- Approval Id
- a0df689c2fd70fff
- Drug Name
- NATRILIX SR TABLET 1.5 MG
- Product Name
- NATRILIX SR TABLET 1.5 MG
- Approval Number
- SIN09074P
- Approval Date
- 1996-12-14
- Registrant
- SERVIER (S) PTE LTD
- Licence Holder
- SERVIER (S) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed. At higher doses the antihypertensive action of indapamide is not enhanced but the saluretic effect is increased.</p>
<p>Special populations</p>
<p><u><em>Renal impairment (see sections 4.3 and 4.4</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>):</em></u></p>
<p>In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated.<br>
Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired.</p>
<p><u><em>Hepatic impairment (see sections 4.3 and 4.4</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>):</em></u></p>
<p>In severe hepatic impairment, treatment is contraindicated.</p>
<p><u><em>Elderly (see section 4.4</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>):</em></u></p>
<p>In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Natrilix SR 1.5 mg when renal function is normal or only minimally impaired.</p>
<p><em><u>Paediatric population:</u></em></p>
<p>The safety and efficacy of Natrilix SR 1.5 mg in children and adolescents have not been established. No data are available.</p>
<p><u>Method of administration</u></p>
<p>Oral use</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Natrilix SR is indicated for essential hypertension in adults.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Hypersensitivity to the active substance, to other sulfonamides 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>Severe renal failure.</li>
<li>Hepatic encephalopathy or severe liver failure.</li>
<li>Hypokalaemia.</li>
</ul>
- Atc Code
- C03BA11
- Atc Item Name
- indapamide
- Pharma Manufacturer Name
- SERVIER (S) PTE LTD
