Each modified release tablet contains Trimetazidine Hydrochloride 35 mg.
Trimetazidine HCl (Whilst) has been proven to exert anti-anginal properties due to its specific metabolic mechanism of action. Indeed, Trimetazidine Hydrochloride reduces the metabolic damage caused during ischemia, by acting on a critical step in cardiac metabolism: fatty acid B-oxidation. This is made possible by selective inhibition of an enzyme of fatty acid B-oxidation: the long-chain 3-ketoacyl CoA thiolase (3-KAT). This inhibition results in reduction in fatty acid oxidation & stimulation of glucose oxidation. Thus, the coupling of glycolysis with glucose oxidation is improved, and ATP production is further increased, while the deleterious consequences of acidosis and of Ca²⁺ overload are limited.
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 anti-anginal therapies.
1 tablet at meal times in the morning and evening.
Patients with renal impairment:
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.
Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function. In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35 mg in the morning during breakfast.
Dose titration in elderly patients should be exercised with caution.
The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.
Trimetazidine is contraindicated in-patients with a known hypersensitivity to its components.
Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders, severe renal impairment (creatinine clearance <30 ml/min).
This medicine is not a curative treatment for angina attacks, nor is it 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 reevaluated and an adaptation of the treatment considered (medicinal treatment and possibly 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.
The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
These cases have a low prevalence and are usually reversible after treatment discontinuation. The majority of the patients recovered within 4 months after trimetazidine withdrawal. If parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist opinion should be sought.
Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment.
Caution should be exercised when prescribing trimetazidine to patients in whom an increase exposure is expected: Moderate renal impairment, Elderly patients older than 75 years old.
Use in Pregnancy: Studies in animals have not demonstrated a teratogenic effect. However, in the absence of clinical data and for safety reasons, prescription should be avoided during pregnancy.
Use in Lactation: This medicinal product is generally not recommended during lactation.
In the absence of data, breastfeeding is not recommended during treatment.
Pregnancy: Studies in animals have not demonstrated a teratogenic effect. However, in the absence of clinical data and for safety reasons, prescription should be avoided during pregnancy.
Breastfeeding: In the absence of data, breastfeeding is not recommended during treatment.
Common adverse effects include dizziness, headache, gastrointestinal disorders such as abdominal pain, diarrhea, dyspepsia, nausea and vomiting, rashes, pruritus, urticaria, and asthenia.
No Drug interactions so far have been reported. In particular, no interactions have been reported. In particular, no interactions have been reported with beta-blocker, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.
Store at temperatures not exceeding 30°C. Protect from light.
C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.