercourse). All women should have regular cervical smears (Pap tests).
Kontracept must not be used if the patient has or has had breast cancer. Kontracept slightly increases the risk of developing breast cancer. This risk increases with duration of use but decreases within 10 years after stopping the medication.
Breast cancer is rare in women under 40 years of age; therefore, the risk of additional breast cancer cases in women currently or recently using Kontracept is small. For example:

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

The risk of breast cancer is higher:

• if a close female relative (mother, sister, or grandmother) has had breast cancer,
• in cases of significant overweight.

Contact the doctor immediately if any changes in the breasts are noticed, such as skin dimpling, nipple changes, or lumps that can be seen or felt.
Rarely, the use of Kontracept has also been associated with liver disorders, such as jaundice and benign liver tumors. Very rarely, long-term use has been linked to certain types of liver cancer in women.
If severe abdominal pain or yellowing of the skin or eyes (jaundice) occurs, contact the doctor immediately. It may be necessary to discontinue Kontracept.

Intermenstrual bleeding
Some women may experience light unexpected bleeding or spotting while taking Kontracept, especially during the first few months. This is usually not a cause for concern and typically resolves within one or two days. Continue taking Kontracept as usual. Bleeding or spotting should stop after taking a few packs of the medication.
Unexpected bleeding may also occur if tablets are not taken regularly; therefore, try to take the tablets at the same time every day. Unexpected bleeding may also be caused by concomitant use of other medications.
Contact the doctor if intermenstrual bleeding or spotting:

• persists for longer than the first few months,
• starts after some time (e.g., several months) after beginning Kontracept,
• continues after stopping Kontracept.

What to do if withdrawal bleeding does not occur during the tablet-free interval
If all tablets were taken correctly, there were no episodes of vomiting or severe diarrhea, and no other medications were taken, the likelihood of pregnancy is low. If withdrawal bleeding does not occur in two consecutive cycles, pregnancy is possible. Inform the doctor immediately. Do not start the next pack until the doctor confirms that the patient is not pregnant.

Kontracept and other medicines
Inform the doctor who prescribed Kontracept about all recently used medications or herbal supplements. Also inform other physicians, dentists, or pharmacists prescribing other medications about the use of Kontracept. The patient will be advised whether additional contraceptive methods (e.g., condoms) are needed and, if so, for how long.

• Some medications may reduce the contraceptive effectiveness of Kontracept or cause unexpected bleeding. These include drugs used to treat epilepsy (e.g., hydantoin, topiramate, felbamate, lamotrigine, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (e.g., rifampicin), immunomodulating agents (cyclosporine), drugs used in HIV infection (ritonavir) or other infectious diseases (griseofulvin), and herbal products containing St. John’s wort (Hypericum perforatum).
• Contact the doctor if the patient intends to use products containing St. John’s wort (Hypericum perforatum) while taking Kontracept.
• Kontracept may affect the effectiveness of certain drugs, e.g., medications containing cyclosporine (used in infectious diseases) or antiepileptic drugs containing lamotrigine (which may lead to increased seizure frequency).
• Do not take Kontracept if the patient has severe liver disease and is taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as this may lead to increased liver function test results (elevated liver enzyme ALT activity).
  The doctor will prescribe another type of contraception before starting treatment with these medications.
  Kontracept may be restarted approximately 2 weeks after completing antiviral treatment (see section “When not to use Kontracept”).
• Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Laboratory tests
Since combined oral contraceptives may affect the results of certain laboratory tests, inform the doctor or laboratory staff about their use.

Pregnancy and breastfeeding
Kontracept must not be used during pregnancy. If the patient becomes pregnant while taking Kontracept, the medication should be stopped immediately and the doctor contacted.
Before taking any medicine, consult a doctor or pharmacist.
Use of Kontracept is not recommended during breastfeeding.
If the patient intends to use Kontracept while breastfeeding, contact the doctor.

Driving and operating machinery
There is no information suggesting that Kontracept affects the ability to drive or operate machinery.

Kontracept contains lactose and sucrose.
If the patient has an intolerance to certain sugars, consult a doctor before taking Kontracept.

3. How to use Kontracept

Take one Kontracept tablet every day, swallowing it with a small amount of water if necessary.
The tablets may be taken with or without food, but should be taken at the same time each day.
The blister pack contains 21 tablets. Each tablet in the blister is marked with the day of the week on which it should be taken.
For example, if you start taking the medicine on Wednesday, take the tablet marked "Wed".
Continue taking the tablets in the order indicated by the arrow on the packaging until all 21 tablets have been used.
After this, do not take any tablets for the next 7 days. During this 7-day break (called the weekly break),
withdrawal bleeding will occur. This so-called "withdrawal bleeding" usually appears on the second or third day of the weekly break.
On the eighth day after taking the last Kontracept tablet (i.e. after the 7-day break), start taking tablets from the next blister pack,
even if bleeding has not yet finished. This means that you will start the next pack on the same day of the week,
and withdrawal bleeding will occur on the same days each month.
If Kontracept is taken according to these instructions, contraceptive protection continues throughout the 7-day tablet-free period.

