Ciprodiol

PATIENT INFORMATION LEAFLET: USER INFORMATION

Cyprodiol, 2 mg + 0.035 mg, coated tablets

Cyproterone acetate + Ethinylestradiol

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Cyprodiol is and what it is used for
• 2. Important information before using Cyprodiol
• 3. How to use Cyprodiol
• 4. Possible side effects
• 5. How to store Cyprodiol
• 6. Contents of the pack and other information

1. What Cyprodiol is and what it is used for

Cyprodiol is used to treat skin conditions such as acne, very oily skin, and excessive hair growth in women of childbearing age. Due to its contraceptive properties, this medicine should only be prescribed to a patient if the doctor considers that treatment with hormonal contraceptives is appropriate.
The patient should use Cyprodiol to treat acne only if there has been no improvement in the skin condition after using other anti-acne therapies, including local treatments and antibiotics.

2. Important information before using Cyprodiol

When not to use Cyprodiol

You should inform your doctor if any of the following conditions are present before starting Cyprodiol. The doctor may then recommend an alternative treatment:

• if you are allergic to ethinylestradiol, cyproterone acetate, or any of the other ingredients of this medicine (listed in section 6);
• if you have hepatitis C and are taking medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see "Cyprodiol and other medicines");
• if you are taking another hormonal contraceptive;
• if you currently have (or have ever had) a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), or in any other part of your body;
• if you have ever had a blood clot in a vein caused by an unknown reason (confirmed idiopathic venous thromboembolism (VTE) with a thrombotic event in siblings or parents at a relatively young age);
• if you currently have (or have ever had) diseases that may indicate a previous heart attack (e.g., angina pectoris, which causes severe chest pain) or a "mini-stroke" (transient ischaemic attack);
• if you have a blood clotting problem (e.g., protein C deficiency);
• if you currently have (or have ever had) a heart attack or stroke;
• if you have factors that may increase the risk of a blood clot. These include:
• diabetes that affects blood vessels;
• very high blood pressure;
• very high levels of fat in the blood (cholesterol or triglycerides);
• if you have a certain blood disease (sickle cell anaemia);
• if you have had pancreatitis (inflammation of the pancreas) with high levels of fats in the blood;
• if you have had severe liver disease (including liver tumours) or if you have had liver disease in the past and your liver function tests have not returned to normal;
• if you have had (or have) liver tumours (benign or malignant);
• if you have unexplained vaginal bleeding;
• if you currently have (or have ever had) migraine with visual disturbances;
• if you are a smoker (see "Warnings and precautions");
• if you have been diagnosed with or suspected to have hormone-dependent cancer of the breast or genitals;
• if you have jaundice, chronic itching, or blistering rash (pruritus or pemphigoid gestationis) or worsening of hearing in women with ear problems (otosclerosis) during a previous pregnancy;
• if you plan to become pregnant, are pregnant, or are breastfeeding;
• if you have a meningioma or have been diagnosed with a meningioma (usually a benign tumour of the tissue layer between the brain and the skull).

Cyprodiol should not be used in men.
If any of the above conditions occur during treatment with Cyprodiol, you should stop taking the medicine immediately and consult a doctor. In the meantime, you should use a non-hormonal method of contraception.

Warnings and precautions

General notes
This leaflet indicates various situations in which you should stop using Cyprodiol or in which the contraceptive effect may be reduced. In such situations, you should either abstain from sex or use another non-hormonal method of contraception, such as condoms or other barrier methods. However, you should not use the rhythm or temperature method.
There have been reports of an increased risk of developing a benign brain tumour (meningioma) in association with the use of high doses (25 mg and above) of cyproterone acetate. If a meningioma is diagnosed, the doctor will stop treatment with products containing cyproterone, including Cyprodiol, as a precautionary measure (see "When not to use Cyprodiol").

Cyprodiol does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Consultations and/or medical examinations
Before starting treatment with hormonal medicines like Cyprodiol, you should have a thorough medical examination (including measurement of weight, blood pressure, heart, lower limbs, and skin examination, urine glucose test, and, if appropriate, liver function tests) and a gynaecological examination (including breast examination and cervical smear) and a detailed medical history. Before starting Cyprodiol, you should exclude pregnancy. If relatives have had blood clots at a young age, you should exclude coagulation disorders. During treatment with Cyprodiol, it is recommended to have check-ups on average every 6 months.

