Oc-35

Patient Information Leaflet

OC-35 2 mg + 0.035 mg film-coated tablets
Cyproteroni acetas + Ethinylestradiolum
This medicinal product will be subject to additional monitoring. This will allow rapid identification of new safety information. Patients can also help by reporting any suspected adverse reactions that occur after starting treatment. For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult 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 adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What OC-35 is and what it is used for
2. What you need to know before taking OC-35
3. How to take OC-35
4. Possible side effects
5. How to store OC-35
6. Contents of the pack and other information

1. What OC-35 is and what it is used for

OC-35 is used in the treatment of skin disorders such as acne, very oily skin, and excessive hair growth in women of reproductive age. Due to its contraceptive properties, this medicine should only be prescribed if the doctor considers hormonal contraception appropriate.
A patient should use OC-35 for acne treatment only when there has been no improvement in skin condition after other anti-acne therapies, including topical treatments and antibiotics.

2. Information before using the medicine OC-35

When not to use OC-35
You should inform your doctor if any of the following conditions apply to the patient before starting treatment with OC-35. In such cases, the doctor may recommend alternative treatment:

• if the patient is already 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 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 currently has (or has ever had) a heart attack or stroke;
• if the patient has risk factors that may increase the likelihood of blood clots, including:
• diabetes affecting blood vessels;
• very high blood pressure;
• very high levels of blood fats (cholesterol or triglycerides);
• if the patient has a blood clotting disorder (e.g. protein C deficiency);
• if the patient currently has (or has ever had) migraine with visual disturbances;
• if the patient has meningioma or has ever been diagnosed with meningioma (usually a benign tumour of the tissue layer between the brain and skull). If any of the above conditions occur for the first time while taking OC-35, the medicine should be stopped immediately. OC-35 must not be used in men.

Warnings and precautions
Before starting treatment with OC-35, discuss this with your doctor or pharmacist.
Special caution should be exercised when using OC-35 if the patient has diabetes, obesity,
high blood pressure, heart valve disease, cardiac arrhythmia, superficial venous inflammation, varicose veins, migraine attacks, epilepsy, thrombosis, heart attack or stroke in close relatives, liver or gallbladder disease, systemic lupus erythematosus (SLE), skin pigmentation disorders (yellowish-brown discolouration, so-called chloasma), elevated cholesterol or triglyceride levels in the blood, Crohn’s disease or ulcerative colitis.
If any of the above symptoms occur for the first time, recur, or worsen during treatment with OC-35, contact your doctor.
Hirsutism (excessive hair growth) – if symptoms have recently appeared or worsened, inform your doctor immediately.

Circulatory disorders

• The use of combined oral contraceptives increases the risk of venous or arterial thrombosis and thromboembolic disorders such as myocardial infarction, cerebrovascular incidents, deep vein thrombosis, or pulmonary embolism. These events are rare.
• During treatment with any combined oral contraceptive, venous thromboembolic disorders may occur, such as deep vein thrombosis or pulmonary embolism. Very rarely, blood clots may occur in other blood vessels (e.g. liver, mesentery, kidneys, or eyes) in women taking combined oral contraceptives.

Tumours
Epidemiological studies have shown:

• an increased risk of cervical cancer during long-term use of oral contraceptives. However, this risk may not be directly related to the use of these medicines but may result from specific sexual behaviours or other factors, such as human papillomavirus (HPV) infection.
• a slight increase in the relative risk of breast cancer in women using hormonal contraception. This risk gradually decreases within 10 years after stopping hormonal contraceptives. The observed slight increase in breast cancer risk may be due to earlier detection, the effect of hormonal contraceptives, or a combination of both factors. Breast cancer is more frequently detected at an early stage among users of hormonal contraception compared to women who have never used combined contraceptives.
• in rare cases, life-threatening intra-abdominal bleeding may occur in patients with benign or malignant liver tumours. Severe upper abdominal discomfort, liver enlargement, or symptoms of intra-abdominal bleeding may indicate the presence of a liver tumour.

