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Use of the product is not recommended in case of severe liver failure in the absence of adequate clinical data.
This medicinal product 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 hospitalisation.
In the event of an angina attack, the coronaropathy should be re-evaluated and an adaptation of the treatment should be 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.
Serious skin reactions (severe cutaneous adverse reaction, SCAR): Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with trimetazidine treatment, which can be life-threatening or fatal.
At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, trimetazidine should be withdrawn immediately and an alternative treatment considered (as appropriate).
Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment (see Adverse Reactions).
Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected: moderate renal impairment (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions), elderly patients older than 75 years old (see Dosage & Administration).
This drug contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Athletes: This medicinal product contains a drug substance that may give a positive result in anti-doping tests.
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 (see Adverse Reactions), which may affect ability to drive and use machines.