When to contact a doctor

Contraceptive pills and vascular disorders

Compared to non-users, the use of contraceptive pills or Cyprodiol is associated with an increased risk of blood clots in the veins (venous thromboembolism), which can sometimes break loose and reach organs such as the lungs (pulmonary embolism).
The additional risk of venous thromboembolism is highest during the first year of use of contraceptive pills for the first time. However, the risk of vascular disease is still lower than the risk during pregnancy (estimated at 60 cases per 100,000 pregnant women).

You should stop taking the pills and contact a doctor immediately if you notice symptoms that may indicate a blood clot, such as those described in section 2 "Blood clots".

Cyprodiol also acts as an oral contraceptive. The patient and doctor should consider all the usual rules for safe use of oral hormonal contraception.
Blood clots (thrombosis)
The use of Cyprodiol may slightly increase the risk of blood clots in the patient (so-called thrombosis). The likelihood of blood clots in patients using Cyprodiol is only slightly increased compared to women who do not use Cyprodiol or any oral contraceptive. Not all patients recover fully, 1-2% of cases can be fatal.
Blood clots in veins
A blood clot in a vein (known as deep vein thrombosis) can block a vein. This can happen in the veins of the legs, lungs (pulmonary embolism), or any other organ.
The use of combined oral contraceptives increases the risk of such blood clots in women compared to women who do not take any combined oral contraceptives. The risk of venous thromboembolism is increased by:

• increasing age;
• if you smoke. When using a hormonal contraceptive like Cyprodiol, it is strongly recommended to quit smoking, especially if you are over 35 years old;
• if you have a family history of blood clots in a young age;
• if you are overweight;
• if you have to undergo surgery, are immobile for a long time due to injury or illness, or have a leg in a cast.

If any of these conditions apply to you, it is important to inform your doctor about the use of Cyprodiol, as treatment may need to be discontinued. Your doctor may advise you to stop taking Cyprodiol for a few weeks before surgery or when your mobility is limited. Your doctor will also inform you when you can start taking Cyprodiol again after you have regained mobility.
Blood clots in arteries
Blood clots in arteries can cause serious damage. For example, a blood clot in the coronary artery can cause a heart attack, or in the brain, it can cause a stroke.
The use of combined oral contraceptives is associated with an increased risk of blood clots in arteries. This risk is increased by:

• increasing age;
• if you smoke. When using a hormonal contraceptive like Cyprodiol, it is strongly recommended to quit smoking, especially if you are over 35 years old;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age;
• if you have high levels of fat in the blood (cholesterol or triglycerides);
• if you have migraines;
• if you have heart disease (valve damage, heart rhythm disorders).

Symptoms caused by a blood clot

You should stop taking the pills and contact a doctor immediately if you notice symptoms that may indicate a blood clot, such as:

• unusual sudden cough;
• severe chest pain that may radiate to the left arm;
• shortness of breath;
• any unusual, severe, or prolonged headache or worsening migraine;
• partial or complete loss of vision or double vision;
• slurred speech or loss of speech;
• sudden hearing loss, smell, or taste disorders;
• dizziness or fainting;
• numbness or paralysis of part of the body;
• severe abdominal pain;
• severe pain or swelling of the legs.

Not all patients recover fully after a blood clot. Occasionally, thrombosis can cause permanent disability or death.
After childbirth, women are at increased risk of blood clots (see also "Pregnancy and breastfeeding").
Epidemiological studies have shown that thrombosis occurs more frequently during the use of Cyprodiol than in patients using low-dose estrogen combined oral contraceptives (less than 50 micrograms of ethinylestradiol).
Very rarely, blood clots can occur in the blood vessels of the liver, abdominal cavity, kidneys, or eyes.
In women using Cyprodiol for the treatment of severe acne or mild hirsutism (excessive hair growth on the face and body), there is an increased risk of cardiovascular disorders, such as the development of ovarian cysts (polycystic ovary syndrome).

You should stop taking Cyprodiol immediately in the following cases:

• headaches resembling migraines, which occur for the first time or with increased severity, or very frequent or severe headaches;
• sudden severe visual or hearing disturbances or motor disturbances, especially paralysis (possible early symptoms of a stroke) or other perception and sensation disorders;
• first symptoms of phlebitis with simultaneous thrombosis (thrombophlebitis) or thromboembolic symptoms (see section 2 "Special medical supervision is necessary in case of");
• 4 weeks before planned surgery (e.g., abdominal, orthopedic), (see section "The risk of blood clots in veins in patients using combined oral contraceptives is further increased");
• if jaundice, hepatitis, or itching of the whole body occurs;
• if epilepsy worsens;
• if there is a sudden increase in blood pressure;
• if severe depression occurs;
• if there is sudden severe abdominal pain or liver enlargement;
• if there is a significant worsening of diseases known to worsen during the use of hormonal contraceptives or during pregnancy;
• if the patient is pregnant or suspects pregnancy. Pregnancy is a reason to stop the medicine immediately, as some studies suggest that oral contraceptives taken at the beginning of pregnancy may slightly increase the risk of birth defects in the fetus. If pregnancy is suspected, a doctor should be consulted.

