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Package leaflet: Information for the user

Omacor 1000 mg soft capsules
(omega-3-acid ethyl esters 90)
The name of your medicine is Omacor 1000 mg soft capsules
but will be referred to as Omacor throughout the rest of this
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
- 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 size-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
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.
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.

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
Ask your doctor or pharmacist for advice before using any
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.
Always take Omacor exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not

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

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

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.
Continued overleaf

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
• gout
• dizziness
• problems with taste
• headache
• low blood pressure
• nose bleed
• blood in your stools
• rash

Product Licence Holder
Procured from within the EU.
Product Licence Holder Ginova Ltd and repackager Ginova
UK Ltd, both of St James' House, 8 Overcliffe, Gravesend,
Kent, DA11 0HJ.
Pronova BioPharma Norge AS, P.O. Box 420, N0-1327
Lysaker, Norway.

Omacor 1000 mg soft capsules
PL No: 18067/0490



This leaflet was last revised on 13 June 2016.

Omacor is the registered trademark of Pronova BioPharma
Norge AS.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.
• Keep out of the sight and of reach 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 above 25°C. Do not freeze.
Medicines should not be disposed of via wastewater or
household waste. Ask you pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
If you notice any sign of deterioration or discolouration of your
medicine, please tell your pharmacist immediately.
What Omacor contains
The active substances are omega-3-acid ethyl esters, 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 dalpha-tocopherol (mixed with a vegetable oil e.g. soya-bean
The soft capsule shell is made up of gelatin, glycerol, purified
water, medium-chain triglycerides and 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 a pack size of 1 x 28 capsules.


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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.