Vastarel MR Special Precautions

Vastarel MR is generally not recommended during breastfeeding (see Use in lactation as follows).
Vastarel MR 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 prehospital 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 eg, 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 >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 (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 >75 years (see Dosage & Administration).
Effects on the Ability to Drive or Operate Machinery: Trimetazidine does not have haemodynamic effects in clinical studies; however, cases of dizziness or drowsiness have been observed in post-marketing experience (see Adverse Reactions), which may affect ability to drive and use machines.
Use in Pregnancy: Studies in animals have not demonstrated a teratogenic effect; however, in the absence of clinical data, the risk of malformation cannot be excluded. Therefore, for safety reasons, it is preferable to avoid prescription during pregnancy.
Use in Lactation: In the absence of excretion in breastmilk, breastfeeding is not recommended during treatment.