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VASTAREL TABLET 20 MG [SIN01673P]
Active ingredients: VASTAREL TABLET 20 MG
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Product Info
VASTAREL TABLET 20 MG
[SIN01673P]
Product information
Active Ingredient and Strength | TRIMETAZIDINE - 20 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | LES LABORATOIRES SERVIER INDUSTRIE - FRANCE |
Registration Number | SIN01673P |
Licence Holder | SERVIER (S) PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | C01EB15 |
4.1 Therapeutic indications
Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
4.2 Posology and method of administration
Posology
Oral use.
Method of administration
The dose is one tablet of 20 mg of trimetazidine three times a day during meals.
The benefit of the treatment should be assessed after three months and trimetazidine should be discontinued if there is no treatment response.
Special populations
Patients with renal impairment
In patients with moderate renal impairment (creatinine clearance [30–60] ml/min) (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), the recommended dose is 1 tablet of 20 mg twice daily, i.e., one in the morning and one in the evening during meals.
Elderly patients
Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients with moderate renal impairment (creatinine clearance [30–60] ml/min), the recommended dose is 1 tablet of 20 mg twice daily, i.e., one in the morning and one in the evening during meals.
Dose titration in elderly patients should be exercised with caution (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population:
The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients;
Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders;
Severe renal impairment (creatinine clearance < 30ml/min).