An increased risk of benign brain tumours (meningiomas) has been reported with the use of high doses (25 mg or more) of cyproterone acetate. If a meningioma is diagnosed, the doctor will discontinue treatment with products containing cyproterone, including OC-35, as a precautionary measure (see section "When not to use OC-35").

When to contact your doctor
Regular check-ups:
While taking OC-35, your doctor will inform you about the need for regular medical examinations.
Contact your doctor immediately if:

• any concerning changes in health occur (especially any of the symptoms listed in section 2 of this leaflet "Information before using OC-35");
• a breast lump is detected;
• unexplained heavy vaginal bleeding occurs;
• surgery or immobilisation is planned;
• acute diarrhoea occurs;
• a tablet is missed in the first week of the cycle (each first week of taking OC-35), and sexual intercourse occurred in the previous 7 days;
• no withdrawal bleeding occurs for two consecutive months, or pregnancy is suspected.

Stop taking the tablets and contact your doctor immediately
if symptoms suggesting a possible blood clot occur. These symptoms are described in section 2 under "Blood clots (thrombosis)".
OC-35 also acts as an oral contraceptive. The patient and doctor should consider all standard guidelines for the safe use of oral hormonal contraception.

Blood clots (thrombosis)
Taking OC-35 may slightly increase the risk of blood clots (so-called thrombosis) in the patient. The likelihood of blood clots in women taking OC-35 is only slightly higher compared to women who do not use OC-35 or any other combined oral contraceptive. Full recovery is not always possible, and 1–2% of cases may be fatal.

Venous blood clots
A blood clot in a vein (known as venous thrombosis) can block a vein. This may occur in leg veins, pulmonary arteries (pulmonary embolism), or in any other organ.
Using a combined oral contraceptive increases the risk of such blood clots in women compared to those who do not use any combined oral contraceptives. The risk of venous thrombosis is highest during the first year of taking an oral contraceptive. This risk is lower than the risk of blood clots during pregnancy.

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

• increasing age;
• if the patient smokes. When using a hormonal contraceptive such as OC-35, quitting smoking is strongly recommended, 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, prolonged immobility due to injury or illness, or has a leg in a cast.

If any of the above conditions apply, it is important to inform the doctor about the use of OC-35, as treatment may need to be discontinued. The treating doctor may instruct the patient to stop taking OC-35 several weeks before surgery or when mobility is limited. The doctor will also inform the patient when it is safe to resume OC-35 after regaining mobility.

Psychiatric disorders
Some women using hormonal contraceptives, including OC-35, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.

Arterial blood clots
Arterial blood clots can cause serious complications. For example, a blood clot in an artery of 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:

• increasing age;
• if the patient smokes. When using a hormonal contraceptive such as OC-35, quitting smoking is strongly recommended, 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 fat levels (cholesterol or triglycerides);
• if the patient has migraines;
• if the patient has heart disease (valve damage, cardiac arrhythmia).

Symptoms caused by blood clots
Stop taking the tablets and contact your doctor immediately
if symptoms suggesting a possible blood clot occur, such as:

• unusual sudden cough;
• severe chest pain, possibly radiating to the left arm;
• shortness of breath;
• any unusual, sudden, or persistent 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.

Full recovery after a blood clot is not always possible. Occasionally, thrombosis may lead to permanent disability or death.
Shortly after childbirth, women are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery OC-35 can be started.

OC-35 and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Some medicines may reduce the effectiveness of oral contraceptives. These include mainly:

• antibiotics such as penicillins and tetracyclines (e.g. ampicillin, rifampicin, griseofulvin);
• ritonavir – a medicine used in HIV infection;
• certain antiepileptic drugs (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate).

If any of the above medicines or others are used concomitantly with oral contraceptives for no longer than one week, additional contraceptive methods should be used both during treatment and for 7 days after discontinuation.
Women treated with rifampicin or other enzyme-inducing drugs should use additional contraceptive methods during antibiotic treatment and for 28 days after stopping it.
Do not use herbal remedies containing St. John’s wort (Hypericum perforatum) during treatment with OC-35.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not take OC-35 during pregnancy or if pregnancy is suspected.
Do not take OC-35 while breastfeeding.

