OMACOR 1000MG CAPSULE SOFT

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

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MKP-02156-2013

PACKAGE LEAFLET:
INFORMATION FOR THE USER

1000 mg soft capsules
Omega-3-acid ethyl esters 90

FOR POSITION ONLY

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
d
­ octor 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

Please tell your doctor or pharmacist if you are using
or have recently used other medicines including
m
­ edicines 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.

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:
•  ogether with other medicines for treatment after a
t
heart attack.
•  o treat certain forms of increased triglycerides (fats)
t
in the blood after changes to the diet have not
worked.
2. BEFORE YOU TAKE OMACOR
Do not take Omacor, if
•  ou are allergic (hypersensitive) to the main ­ngredient
y
i
or any of the other ingredients of Omacor (see
S
­ ection: 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
•  ou have problems with your liver. Your doctor will
y
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.

MKP-02156-2013_d3

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.

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 ­ llergic
a
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.
•  ou may take the capsules at meal times to help
Y
reduce gastro-intestinal side effects.
•  our doctor will decide how long you should take
Y
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 ­ ypertriglyceridaemia)
h
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.

FRONT

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 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)
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

acids) ­ncluding as antioxidant 4 mg d-alpha-­ocopherol
i
t
(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 transparent soft gelatin capsules
containing pale yellow oil.
Omacor is available in the following pack sizes:
– 1 x 20 capsules
– 1 x 28 capsules
– 1 x 60 capsules
– 1 x 100 capsules
– 10 x 28 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer
of Omacor is:
Pronova BioPharma Norge AS
PO Box 420
N-1327 Lysaker
Norway.
This leaflet was last updated: April 2013
Omacor is supplied in the United Kingdom by Abbott
Healthcare Products Limited, Mansbridge Road,
S
­ outhampton, SO18 3JD.
Omacor is supplied in Ireland by Abbott Healthcare
Products Limited, United Drug House, Magna Business
Park, Citywest Road, Dublin 24.

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.
5. HOW TO STORE OMACOR
• Keep out of the reach and sight of children.
•  o not use Omacor after the expiry date which is
D
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 your pharmacist how to
d
­ ispose of medicines no longer required. These
m
­ easures will help to protect the environment.
6. FURTHER INFORMATION
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
d
­ ocosahexaenoic acid (DHA) ethyl esters (these
s
­ ubstances are called omega-3 polyunsaturated fatty

MKP-02156-2013_d3

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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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