Psychiatric disorders

Some women using hormonal contraceptives, including Cyprodiol, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should consult a doctor as soon as possible for further medical advice.

Special medical supervision is necessary in case of:

• diabetes;
• blood pressure above 140/90 mmHg (high blood pressure);
• tendency to superficial vein inflammation or significant varicose veins;
• certain hearing disorders (otosclerosis);
• migraine;
• certain forms of chorea (Sydenham's chorea, minor chorea);
• epilepsy, see "Cyprodiol and other medicines";
• porphyria attacks (disorders of haemoglobin production) and if an attack occurs while using Cyprodiol;
• blistering rash during pregnancy (pruritus or pemphigoid gestationis);
• age 40 and above;
• multiple sclerosis;
• calcium deficiency with painful muscle cramps (tetany);
• history of liver disease or gallstones;
• polycystic ovary syndrome (PCOS);
• a blood disease called haemolytic uraemic syndrome, which damages the kidneys;
• Crohn's disease or inflammatory bowel disease (ulcerative colitis);
• if the patient or their close relatives have had heart, circulatory, or blood clotting disorders;
• obesity;
• if there is a history of breast cancer in the patient's family;
• if there is a history of severe depression;
• systemic lupus erythematosus (an autoimmune disease);
• intolerance to contact lenses;
• brown spots on the face or body (chloasma);
• asthma.

You should contact a doctor in the following case:

• if you experience symptoms of angio-oedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing, you should contact a doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angio-oedema. Women with a tendency to develop brown-yellow pigment spots should avoid exposure to the sun or ultraviolet radiation (e.g., solarium).

If the symptoms of hirsutism (excessive hair growth on the body) in women using Cyprodiol worsen significantly, you should discuss the cause with a doctor.
After childbirth, women are at increased risk of thromboembolic events (see also "Pregnancy and breastfeeding").

Contraceptive pills and cancer

The occurrence of cervical cancer has been reported slightly more frequently in women using contraceptive pills for a longer time. It is not yet clear what role the patient's sexual behaviour (e.g., frequent changes of partners) or other factors play compared to the use of contraceptive pills themselves.
Breast cancer is diagnosed slightly more frequently in women taking contraceptive pills than in women of the same age who do not take them. After stopping the use of contraceptive pills, the difference in the number of breast cancers in women who have used contraceptive pills compared to other women gradually decreases and is no longer noticeable after 10 years.
Since breast cancer is rare in women under 40, the number of additional breast cancer cases diagnosed in patients currently or recently using contraceptive pills is small compared to the overall risk of breast cancer. These studies do not provide evidence of a causal relationship. The observed increased risk of breast cancer may be related to its earlier detection in women using contraceptive pills, the biological effect of these medicines, or both factors combined. In women who have always used contraceptive pills, the detected breast cancer is less advanced clinically than in women who have never used contraceptive pills.
In rare cases, women using contraceptive pills have developed benign and (even more rarely) malignant liver tumours. In very rare cases, these have led to life-threatening bleeding in the abdominal cavity. If sudden severe abdominal pain occurs, you should contact a doctor immediately.
Malignant tumours can be life-threatening or fatal.
Reduced efficacy
The efficacy of Cyprodiol may be reduced in the following situations:

• incorrect dosing
• missed pill
• vomiting and/or diarrhoea
• concomitant use of certain medicines

For more information, see also section 3.

Cyprodiol and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Interactions between hormonal medicines like Cyprodiol and other medicines may lead to breakthrough bleeding and/or reduced contraceptive efficacy.
The following medicines may interfere with the action of Cyprodiol:

• medicines used to treat epilepsy, such as hydantoin derivatives (e.g., phenytoin), barbiturates (e.g., barbexaclone), primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate;
• medicines used to treat tuberculosis (e.g., rifampicin);
• medicines used to treat HIV and hepatitis C virus infections (protease inhibitors or non-nucleoside reverse transcriptase inhibitors) and other infections (griseofulvin);
• medicines used to treat arthritis, degenerative joint disease (etoricoxib);
• medicines containing St. John's Wort (Hypericum perforatum).

