ABRIDGED PRESCRIBING INFORMATION

Composition: TRIMACONTINTM tablets for oral administration contain 35/60 mg of Trimetazidine Hydrochloride BP in a CONTINUSTM controlled release system. Each tablet is pink, round, biconvex and film-coated.

Clinical Pharmacology: Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain 3-ketoacyI-CoA thiolase, which enhances glucose oxidation. In an ischemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the β-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia.

Indications: 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.

Dosage & Administration: The usual dose of TRIMACONTINTM 35 CONTINUSTM  tablet is one tablet twice daily after meals. TRIMACONTINTM 60 CONTINUSTM tablet should be taken once daily after meals. The tablet must be swallowed whole and not chewed.

Contraindications: Hypersensitivity to trimetazidine or any of the excipients. Parkinson’s disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders. Severe Renal impairment (creatinine clearance <30 ml/min)

Pregnancy & Lactation: There is insufficient evidence to recommend the use of trimetazidine in pregnancy. There is no information on the secretion of trimetazidine into breast milk. Drug Interactions: No drug interactions have been reported. In particular, no interactions have been reported with beta-blockers, calcium channel antagonists, nitrates, heparin, hypolipidaemic agents or digitalis preparation. Since non-interaction with monoamine oxidase inhibitors (MAOls) has not been established, trimetazidine should not be co-administered with these agents.

Storage Precautions: Store at a temperature not exceeding 30o C, protected from light & moisture. Keep out of reach of children.

Presentation: TRIMACONTINTM 35: Box of 30 tablets (3 x 10’s blister strip). TRIMACONTINTM 60: Box of 60 tablets (3 x 10’s blister strip).