OMACOR 1000MG SOFT CAPSULES

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

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Assessed against UK PIL dated April 2010
PACKAGE LEAFLET: INFORMATION FOR THE USER

OMACOR® 1000mg soft capsules
(Omega-3-acid ethyl esters 90)
Your medicine is available using the name Omacor 1000mg 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.
2.
3.
4.
5.
6.

What Omacor is and what it is used for
Before you take Omacor
How to take Omacor
Possible side effects
How to store Omacor
Further information

Take special care with Omacor if:
you
you
you
you
you
any

are due to have or have had surgery recently
have had a trauma recently
have a kidney problem
have diabetes which is not controlled
have problems with your liver. Your doctor will monitor
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 gastro-intestinal area).

Use in elderly

Use Omacor with care if you are over 70 years.

Use in children

Children should not take this medicine.

Omacor contains highly purified omega-3 polyunsaturated fatty
acids.

Pregnancy and breast-feeding

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.

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.

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.

By addisonf at 2:27 pm, Sep 06, 2013

1. What Omacor is and what it is used for

Omacor belongs to a group of so called reducers of cholesterol
and triglycerides.

Dose after a heart attack

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.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

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

Common side effects (occur in 1 to 10 users in
100):
stomach problems and indigestion (dyspepsia)
feeling sick (nausea)

Uncommon side effects (occur in 1 to 10 users in
1,000):
abdominal and stomach pain
allergic reactions
dizziness
problems with taste
diarrhoea
being sick (vomiting)

Rare side effects (occur in 1 to 10 users in 10,000):
headache
acne
itchy rash (pruritus)
high blood sugar levels
liver problems

Very rare side effects (occur in less than 1 in 10,000
users):
blood in your stools
low blood pressure
dry nose
raised red skin rash (hives or urticaria)
changes in the results of certain blood tests

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.
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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.
If your doctor decides to stop your treatment, take any
leftover capsules back to the pharmacy.
If your capsules appear to be discoloured or show any other
signs of deterioration, take them to your pharmacist who will
advise you.
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.

6. Further information
What Omacor contains

Each capsule contains 1000mg of Omega-3-acid ethyl esters 90,
comprising 840mg eicosapentaenoic acid (EPA) ethyl ester
(460mg) and docosahexaenoic acid (DHA) ethyl ester (380mg)
including an antioxidant 4mg d-alpha-tocopherol (mixed with
a vegetable oil e.g. soya-bean oil).
The soft capsule shell is made of gelatin, glycerol (E422),
purified water, medium chain triglycerides and soya lecithin.

What Omacor looks like and contents of the pack

Omacor are soft, oblong, transparent gelatin capsules containing
pale yellow oil.
Omacor is available in the packs of 28 and 100 soft capsules.

Manufacturer

Manufactured by: Pronova BioPharma Norge AS, P.O. Box 420,
N-1327 Lysaker, Norway.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0556

P

Leaflet revision and issue date: 05.09.13
OMACOR® is a registered trademark of Pronova BioPharma
Norge AS.

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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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