Cyprodiol may also affect the metabolism of other medicines. For example, Cyprodiol may interfere with the efficacy or tolerance of cyclosporin (used to suppress the immune system), lamotrigine (used to treat epilepsy), theophylline (used to treat respiratory disorders), or tizanidine [used to treat muscle pain and/or muscle spasms].
Women treated with the above groups of substances should use additional barrier methods of contraception during treatment and for 28 days after stopping treatment.
If a barrier method is used after stopping the blister pack, you should start taking tablets from the next blister pack without a 7-day break.
It may be necessary to adjust the dose of antidiabetic medicines.
This information may also apply to medicines taken recently.

Warning

Cyprodiol should not be used at the same time as other hormonal contraceptives; if applicable, you should stop using such medicines before starting treatment with Cyprodiol (for more information, see also "How to use Cyprodiol").
Cyprodiol should not be used if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause elevated liver enzyme test results (increased ALT activity).
Your doctor will recommend an alternative method of contraception before starting these medicines.
You can start taking Cyprodiol again about 2 weeks after stopping treatment. See section "When not to use Cyprodiol".
Laboratory test results
If a blood test is necessary, you should inform your doctor or laboratory staff that you are taking contraceptive pills, as the hormones in the pills may affect the results of some laboratory tests.

Pregnancy and breastfeeding

Before taking any medicine, you should consult a doctor or pharmacist.
Cyprodiol should not be used during pregnancy or if pregnancy is suspected. If you become pregnant while taking Cyprodiol, you should stop taking the medicine immediately. However, previous use of Cyprodiol is not a reason to terminate the pregnancy.
Cyprodiol should not be used during breastfeeding, as the medicine may reduce the amount of milk produced and small amounts of active substances may pass into breast milk.

Driving and using machines

No special precautions are required.

Cyprodiol contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially "sodium-free".

3. How to use Cyprodiol

When, how often, and for how long to use Cyprodiol

Cyprodiol inhibits ovulation and thus has a contraceptive effect. Patients using Cyprodiol should not use an additional hormonal contraceptive, as this would lead to an overdose of hormones and is not necessary for effective contraception. For the same reason, women planning a pregnancy should not use Cyprodiol.
The following information applies unless your doctor has advised you to take Cyprodiol in a different way. You should follow the instructions, as otherwise, Cyprodiol may not work properly.
You should start taking Cyprodiol on the first day of your menstrual period. Only women who do not menstruate should start treatment as prescribed by a doctor. In this case, the first day of tablet intake is considered the first day of the cycle, and the further schedule is determined based on this.
You should press out the tablet marked on the packaging with the symbol of the day of the week when you start taking the medicine (e.g., "Mon" if you start on a Monday). Swallow the tablet whole (do not chew), if necessary, with a liquid.
If you start taking Cyprodiol soon after childbirth or miscarriage, you should ask your doctor if additional contraception is necessary during the first cycle to effectively prevent pregnancy.
Then, take one tablet daily in the order indicated by the arrows on the packaging until the blister pack is finished. You should maintain a consistent time for taking the tablets.
Then, take a 7-day break from taking the tablets, during which withdrawal bleeding will start 2-4 days after taking the last tablet.
After the 7-day break, continue taking the tablets from the next blister pack, regardless of whether the withdrawal bleeding has stopped or not.

Warning

Contraceptive protection begins on the first day of tablet intake and is maintained during the 7-day break. For this reason, you should not use another hormonal contraceptive at the same time.

