MICROPIL Norethisterone + Ethinylestradiol Tablet 400 mcg / 35 mcg
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DESCRIPTION
MICROPIL is a combined oral contraceptive (COC) containing norethisterone (progestin) and ethinylestradiol (estrogen).
Each tablet contains:
• Norethisterone 400 mcg (0.4 mg)
• Ethinylestradiol 35 mcg
It works by:
• Inhibiting ovulation
• Thickening cervical mucus, preventing sperm penetration
• Altering the endometrium, reducing the likelihood of implantation
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USES
• Prevention of pregnancy (oral contraception)
• Regulation of menstrual cycles
• Management of:
o Dysmenorrhea (painful menstruation)
o Menorrhagia (heavy menstrual bleeding)
o Irregular menstruation
o Premenstrual symptoms
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DOSAGE AND ADMINISTRATION
• Adults and adolescents:
o Take one tablet daily, preferably at the same time each day
Typical Regimen:
• 21-day regimen:
o Take 1 tablet daily for 21 consecutive days
o Follow with a 7-day tablet-free interval before starting the next pack
(Follow specific product pack instructions if a 28-day regimen is provided.)
Initiation:
• Start on the first day of menstruation
• If started later, use additional contraception for the first 7 days
Missed Dose:
• 1 tablet missed: Take as soon as remembered, then continue as usual
• 2 consecutive tablets missed: Take the most recent missed tablet and continue; use backup contraception for 7 days
• ≥3 tablets missed: Continue taking tablets and use backup contraception for 7 days
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PRECAUTIONS
Use with caution or avoid in patients with:
• History of thromboembolic disorders (e.g., DVT, pulmonary embolism)
• Cerebrovascular or coronary artery disease
• Breast cancer or estrogen-dependent tumors
• Severe liver disease
• Uncontrolled hypertension
• Migraine with aura
• Diabetes with vascular complications
General Precautions:
• Does not protect against HIV or other sexually transmitted infections (STIs)
• Smoking increases risk of cardiovascular events, especially in women ≥35 years
• Requires medical supervision and periodic evaluation
Drug Interactions:
• Reduced contraceptive effectiveness with:
o Rifampicin, rifabutin
o Certain antiepileptics (e.g., phenytoin, carbamazepine)
o Some antiretrovirals
• Increased hormone levels with:
o Azole antifungals
o Macrolide antibiotics
o Grapefruit juice
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SIDE EFFECTS
Common:
• Nausea
• Headache
• Breast tenderness
• Weight changes
• Mood changes
• Breakthrough bleeding or spotting
Less Common:
• Acne
• Decreased libido
• Fluid retention
Serious (seek immediate medical attention):
• Thromboembolic events (e.g., DVT, pulmonary embolism)
• Stroke or myocardial infarction
• Severe abdominal pain (possible liver disorder)
• Jaundice
• Severe headache or visual disturbances
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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