Driving and operating machinery
The medicine has no influence on psychophysical performance, ability to drive vehicles, or operate machinery.

OC-35 contains lactose and sucrose
This medicine contains lactose and sucrose. If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use OC-35

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is one coated tablet daily, taken at the same time each day, for 21 days,
followed by a 7-day break before starting the next pack. Regular use of OC-35 ensures effective
therapeutic action and prevents pregnancy.
Duration of treatment
Your treating physician will inform you how long you should take OC-35.
Starting OC-35 for the first time
Begin taking the medicine on the first day of your menstrual period – this ensures protection
against unintended pregnancy already in the first treatment cycle. If the first tablet is taken on the
5th day of the cycle, an additional contraceptive method should be used throughout the first cycle
or sexual intercourse should be avoided. This cycle may be fertile (ovulation may occur due to
insufficient, too late – from day 5 – control of sex hormone secretion). After 21 days, a 7-day break
in taking the medicine follows before starting the next pack. During this break, a withdrawal
bleeding should occur. Regardless of whether the bleeding has ended, the first tablet from the next
pack must be taken after 7 days.
If you previously used another combined oral contraceptive
Begin taking OC-35 the day after the 7-day break associated with your previous contraceptive
regimen, or the day after taking the last inactive tablet (without hormones) from your current pack
(in case of doubt, consult a doctor or pharmacist).
If you previously used progestogen-only pills (mini-pills)
You may discontinue mini-pills at any time and start taking OC-35 instead, at the same time of day.
If you have sexual intercourse during the first 7 days of taking OC-35, you should also use another
contraceptive method.
If you previously used injectable contraception, an implant, or an intrauterine device releasing a progestogen
Begin taking OC-35 on the day the next injection would have been administered, or on the day of
implant or intrauterine device removal. If you have sexual intercourse during the first 7 days of
taking OC-35, you should also use another contraceptive method.
Taking OC-35 after childbirth or after spontaneous or induced abortion
Start taking OC-35 21 to 28 days after childbirth. If you had sexual intercourse before starting the
medicine, do not take OC-35 until the first natural menstrual period occurs, to confirm you are not
pregnant. Use additional contraceptive methods during the first 7 days of taking OC-35.
Do not use the medicine during breastfeeding.
How long to use OC-35
The duration of OC-35 treatment depends on the severity of the condition and usually lasts several
months. It is recommended to continue treatment for at least 3–4 cycles after symptoms resolve. If
the condition recurs several weeks or months after stopping the tablets, treatment with OC-35 may
be resumed.
Taking more than the recommended dose of OC-35
Overdose may cause adverse effects such as nausea, vomiting, and slight genital bleeding. There
is no specific antidote.
If an excessive dose has been taken, consult a doctor who may administer appropriate symptomatic
treatment if necessary.
Missed dose of OC-35
If a missed tablet is taken within 12 hours, contraceptive effectiveness is maintained. Take the
tablet as soon as possible and continue with the next tablet at the usual time. If more than 12 hours
have passed, contraceptive effectiveness may be reduced. Therefore, it is recommended to use
additional contraceptive methods for the next 7 days (during the intake of 7 consecutive tablets). If
you forgot to take tablets and no expected bleeding occurred during the first break, pregnancy may
have occurred.
In case of doubt regarding a missed dose, consult a 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,
and continue taking the next tablets at the usual time. Use additional contraceptive methods for the
next 7 days. If you had sexual intercourse in the week before the missed tablet, pregnancy may
have occurred.
Missed tablet in Week 2
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time,
and continue taking the next tablets at the usual time. The contraceptive effectiveness of OC-35
is maintained, and additional contraceptive methods are not required.
Missed tablet in Week 3
You may choose one of the following options:

1. Take the missed tablet as soon as possible and the next one at the usual time, even if this means taking two tablets simultaneously. Start the next pack immediately after finishing the current one, without a 7-day break. Bleeding will occur after finishing the second pack, but spotting or slight bleeding may occur during tablet intake.
2. Alternatively, stop taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), and then continue taking tablets from the next pack.

