- Approval Id
- 9b471b8f3fe1fbb8
- Drug Name
- VASTAREL XR EXTENDED-RELEASE HARD CAPSULE 80 mg
- Product Name
- VASTAREL XR EXTENDED-RELEASE HARD CAPSULE 80 mg
- Approval Number
- SIN15877P
- Approval Date
- 2020-01-20
- Registrant
- SERVIER (S) PTE LTD
- Licence Holder
- SERVIER (S) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Dosage
- **4.2 Posology and method of administration**
Posology
The dose is one capsule of 80mg of trimetazidine once daily during breakfast.
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 Vastarel MR 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 Vastarel MR 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.
Method of administration
Capsule must be taken orally without opening it, once daily _i.e._ one in the morning during breakfast.
- 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 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 < 30ml/min).
- Atc Code
- C01EB15
- Atc Item Name
- trimetazidine
- Pharma Manufacturer Name
- SERVIER (S) PTE LTD
- Company Detail Path
- /organization/2aeee3bc25395c01/servier-s-pte-ltd
