- Approval Id
- c84a642a67034243
- Drug Name
- TRIMEZEN MODIFIED-RELEASE TABLETS 35MG
- Product Name
- TRIMEZEN MODIFIED-RELEASE TABLETS 35MG
- Approval Number
- SIN16614P
- Approval Date
- 2022-09-28
- Registrant
- PHARMAZEN MEDICALS PTE LTD
- Licence Holder
- PHARMAZEN MEDICALS PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Dosage
- **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.
- Route Of Administration
- ORAL
- Indication Info
- **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.
- Contraindications
- **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).
- Atc Code
- C01EB15
- Atc Item Name
- trimetazidine
- Pharma Manufacturer Name
- PHARMAZEN MEDICALS PTE LTD
- Company Detail Path
- /organization/4dd0b1ec78308c41/pharmazen-medicals-pte-ltd