If you forgot to take tablets and no expected bleeding occurred during the first break, consider the
possibility of pregnancy. Consult a doctor before starting the next pack.
Missed tablet management chart:
Missed more than 1 tablet in a cycle – Consult a doctor
Sexual intercourse occurred – Yes / No
or
Week 1 – Sexual intercourse in the week preceding the missed tablet

• Take the missed tablet
• Use additional contraceptive method for 7 days
• Finish the tablets in the pack

Missed only 1 tablet (more than 12 hours late)
Week 2 – Take the missed tablet
– Finish the tablets in the pack

• Take the missed tablet
• Finish the current pack
• Do not take a 7-day break
• Continue with the next pack
  Week 3
• Discard remaining tablets in the pack
• Take a break (no more than 7 days, including the day of the missed tablet)
• Continue with the next pack

Managing vomiting or acute diarrhea
If vomiting or acute diarrhea occurs, the active ingredients may not be fully absorbed.
If vomiting or acute diarrhea occurs within 3 to 4 hours after taking a tablet, follow the
recommendations above for missed tablets.
Delaying the onset of withdrawal bleeding
You can delay withdrawal bleeding by starting the next pack immediately after finishing the
current one, without a 7-day break. Tablets may be taken continuously until the pack is finished.
During this time, slight bleeding or spotting may occur. Begin the next pack after a 7-day break.
Changing the day of withdrawal bleeding
To shift the bleeding to a different day of the week than indicated by the usual regimen, shorten the
next tablet-free interval by as many days as you wish to shift the bleeding. The shorter the break,
the greater the risk that withdrawal bleeding will not occur. Slight bleeding or spotting may occur
during the next pack.
Unexpected bleeding
During the first few months of taking OC-35, irregular genital bleeding (spotting or menstrual
bleeding) may occur. Despite this, continue taking the tablets. Irregular genital bleeding usually
resolves after 3 cycles of OC-35 use. If bleeding persists, becomes heavy, or recurs, inform your
doctor.
Absence of bleeding
If you took all tablets on time, did not experience acute diarrhea or vomiting, and did not take other
medicines, the likelihood of pregnancy is low. Continue taking OC-35.
The absence of bleeding for two consecutive months may indicate pregnancy. Consult a doctor
immediately. Do not start the next pack until pregnancy has been ruled out.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Rare adverse effects:

• blood clot in veins.

Severe adverse effects:

• thromboembolic disorders;
• hormone-dependent neoplasms;
• liver diseases;
• systemic lupus erythematosus (SLE);
• chorea.

Other adverse effects:
Milder adverse symptoms occurring mainly during the first few months of taking the OC-35 oral contraceptive:

• spotting or mid-cycle bleeding;
• headaches;
• rash;
• itching;
• fungal infections;
• nausea and gastrointestinal discomfort;
• chest pain;
• changes in libido, depression;
• change in body weight;
• skin changes;
• eye discomfort while wearing contact lenses;
• hair loss.

Reporting adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine OC-35

Store below 25 °C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
EXP:. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What OC-35 contains

• The active substances are cyproterone acetate and ethinylestradiol. Each coated tablet contains 2 mg of cyproterone acetate and 0.035 mg of ethinylestradiol.
• The other ingredients are: monohydrate lactose, maize starch, povidone, talc, magnesium stearate. Coating: sucrose, calcium carbonate, talc, titanium dioxide (E 171), povidone, macrogol 6000, glycerol 85%, yellow iron oxide (E 172), ethylene glycol esterified montan wax.

What OC-35 looks like and contents of the pack
OC-35 is available as coated tablets.
Pack sizes contain 21 or 63 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]
For further information, please contact the local representative of the Marketing Authorisation Holder:
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: 24 357 44 44
e-mail: [email protected]