Regulatory Information
DCH AURIGA SINGAPORE
DCH AURIGA SINGAPORE
Therapeutic
Prescription Only
Formulation Information
CAPSULE
**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_).
ORAL
Medical Information
**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).
**4.3 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.
C10AX06
omega-3-triglycerides incl. other esters and acids
Manufacturer Information
DCH AURIGA SINGAPORE
Patheon Softgels B.V.
Trommsdorff GmbH & Co. KG (Primary Packager)
Active Ingredients
Omega-3-acid ethyl esters 90 (containing: Eicosapent (EPA) 460mg and doconexent (DHA) 380mg ethyl esters and α-tocopherol 4 mg)
1000mg
Documents
Package Inserts
Omacor Soft Capsule PI.pdf
Approved: April 14, 2020