Opsumit 10 Mg FC Tablets 10 mg FC tablet
PDF Leaflet Revision Date: 21 September 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of pulmonary arterial hypertension (PAH) to delay progression.
Dosage (summary)
10 mg orally once daily.
Special Populations
- Elderly
- Hepatic impairment
- Renal impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding; reliable contraception required.
Key Drug Interactions
- Strong CYP3A4 inducers (e.g., rifampicin)
- Strong CYP3A4 inhibitors (e.g., ketoconazole)
- Warfarin
- Sildenafil
Contraindications
- Hypersensitivity to macitentan or excipients
- Severe hepatic impairment
- Pregnancy
- Breastfeeding
- Women of childbearing potential not using reliable contraception
Common side effects
- Anaemia
- Headache
- Hypotension
- Oedema
- Nasopharyngitis
Counselling Points
- Take at the same time daily.
- Do not chew or crush tablets.
- Report signs of liver injury or anaemia.
- Use reliable contraception.
Serious warnings
- Elevations of liver aminotransferases
- Risk of pulmonary veno-occlusive disease
- Caution in renal impairment
Important Disclaimer
The Opsumit 10 Mg FC Tablets 10 mg FC tablet professional information leaflet below is the property of Janssen Pharmaceutica 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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