Compositon/Ingredients: Trimetazidine

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.

• Hypersensitivity to the active substance or to any of the excipients listed in product.
• Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
• Severe renal impairment (creatinine clearance < 30ml/min).

• Usual dose: One tablet, twice daily during meals.
• Elderly patients, patients with moderate renal impairment (creatinine clearance 30 – 60ml/min): The recommended dose is one tablet in the morning during breakfast.
• Children: The safety and efficacy of trimetazidine in children aged below 18 years have not been established.

• In the absence of clinical data and for safety reasons, trimetazidine should not be prescribed to pregnancy and nursing women.
• Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients.
• The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
• Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment.
• Caution should be exercised when use for patients with moderate renal impairment, elderly patients older than 75 years old.
• Trimetazidine may cause symptoms, such as dizziness and drowsiness which may affect ability to drive and use machines. Patients should be aware of how they react to drug before driving or operating machinery.

Store at temperature below 30°C, protect from light.