Roltesim 40 mg, 80 mg FC tablets)
PDF Leaflet Revision Date: 24 November 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Indicated for hypercholesterolaemia and coronary heart disease.
Dosage (summary)
Adults: Initial dose 10 mg daily in the evening for hypercholesterolaemia; 20 mg daily for coronary heart disease.
Special Populations
- Renal insufficiency
- Elderly
Pregnancy & Breastfeeding
Not recommended in pregnancy or lactation; foetotoxic and teratogenic.
Key Drug Interactions
- Strong CYP3A4 inhibitors
- Gemfibrozil
- Ciclosporin
Contraindications
- Hypersensitivity to simvastatin
- Acute or chronic liver disease
- Pregnancy
- Lactation
Common side effects
- Myalgia
- Headache
- Dizziness
- Constipation
Counselling Points
- Report unexplained muscle pain
- Avoid grapefruit juice
- Monitor liver function tests
Serious warnings
- Risk of myopathy and rhabdomyolysis
- Liver function abnormalities
Important Disclaimer
The Roltesim 40 mg, 80 mg FC tablets) professional information leaflet below is the property of Strides Pharma Sa 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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