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Special Precautions

This medicinal product is generally not recommended during breastfeeding.

This medicinal product is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina, nor myocardial infarction, nor in the pre-hospital phase nor 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 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 (see Pharmacology: Pharmacokinetics under Actions and Dosage & Administration), elderly patients older than 75 years old (see Dosage & Administration).

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.

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