Cyprodiol, 2 mg + 0.035 mg, film-coated tablets
Cyproterone acetate + Ethinylestradiol
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual only. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet Contents

What Cyprodiol is and what it is used for
Important information before taking Cyprodiol
How to take Cyprodiol
Possible side effects
How to store Cyprodiol
Contents of the pack and other information

1. What Cyprodiol is and what it is used for

Cyprodiol is used in the treatment of skin disorders such as acne, very oily skin, and hirsutism in women of reproductive age. Due to its contraceptive properties, this medicine should only be prescribed to a patient if the physician considers hormonal contraceptive therapy to be appropriate.
The patient should use Cyprodiol for acne treatment only when there has been no improvement in the skin condition after other anti-acne therapies, including topical treatment and antibiotics.

2. Important information before using Cyprodiol

When not to use Cyprodiol
Inform your doctor if any of the following conditions apply to the patient before starting treatment with Cyprodiol. The doctor may then recommend alternative treatment:

if the patient is allergic to ethinylestradiol, cyproterone acetate, or any of the components of this medicine (listed in section 6);
if the patient has hepatitis C and is taking medications containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section "Cyprodiol with other medicines");
if the patient is taking another hormonal contraceptive;
if the patient currently has (or has ever had) a blood clot in the leg (thrombosis), a blood clot in the lungs (pulmonary embolism), or in another part of the body;
if the patient or her family has a history of venous thromboembolism due to an unknown cause (confirmed idiopathic venous thromboembolism (VTE) with occurrence of thromboembolic events in siblings or parents at a relatively young age);
if the patient currently has (or has ever had) diseases that may indicate a previous heart attack (e.g. angina pectoris, causing severe chest pain) or a "mini-stroke" (transient ischaemic attack);
if the patient has a blood clotting disorder (e.g. protein C deficiency);
if the patient currently has (or has ever had) a heart attack or stroke;
if the patient has risk factors that may increase the risk of blood clots, including:
- diabetes affecting blood vessels;
- very high blood pressure;
- very high blood lipid levels (cholesterol or triglycerides);
if the patient has a certain blood disorder (sickle cell anaemia);
if the patient currently has or has previously had pancreatitis with elevated blood lipid levels;
if the patient currently has or has previously had severe liver disease (including excretory disorders such as Dubin-Johnson syndrome and Rotor syndrome), provided liver function parameters have not returned to normal;
if the patient currently has or has previously had (benign or malignant) liver tumours;
if the patient has unexplained vaginal bleeding;
if the patient currently has (or has ever had) migraine with visual disturbances;
if the patient is a smoker (see "Warnings and precautions");
if a hormone-dependent tumour of the breast or reproductive organs has been diagnosed or is suspected;
if the patient has jaundice, chronic itching, or blistering rash (pemphigoid gestationis) or worsening hearing in women with middle ear disorders (otosclerosis) during a previous pregnancy;
if the patient plans to become pregnant, is pregnant, or is breastfeeding;
if the patient has meningioma or has ever been diagnosed with meningioma (usually a benign tumour of the membrane between the brain and skull).

Cyprodiol must not be used in men.
If any of the above conditions occur during treatment with Cyprodiol, the medicine must be stopped immediately and the doctor contacted. During this time, a non-hormonal method of contraception should be used.

Warnings and precautions
General notes
This leaflet describes various situations in which you should immediately stop taking Cyprodiol or when contraceptive effectiveness may be reduced. In such cases, either abstain from sexual intercourse or use another non-hormonal method of contraception, such as condoms or other barrier methods. However, do not use the calendar method or temperature method.

An increased risk of benign brain tumour (meningioma) has been reported with high-dose (25 mg or higher) cyproterone acetate treatment. If a patient is diagnosed with meningioma, the doctor will discontinue treatment with cyproterone-containing products, including Cyprodiol, as a precaution (see section "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 such as Cyprodiol, a thorough general examination (including body weight, blood pressure, heart, lower limbs and skin examination, urine glucose test, and, if appropriate, liver function tests) and gynaecological examination (including breast and cervical cytology) should be performed, along with a detailed medical history. Pregnancy must be ruled out before starting Cyprodiol. If relatives have had blood clots (thromboembolic disease, e.g. deep vein thrombosis, stroke, myocardial infarction) at a relatively young age, coagulation disorders should be excluded. During treatment, check-ups are recommended approximately every 6 months.

