- Approval Id
- 431a69cf1526d1c4
- Drug Name
- VASTAREL TABLET 20 mg
- Product Name
- VASTAREL TABLET 20 mg
- Approval Number
- SIN01673P
- Approval Date
- 1988-06-08
- Registrant
- SERVIER (S) PTE LTD
- Licence Holder
- SERVIER (S) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration**
Posology
Oral use.
Method of administration
The dose is one tablet of 20 mg of trimetazidine three times a day 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 20 mg twice daily, i.e., one in the morning and one in the evening during meals.
_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 20 mg twice daily, i.e., one in the morning and one in the evening during meals.
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.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 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 first-line antianginal therapies.
- Contraindications
- **4.3 Contraindications**
- Hypersensitivity to the active substance or to any of the excipients;
- Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders;
- Severe renal impairment (creatinine clearance < 30ml/min).
- Atc Code
- C01EB15
- Atc Item Name
- trimetazidine
- Pharma Manufacturer Name
- SERVIER (S) PTE LTD
- Company Detail Path
- /organization/servier-s-pte-ltd
