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HSA Approval

VASTAREL TABLET 20 mg

SIN01673P

VASTAREL TABLET 20 mg

VASTAREL TABLET 20 mg

June 8, 1988

SERVIER (S) PTE LTD

SERVIER (S) PTE LTD

Regulatory Information

SERVIER (S) PTE LTD

SERVIER (S) PTE LTD

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**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.

ORAL

Medical Information

**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.

**4.3 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).

C01EB15

trimetazidine

Manufacturer Information

SERVIER (S) PTE LTD

LES LABORATOIRES SERVIER INDUSTRIE

Active Ingredients

TRIMETAZIDINE

20 mg

Trimetazidine

Documents

Package Inserts

Vastarel Tablet 20mg PI.pdf

Approved: July 6, 2021

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