- Approval Id
- e965b6f988742968
- Drug Name
- NATRIXAM MODIFIED RELEASE TABLET 1.5 mg/10 mg
- Product Name
- NATRIXAM MODIFIED RELEASE TABLET 1.5 mg/10 mg
- Approval Number
- SIN14902P
- Approval Date
- 2015-12-03
- Registrant
- SERVIER (S) PTE LTD
- Licence Holder
- SERVIER (S) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>One tablet per day as single dose, preferably to be taken in the morning, to be swallowed whole with water and not chewed.</p>
<p>The fixed dose combination is not suitable for initiation therapy.</p>
<p>If a change of the posology is required, titration should be done with the individual components.</p>
<p><u>Special populations</u></p>
<p><em>Paediatric population</em><br>
The safety and efficacy of Natrixam in children and adolescents have not been established.<br>
No data are available.</p>
<p><em>Patients with 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><br>
In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated.<br>
In patients with mild to moderate renal impairment, no dose adjustment is needed.</p>
<p><em>Older people (see section 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>):</em><br>
Older people can be treated with Natrixam according to renal function.</p>
<p><em>Patients with 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><br>
In severe hepatic impairment, treatment is contraindicated.<br>
Dosage recommendations of amlodipine have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (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>).</p>
<p><strong>Method of administration</strong></p>
<p>Oral administration.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Natrixam is indicated as substitution therapy for treatment of essential hypertension in patients already controlled with indapamide and amlodipine given concurrently at the same dose level.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>hypersensitivity to the active substances, to other sulfonamides, to dihydropyridine derivatives 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 (creatinine clearance below 30 ml/min)</li>
<li>hepatic encephalopathy or severe impairment of liver function</li>
<li>hypokalaemia</li>
<li>severe hypotension</li>
<li>shock (including cardiogenic shock)</li>
<li>obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis) – haemodynamically unstable heart failure after acute myocardial infarction</li>
</ul>
- Atc Code
- C08GA02
- Atc Item Name
- amlodipine and diuretics
- Pharma Manufacturer Name
- SERVIER (S) PTE LTD
