Oc-35

Package Leaflet: Information for the User

OC-35 2 mg + 0.035 mg film-coated tablets

Cyproterone acetate + Ethinylestradiol
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see point 4.

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See point 4.

Contents of the package leaflet

• 1. What is OC-35 and what is it used for
• 2. Important information 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 is OC-35 and what is it used for

OC-35 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 only use OC-35 to treat acne 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 taking OC-35

When not to take OC-35

Tell your doctor if you have any of the following conditions before starting to take OC-35. Your doctor may then advise you to use a different treatment:

• if you are taking another hormonal contraceptive;
• if you currently have (or have ever had) a blood clot in the leg (thrombophlebitis), a blood clot in the lungs (pulmonary embolism), or in any other part of the body;
• 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 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 blood clotting problem (e.g., protein C deficiency);
• if you currently have (or have ever had) migraine with visual disturbances;
• if you have a brain tumor or have been diagnosed with a brain tumor (usually a benign tumor of the tissue between the brain and the skull). If any of the above conditions occur for the first time while taking OC-35, you should stop taking it immediately. OC-35 should not be taken by men.

Warnings and precautions

Before taking OC-35, discuss this with your doctor or pharmacist.
Particular care should be taken when taking OC-35 if you have diabetes, are overweight, have high blood pressure, heart valve problems, or irregular heart rhythms, superficial vein inflammation, varicose veins, migraine attacks, epilepsy, blood clots, heart attack, or stroke in close relatives, liver or gallbladder disease, systemic lupus erythematosus (SLE), skin discoloration (yellow-brown pigment spots, so-called chloasma), increased cholesterol or triglyceride levels in the blood, Crohn's disease, or ulcerative colitis.
If any of the above symptoms occur for the first time or worsen while taking OC-35, you should contact your doctor.
Hirsutism (excessive hair growth) - if symptoms of the disease have occurred recently or have worsened, you should inform your doctor immediately.
Blood circulation disorders

• Taking combined oral contraceptives increases the risk of developing venous or arterial thrombosis and thromboembolic diseases, such as heart attack, stroke, deep vein thrombosis, and pulmonary embolism. These cases are rare.
• While taking any combined oral contraceptive, a blood clot may occur in the veins, such as deep vein thrombosis or pulmonary embolism. Very rarely, in women taking combined oral contraceptives, blood clots may occur in other blood vessels, such as the liver, spleen, kidneys, or eyes.

Tumors
Epidemiological studies have shown:

• an increased risk of cervical cancer in women taking oral contraceptives for an extended period. However, this risk may not be directly related to the use of these drugs but may result from specific sexual behaviors or other factors, such as human papillomavirus (HPV) infection.
• a slight increase in the relative risk of breast cancer in women taking hormonal contraceptives. This risk gradually decreases within 10 years after stopping hormonal contraceptives. The observed small increase in breast cancer risk may be due to earlier detection, the effect of hormonal contraceptives, or the coexistence of both factors. Among women taking hormonal contraceptives, breast cancer is more often detected in its early stages than in women who have never taken combined oral contraceptives.
• a rare possibility of life-threatening bleeding into the abdominal cavity in patients with liver tumors, whether benign or malignant. The occurrence of severe abdominal symptoms, liver enlargement, or signs of bleeding into the abdominal cavity may indicate the presence of a liver tumor.

Reports have indicated an increased risk of developing a benign brain tumor (meningioma) when taking high doses (25 mg or higher) of cyproterone acetate. If a meningioma is detected, the doctor will stop treatment with products containing cyproterone, including OC-35, as a precautionary measure (see "When not to take OC-35").
When to contact your doctor
Regular check-ups:
While taking OC-35, your doctor will inform you about the need for check-ups.
You should contact your doctor immediately if:

• you experience worrying changes in your health (especially any of the symptoms listed in point 2 of the leaflet "Important information before taking OC-35");
• a breast lump is detected;
• there is heavy vaginal bleeding of unknown cause;
• a surgical operation is planned or immobilization is anticipated;
• you experience severe diarrhea;
• a tablet is missed in the first week of the cycle (every first week of taking OC-35), and there has been sexual intercourse during the previous 7 days;
• no bleeding occurs within two months or if pregnancy is suspected.

You should stop taking the tablets and contact your doctor immediately if you notice symptoms that may indicate a blood clot. These symptoms are described in point 2, "Blood clot (thrombosis)".

OC-35 also acts as an oral contraceptive. The patient and doctor should consider all the usual rules for safe oral hormonal contraception.
Blood clots (thrombosis)
Taking OC-35 may slightly increase the risk of developing blood clots (so-called thrombosis). The likelihood of developing blood clots in patients taking OC-35 is only slightly increased compared to women who do not take OC-35 or any oral contraceptive. Not all patients recover fully, and 1-2% of cases can be fatal.
Blood clots in veins
A blood clot in a vein (known as venous thrombosis) can block a vein. This can occur in the veins of the legs, lungs (pulmonary embolism), or any other organ.
Taking a combined oral contraceptive increases the risk of developing such blood clots in women compared to women who do not take any combined oral contraceptives. The risk of developing a blood clot in the veins is highest during the first year of taking an oral contraceptive. The risk is not as high as the risk of developing a blood clot during pregnancy.

