VASTAREL XR EXTENDED-RELEASE HARD CAPSULE 80 mg

CAPSULE, EXTENDED RELEASE

**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.