OMACOR SOFT CAPSULES

Active substance: EICOSAPENTAENOIC ACID ETHYL ESTER

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PACKAGE LEAFLET: INFORMATION FOR THE USER

OMACOR ® SOFT CAPSULES
(Omega-3-acid ethyl esters 90 1000 mg, comprising 840 mg
eicosapentaenoic acid (EPA) ethyl ester 46% and
docosahexaenoic acid (DHA) ethyl ester 38%)
This leaflet tells you about your medicine, Omacor Soft Capsules.
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 Soft Capsules is and what it is used for
2. Before you take Omacor Soft Capsules
3. How to take Omacor Soft Capsules
4. Possible side effects
5. How to store Omacor Soft Capsules
6. Further information

Taking Omacor Soft Capsules 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 Soft Capsules 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 breastfeeding, 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 Soft Capsules may contain soya-bean oil. If you are
allergic to peanut or soya, do not use this medicinal product.
3. HOW TO TAKE OMACOR SOFT CAPSULES

1. WHAT OMACOR SOFT CAPSULES IS AND WHAT IT IS
USED FOR

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

Omacor Soft Capsules contains highly purified omega-3
polyunsaturated fatty acids.




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



Omacor Soft Capsules 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.

Dose after a heart attack
The usual dose is one capsule a day.

2. BEFORE YOU TAKE OMACOR SOFT CAPSULES
Do not take Omacor Soft Capsules, if
• you are allergic (hypersensitive) to the main ingredient
or any of the other ingredients of Omacor Soft Capsules (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 Soft Capsules 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 Soft Capsules 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.

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 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 Soft Capsules 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 Soft Capsules
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

Like all medicines, Omacor Soft Capsules 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 like abdominal distension, pain,
constipation, diarrhoea, indigestion (dyspepsia), gas, belching
(eructation), acid reflux, feeling sick (nausea) and being sick
(vomiting)
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
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.
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 SOFT CAPSULES






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 Omacor Soft Capsules 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.

6. FURTHER INFORMATION
Each soft capsule contains Omega-3-acid ethyl esters 90 1000
mg, comprising 840 mg eicosapentaenoic acid (EPA) ethyl ester
46% and docosahexaenoic acid (DHA) ethyl ester 38%. These
substances are called omega-3 polyunsaturated fatty acids and
are also found in some oily marine fish.
Omacor Soft Capsules also contain 4mg alpha-tocopherol,
gelatin, glycerol and purified water.
What Omacor Soft Capsules looks like and contents of the
pack
Omacor Soft Capsules are soft, oblong, transparent gelatin
capsules containing pale yellow oil with a slight fish-like odour.
Omacor Soft Capsules come in packs of 28 soft capsules.
The manufacturer is Pronova BioPharma Norge AS, N-1327
Lysaker, Norway.
Procured from within the EU and repackaged in the UK by the
Parallel Import Product Licence holder: CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Herts. WD6 1EE.
Omacor ® Soft Capsules

PL 20492/0305

Omacor is a registered trademark of Pronova BioPharma AS

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Date of preparation 18 December 2013

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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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