Uses

See also Warning section.

This medication is used to treat severe acne in women who have an oily skin condition called seborrhea and unwanted/extra hair growth on the body (such as face, chest). It contains 2 hormones: cyproterone (a progestin) and ethinyl estradiol (an estrogen). This medication helps to decrease the amount of oil on the skin which helps to clear acne. It also decreases hair growth.

Cyproterone also has anti-androgen (anti-testosterone) effects. Testosterone is a male hormone (also normally found in women in small amounts) that can worsen acne and cause extra hair growth. Cyproterone works by blocking testosterone. Ethinyl estradiol is used to balance the effects of cyproterone on the menstrual cycle. This medication is used when other acne treatments have not worked.

If taken daily as prescribed, these hormones prevent pregnancy by preventing the release of an egg (ovulation) and changing the womb and cervical mucus to make it more difficult for an egg to meet sperm (fertilization) or attach to the wall of the womb (implantation). This medication can also be used as a form of birth control by women taking it mainly to treat severe acne with seborrhea. However, this medication must not be used just for birth control because of its risks of very serious side effects (such as blood clots).

Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How To Use

Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your medication and what to do if you miss a dose. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your medication at the same time each day.

Each pack contains 21 tablets. If this is your first time using this medication, take your first tablet on the first day of your menstrual period, and continue to take 1 tablet once daily for 21 days in a row until the pack is finished. Then, do not take any tablets for 7 days unless directed by your doctor. You should have your period during the 7 days without medication. After you have gone 7 days without taking this medication, start a new pack the next day whether or not you have your period.

Start each new pack/cycle on the same day of the week that you started the previous pack/cycle, even if you are still having your period. If you do not get your period, contact your doctor.

According to the manufacturer, you should not use this medication long-term. Once the acne has improved, stop this medication 3 to 4 cycles later. Ask your doctor or pharmacist for more details.

It may take up to several months before you get the full benefit of this drug. Tell your doctor if your condition lasts or gets worse.

Pregnancy is more likely if you miss pills, start a new pack/cycle late, or take your pill at a different time of day than usual. Vomiting and diarrhea may also make this medication work less well. Talk to your doctor if you have vomiting or diarrhea to see if you need to start using an additional form of birth control. See also Missed Dose section.

Side Effects

Nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, changes in sexual interest, or breast tenderness/enlargement may occur. Vaginal bleeding between periods (called breakthrough bleeding or spotting) and irregular periods may also occur as your body adjusts to the medication. If you do not have bleeding during the 7 days when you are not taking the medication, ask your doctor for a pregnancy test. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods)
• dark patches on the skin (melasma)
• swelling of the ankles/feet
• weight changes (gain or loss)
• butterfly-shaped rash around the nose and cheeks
• signs of liver problems (such as nausea/vomiting that doesn't stop, unusual tiredness, dark urine, yellowing eyes/skin)
• joint pain/swelling

Get medical help right away if you have any very serious side effects, including:

• new/worsening seizures
• severe stomach/abdominal/pelvic pain or swelling
• breast lumps
• mental/mood changes (such as depression, suicidal thoughts)

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other birth control pills/patch/ring or female hormone products (estrogens/progestins); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood clots (such as in the legs, eyes, lungs)
• close family history of blood clots
• blood clotting disorders (such as protein C or protein S deficiency)
• stroke
• high blood pressure
• cancer (especially of the breast, ovary, uterus, or the brain coverings-meningioma)
• diabetes
• headaches/migraines
• heart problems (such as heart attack, chest pain, heart failure, heart valve disease)
• liver problems (such as liver tumor, active liver disease, cholestatic jaundice)
• history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills
• vaginal bleeding of unknown cause
• a certain eye problem (loss of vision caused by blood vessel disease in the eye)
• a certain type of hearing loss worsened by pregnancy (otosclerosis)
• high blood cholesterol/fat (triglyceride) levels
• depression
• swelling (edema)
• family or personal history of a certain swelling disorder (angioedema)
• gallbladder problems
• kidney disease
• obesity
• underactive thyroid (hypothyroidism)
• fibroids of the uterus

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

This medication passes into breast milk. This may affect milk production and may harm a nursing infant. Breast-feeding is not recommended while using this product. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aromatase inhibitors (such as anastrozole, exemestane)
• "blood thinners" (anticoagulants such as warfarin)
• other birth control pills/patch/ring
• other female hormone products (products that contain estrogens or progestins)
• raloxifene
• ospemifene
• tamoxifen
• tizanidine
• tranexamic acid
• certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir)

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others.

Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This drug can speed up or slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include aspirin, certain beta blockers (such as metoprolol), clofibrate, corticosteroids such as prednisolone, and certain benzodiazepines such as lorazepam/temazepam, among others. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

This medication may interfere with certain laboratory tests (such as blood tests for clotting factors, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, sudden/unusual vaginal bleeding.

Notes

Do not share this medication with others.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If more than 12 hours have passed since the missed dose, throw away the missed tablet. Take your next dose at the regular time. Do not double the dose to catch up.

If you miss a dose, you must use an additional form of birth control (non-hormonal method such as condoms, spermicide) until the pack is finished in order to prevent pregnancy. Ask your doctor or pharmacist for more details.

If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.