Trimetazidine

In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35 mg in the morning during breakfast.

There are no adequate data from the use of Trimetazidine in pregnant women. Animal studies are insufficient. The potential risk for humans is unknown. Trimetazidine should not be taken during pregnancy unless clearly necessary.

It is unknown whether trimetazidine is excreted in human or animal breast milk. Since excretion in breast milk and a risk to the suckling child cannot be excluded, trimetazidine should not be used during breastfeeding.

Trimetazidine has not shown 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.

Classification of expected frequencies: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Nervous system disorders

Common: Dizziness, headache

Not known: Parkinsonian symptoms (tremor, akinesia, hypertonia), gait instability, restlessleg syndrome, other related movement disorders, usually reversible after treatment discontinuation, Sleep disorders (insomnia, drowsiness)

Cardiac disorders

Rare: Palpitations, extrasystoles, tachycardia

Vascular disorders

Rare: Arterial Hypotension, Orthostatic hypotension that may be associated with malaise, dizziness or fall, in particular in patients taking antihypertensive treatment, flushing

Gastrointestinal disorders

Common: Abdominal pain, diarrhoea, dyspepsia, nausea and vomiting

Not known: Constipation

Skin and subcutaneous tissue disorders

Common: Rash, pruritus, urticaria.

Not known: Acute generalized exanthematus pustulosis (AGEP), angioedema

General disorders and administration conditions

Common: Asthenia

Blood and lymphatic system disorders

Not known: Agranulocytosis, Thrombocytopenia, Thrombocytopenic purpura

Hepatobiliary disorders

Not known: Hepatitis