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VASTAREL XR EXTENDED-RELEASE HARD CAPSULE 80 MG [SIN15877P]
Active ingredients: VASTAREL XR EXTENDED-RELEASE HARD CAPSULE 80 MG
Last updated 26 October 2025
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Product Info
VASTAREL XR EXTENDED-RELEASE HARD CAPSULE 80 MG
[SIN15877P]
Product information
Active Ingredient and Strength | TRIMETAZIDINE DIHYDROCHLORIDE - 80 MG |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Manufacturer and Country | EGIS PHARMACEUTICALS PLC (PRODUCTION SITE OF KÖRMEND) - HUNGARY |
Registration Number | SIN15877P |
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
The dose is one capsule of 80mg of trimetazidine once daily during breakfast.
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 Vastarel MR 35 mg in the morning during breakfast.
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 Vastarel MR 35 mg in the morning during breakfast. 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.
Method of administration
Capsule must be taken orally without opening it, once daily i.e. one in the morning during breakfast.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Severe renal impairment (creatinine clearance < 30ml/min).