When to start taking Kontracept for the first time

• If you have not used oral hormonal contraceptives in the past month
  Start taking tablets on the first day of your natural menstrual cycle (i.e. the first day of menstrual bleeding).
  If you start taking Kontracept on the first day of menstrual bleeding, contraceptive protection begins immediately.
  You may also start between days 2 and 5 of your cycle, but in this case, you must use additional contraceptive methods (e.g. condoms) for the first 7 days.

• Switching from a previously used combined oral contraceptive, vaginal ring, or contraceptive patch
  Start taking Kontracept the day after the tablet-free interval of your previous contraceptive ends (or the day after taking the last placebo tablet of your previous contraceptive).
  If switching from a combined contraceptive in the form of a vaginal ring or patch, follow your doctor's advice.

• Switching from a previously used progestogen-only contraceptive (progestogen-only pills, injections, implants, or intrauterine system releasing progestogen - IUS)
  Switch on the day when the next injection would have been administered, or on the day when the next progestogen-only pill was due.
  If switching from an implant or IUS, switch on the day of removal.
  However, in all these cases, it is recommended to use additional contraceptive precautions (e.g. condoms) for the first 7 days of tablet intake.

• After miscarriage
  Follow your doctor's advice.

• After childbirth
  Start taking tablets between 21 and 28 days after delivery.
  If you start after 28 days, use barrier methods (e.g. condoms) for the first 7 days of tablet intake.
  If you had sexual intercourse after childbirth before starting Kontracept, ensure you are not pregnant, or wait until the first menstrual bleeding occurs.

If you are unsure when to start, consult your doctor.

• If you are breastfeeding and wish to start taking Kontracept
  Kontracept must not be used during breastfeeding. See section "Breastfeeding".

Taking more Kontracept than you should
No serious adverse effects have been reported after taking an excessive amount of Kontracept tablets.
If several tablets are taken, nausea or vomiting may occur. In young girls, vaginal bleeding may occur.
If an overdose of Kontracept is taken or if a child has taken several tablets, contact a doctor or pharmacist immediately.

Missed dose of Kontracept

• If the delay in taking a tablet is less than 12 hours, contraceptive effectiveness remains unchanged.
  Take the missed tablet as soon as possible and continue taking the remaining tablets at the usual time.

• If the delay in taking a tablet is more than 12 hours, contraceptive effectiveness may be reduced.
  The greater the number of missed tablets, the higher the risk of reduced contraceptive effectiveness.

The risk of reduced contraceptive effectiveness is greater if a tablet is missed at the beginning or end of the pack.
In such cases, follow the instructions below (see the scheme below).

• More than one tablet missed from the pack
  Contact your doctor.

• Missed tablet in Week 1
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time.
  Continue taking the remaining tablets at the usual time.
  Additionally, use additional contraceptive methods (e.g. condoms) for the next 7 days.
  If sexual intercourse occurred in the past week or if you forgot to start a new pack after the weekly break,
  consider the possibility of pregnancy. In this case, contact your doctor.

• Missed tablet in Week 2
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time.
  Continue taking the remaining tablets at the usual time.
  Contraceptive effectiveness is not reduced, and there is no need to use additional contraceptive methods.

• Missed tablet in Week 3
  Apply one of the following recommendations:

  1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time.
     Continue taking the remaining tablets at the usual time.
     Immediately after finishing the current pack, start the next pack without a break.
     Withdrawal bleeding will most likely occur at the end of the second pack, but breakthrough bleeding or spotting may occur during the second pack.

  2. Alternatively, stop taking tablets from the current pack.
     Take a 7-day break (including the days when tablets were missed), then start a new pack.
     If you wish to start the new pack on a specific day, make the break shorter than 7 days.
     If you follow either of these recommendations, there is no need to use additional contraceptive methods.
     If no withdrawal bleeding occurs during the first proper tablet-free interval after missing a tablet, consider the possibility of pregnancy.
     Contact your doctor before starting the next pack.

Missed several tablets from the pack — Seek medical advice

What to do if you vomit or have severe diarrhoea
If vomiting or severe diarrhoea occurs within 3–4 hours of taking a tablet, there is a risk that the active ingredients may not be fully absorbed.
This situation is similar to missing a tablet.
After vomiting or diarrhoea, take a tablet from the next pack as soon as possible.
If possible, take the tablet within 12 hours of your usual tablet-taking time.
If this is not possible or if more than 12 hours have passed, follow the instructions under "Missed dose of Kontracept".

How to delay withdrawal bleeding
Delaying withdrawal bleeding is possible, but not recommended.
To delay withdrawal bleeding, start the next pack of Kontracept without taking the usual 7-day break.
Breakthrough bleeding or spotting may occur during the second pack.
Regular use of Kontracept should resume after observing a proper 7-day tablet-free interval.
Before deciding to delay withdrawal bleeding, consult your doctor.

How to change the day of the week when withdrawal bleeding starts
If tablets are taken according to the schedule, withdrawal bleeding occurs during the tablet-free interval.
To shift the timing of withdrawal bleeding, shorten (but never extend) the tablet-free interval by the number of days you wish to shift the bleeding.
For example, if the tablet-free interval normally starts on Friday, and you wish to shift it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual.
If the tablet-free interval is very short (e.g. 3 days or less), bleeding may not occur.
Instead, spotting or breakthrough bleeding may occur during the cycle.
If you are unsure how to proceed, contact your doctor.

