Omacor 1000 mg Soft Capsules

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Omega-3-acid ethyl esters 90

Dostupné s:

PCO Manufacturing Ltd.

ATC kód:

C10AX; C10AX06

INN (Mezinárodní Name):

Omega-3-acid ethyl esters 90

Dávkování:

1000 milligram(s)

Léková forma:

Capsule, soft

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

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

Stav Autorizace:

Authorised

Datum autorizace:

2014-06-20

Informace pro uživatele

_ _
_ _
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,

Charakteristika produktu

Health Products Regulatory Authority
01 April 2020
CRN009NR3
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).
Excipient(s) with known effect:
May contain soya-bean 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 (E422)
Purified water
Medium-chain triglycerides
Lecithin (soya)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
01 April 2020
CRN009NR3
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC. Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
White bottle containing 28 capsules
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/335/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20th June 2014
10 DATE OF REVISION OF THE TEXT
April 2020