Tricard MR^®

Tricard MR is a preparation of Trimetazidine Hydrochloride. By preserving energy metabolism in cells exposed to hypoxia or ischemia, Trimetazidine prevents a decrease in intracellular ATP levels, thereby ensuring the proper functioning of ionic pumps and transmembrane sodium-potassium flow whilst maintaining cellular homeostasis. Trimetazidine inhibits !?,-oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation. In an ischemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the !?,-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischemia.

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Tricard MR 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.

Route of administration: Tricard® MR should be taken in oral route during meal.
The recommended dose is 35 mg at mealtimes in the morning and evening. The benefit of the treatment should be assessed after three months and Tricard® MR should be discontinued if there is no treatment response.

Renal impairment
In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), the recommended dose is 35 mg in the morning during

Pregnancy: There are no data from the use of trimetazidine in pregnant women. As a precautionary measure, it is preferable to avoid the use of trimetazidine during pregnancy.

Lactation: There is no information on the secretion of trimetazidine into breast milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breastfeeding.

Use in children and adolescents
The safety and efficacy of trimetazidine in children aged below 18 years have not been established.

Trimetazidine should be used with caution in patients who are predisposed to closed-angle glaucoma. It is not a curative treatment for angina attacks nor is indicated as an initial treatment for unstable angina or myocardial infarction, nor in the pre-hospital phase or during the first days of hospitalization. In the event of an angina attack, the coronaropathy should be re-evaluated and an adaptation of the treatment considered (medicinal treatment and possible revascularization). Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients. In doubtful cases, patients should be referred to a neurologist for appropriate investigations. This medicine contains an active substance which may give a positive reaction in doping tests. Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment.

The most common side effects are dizziness, headache, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria and asthenia.

It is contraindicated in patients with hypersensitivity to trimetazidine hydrochloride or any other components of this product. It is also contraindicated in parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome and other related movement disorders, severe renal impairment (creatinine clearance < 30 ml/min).

Drug interaction with medication: No drug interactions have been identified.

Drug interaction with food and others: Not applicable.

Limited information is available on trimetazidine overdose. Treatment should be symptomatic.

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Storage
Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children. 

Packing

Tricard MR 35 tablet: Each modified release tablet contains Trimetazidine Hydrochloride BP 35 mg.

Tricard MR 35 tablet: Carton of 30 tablets in blister pack.