OMACOR 1000 MG SOFT CAPSULES

Active substance: OMEGA-3-ACID ETHYL ESTERS 90%

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OMACOR® 1000 mg soft
capsules
(Omega-3-acid ethyl
esters 90)
PATIENT INFORMATION LEAFLET
This medicine is called OMACOR 1000 mg soft
capsules but will be referred to as Omacor
throughout this leaflet.
Read all of this leaflet carefully before you start
taking this medicine.

Keep this leaflet. You may want 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Omacor is and what it is used for
2.
Before you take Omacor
3.
How to take Omacor
4.
Possible side effects
5.
How to store Omacor
6.
Further 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:

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.

2. 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 have 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 may have to be changed.
Please tell your doctor or pharmacist if you are using
or have recently used other medicines including
medicines obtained without prescription.
Taking Omacor with food or drink
You should take the capsules at meal times. This is
to help lower the chances of side effects that affect
the area in and around the stomach (the gastrointestinal area).
Use in elderly
Use Omacor with care if you are over 70 years.
Use in children
Children should not take this medicine.
Pregnancy and breast-feeding
You should not take this medicine if you are
pregnant or breast-feeding, unless your doctor
decides it is absolutely necessary.
Ask your doctor or pharmacist for advice before
using any medicine.
Driving and using machines
This medicine is not likely to affect you being able to
drive or use any tools or machines.
Important Information about some of the
ingredients
Omacor may contain soya-bean oil. If you are
allergic to peanut or soya, do not use this medicinal
product.

3. How to take Omacor
Always take Omacor exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.

Swallow the capsules with a drink of water.

You may take the capsules at meal times to
help reduce gastro-intestinal side effects.

Your doctor will decide how long you should
take this medicine.
Dose after a heart attack
The usual dose is one capsule a day.

Dose to treat high blood triglyceride levels (high
levels of fat in the blood or
hypertriglyceridaemia)
The usual dose is 2 capsules a day, as
recommended by a doctor.
If the medicine is not working well enough at this
dose, your doctor may increase this to 4 capsules a
day.
If you take more of Omacor than you should
If you accidentally take more of this medicine than
you should, do not worry, as this is unlikely to need
special treatment. However, you should contact your
doctor or pharmacist for further advice.
If you forget to take Omacor
If you miss a dose, take it when you remember
unless it is almost time for your next dose, in which
case take the next dose as usual. Do not take a
double dose (twice the dose recommended by your
doctor) to make up for a forgotten dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects

5. How to store Omacor








Keep out of the sight and reach of children.
Do not use Omacor after the expiry date which
is printed on the carton and the label. The
expiry date refers to the last day of the month.
Do not store above 25°C.
Do not freeze.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
If your capsules show any signs of
discolouration or deterioration return them to
your pharmacist

6. Further Information
What Omacor contains
Each 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 as
antioxidant 4 mg d-alpha- tocopherol (mixed with a
vegetable oil e.g. soya-bean oil).

Like all medicines, Omacor can cause side effects,
although not everybody gets them. The following are
side effects that may happen with this medicine:

The soft capsule shell is made up of gelatin, glycerol
(E422), purified water, medium chain triglycerides
and lecithin soya.

Common side effects (occur in 1 to 10 users in
100):

stomach problems like abdominal distension,
pain, constipation, diarrhoea, indigestion
(dyspepsia), gas, belching (eructation), acid
reflux, feeling sick (nausea) and being sick
(vomiting)

What Omacor looks like and contents of the pack
Omacor capsules are soft, oblong, transparent
gelatin capsules containing pale yellow oil.

Uncommon side effects (occur in 1 to 10 users in
1,000):

high blood sugar levels

gout

dizziness

problems with taste

headache

low blood pressure

nose bleed

blood in your stools

rash
Rare side effects (occur in 1 to 10 users in
10,000):

allergic reactions

raised red skin rash (hives or urticaria)

liver disorders, with possible changes in the
results of certain blood tests

Omacor is available in the following pack sizes:
– 1 x 28 capsules
Manufacturer
The manufacturer of Omacor is:
Pronova BioPharma Norge AS
N-1327 Lysaker,
Norway.
Procured from within the EU and repackaged by
Mediwin Limited, PL Holder: Mediport Limited,
13 Martello Enterprise Centre, Courtwick Lane,
Littlehampton, West Sussex, BN17 7PA. UK.

P

PL: 18980/0855

OMACOR® is a registered Trademark of Pronova
BioPharma Norge AS

Date of Leaflet Preparation: 9/12/2013

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.

REF: ####
PIL-8340189800855

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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