When to contact your doctor

Oral contraceptives and vascular disorders
Compared to women not taking these types of medicines, taking oral contraceptives or Cyprodiol increases the risk of developing a blood clot in the deep veins (thrombosis), which may sometimes break loose and travel to organs such as the lungs (pulmonary embolism).
The additional risk of venous thromboembolism and pulmonary embolism (known as venous thromboembolic disease) is highest during the first year of taking oral contraceptives for the first time. However, the risk of thromboembolic disease remains lower than during pregnancy (estimated at 60 cases per 100,000 pregnant women).
You must stop taking the tablets and contact your doctor immediately if you notice symptoms suggesting a possible blood clot. Symptoms are described in section 2 "Blood clots (thrombosis)".

Cyprodiol also acts as an oral contraceptive. The patient and doctor should consider all standard guidelines for safe use of oral hormonal contraception.

Blood clots (thrombosis)
Taking Cyprodiol may slightly increase the risk of blood clots (so-called thrombosis) in the patient. The likelihood of blood clots in patients taking Cyprodiol is only slightly higher compared to women who do not take Cyprodiol or any other oral contraceptive. Complete recovery does not always occur, and 1–2% of cases may be fatal.

Venous blood clots
A blood clot in a vein (known as venous thrombosis) may block the vein. This may occur in leg veins, lung vessels (pulmonary embolism), or any other organ.
Taking a combined oral contraceptive increases the risk of such blood clots compared to women not taking any combined oral contraceptives. The risk of venous blood clots is highest during the first year of taking an oral contraceptive. The risk is not as high as during pregnancy.

The risk of venous blood clots in patients taking combined oral contraceptives is further increased by:

advancing age;
if the patient smokes. When using a hormonal contraceptive such as Cyprodiol, it is strongly recommended to stop smoking, especially if the patient is over 35 years of age;
if a close relative had a blood clot in the leg, lungs, or another organ at a young age;
if the patient is overweight;
if the patient requires surgery, is immobilised for a prolonged period due to injury or illness, or has a leg in a cast.

If any of the above conditions apply to the patient, it is important to inform the doctor about taking Cyprodiol, as treatment may need to be discontinued. The treating doctor may instruct the patient to stop taking Cyprodiol several weeks before surgery or when mobility is limited. The doctor will also inform the patient when she can resume taking Cyprodiol after regaining mobility.

Arterial blood clots
Arterial blood clots may cause serious disorders. For example, a blood clot in an artery in the heart may cause a heart attack, or in the brain may cause a stroke.
The use of combined oral contraceptives is associated with an increased risk of arterial blood clots. This risk is further increased by:

advancing age;
if the patient smokes. When using a hormonal contraceptive such as Cyprodiol, it is strongly recommended to stop smoking, especially if the patient is over 35 years of age;
if the patient is overweight;
if the patient has high blood pressure;
if a close relative had a heart attack or stroke at a young age;
if the patient has high blood lipid levels (cholesterol or triglycerides);
if the patient has migraines;
if the patient has heart disease (valve damage, cardiac arrhythmias).

Symptoms caused by blood clots
You must stop taking the tablets and contact your doctor immediately if you notice symptoms suggesting a possible blood clot, such as:

unusual sudden cough;
severe chest pain, which 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, smell or taste disturbances;
dizziness or fainting;
numbness or weakness in part of the body;
severe abdominal pain;
severe pain or swelling in the legs.

Complete recovery after a blood clot does not always occur. Occasionally, thrombosis may lead to permanent disability or death.
Immediately after childbirth, women are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Cyprodiol after delivery.

Epidemiological studies have shown that thrombosis occurs more frequently during Cyprodiol treatment than in patients taking combined oral contraceptives with a low dose of oestrogen (less than 50 micrograms of ethinylestradiol).
Very rarely, thromboembolism may occur in blood vessels of the liver, abdominal cavity, kidneys, or eyes.

