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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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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Omacor® 1000mg Soft Capsules
(omega-3-acid ethyl esters 90)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.

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FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

WARNING!

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.

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.

DATE:

Please tell your doctor or pharmacist if you are using or have recently used other medicines including
medicines obtained without prescription.

03/06/14

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.

TVT CHECKED

Use in children
Children should not take this medicine.

UK PIL DATE APRIL 2013
REPORTING OF SIDE EFFECTS

06464/2963A
CODE:

DT

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.

DATE OF PROOF:

ARTWORKER:
Omacor 1000mg soft caps
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

If any of the above applies to you, talk to your doctor or pharmacist before taking 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.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

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).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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.
Your medicine is called Omacor 1000mg Soft Capsules but will be referred to as Omacor throughout this
leaflet.

PROOF HISTORY:
v.2 - waymade - 03/06/14

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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FONT SIZE 8
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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 like abdominal distension, pain, constipation, diarrhoea, indigestion (dyspepsia),
gas, belching (eructation), acid reflux, feeling sick (nausea) and being sick (vomiting)

WARNING!

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

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 store above 25°C.
Do not freeze
Do not take this medicine after the expiry date shown on the carton and bottle label. If your doctor
tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe
disposal. Only keep this medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines that are no longer required. These measures will help to protect the
environment.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist
who will advise you what to do.






TVT CHECKED

6. Further information
What this medicine 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 as antioxidant
4mg d-alpha-tocopherol (mixed with a vegetable oil e.g. soya-bean oil).
The soft capsule shell is made up of gelatin, glycerol (E422), purified water, medium-chain triglycerides and
Lecithin (soya).

UK PIL DATE APRIL 2013
REPORTING OF SIDE EFFECTS

What this medicine looks like and contents of the pack
Omacor capsules are soft, oblong, transparent, gelatin capsules containing pale yellow oil.
06464/2963A

03/06/14
DATE OF PROOF:



CODE:

DATE:

DT
ARTWORKER:
PRODUCT:

Omacor 1000mg soft caps

Q.A.
APPROVED:
05-0440
CUSTOMER: Waymade

PRE-PRESS NO.:



Omacor 1000mg Soft Capsules is available as bottles of 28 and 100 Capsules.
P

PL No: 06464/2963

This product is manufactured by Pronova BioPharma Norge AS, P.O Box 420 N-1327 Lysaker, Norway and
is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 03.06.2014
Omacor is a registered trademark of Pronova BioPharma Norge AS.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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.

PROOF HISTORY:
v.2 - waymade - 03/06/14

Leaflet Flat Size = 148 x 317

27mm

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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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