Stopping use of Kontracept
You may stop taking Kontracept at any time.
If you do not wish to become pregnant, consult your doctor about alternative methods of birth control.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Kontracept, medical advice should be sought immediately.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using (the medicine) Kontracept".
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema:
Swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

Serious adverse reactions – seek immediate medical advice
Rare (occur in less than 1 in 1,000 women)

• Harmful blood clots in a vein or artery, for example:
  o in the leg or foot (e.g. deep vein thrombosis)
  o in the lungs (e.g. pulmonary embolism)
  o heart attack
  o stroke
  o mini-stroke or transient ischaemic attack (TIA)
  o 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 clot formation).

Symptoms of blood clots (see section 2 "Blood clots")

• Symptoms of severe allergic reaction or exacerbation of hereditary angioedema
  o swelling of hands, face, lips, mouth, tongue or throat. Swelling of the tongue and/or throat may cause difficulty in swallowing and breathing.
  o red, raised, itchy rash (urticaria).

• Liver cancer

Symptoms of breast cancer include:

• dimpling of the skin
• changes in the nipple
• any visible or palpable lumps

Symptoms of cervical cancer include:

• vaginal discharge with unpleasant odour and/or containing blood
• unexplained vaginal bleeding
• pelvic pain
• pain during sexual intercourse

Symptoms of severe liver failure include:

• sudden pain in the upper abdomen
• yellowing of the skin or eyes (jaundice)
• liver inflammation
• itching of the whole body

If the patient suspects any of the above symptoms, she should seek medical advice immediately. Discontinuation of Kontracept may be necessary.

Less serious adverse reactions
Very common (occur in more than 1 in 10 women)

• headaches
• nervousness

Common (occur in less than 1 in 10 women)

• nausea
• abdominal pain
• weight gain
• depressive states or mood changes
• breast pain or tenderness
• vaginal inflammation, including candidiasis
• fluid retention
• migraine
• increased or decreased libido
• dizziness
• visual disturbances
• acne
• irregular bleeding
• absence of menstruation
• scanty menstruation

Uncommon (occur in less than 1 in 100 women)

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

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

• reduced tolerance to contact lenses
• vaginal discharge
• systemic lupus erythematosus (autoimmune disease)
• glucose intolerance
• hereditary deafness (otosclerosis)
• gallstones (cholelithiasis)
• yellowing of the skin (jaundice)
• painful red nodules (erythema nodosum)
• decreased serum folate levels

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

• liver adenomas (benign liver tumours)
• changes in glucose tolerance or effects on peripheral insulin resistance
• exacerbation of porphyria (hereditary disease)
• optic neuritis
• retinal vessel thrombosis
• pancreatitis
• erythema multiforme (skin lesions)
• haemolytic-uraemic syndrome (kidney disease)

Other reported adverse reactions
Very common (occur in more than 1 in 10 women)

• During the first few months of use, bleeding and spotting between periods may occur, which usually resolves as the woman's body adapts to Kontracept. If bleeding persists, becomes heavy or recurs, it should be reported to a doctor (see section 2 "Bleeding between periods").

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

• Chloasma (yellow or brown patches on the skin). This may occur even after several months of using Kontracept. These patches can be minimized by avoiding exposure to sunlight and sunbeds or UV lamps.

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

• movement disorders known as chorea
• Conditions that may worsen during use of the medicine during pregnancy or before becoming pregnant:
  • yellowing of the skin (jaundice)
  • persistent itching (pruritus)
  • gallstones
  • some rare diseases, e.g. systemic lupus erythematosus
  • herpes gestationis (vesicular rash)
  • hereditary deafness (otosclerosis)
  • porphyria (hereditary disease)

Inform a doctor, pharmacist or nurse if the patient suspects that any adverse reaction may be due to the use of Kontracept. If any pre-existing condition worsens during treatment with Kontracept, this should also be reported to a doctor, pharmacist or family planning advisor.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw,
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Kontracept

Do not store at temperatures above 30°C.
Keep the medicine in a place out of sight and reach of children.
Do not use Kontracept after the expiry date stated on the packaging.
The expiry date refers to the last day of the 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 packaging and other information

What Kontracept contains
The active substances in this medicine are:
Each coated tablet contains 0.02 mg ethinylestradiol and 0.075 mg gestodene.
Other ingredients in the medicine are:
tablet core: magnesium stearate, povidone K-25, corn starch, lactose monohydrate,
tablet coating: povidone K-90, macrogol 6000, talc, calcium carbonate, sucrose, montanic glycol wax.

What Kontracept looks like and contents of the pack
Kontracept is available as white, round, biconvex, sugar-coated tablets, without any markings on either side.
The tablets are packed in blisters – each blister contains 21 tablets. The blisters are placed in a cardboard box. Each cardboard box contains 1, 3 or 6 blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +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 authorised in the European Economic Area countries 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