- 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 MEDICINES
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Dosage
- <p><strong>Posology and method of administration</strong><br>
<strong><u>Posology</u></strong><br>
Oral use.<br>
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.<br>
The benefit of the treatment should be assessed after three months and trimetazidine should be discontinued if there is no treatment response.</p>
<p><strong>Special populations</strong></p>
<p><em>Patients with renal impairment</em><br>
<em>In patients with moderate renal impairment (creatinine clearance [30–60] ml/min) (see Sections 4.4 and 5.2</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>), the recommended dose is 1 tablet of 35 mg in the morning during breakfast.</em></p>
<p><u>Elderly patients:</u><br>
Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). 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.</p>
<p>Dose titration in elderly patients should be exercised with caution (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Paediatric population:</u><br>
The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Therapeutic indications:</strong> 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.</p>
- Contraindications
- <p><strong>Contraindications:</strong><br>
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.<br>
Severe renal impairment (creatinine clearance < 30ml/min).</p>
- Atc Code
- C01EB15
- Atc Item Name
- trimetazidine
- Pharma Manufacturer Name
- PHARMAZEN MEDICALS PTE LTD
