OMACOR Capsule, soft Ref.[50866] Active ingredients: Docosahexaenoic acid Eicosapentaenoic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: BASF AS, P.O Box 420, 1327 Lysaker, Norway

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/III in combination with statins, when control of triglycerides is insufficient.

4.2. Posology and method of administration

Hypertriglyceridaemia

Initial treatment two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily.

The capsules may 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). There is no information regarding the use of Omacor in children and adolescents or in patients with hepatic impairment (see section 4.4).

4.9. Overdose

There are no special recommendations.

Treatment should be symptomatic.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25ยบC. Do not freeze.

6.5. Nature and contents of container

White high density polyethylene (HDPE) bottle:

  • 1x20 capsules
  • 1x28 capsules
  • 1x30 capsules
  • 1x60 capsules
  • 1x100 capsules
  • 10x28 capsules

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

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