Trimetazidine
Regulatory sources consulted
- AEMPS CIMA SPC: https://cima.aemps.es/cima/dochtml/ft/56704/FT_56704.html
- AEMPS CIMA · nº registro 56704 ↗
- RxNorm rxcui 10826 ↗
Approved indications
- Add-on therapy for the symptomatic treatment of adult patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
- Severe renal impairment (creatinine clearance < 30 ml/min).
Clinical warnings
- Major warning · Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia). Patients, especially the elderly, should be monitored regularly. If they appear, treatment should be discontinued. — AEMPS SPC
- Not a treatment for angina attacks, unstable angina or myocardial infarction. — AEMPS SPC
Adverse events
Common (≥1%)
dizziness · headache · abdominal pain · diarrhoea · dyspepsia · nausea · vomiting · rash · pruritus · urticaria · asthenia
Rare but serious
parkinsonian symptoms · agranulocytosis · thrombocytopenia · hepatitis
Pregnancy and lactation
Pregnancy: As a precautionary measure, it is preferable to avoid the use of trimetazidine during pregnancy. Lactation: Should not be used during breast-feeding.