Women using Cyprodiol to treat severe acne or milder forms of hirsutism (excessive facial and body hair) have an increased risk of cardiovascular disorders, for example due to the development of ovarian cysts (polycystic ovary syndrome).

Cyprodiol must be discontinued immediately in the following cases:

headaches resembling migraine occurring for the first time or with increased intensity, or the occurrence of very frequent or very severe headaches;
sudden, severe visual or hearing disturbances or motor disorders, particularly muscle paralysis (possible early signs of stroke) or other sensory or perceptual disturbances;
first signs of vein inflammation with blood clot formation (thrombophlebitis) or thromboembolic symptoms (see section 2 "Special medical supervision is required if the following occur");
4 weeks before planned surgery (e.g. abdominal or orthopaedic);
development of jaundice, hepatitis, or whole-body itching;
worsening of epileptic seizures;
sudden increase in blood pressure;
onset of severe depression;
sudden severe upper abdominal pain or liver enlargement;
significant worsening of diseases known to worsen during hormonal contraceptive use or pregnancy;
if the woman is pregnant or suspects she is pregnant. Pregnancy is a reason to discontinue the medicine immediately, as some studies suggest that oral contraceptives taken early in pregnancy may slightly increase the risk of congenital malformations in the foetus. If pregnancy is suspected, contact your doctor.

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

Special medical supervision is required if the following occur:

diabetes;
blood pressure above 140/90 mmHg (high blood pressure);
tendency to superficial vein inflammation or significant varicose veins;
a certain form of hearing disorder (otosclerosis);
migraine;
a certain form of chorea (chorea minor, Sydenham's chorea);
epilepsy (see section "Cyprodiol with other medicines");
porphyria attacks (a disorder in haemoglobin production), and if an attack occurs during Cyprodiol treatment;
blistering skin rash during pregnancy (pemphigoid gestationis);
age 40 years or older;
multiple sclerosis;
calcium deficiency with painful muscle spasms (tetany);
previous liver function disorders or gallstones;
ovarian cysts (polycystic ovary syndrome);
a blood disorder known as haemolytic-uraemic syndrome, which causes kidney damage;
Crohn's disease or inflammatory bowel disease (ulcerative colitis);
heart, circulatory, or blood clotting disorders in the patient or close family members;
obesity;
previous family history of breast cancer;
previous history of severe depression;
systemic lupus erythematosus (an autoimmune disorder);
intolerance to contact lenses;
brown patches on the face or body (melasma);
asthma.

Contact your doctor if:

the patient experiences symptoms of angioedema, such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or urticaria potentially with breathing difficulties, contact your doctor immediately. Medicines containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema. Women prone to yellowish-brown pigmentation should avoid exposure to sunlight or ultraviolet radiation (e.g. sunbeds).

If symptoms worsen significantly in women with hirsutism (excessive body hair) taking Cyprodiol, the cause should be discussed with the doctor.
Immediately after childbirth, women are at increased risk of thromboembolic episodes (see also "Pregnancy and breastfeeding").

Oral contraceptives and cancer
Cervical cancer has been reported slightly more frequently in women taking oral contraceptives for a prolonged period. The role of the patient's sexual behaviour (e.g. frequent partner changes) or other factors compared to the actual use of oral contraceptives has not yet been clearly established.
Breast cancer is detected slightly more frequently in women taking oral contraceptives than in women of the same age who do not. After stopping oral contraceptives, the difference in breast cancer incidence between former users and non-users 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 taking oral contraceptives is small compared to the overall risk of developing breast cancer. These studies do not provide evidence of a causal relationship. The observed increased risk of breast cancer may be related to earlier detection in women taking oral contraceptives, the biological effect of these medicines, or both. Breast cancer detected in women who have always taken oral contraceptives tends to be less clinically advanced than in women who have never taken them.
In rare cases, benign and (even more rarely) malignant liver tumours have been observed in women taking oral contraceptives. In very few cases, these have led to life-threatening intra-abdominal bleeding. If sudden, severe abdominal pain occurs, contact your doctor immediately.
Malignant tumours may be life-threatening or lead to death.

