Vastarel capsule

What is this product?

Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
 

Dosage / Direction for Use

Dosage: Oral route.

The dose is one tablet of trimetazidine 35 mg twice daily, i.e. once in the morning and once in the evening, during meals.
 

The benefit of the treatment should be assessed after three months and trimetazidine should be discontinued if there is no treatment response.

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

Elderly patients: Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function. In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast.

Dose titration in elderly patients should be exercised with caution.

Paediatric population: The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.

Overdosage

Limited information is available on trimetazidine overdose. Treatment should be symptomatic.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Description.

Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders,

Severe renal impairment (creatinine clearance < 30ml/min).

Special Precautions

This medicinal product is generally not recommended during breastfeeding.

This medicinal product is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina, nor myocardial infarction, nor in the pre-hospital phase nor during the first days of hospitalisation.

In the event of an angina attack, the coronaropathy should be reevaluated and an adaptation of the treatment considered (medicinal 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, 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.

Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected: moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions and Dosage & Administration), elderly patients older than 75 years old (see Dosage & Administration).

Effects on ability to drive and use machines: Trimetazidine does not have 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.

Use In Pregnancy & Lactation

Pregnancy: There are no data from the use of trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine during pregnancy.

Breast-feeding: It is unknown whether trimetazidine/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breast-feeding.

Fertility: Reproductive toxicity studies have shown no effect on fertility in female and male rats.