• increasing age;
• if you smoke.

When taking a hormonal contraceptive like OC-35, it is strongly recommended to quit smoking, especially if you are over 35 years old;

• if one of your close relatives had a blood clot in the leg, lungs, or other organ at a young age;
• if you are overweight;
• if you need to have surgery, are immobilized for a long time due to injury or illness, or have a leg in a cast.

If the above conditions apply to you, it is essential to inform your doctor about taking OC-35, as treatment may need to be discontinued. Your doctor may advise you to stop taking OC-35 for a few weeks before surgery or when your mobility is restricted. Your doctor will also inform you when you can start taking OC-35 again after you have regained mobility.
Mental disorders
Some women taking hormonal contraceptives, including OC-35, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible for further medical advice.
Blood clots in arteries
Blood clots in arteries can cause severe disorders. For example, a blood clot in the heart can cause a heart attack, or in the brain, it can cause a stroke.
Taking combined oral contraceptives is associated with an increased risk of developing blood clots in arteries. This risk is further increased by:

• increasing age;
• if you smoke.

When taking a hormonal contraceptive like OC-35, 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 a high level of fat in the blood (cholesterol or triglycerides);
• if you have migraines;
• if you have heart disease (valve damage, irregular heart rhythms).

Symptoms caused by a blood clot

You should stop taking the tablets and contact your 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 disturbances in hearing, smell, and taste;
• dizziness or fainting;
• numbness or weakness 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 and even death.
After childbirth, women are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking OC-35 after childbirth.

OC-35 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may reduce the effectiveness of oral contraceptives.
This applies mainly to:

• antibiotics from the penicillin and tetracycline groups (e.g., ampicillin, rifampicin, griseofulvin);
• ritonavir - a medicine used to treat HIV infection;
• certain medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate).

If the above medicines or others are taken at the same time as oral contraceptives for less than 7 days, you should use additional contraceptive methods during and for 7 days after stopping the medicine.
Women treated with rifampicin or other liver enzyme-inducing drugs should use additional contraceptive methods during and for 28 days after stopping the antibiotic.
You should not take herbal medicines containing St. John's Wort while taking OC-35.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take OC-35 if you are pregnant or think you may be pregnant.
You should not take OC-35 while breastfeeding.

Driving and using machines

The medicine has no influence on the ability to drive and use machines.

OC-35 contains lactose and sucrose

The medicine contains lactose and sucrose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take OC-35

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one film-coated tablet per day, at the same time, for 21 days. Then, a 7-day break before starting the next pack. Regularly taking OC-35 ensures therapeutic effectiveness and prevents pregnancy.

Duration of treatment

Your doctor will inform you how long you should take OC-35.
Starting OC-35 for the first time
Start taking the medicine on the first day of your period - this ensures protection against unwanted pregnancy from the first cycle of treatment. If you start taking the first tablet on the 5th day of your cycle, you should use an additional contraceptive method for the entire first cycle or abstain from sexual intercourse. This cycle may be fertile (possibility of ovulation due to insufficient, too late - from the 5th day - control of sex hormone secretion). After 21 days, there is a 7-day break before starting the next pack. During this break, you should experience menstrual bleeding. Regardless of whether it has ended, you must take the first tablet from the next pack after 7 days.
If you have been taking another combined oral contraceptive
Start taking OC-35 the next day after the 7-day break from your previous contraceptive or the day after taking the last inactive tablet (without hormones) from your current pack (if in doubt, consult your doctor or pharmacist).

If you have been taking a progestogen-only pill (mini-pill)

You can stop taking the mini-pill at any time and start taking OC-35 at the same time. If you have sexual intercourse within the first 7 days of taking OC-35, you should use an additional contraceptive method.

If you have been taking a contraceptive injection, implant, or intrauterine device that releases a progestogen

Start taking OC-35 on the day you would have had your next injection or on the day the implant or intrauterine device is removed. If you have sexual intercourse within the first 7 days of taking OC-35, you should use an additional contraceptive method.

Taking OC-35 after childbirth or miscarriage

Start taking OC-35 21 to 28 days after childbirth. If you have had sexual intercourse before starting the medicine, you should not take it until you have had your first natural period, to ensure you are not pregnant. During the first 7 days of taking the medicine, use an additional contraceptive method.
Do not take OC-35 while breastfeeding.
How long to take OC-35
The duration of treatment with OC-35 depends on the severity of the disease and usually lasts several months. It is recommended to continue treatment for at least 3-4 cycles after the symptoms have disappeared. If the symptoms recur after a few weeks or months after stopping the tablets, you can restart treatment with OC-35.

Overdose

In case of overdose, side effects such as nausea, vomiting, or slight vaginal bleeding may occur. There is no specific antidote.
If you have taken too much of the medicine, consult your doctor, who will provide appropriate symptomatic treatment if necessary.

