Sign Out
This drug is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina, nor myocardial infarction. It should not be used in the pre-hospital phase nor during the first days of hospitalisation.
In the event of an angina attack, the coronary heart disease should be re-evaluated and an adaptation of the treatment considered (drug 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, postural 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 recover within 4 months after trimetazidine withdrawal. If parkinsonian symptoms persist more than 4 months after treatment discontinuation, a neurologist opinion should be sought.
Severe cutaneous adverse reactions (SCARs): Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with trimetazidine treatment. 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 If signs and symptoms suggestive of these reactions appear, trimetazidine should be withdrawn immediately and an alternative treatment considered (as appropriate).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 postural 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), patients older than 75 years (see Dosage & Administration).
This medicinal product is generally not recommended during breastfeeding (see Use in Pregnancy & Lactation).
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 did not show any 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.
