Active substance(s): DOCOSAHEXAENOIC ACID ETHYL ESTER / EICOSAPENTAENOIC ACID ETHYL ESTER / DOCOSAHEXAENOIC ACID ETHYL ESTER / EICOSAPENTAENOIC ACID ETHYL ESTER / DOCOSAHEXAENOIC ACID ETHYL ESTER / EICOSAPENTAENOIC ACID ETHYL ESTER
(omega-3-acid ethyl esters 90)
This medicine is available as the above name but will be referred to as Omacor
throughout the following 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
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
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
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
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.
If you have any further questions on the use of this product, ask your doctor or
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)
Uncommon side effects (occur in 1 to 10 users in 1,000):
• high blood sugar levels
• problems with taste
• low blood pressure
• nose bleed
• blood in your stools
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
5. HOW TO STORE OMACOR
Do not store your capsules above 25°C. Do not freeze.
Keep out of the sight and reach of children.
If your doctor tells you to stop taking the capsules, please take them back to the
pharmacist for safe disposal. Only keep the capsules if your doctor tells you to.
If the capsules become discoloured or show signs of any deterioration, you should seek
the advice of your pharmacist.
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 (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).
The soft capsule shell is made up of gelatin, glycerol and purified water.
What Omacor looks like and contents of the pack
Omacor® Capsules are soft, oblong, transparent, gelatin capsules containing pale
yellow oil with a slight fish-like odour. Omacor® Capsules are supplied in tamper-proof
bottles of 28 and 100 soft capsules.
This product is manufactured by Pronova BioPharma Norge AS, P.O.Box 420, Lysaker,
N-1327, Norway and is procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24
Leaflet revision and issue date (Ref.) 23.06.2016.
Omacor is a registered trademark of Pronova BioPharma Norge AS, Norway.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
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.