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Posology: The dose is one capsule of 80 mg of trimetazidine once daily during breakfast.
This dosage regimen with Vastarel 80 mg is equivalent to the following regimen with Vastarel 20 mg or Vastarel 35 mg.
Vastarel 20 mg: one tablet of 20 mg of trimetazidine three times a day during meals.
Vastarel 35 mg: one tablet of 35 mg of trimetazidine twice daily, i.e. once in the morning and once in the evening, 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 Precautions and Pharmacology: Pharmacokinetics under Actions), the recommended dose is reduced by half ie, 1 tablet of 20 mg twice daily, one in the morning and one in the evening during meals or 1 tablet of 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 Pharmacology: Pharmacokinetics under Actions). In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is reduced by half ie, 1 tablet of 20 mg twice daily, one in the morning and one in the evening during meals or 1 tablet of 35 mg in the morning during breakfast. Dose titration in elderly patients should be exercised with caution (see Precautions).
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.
