OMACOR 1000 MG SOFT CAPSULES

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

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Omacor® 1000 mg soft capsules

2500
17.06.13[2]

(Omega-3-acid ethyl esters 90)
PATIENT INFORMATION LEAFLET
Your medicine will be referred to as Omacor throughout the 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

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.

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.

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.

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.

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:

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).

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

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
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.
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.

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.
5. HOW TO STORE OMACOR
Keep out of the sight and reach of children.
Do not store Omacor above 25°C. Do not freeze.
Do not use Omacor after the expiry date which is stated on the blister and
carton. The expiry date refers to the last day of that month.
If the capsules become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.

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 1000 mg of omega-3-acid ethyl esters 90
comprising 460 mg eicosapentaenoic acid (EPA) ethyl ester and 380 mg
docosahexaenoic acid (DHA) ethyl ester.
The soft capsule shell contains gelatin, glycerol E422, purified water,
medium-chain triglycerides, lecithin (soya).
What Omacor looks like and contents of the pack
Omacor capsules are transparent soft gelatin capsules containing pale
yellow oil.
Omacor is available in the plastic bottle pack sizes of 28 and 100 capsules.
Manufacturer and Product Licence holder
Manufactured by Pronova BioPharma Norge AS, P. O. Box 420, N-1327
Lysaker, Norway. Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
P

PL 20636/2500

Leaflet revision and issue date: (Ref) 17.06.13[2]
Omacor is a 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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