Starting Cyprodiol

• If you have not used any oral contraceptive in the last month
  You should start taking Cyprodiol on the first day of your menstrual cycle, i.e., on the first day of menstrual bleeding. If you start taking the tablets between the 2nd and 5th day of your cycle, it is recommended to use an additional barrier method of contraception (e.g., condoms).
• If you have used combined oral contraceptives (with two active substances), a vaginal ring, or a transdermal patch
  You should start taking Cyprodiol preferably on the day after taking the last active tablet of your previous oral contraceptive (or after removing the vaginal ring or transdermal patch), but no later than the day after the usual tablet-free interval (or after removing the vaginal ring or transdermal patch). If your previous contraceptive contained placebo tablets (without active substances), you should start taking Cyprodiol on the day after taking the last placebo tablet.
• If you have used progestogen-only pills (mini-pills)
  You can stop taking the mini-pills on any day and start taking Cyprodiol the next day. During the first 7 days, you should also use a barrier method of contraception (e.g., condoms).
• Changing from an injection, implant, or intrauterine system that releases progestogen
  You should start taking Cyprodiol on the day you would normally have your next injection or on the day the implant or intrauterine system is removed. During the first 7 days, you should also use a barrier method of contraception (e.g., condoms).
• After childbirth
  You should not use Cyprodiol for at least 21-28 days after childbirth. If you start taking Cyprodiol later, you should also use a barrier method of contraception for the first 7 days. If you have had sexual intercourse before starting Cyprodiol, you should make sure you are not pregnant or wait for your first menstrual period.
• After miscarriage or abortion:
  You should consult a doctor.

Duration of treatment

The time needed to alleviate symptoms is at least 3 months.
Your doctor will inform you how long you should take Cyprodiol.

In case of overdose

Possible symptoms of overdose include nausea and vomiting (usually within 12-24 hours, in some cases lasting for several days) and slight vaginal bleeding.
If you have taken more than the prescribed dose, you should consult a doctor, who will recommend the necessary actions.

What to do if you miss a pill

• If the delay in taking a pill is less than 12 hours, the contraceptive effect of Cyprodiol is maintained. In this case, you should take the missed pill as soon as possible, and the next pills should be taken at the usual time.
• If the delay in taking a pill is more than 12 hours, the contraceptive effect is not maintained. The risk of unintended pregnancy is particularly high if you miss a pill at the beginning or end of the blister pack. In this case, you should follow the instructions below.

If you miss more than one pill from the current blister pack

You should consult a doctor.

If you miss one pill in the first week

You should take the missed pill as soon as possible, even if it means taking two pills at the same time. The next pills should be taken at the usual time. Additionally, you should use an extra barrier method of contraception (e.g., condoms) for the next 7 days.
If you have had sexual intercourse during the week before missing the pill, there is a risk of pregnancy. In this case, you should consult a doctor immediately.

If you miss one pill in the second week

You should take the missed pill as soon as possible, even if it means taking two pills at the same time.
Provided that the pills have been taken correctly for the 7 days preceding the missed pill, the contraceptive protection is maintained, and there is no need to use additional methods of contraception.

If you miss one pill in the third week

You can choose one of the following options:

• 1. Take the missed pill as soon as possible, even if it means taking two pills at the same time. Take the next pills at the usual time. Then, start taking the pills from the next blister pack immediately after finishing the current one, skipping the 7-day break. In this case, it is very likely that the usual withdrawal bleeding will not occur until after finishing the second blister pack. However, during the intake of the second blister pack, spotting or breakthrough bleeding may occur.

or

• 2. You can also stop taking the pills from the current blister pack and take a break of no more than 7 days (including the day you missed the pill), and then start taking the pills from the next blister pack. If you want to start the next blister pack on the same day of the week as usual, you can shorten the break.

If you miss several pills and after finishing the blister pack, withdrawal bleeding does not occur during the usual break, there is a possibility of pregnancy. In this case, you should consult a doctor before starting the next blister pack.

What to do if you vomit or have diarrhoea

In case of acute gastrointestinal disorders, the active substances may not be fully absorbed, so you should use additional methods of contraception.
If vomiting occurs within 3-4 hours after taking a pill, you should follow the instructions for missing a pill. You should take a replacement pill from the next blister pack, which will maintain the schedule of tablet intake.

What to do if you experience unexpected bleeding

Unexpected bleeding (spotting or breakthrough bleeding) may occur, especially during the first few months. However, you should continue taking the pills as usual.
Such irregular bleeding usually stops after about three cycles (three blister packs), once the body has adapted to Cyprodiol. However, you should consult a doctor if the bleeding persists, worsens, or recurs.

