TRIMEZEN MODIFIED-RELEASE TABLETS 35MG [SIN16614P]

Product Info

TRIMEZEN MODIFIED-RELEASE TABLETS 35MG

[SIN16614P]

Therapeutic indications: 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 firstline antianginal therapies.

Posology and method of administration
Posology
Oral use.
The dose is one tablet of 35 mg of trimetazidine 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) (see Sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), the recommended dose is 1 tablet of 35 mg in the morning during breakfast.

Elderly patients:
Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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. Dose titration in elderly patients should be exercised with caution (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

Contraindications:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Severe renal impairment (creatinine clearance < 30 ml/min).