Melodene 0.02 mg/0.075 mg Coated tablets

Melodene 0.02 mg/0.075 mg Coated tablets

S3
PDF Leaflet Revision Date: 20 May 2022


Clinical Summary

Quick overview from the medicine insert

Indication

Prevention of pregnancy.

Dosage (summary)

One tablet daily for 28 days, starting on day 1 of the menstrual cycle.

Special Populations

  • Paediatric patients (after menarche)
  • Hepatic impairment
  • Renal impairment

Pregnancy & Breastfeeding

Contraindicated in pregnancy; may reduce breast milk quantity and change composition during lactation.

Key Drug Interactions

  • Enzyme inducers (e.g., phenytoin, rifampicin)
  • CYP3A4 inhibitors (e.g., azole antifungals)

Contraindications

  • Hypersensitivity to active substances
  • History of thromboembolic events
  • Severe hepatic disease
  • Undiagnosed vaginal bleeding
  • Known or suspected pregnancy

Common side effects

  • Nausea
  • Abdominal pain
  • Headache
  • Depressed mood
  • Breast tenderness

Counselling Points

  • Take at the same time daily
  • Use barrier method if tablets are missed
  • Consult if mood changes occur

Serious warnings

  • Increased risk of thromboembolic events
  • Monitor for signs of thrombosis
  • May exacerbate conditions like hypertension and migraines
Important Disclaimer

The Melodene 0.02 mg/0.075 mg Coated tablets professional information leaflet below is the property of Bayer and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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