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OMACOR 1000MG SOFT CAPSULES

Active substance(s): OMEGA-3-ACID ETHYL ESTERS / OMEGA-3-ACID ETHYL ESTERS 90 / OMEGA-3-ACID ETHYL ESTERS 90%

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Omacor® 1000mg Soft Capsules
(omega-3-acid ethyl esters 90% )
Your medicine is known by the above name but will be referred to as Omacor
throughout the following patient information leaflet.
Patient Information 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.

 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 the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

6) Further information

4) Possible side effects

What Omacor contain
Each capsule contains 1000 mg of omega-3-acid ethyl esters 90% comprising
460 mg eicosapentaenoic acid (EPA) and 380 mg docosahexaenoic acid
(DHA) ethyl esters (these substances are called omega-3 polyunsaturated
fatty acids) 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, medium-chain
triglycerides, lecithin soya and purified water.

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 the contents of the pack
Omacor capsules are transparent soft gelatin capsules containing pale yellow
oil.

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

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
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.

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.

Omacor capsules are available in a plastic bottle containing 28 and 100
capsules.
PL 10383/2012

Omacor 1000mg Soft Capsules

P

Product Licence Holder and Manufacturer
Your medicines are manufactured by Pronova BioPharma Norge AS, P.O.Box
420 N-1327 Lysaker, Norway. Procured from within the EU and repackaged
by the Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue road, Northolt, Middlesex UB5 5QS
Leaflet date: 13.04.2016
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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