TRIMETAZIDINE Prolonged-release tablets Ref.[8260] Active ingredients: Trimetazidine

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 (see section 4.8).

Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected:

• moderate renal impairment (see sections 4.2 and 5.2),
• elderly patients older than 75 years old (see section 4.2).

Occurrence of interactions with other medicinal products or foodstuffs has not been found.

Trimetazidine can be used with heparin, calciparine, oral anticoagulants, medicinal products used in disturbances of lipid metabolism, salicylic acid, β-adrenolytic medicinal products, calcium channel blocking medicinal products, digitalis glycosides.

Pregnancy

There are no adequate data from the use of Trimetazidine in pregnant women. Animal studies are insufficient (see section 5.3). The potential risk for humans is unknown. Trimetazidine should not be taken during pregnancy unless clearly necessary.

Lactation

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 does not have haemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience (see section 4.8), 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

Not applicable.