ALTHEA Cyproterone Acetate + Ethinylestradiol Tablet 2 mg / 35 mcg (21 Tablets)
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DESCRIPTION
ALTHEA is a combined hormonal preparation containing cyproterone acetate (anti-androgenic progestin) and ethinylestradiol (estrogen).
Each tablet contains:
• Cyproterone acetate 2 mg
• Ethinylestradiol 35 mcg
It acts by:
• Suppressing ovulation
• Reducing androgen production and activity
• Decreasing sebum production
• Altering cervical mucus and endometrial lining
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USES
• Treatment of moderate to severe acne related to androgen sensitivity
• Management of hirsutism (excessive hair growth)
• Treatment of polycystic ovary syndrome (PCOS)-related symptoms
• Oral contraception in women requiring anti-androgen therapy
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DOSAGE AND ADMINISTRATION
• Adults and adolescents:
o Take one tablet daily for 21 consecutive days, preferably at the same time each day
o Follow with a 7-day tablet-free interval
o Start the next pack after the 7-day break
Initiation:
• Start on the first day of menstruation
• If started later, use additional contraception for the first 7 days
Missed Dose:
• <12 hours late: Take immediately, continue as usual
• >12 hours late: Take the missed tablet as soon as remembered and use backup contraception for 7 days
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PRECAUTIONS
Use with caution or avoid in patients with:
• History of thromboembolic disorders
• Severe liver disease or liver tumors
• Hormone-dependent malignancies (e.g., breast cancer)
• Undiagnosed vaginal bleeding
• Uncontrolled hypertension
• Migraine with aura
• Diabetes with vascular complications
General Precautions:
• Does not protect against HIV or other sexually transmitted infections (STIs)
• Increased risk of venous thromboembolism, especially in smokers and women ≥35 years
• Monitor for liver function abnormalities with prolonged use
• Use under medical supervision
Drug Interactions:
• Reduced effectiveness with:
o Rifampicin, rifabutin
o Antiepileptics (e.g., phenytoin, carbamazepine)
o Certain antiretrovirals
• Increased hormone levels with:
o Azole antifungals
o Macrolide antibiotics
o Grapefruit juice
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SIDE EFFECTS
Common:
• Nausea
• Breast tenderness
• Headache
• Weight changes
• Mood changes
• Decreased libido
• Breakthrough bleeding or spotting
Androgen-related improvements:
• Reduction in acne and oily skin
• Decrease in unwanted hair growth (with continued use)
Serious (seek immediate medical attention):
• Venous thromboembolism (e.g., DVT, pulmonary embolism)
• Stroke or myocardial infarction
• Severe abdominal pain (possible liver disorder)
• Jaundice
• Severe depression or mood changes
• Visual disturbances or severe migraine
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STORAGE
• Store at temperatures below 25–30°C
• Keep in a cool, dry place, protected from light and moisture
• Keep out of reach of children