Each modified release film-coated tablet contains: Trimetazidine dihydrochloride 35 mg (Trimetazidine hydrochloride).
Excipients/Inactive Ingredients: Dicalcium phosphate dihydrate, hypromellose, povidone K30, colloidal anhydrous silica, magnesium stearate, macrogol 6000, talc, titanium dioxide, red ferric oxide.
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.
For the symptomatic treatment of tinnitus, vertigo and visual field disturbances, the EU health authority concluded that the benefits no longer outweigh the risks and that these uses should no longer be authorized.
Administration: Oral administration.
Dosage: The dose is one tablet of 35 mg of trimetazidine twice daily during meals.
Special populations: Renal impairment: 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.
Elderly: 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.
Paediatric population: The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.
Limited information is available on trimetazidine overdose. Treatment should be symptomatic.
Hypersensitivity to the active substance or to any of the excipients of the product.
Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Severe renal impairment (creatinine clearance < 30 ml/min).
This product should be use with caution in patients who are predisposed to closed-angle glaucoma.
This medicine is not a curative treatment for angina attacks, nor is indicated as an initial treatment for unstable angina, or myocardial infarction, nor in the prehospital phase or during the first days of hospitalisation.
In the event of an angina attack, the coronaropathy should be reevaluated and an adaptation of the treatment considered (medicinal treatment and possibly revascularisation).
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 incidence 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's 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 increased exposure is expected: Moderate renal impairment; Elderly patients older than 75 years old.
Effects on ability to drive and use machines: Trimetazidine does not have haemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience, which may affect ability to drive and use machines.
Pregnancy: There are no data from the use of trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of trimetazidine during pregnancy.
Lactation: It is unknown whether trimetazidine/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during lactation.
Trimetazidine may cause the following undesirable effects ranked under the following frequency: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000).
Nervous system disorders:
Common: Dizziness, headache.
Rare: Palpitations, extrasystoles, tachycardia.
Rare: Arterial hypotension, orthostatic hypotension that may be associated with malaise, dizziness or fall, in particular in patients taking antihypertensive treatment, flushing.
Common: Abdominal pain, diarrhoea, dyspepsia, nausea and vomiting.
Skin and subcutaneous tissue disorders:
Common: Rash, pruritus, urticaria.
General disorders and administration conditions:
No drug interactions have been identified.
Store in a well-closed container, in a dry place.
Do not store above 30°C.
C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.
MR-FC tab 35 mg (light pink, round-shaped, biconvex and plain on both sides) x 3 x 10's.