- 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 MEDICINES
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>The dose is one capsule of 80mg of trimetazidine once daily during breakfast.</p>
<p>The benefit of the treatment should be assessed after three months and trimetazidine should be discontinued if there is no treatment response.</p>
<p><u>Special populations</u></p>
<p><em>Patients with renal impairment</em><br>
In patients with moderate renal impairment (creatinine clearance [30–60] ml/min) (see sections 4.4 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>), the recommended dose is 1 tablet of Vastarel MR 35 mg in the morning during breakfast.</p>
<p><em>Elderly patients</em><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 Vastarel MR 35 mg in the morning during breakfast. 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><em>Paediatric population:</em><br>
The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.</p>
<p><u>Method of administration</u></p>
<p>Capsule must be taken orally without opening it, once daily <em>i.e.</em> one in the morning during breakfast.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>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.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>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>.</li>
<li>Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.</li>
<li>Severe renal impairment (creatinine clearance < 30ml/min).</li>
</ul>
- Atc Code
- C01EB15
- Atc Item Name
- trimetazidine
- Pharma Manufacturer Name
- SERVIER (S) PTE LTD