What to do if you do not experience withdrawal bleeding

If you have taken all the pills correctly, have not vomited, or had severe diarrhoea, and have not taken any other medicines, pregnancy is very unlikely. Nevertheless, you should consult a doctor and stop taking the pills until the doctor has ruled out pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In all women using Cyprodiol, the risk of venous and arterial thromboembolic disease (e.g., venous thromboembolic disease, pulmonary embolism, stroke, myocardial infarction) increases. For further information, see also "Warnings and precautions". This risk may be further increased by additional factors (smoking, high blood pressure, blood clotting or lipid metabolism disorders, significant obesity, varicose veins, past history of phlebitis or thrombosis); see "Important information before taking Cyprodiol". Other severe side effects, such as liver tumors, breast cancer, or cervical cancer, are described in the "Warnings and precautions" section. The following list contains side effects associated with the use of Cyprodiol. Frequentside effects (may occur in up to 1 in 10 patients):

• nausea
• abdominal pain
• weight gain
• headache
• depressive mood, mood changes
• breast pain, breast tenderness
• intermenstrual bleeding (occurring between regular menstrual bleedings)

Less frequentside effects (may occur in up to 1 in 100 patients):

• vomiting
• diarrhea
• increased blood pressure
• fluid retention in the body
• migraine
• decreased libido
• breast enlargement
• rash, hives
• yellow-brown spots on the skin (chloasma)

Rareside effects (may occur in up to 1 in 1,000 patients):

• intolerance to contact lenses (dry eyes)
• blood clots in veins
• hypersensitivity reactions
• weight loss
• increased libido
• breast discharge
• changes in vaginal discharge (e.g., increased discharge)
• erythema nodosum (red nodules on the skin), severe skin rash (erythema multiforme)

Side effectswith an unknown frequency (frequency cannot be determined based on available data):

• increased blood pressure

Additionally, the following side effects have been reported in women taking oral contraceptives:

• Closure of the arterial vessel lumen (arterial thrombosis) due to blood clots;
• Closure of the venous vessel lumen (venous thrombosis) due to blood clots;
• Hypertension;
• Liver tumors (benign or malignant);
• Occurrence or worsening of diseases whose relationship to the use of combined oral contraceptives is not clear: chronic bowel disease (Crohn's disease and ulcerative colitis), epilepsy, uterine fibroids, metabolic disorder characterized by hemoglobin production disorders (porphyria), immune system disease (systemic lupus erythematosus), blistering rash (pemphigoid gestationis), neurological disorder characterized by involuntary muscle movements (Sydenham's chorea), blood disease leading to kidney damage (hemolytic-uremic syndrome), jaundice, and (or) itching associated with bile stasis (cholestasis);
• Pigmentation disorders (chloasma);
• Acute or chronic liver function disorders may require discontinuation of oral contraceptives until liver function test results return to normal;
• You should immediately contact your doctor if you experience any of the following symptoms of angioedema: facial swelling, tongue and (or) throat swelling, and (or) difficulty swallowing or hives potentially with breathing difficulties (see also section 2 "Warnings and precautions").

The frequency of breast cancer diagnosis is slightly increased in women taking oral contraceptives. Since breast cancer rarely occurs in women under 40 years of age, the increased risk is small compared to the overall risk of breast cancer. It is not known whether the development of cancer is related to the use of oral contraceptives. More information can be found in the "Oral contraceptives and tumors" section. Information on the incidence of breast cancer in women taking oral contraceptives compared to women not taking oral contraceptives can be found in section 2 "Warnings and precautions". In patients with increased body hair (hirsutism) whose symptoms have recently worsened, the causes (androgen-producing tumor, adrenal enzyme defect) must be explained by the doctor. Due to its composition, Cyprodiol has a contraceptive effect if taken regularly. Irregular intake of Cyprodiol may lead to menstrual cycle disorders and loss of contraceptive effectiveness.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the address below. By reporting side effects, more information can be gathered on the safety of the medicine. Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products Registration Office Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Cyprodiol

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. The batch number is stated on the packaging after the abbreviation "Lot". Medicines should 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. Package contents and other information

What Cyprodiol contains

The active substances are: cyproterone acetate and ethinylestradiol. One coated tablet contains 2 mg of cyproterone acetate and 0.035 mg of ethinylestradiol. The other ingredients are: Tablet core: lactose monohydrate, cornstarch, maltodextrin, and magnesium stearate. Tablet coating: hypromellose, macrogol 4000, macrogol 400, titanium dioxide (E 171), lactose monohydrate, sodium citrate, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), and quinoline yellow lake (E 104).

What Cyprodiol looks like and package contents

Cyprodiol is available in the form of round, yellowish coated tablets in PVC/PE/PVDC/Aluminum blisters, each containing 21 coated tablets. Pack sizes: 21 coated tablets, 2 x 21 coated tablets, 3 x 21 coated tablets, 6 x 21 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki

Manufacturer:

mibe GmbH Arzneimittel Münchener Straße 15 06796 Brehna Germany Date of last update of the leaflet:12.2022