GENERIC NAME: ETHINYL ESTRADIOL - CYPROTERONE - ORAL (ETH-in-ill ess-truh-DYE-ohl/sye-PRO-turr-own)
WARNING: Smoking cigarettes while using this medication increases your chance of having heart problems. Do not smoke while using this medication. The risk of heart problems increases with age (in women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).
USES: This product is a hormone combination used to treat women with severe acne who have not responded to other treatments, and to treat women with a moderately severe condition known as hirsutism, which is male-pattern hair growth. This medication is not to be used just for birth control purposes, due to the possibility of increased side effects (such as blood clots). Once the treated condition (severe acne or hirsutism) is under control, this medication should be stopped 3 or 4 menstrual cycles later. It should not be continued indefinitely. Consult your doctor or pharmacist for more details.
HOW TO USE: Take this medication by mouth, once a day, at the same time each day; or take as directed by your doctor. If this is your first time using this medicine, take your first dose on the first day of your period (menstruation) and continue each day for 21 days until all the tablets are taken. Wait 7 days and begin another packet. Menstrual bleeding should occur during the 7 days without medication. Each new packet should begin on the same day of the week that started the previous course, regardless of whether your period has begun. Wait 7 days after finishing each packet before starting the next packet. It may take up to several months of continued use to notice a relief in symptoms. If you are unsure how to use this medication, ask your doctor or pharmacist.
SIDE EFFECTS: Nausea, vomiting, cramps, headache, breast tenderness, change in sexual desire, or mid-cycle (breakthrough) bleeding/spotting may occur. If these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if you have any of these serious side effects: swelling or pain in the legs, dizziness, vision changes. Tell your doctor immediately if you have any of these unlikely but serious side effects: chest pain, one-sided weakness, irregular heartbeat, dark urine, yellowing of the eyes or skin, stomach/abdominal pain, mental/mood changes, an unusual change in amount of urine. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially of: migraine headaches, blood clots, strokes, eye (vascular retinal) disease, high blood pressure, diabetes, obesity, asthma, high cholesterol, seizures, heart problems, kidney problems, liver problems, cancer, abnormal vaginal bleeding, vaginal fibroids, family history of cancer, lupus (SLE) or rheumatoid arthritis, mood disorders (e.g., depression), drug allergies. If you become bedridden, you are more likely to experience serious drug side effects (blood clots); consult your doctor. This drug may cause a patchy, darkening of the skin on the face (melasma). Sunlight may intensify this darkening, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. Avoid pregnancy for at least one month after stopping this medication. Use non-hormone birth control (e.g., latex condoms) during that time. Tell your doctor immediately if you miss your menstrual period, since this medication must not be used if you are pregnant. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially of: all antibiotics, barbiturates (e.g., phenobarbital, primidone), carbamazepine, ethosuximide, phenytoin, rifamycins (e.g., rifampin), pain medication, antihistamines (e.g., diphenhydramine), migraine medication (e.g., sumatriptan), griseofulvin, isoniazid, ascorbic acid (vitamin C), nitrofurantoin, high blood pressure drugs, beta-blockers (e.g., propranolol), corticosteroids (e.g., prednisone), diabetes medications, "blood thinners" (e.g., warfarin), psychiatric medications, theophylline, certain anti-anxiety drugs (e.g., diazepam), phenylbutazone. Cigarette smoking increases the risk of serious side effects. Tell your doctor if you smoke or if you have recently stopped smoking. Do not smoke while using this medication. Oral birth control pills should not be taken while using this product, since this medication can act as a birth control pill. Also, side effects may be increased if you take this with birth control pills. Ask your doctor or pharmacist for details. This drug may interfere with certain laboratory tests (such as LH and FSH levels). Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include nausea and vomiting. Females may experience vaginal bleeding.
NOTES: Do not share this medication with others. Laboratory and/or medical tests will be performed to monitor your progress (e.g., pregnancy testing, breast examinations).
MISSED DOSE: If you miss a dose, the tablet may be taken within the next 12 hours. If more than 12 hours have passed since the last dose, discard the missed tablet and continue to take the remaining tablets in the pack at the usual time. An alternate form of birth control (e.g., latex condoms) must be used until the pack is empty in order to prevent pregnancy.
STORAGE: Store at room temperature between 59 and 79 degrees F (15 and 26 degrees C).
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