Diane-35 0,035 mg/2,0 mg Coated tablets
PDF Leaflet Revision Date: 21 July 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Moderate to severe acne and/or hirsutism in women of reproductive age.
Dosage (summary)
One tablet daily for 28 days; start on day 1 of menstrual cycle or after previous hormonal contraceptive.
Onset of Action / Duration
Onset: 3 months, Duration: Continuous use recommended.
Special Populations
- Obesity
- Hypertension
- Migraine
Pregnancy & Breastfeeding
Contraindicated in pregnancy and lactation.
Key Drug Interactions
- Phenytoin
- Rifampicin
- St. John's wort
Contraindications
- Venous thrombosis
- Arterial thrombosis
- Severe hepatic disease
- Known or suspected pregnancy
Common side effects
- Nausea
- Headache
- Depressed mood
- Breast tenderness
Counselling Points
- Take at the same time daily
- Use barrier contraception during first 14 days
- Report mood changes
Serious warnings
- Increased risk of venous thromboembolism
- Monitor for signs of thrombosis
- May exacerbate migraine
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