Reduced effectiveness
The effectiveness of Cyprodiol may be reduced in the following circumstances:

incorrect dosing;
missed tablet;
vomiting and (or) diarrhoea;
concomitant use of certain medicines.

For detailed information, see also section 3.

Cyprodiol with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, and any medicines you plan to take.
Interactions between hormonal medicines such as Cyprodiol and other medicines may lead to withdrawal bleeding and (or) loss of contraceptive effectiveness.
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 for arthritis and osteoarthritis (etoricoxib);
herbal products containing St John's wort (Hypericum perforatum).

Cyprodiol may also affect the metabolism of other medicines. For example, Cyprodiol may interfere with the effectiveness or tolerance of cyclosporine (used to suppress the immune system), lamotrigine (used to treat epilepsy), theophylline (used to treat breathing disorders), and tizanidine (used to treat muscle pain and (or) muscle spasms).
Women treated with the above-mentioned groups of substances should use additional barrier methods of contraception during treatment and for 28 days after its completion.
If an additional barrier method is used after finishing a blister pack, start taking tablets from the next blister pack without a 7-day break.
Dosage adjustments of antidiabetic medicines may be necessary.
This information may also apply to recently used medicines.

Warning
Do not take Cyprodiol simultaneously with hormonal contraceptives; if applicable, discontinue such medicines before starting treatment with Cyprodiol (for further information, see also "How to take Cyprodiol").
Do not take Cyprodiol if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause elevated liver function test results (increased liver enzyme AlAT activity).
The doctor will recommend another type of contraception before starting these medicines.
Cyprodiol treatment may be resumed approximately 2 weeks after completing the treatment. See section "When not to use Cyprodiol".

Laboratory test results
If blood tests are required, inform the doctor or laboratory staff that you are taking oral contraceptives, as the hormones in oral contraceptives may affect the results of certain laboratory tests.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Do not take Cyprodiol during pregnancy or if pregnancy is suspected. If the patient becomes pregnant while taking Cyprodiol, treatment must be stopped immediately. However, previous use of Cyprodiol does not justify terminating a pregnancy.
Do not take Cyprodiol while breastfeeding, as it may reduce milk production and small amounts of active substances may pass into breast milk.

Driving and using machines
No special precautions are required.

Cyprodiol contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Cyprodiol

When, how often and for how long to use Cyprodiol
Cyprodiol inhibits ovulation and therefore has contraceptive effects. Patients using Cyprodiol should not use an additional hormonal contraceptive, as this would lead to hormone overdose and is unnecessary for effective contraception. For the same reason, women planning pregnancy should not use Cyprodiol.
The following information applies unless your doctor has advised a different way of taking Cyprodiol. You must follow these instructions, otherwise Cyprodiol may not work properly.
Start taking Cyprodiol on the first day of your menstrual period. Only women who are not menstruating should start treatment as prescribed by a doctor immediately. In such a case, the first day of taking tablets is considered the first day of the cycle, and the subsequent schedule is based on this.
Squeeze out the tablet marked on the packaging with the symbol of the day of the week on which you start taking the medicine (e.g. "Mon" for Monday). Swallow the tablet whole (do not chew), with fluid if necessary. If you started taking Cyprodiol shortly after childbirth or miscarriage, ask your doctor whether additional contraception is needed during the first cycle to effectively prevent pregnancy.
Then take one tablet daily in the order indicated by arrows on the blister pack until the pack is finished. Maintain a consistent time for taking the tablets.
After completing the pack, take a 7-day break from tablets. During this time, withdrawal bleeding usually starts 2–4 days after taking the last tablet.
After the 7-day break, start taking tablets from the next pack, regardless of whether withdrawal bleeding has stopped or not.
Note
Contraceptive protection begins on the first day of taking tablets and continues during the 7-day break. Therefore, you should not use any other hormonal contraceptive simultaneously.

