Vastarel 20 Special Precautions

This drug is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina or myocardial infarction. It should not be used in the pre-hospital phase or 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 or 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 patients recover 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 (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 medicinal product is generally not recommended during breast-feeding (see Use in Pregnancy & Lactation).
This medicinal product contains sunset yellow FCF (E110) and cochineal red A (E124) and may cause allergic reactions.
Athletes: This medicinal product contains a drug substance that may give a positive result in antidoping 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 the ability to drive and use machines.