Source: Health Products Regulatory Authority (IE) Revision Year: 2014 Publisher: Servier Laboratories (Ireland) Limited Block 2 West Pier Business Campus Old Dunleary Road Dun Laoghaire Co. Dublin.
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 20mg of trimetazidine three times a day during meals.
Patients with renal impairment:
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 20mg 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). In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 20mg 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).
Paediatric population:
The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.
Very limited information is available on Trimetazidine overdose. Treatment should be symptomatic.
Shelf life: 3 years.
Do not store above 30°C.
No special requirements.
Cartons of 30, 60 and 90 tablets in PVC/Aluminium blisters.
Not all pack sizes may be marketed.
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