Rovulum 2 mg FC tablets
PDF Leaflet Revision Date: 29 August 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of endometriosis in adolescents and adults.
Dosage (summary)
1 tablet daily, starting on day 1 of the menstrual cycle, without breaks.
Special Populations
- Adolescents (12 years and older)
- Hepatic impairment
- Renal impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and lactation.
Key Drug Interactions
- CYP3A4 inducers (e.g., rifampicin)
- CYP3A4 inhibitors (e.g., ketoconazole)
Contraindications
- Hypersensitivity to dienogest
- Known or suspected pregnancy
- Lactation
- History of venous thromboembolic disorder
- Arterial and cardiovascular diseases
- Diabetes with vascular involvement
- Severe hepatic disease
- Liver tumors
- Sex hormone-dependent malignancies
- Undiagnosed vaginal bleeding
Common side effects
- Headache
- Breast discomfort
- Depressed mood
- Acne
Counselling Points
- Use non-hormonal contraception during treatment.
- Monitor for mood changes.
- Report any unusual bleeding patterns.
- Ensure adequate calcium and vitamin D intake.
Serious warnings
- Risk of depression and suicidality
- Increased risk of thromboembolism
- Potential for changes in bleeding patterns
- Bone mineral density decrease in adolescents
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