Missed tablet

If a tablet is missed and it is less than 12 hours since the missed dose, the effectiveness of the medicine is maintained. Take the missed tablet as soon as possible and take the next one at the usual time. If more than 12 hours have passed, the effectiveness of the medicine may be reduced. Therefore, it is recommended to use additional contraceptive methods for the next 7 days (during the time you take 7 consecutive tablets). If you forget to take a tablet and do not experience the expected menstrual bleeding during the first break, you may be pregnant.
In case of doubt about a missed dose, consult your doctor.

Missed tablet in the 1st week

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and continue taking the tablets at the usual time. Use an additional contraceptive method for the next 7 days. If you had sexual intercourse in the week before missing the tablet, you may be pregnant.

Missed tablet in the 2nd week

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and continue taking the tablets at the usual time. The contraceptive effectiveness of OC-35 is maintained, and you do not need to use additional contraceptive methods.

Missed tablet in the 3rd week

You can 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 it means taking two tablets at the same time. Start the next pack immediately after finishing the current one, without a 7-day break. Menstrual bleeding will occur after finishing the second pack, but you may experience spotting or light bleeding during tablet intake.
• 2. You can also stop taking the tablets from the current pack, take a 7-day or shorter break (including the day you missed the tablet), and then continue taking the tablets from the next pack.

If you forget to take a tablet and do not experience the expected menstrual bleeding during the first break, consider the possibility of pregnancy. Before starting the next pack, consult your doctor.
Procedure in case of a missed tablet:
had intercourse
did not have intercourse
or
Missed more
than 1 tablet in
the cycle
Consult your doctor
Week 1
Had sexual intercourse in the week before missing the tablet

• take the missed tablet
• use an additional contraceptive method for 7 days
• finish the pack

Missed only 1
tablet (break
longer than 12
hours)

• take the missed tablet
• finish the pack
• do not take a 7-day break
• continue with the next pack
• Week 2
• take the missed tablet
• finish the pack
• Week 3
• stop taking the remaining tablets from the pack
• take a break (no more than 7 days, including the day you missed the tablet)
• continue with the next pack

Procedure in case of vomiting or severe diarrhea
If vomiting or severe diarrhea occurs, the active substances may not be fully absorbed. If vomiting or severe diarrhea occurs within 3-4 hours after taking a tablet, follow the same procedure as for a missed tablet.
Procedure in case of a desire to delay the onset of menstrual bleeding
You can delay the onset of menstrual bleeding by starting the next pack immediately after finishing the current one, without a 7-day break. You can take tablets for as long as the pack lasts. During the intake of tablets from the next pack, you may experience light bleeding or spotting. Start the next pack after a 7-day break.
Procedure in case of a desire to change the day of onset of menstrual bleeding
To change the day of onset of menstrual bleeding to a different day of the week than the one resulting from the treatment schedule, you should shorten the next break in tablet intake by the number of days you want to postpone the onset of menstrual bleeding. The shorter the break in tablet intake, the higher the risk that withdrawal bleeding will not occur. Light bleeding or spotting may occur during the intake of the next pack.

Unexpected menstrual bleeding

During the first few months of taking OC-35, irregular vaginal bleeding (spotting or menstrual bleeding) may occur. Despite this, continue taking the tablets. Irregular vaginal bleeding usually disappears after 3 cycles of taking OC-35. If bleeding persists, becomes heavy, or recurs, consult your doctor.
No menstrual bleeding
If you have taken all the tablets at the right time and have not had severe diarrhea or vomiting, or taken other medicines, the likelihood of pregnancy is low. Continue taking OC-35.
Lack of menstrual bleeding over two months may indicate pregnancy. Consult your doctor immediately. You should not start the next pack until you are sure you are not pregnant.

4. Possible side effects

Like all medicines, OC-35 can cause side effects, although not everybody gets them.
Rare side effects:

• blood clot in the veins.

Severe side effects:

• thromboembolic events;
• hormone-dependent tumors;
• liver disease;
• systemic lupus erythematosus (SLE);
• chorea.

Other side effects:
Mild symptoms that occur mainly during the first few months of taking OC-35:

• spotting or bleeding between periods;
• headaches;
• rash;
• itching;
• thrush;
• nausea and stomach upset;
• breast pain;
• changes in sex drive, depression;
• weight changes;
• skin changes;
• eye discomfort when wearing contact lenses;
• hair loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 month stated.
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. Contents of the pack and other information

What OC-35 contains

• The active substances of OC-35 are cyproterone acetate and ethinylestradiol. One film-coated tablet contains 2 mg of cyproterone acetate and 0.035 mg of ethinylestradiol.
• Other ingredients are: lactose monohydrate, 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), montan wax esterified with ethylene glycol.

What OC-35 looks like and contents of the pack

OC-35 is a film-coated tablet.
The pack contains 21 or 63 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Phone: 24 357 44 44
Fax: 24 357 45 45
Email: [email protected]
To obtain more detailed information, contact your local representative of the marketing authorization holder:
Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland
Phone: 24 357 44 44
Email: [email protected]
Date of last revision of the leaflet: