VASTAREL Ref.[4409] Active ingredients: Trimetazidine

This drug is not a curative treatment for angina attacks, nor is indicated as an initial treatment for unstable angina, or myocardial infarction. It should not be used in the prehospital phase nor during the first days of hospitalisation.

In the event of an angina attack, angina pectoris disease should be reevaluated and an adaptation of the treatment considered.

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).

No drug interactions have been identified.

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, prescription should be avoided during pregnancy.

Lactation

In the absence of data on excretion in breast milk, breastfeeding is not recommended during treatment.

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.

Trimetazidine may cause the following undesirable effects ranked under the following frequency: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000),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

Not known: 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

Because of the presence of sunset yellow FCF S (E 110) and cochineal red A (E 124) in Vastarel 20mg, film-coated tablet, risk of allergic reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.