Source: European Medicines Agency (EU)
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.
The dose is one tablet of 35mg of trimetazidine twice daily during meals.
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 35mg in the morning during breakfast.
Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2). In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast.
Dose titration in elderly patients should be exercised with caution (see section 4.4).
The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available
No cases of occurrence of poisoning by trimetazidine owing to its overdose have been reported.
Shelf life: 18 months.
Do not store above 30°C.
Blisters (PVC/PVDC/aluminium) in packs of 20, 60 and 120 prolonged release tablets.
Not all pack sizes may be marketed.
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