Starting Cyprodiol

If the patient has not used any oral contraceptive in the past month: Start taking Cyprodiol on the first day of the cycle, i.e. the first day of menstrual bleeding. If starting between day 2 and day 5 of the cycle, it is recommended to additionally use a barrier method of contraception (e.g. condoms).
If the patient has previously used combined oral contraceptives (containing two active substances), a vaginal contraceptive system, or a transdermal contraceptive system: Start taking Cyprodiol preferably the day after taking the last active tablet of the previous contraceptive (or after removing the vaginal or transdermal system), but no later than the day after the usual break period (or end of use of the vaginal or transdermal system). If the previously used medicine included placebo tablets (without active substance), start taking Cyprodiol the day after the last placebo tablet.
If the patient has used progestogen-only pills (so-called minipills): Minipill use can be stopped on any day, and Cyprodiol can be started the next day. A barrier method of contraception (e.g. condom) should additionally be used for the first 7 days.
Switching from an injectable, implant, or intrauterine system releasing progesterone: Start taking Cyprodiol on the day the next injection would normally be given, or on the day of removal of the implant or intrauterine system. A barrier method of contraception (e.g. condom) should additionally be used for the first 7 days.
After childbirth: Do not take Cyprodiol for at least 21 to 28 days after delivery. If starting later, use a barrier method of contraception for the first 7 days. If sexual intercourse occurred before starting Cyprodiol, ensure the patient is not pregnant or wait until the first menstrual bleeding occurs.
After miscarriage or termination of pregnancy: Consult your doctor.

Duration of treatment
At least 3 months are needed to alleviate symptoms.
Your doctor will inform you how long you should continue taking Cyprodiol.

If you take more Cyprodiol than recommended
Possible symptoms of overdose include nausea and vomiting (usually within 12–24 hours, sometimes lasting several days) and slight vaginal bleeding.
If you have taken more than the recommended dose, contact your doctor, who will advise on appropriate action.

What to do if you miss a dose of Cyprodiol

If the delay in taking the tablet is less than 12 hours, the contraceptive effect of Cyprodiol is maintained. Take the missed tablet as soon as possible and continue taking the following tablets at the usual time.
If the delay in taking the tablet is more than 12 hours, contraceptive effectiveness may not be maintained. The risk of unintended pregnancy is particularly high if a tablet is missed at the beginning or end of the pack. In such cases, follow the recommendations below.

If more than 1 tablet is missed from the current pack
Consult your doctor.

If 1 tablet is missed in the first week
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. Additionally, use a backup method of contraception (e.g. condom) for the next 7 days.
If sexual intercourse occurred within the week before the missed tablet, there is a risk of pregnancy. In this case, contact your doctor immediately.

If 1 tablet is missed in the second week
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time.
If tablets were taken correctly for the 7 days preceding the missed tablet, contraceptive protection is maintained and no additional contraceptive methods are needed.

If 1 tablet is missed in the third week
You may choose one of the following options:

Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. Then immediately start the next pack without the usual 7-day break. In this case, withdrawal bleeding is unlikely to occur until the end of the second pack. However, breakthrough bleeding or spotting may occur during the second pack.

You may also stop taking tablets from the current pack and take a break of no longer than 7 days (including the day the tablet was missed), then start taking tablets from the next pack. If the patient wishes to start the new pack on the same day of the week as usual, the break may be shortened accordingly.

If several tablets were missed and no withdrawal bleeding occurs during the first usual break after finishing the pack, pregnancy may have occurred. In such a case, consult your doctor before starting a new pack.

What to do if vomiting or diarrhoea occurs
In case of acute gastrointestinal disturbances, the active substances may not be completely absorbed; therefore, additional contraceptive methods should be used.
If vomiting occurs within 3–4 hours after taking a tablet, follow the recommendations for a missed tablet. Take a replacement tablet from the next pack to avoid disrupting the dosing schedule.

What to do if unexpected bleeding occurs
Unexpected bleeding (spotting or breakthrough bleeding) may occur, especially during the first few months. Continue taking the tablets as usual. Such irregular bleeding usually resolves after about three cycles (three packs), once the body has adjusted to Cyprodiol. However, consult your doctor if bleeding persists, worsens, or recurs.

What to do if withdrawal bleeding does not occur
If all tablets were taken correctly, there were no episodes of vomiting or severe diarrhoea, and no other medicines were taken, pregnancy is very unlikely. Nevertheless, consult your doctor and stop taking tablets until pregnancy is ruled out.

