OMACOR 1000 Milligram Capsules, Soft
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
12-06-2024
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Virkt innihaldsefni:
OMEGA-3-ACID ETHYL ESTERS
Fáanlegur frá:
B & S Healthcare
INN (Alþjóðlegt nafn):
OMEGA-3-ACID ETHYL ESTERS
Skammtar:
1000 Milligram
Lyfjaform:
Capsules, Soft
Gerð lyfseðils:
Product subject to prescription which may be renewed (B)
Leyfisstaða:
Withdrawn
Leyfisdagur:
2013-01-08
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omacor 1000 mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Omega-3-acid ethyl esters 90-1000 mg
comprising 840 mg eicosapentaenoic acid (EPA) ethyl ester (460mg) and docosahexaenoic acid (DHA) ethyl ester
(380mg).
Excipient(s): may contain soya bean oil
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
_Product imported from the UK_
Soft, oblong, transparent gelatin capsules containing pale yellow oil.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Post Myocardial Infarction
Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g.
statins, antiplatelet medicinal products, betablockers, ACE inhibitors).
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
Post Myocardial Infarction
One capsule daily.
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/12/2010_
_CRN 2089705_
_page number: 1_
There is no information regarding the use of Omacor in children, in elderly patients over 70 years of age, or in patients
with hepatic impairment _(see section 4.4), _and only limited information regarding the use in patients with renal
impairment.
4.3 CONTRAIN
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