- Approval Id
- 1f2c52d4b4ee88c4
- Drug Name
- OMACOR SOFT CAPSULE 1000MG
- Product Name
- OMACOR SOFT CAPSULE 1000MG
- Approval Number
- SIN14504P
- Approval Date
- 2014-02-11
- Registrant
- EURODRUG LABORATORIES SINGAPORE PTE. LTD.
- Licence Holder
- EURODRUG LABORATORIES SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
<u>Hypertriglyceridaemia</u><br>
The daily dose is 4 grams per day taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).</p>
<p>The capsules should be taken with food to avoid gastrointestinal disturbances.<br>
There is limited clinical data regarding the use of Omacor in elderly patients over 70 years of age and patients with renal impairment (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). There is no information regarding the use of Omacor in children and adolescents or in patients with hepatic impairment (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
<u>Hypertriglyceridaemia</u><br>
Endogenous hypertriglyceridaemia: as a supplement to diet when dietary measures alone are insufficient to produce an adequate response.</p>
<ul class="dash">
<li>type IV in monotherapy,</li>
<li>type IIb in combination with statins, when control of triglycerides is insufficient.</li>
</ul>
<p>Omacor is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes).</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
Hypersensitivity to the active substance, to soya 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>.</p>
<p>Omacor contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.</p>
- Atc Code
- C10AX06
- Atc Item Name
- omega-3-triglycerides incl. other esters and acids
- Pharma Manufacturer Name
- DCH AURIGA SINGAPORE