Discontinuing Cyprodiol
If you plan to stop taking Cyprodiol, contact your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In all women using Cyprodiol, there is an increased risk of venous and arterial thromboembolic disease (e.g. venous thromboembolism, pulmonary embolism, stroke, myocardial infarction).
For further information – see also "Warnings and precautions".
This risk may be further increased by additional factors (smoking, high blood pressure, disorders of blood clotting or lipid metabolism, severe obesity, varicose veins, previous history of phlebitis or thrombophlebitis); see "Important information before using Cyprodiol".
Other serious adverse effects, such as liver tumours, breast cancer or cervical cancer, are described in the section "Warnings and precautions".
The list below includes adverse effects associated with the use of Cyprodiol.
Common adverse effects (may occur in up to 1 in 10 women):

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

Uncommon adverse effects (may occur in up to 1 in 100 women):

vomiting
diarrhoea
increased blood pressure
fluid retention
migraine
decreased libido
breast enlargement
rash, urticaria
yellowish-brown skin patches (chloasma)

Rare adverse effects (may occur in up to 1 in 1,000 women):

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

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

increased blood pressure

In addition, the following adverse effects have been reported during the use of oral contraceptive tablets:

Occlusion (blockage) of arteries due to blood clots;
Occlusion (blockage) of veins due to blood clots;
High blood pressure;
Liver tumours (benign or malignant);
Occurrence or worsening of diseases whose relationship with the use of combined oral contraceptives is not clearly established: chronic bowel disease (Crohn's disease and ulcerative colitis), epilepsy, uterine fibroids, metabolic disorder characterised by disturbances in haemoglobin production in the blood (porphyria), autoimmune disease (systemic lupus erythematosus), blistering skin rash (pemphigoid gestationis), neurological disorder characterised by involuntary muscle movements (Sydenham's chorea), blood disorder leading to kidney damage (haemolytic uraemic syndrome), jaundice and (or) itching associated with bile stasis (cholestasis);
Skin pigmentation disorders (chloasma);
Acute or chronic disturbances in liver function may require discontinuation of oral contraceptive tablets until liver function test results return to normal;
Immediate medical advice should be sought if any of the following symptoms of angioedema occur: swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section 2 "Warnings and precautions").

The frequency of breast cancer diagnosis is very slightly increased among women using oral contraceptive tablets. Since breast cancer is rare in women under 40 years of age, the increased risk is small compared to the overall risk of developing breast cancer. It is not known whether the development of cancer is related to the use of oral contraceptive tablets. More information can be found in the section "Oral contraceptives and tumours".
Information on the occurrence of breast cancer in women using oral contraceptive tablets compared to women not using oral contraceptives is provided in section 2 "Warnings and precautions".
In patients with increased body hair (hirsutism) in whom symptoms have recently worsened, underlying causes (androgen-producing tumour, adrenal enzymatic defect) must be investigated by a physician.
Due to its composition, Cyprodiol has a contraceptive effect when taken regularly. Irregular use of Cyprodiol may lead to menstrual cycle disturbances and loss of contraceptive efficacy.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the address below. Reporting adverse effects helps to provide more information on the safety of the medicine.
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Cyprodiol

Keep this medicine 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 indicated month. The batch number is printed on the packaging after the abbreviation "Lot".
Medicines must not be disposed of via the sewage system. Ask your pharmacist how to dispose of medicines you no longer require. This will help protect the environment.

6. Contents of the pack and other information

What Cyprodiol contains
The active substances are:
cyproterone acetate and ethinylestradiol.
Each coated tablet contains 2 mg cyproterone acetate and 0.035 mg ethinylestradiol.
Other components of the medicine are:
Tablet core:
Monohydrate lactose, corn starch, maltodextrin and magnesium stearate.
Tablet coating:
Hypromellose, macrogol 4000, macrogol 400, titanium dioxide (E 171), monohydrate lactose, sodium citrate, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), quinoline yellow (E 104) and aluminium hydroxide.
What Cyprodiol looks like and contents of the pack
Cyprodiol is available as round, yellowish coated tablets in PVC/PE/PVDC/Aluminium blisters 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Manufacturer:
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany