Omacor 1000 mg Soft Capsules

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Omega-3-acid ethyl esters

Tilgjengelig fra:

IMED Healthcare Ltd.

ATC-kode:

C10AX; C10AX06

INN (International Name):

Omega-3-acid ethyl esters

Dosering :

1000 milligram(s)

Legemiddelform:

Capsule, soft

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Other lipid modifying agents; omega-3-triglycerides incl. other esters and acids

Autorisasjon status:

Authorised

Autorisasjon dato:

2011-02-18

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMACOR
® 1000 MG SOFT CAPSULES
Omega-3-acid ethyl esters 90
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

If you get any side effects, talk to your doctor. This includes
any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT OMACOR IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMACOR
3. HOW TO TAKE OMACOR
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE OMACOR
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT OMACOR IS AND WHAT IT IS USED FOR
Omacor contains highly purified omega-3 polyunsaturated fatty
acids.
Omacor belongs to a group of so called reducers of cholesterol and
triglycerides.
Omacor is used:
• to treat certain forms of increased triglycerides (fats) in the
blood
after changes to the diet have not worked.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
OMACOR
DO NOT TAKE OMACOR:

if you are allergic (hypersensitive) to the active substances or
any of the other ingredients of Omacor (listed in section 6:
Contents of the pack and other information).
If any of the above applies to you, do not take this medicine, and
talk to your doctor.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING OMACOR.
• if you are due to have or have had surgery recently
• if you have had a trauma recently
• if you have a kidney problem
• if you have diabetes which is not controlled
• if you have problems with your liver. Your doctor will monitor
any effects Omacor may have on your liver with blood tests.
• if you are allergic to fish.
OTHER MEDICINES AND OMACOR
If you are using a medicine to stop blood clotting in your arteries,
such a

Preparatomtale

Health Products Regulatory Authority
08 April 2022
CRN00CTSP
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omacor 1000 mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_ONE CAPSULE CONTAINS_
Omega-3-acid ethyl esters
90.................................................1000 mg
comprising 840 mg eicosapentaenoic acid (EPA) ethyl ester (460 mg) and
docosahexaenoic acid (DHA) ethyl ester (380 mg),
including also as antioxidant 4 mg d-alpha-tocopherol (mixed with a
vegetable oil e.g. soya oil).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
_Product imported from Spain:_
Soft, oblong, transparent gelatin capsules containing pale yellow oil.
4 CLINICAL PARTICULARS
As per PA1099/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1099/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Capsule core: Alpha-tocopherol
Capsule shell: Gelatin, Glycerol, purified water, Medium-chain
triglycerides Lecithin (soya)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC. Do not freeze.
Health Products Regulatory Authority
08 April 2022
CRN00CTSP
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
White plastic container in a cardboard carton.
Pack size: 28 Capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/042/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
February 2011
10 DATE OF REVISION OF THE TEXT
April 2022