Omacor 1000 mg Soft Capsules

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Omega-3-acid ethyl esters

Tilgjengelig fra:

LTT Pharma Limited

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:

2016-11-11

Informasjon til brukeren

OMACOR 1000MG SOFT CAPSULES
(omega-3-acid ethyl esters 90)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
*
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. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
*
If any of the side effects get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
What Omacor is and what is it used for
Before you take Omacor
How to take Omacor
Possible side effects
How to store Omacor
Further information
WHAT OMACOR IS AND WHAT IS IT 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:
*
together with other medicines for treatment after a heart attack.
*
to treat certain forms of increased triglycerides (fats) in the blood
after
changes to the diet have not worked.
BEFORE YOU TAKE OMACOR
DO NOT TAKE OMACOR, IF
*
you are allergic (hypersensitive) to the main ingredient or any of the
other
ingredients of Omacor (see Section: Important information about some
of
the ingredients, and section 6: Further Information).
If any of the above applies to you, do not take this medicine, and
talk to your
doctor.
TAKE SPECIAL CARE WITH OMACOR IF:
*
you are due to have or had surgery recently
*
you have had a trauma recently
*
you have a kidney problem
*
you have diabetes which is not controlled
*
you have problems with your liver. Your doctor will monitor any
effects
Omacor may have on your liver with blood tests.
If any of the above applies to you, talk to your doctor or pharmacist
before
taking this medicine.
USING OTHER MEDICINES
If you are using a medicine to stop blood clotting in your arteries,
such as
warfarin, you may need extra blood tests and your usual dose of your
blood
thinning medicine m

Preparatomtale

Health Products Regulatory Authority
21 December 2018
CRN008K9D
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 (460mg) and
docosahexaenoic acid (DHA) ethyl ester (380mg) including also as
antioxidant 4 mg
d-alpha-tocopherol (mixed with a vegetable oil e.g. soya oil).
For a 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
gelatin,
glycerol,
purified water,
medium-chain triglycerides,
lecithin (soya)
Health Products Regulatory Authority
21 December 2018
CRN008K9D
Page 2 of 2
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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC. Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
White high density polyethylene (HDPE) bottle
1x28 capsules
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused product or waste material should be disposed of in
accordance with
local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/189/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11
th
November 2016
10 DATE OF REVISION OF THE TEXT
December 2018