OMACOR SOFT CAPSULE 1000MG [SIN14504P]

Product Info

OMACOR SOFT CAPSULE 1000MG

[SIN14504P]

4.1 Therapeutic indications
Hypertriglyceridaemia
Endogenous hypertriglyceridaemia: as a supplement to diet when dietary measures alone are insufficient to produce an adequate response.

• type IV in monotherapy,

• type IIb in combination with statins, when control of triglycerides is insufficient.

Omacor is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes).

4.2 Posology and method of administration
Hypertriglyceridaemia
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).

The capsules should be taken with food to avoid gastrointestinal disturbances.
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There is no information regarding the use of Omacor in children and adolescents or in patients with hepatic impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
Hypersensitivity to the active substance, to soya or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Omacor contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.