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OMACOR 1000MG CAPSULE SOFT

Active substance(s): OMEGA-3-ACID ETHYL ESTERS 90%

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

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15mm

8mm
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ea a o t 1s ea et care u y e ore 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.
his 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
. Possible side effects
5. How to store Omacor
6. Further information

P ease te your actor or p armac1st 1f 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).

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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.

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1. WHAT OMACOR IS AND WHAT IT IS USED
FOR
Driving and using machines
Omacor contains highly purified omega-3 This medicine is not likely to affect you being able
polyunsaturated fatty acids.
to drive or use any tools or machines.
Omacor belongs to a group of so called reducers Important Information about some of the
of cholesterol and triglycerides.
ingredients
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 .

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 orsmm
pharmacist if you are not sure.

2. BEFORE YOU TAKE OMACOR
Do not take Omacor, if
• you are allergic (hypersensitive) to the main • Swallow the capsules with a drink of water.
ingredient or any of the other ingredients of • You may take the capsules at meal times to
help reduce gastro-intestinal side effects.
Omacor (see Section: Important information
about some of the ingredients, and Section 6: • Your doctor will decide how long you should
take this medicine.
Further Information).
If any of the above applies to you, do not take Dose after a heart attack
his medicine, and talk to your doctor.
The usual dose is one capsule a day.






Dose to treat high blood triglyceride levels
ake special care with Omacor if:
you are due to have or have had surgery recently (high levels of fat in the blood or
you have had a trauma recently
hypertriglyceridaemia)
you have a kidney problem
The usual dose is 2 capsules a day, as
you have diabetes which is not controlled
recommended by a doctor.
you have problems with your liver. Your doctor If the medicine is not working well enough at this
will monitor any effects Omacor may have on dose, your doctor may increase this to 4 capsules
your liver with blood tests.
a day.

If any of the above applies to you, talk to your If you take more of Omacor than you should
doctor or pharmacist before taking this medicine. If you accidentally take more of this medicine
Using other medicines
than you should, do not worry, as this is unlikely
to need special treatment. However, you should
If you are using a medicine to stop blood clotting
contact your doctor or pharmacist for further
in your arteries, such as warfarin, you may need
advice.
extra blood tests and your usual dose of your
blood thinning medicine may have to be changed.
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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.

Medicines should n~t 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
If you have any further questions on the use of What Omacor contains
this product, ask your doctor or pharmacist.
The active substances are omega-3-acid ethyl
esters, 1000 mg of omega-3-acid ethyl esters 90
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omacor can cause side comprising 460 mg eicosapentaenoic acid (EPA)
effects, although not everybody gets them. The and 380 mg docosahexaenoic acid (DHA) ethyl
following are side effects that may happen with esters {these substances are called omega-3
polyunsaturated fatty acids) including as
this medicine:
antioxidant 4 mg d-alpha-tocopherol (mixed with
Common side effects
a vegetable oil e.g. soya-bean oil).
(occur in 1 to 10 users in 100):
The soft capsule shell is made up of gelatin,
• stomach problems like abdominal distension, glycerol, purified water, medium-chain triglycerides
pain, constipation, diarrhoea, indigestion and lecithin (soya).
{dyspepsia), gas, belching (eructation), acid
reflux, feeling sick (nausea) and being sick What Omacor looks like and contents of the
pack
(vomiting)
Omacor capsules are transparent soft gelatin
Uncommon side effects
capsules containing pale yellow oil.
(occur in 1 to 10 users in 1,000):
Omacor is available in the following pack sizes:
• high blood sugar levels
- 1 x 20 capsules
• gout
- 1 x 28 capsules
• dizziness
- 1 x 30 capsules
• problems with taste
- 1 x 60 capsules
• headache
- 1 x 100 capsules
• low blood pressure
- 10 x 28 capsules
•nosebleed
• blood in your stools
Not all pack sizes may be marketed.
• rash
Marketing Authorisation Holder and
Rare side effects
Manufacturer
(occur in 1 to 10 users in 10,000):
The marketing authorisation holder and
• allergic reactions
manufacturer of Omacor is:
• raised red skin rash {hives or urticaria)
• liver disorders, with possible changes in the Pronova BioPharma Norge AS
P.O. Box420
results of certain blood tests
N0-1327 Lysaker
Reporting of side effects
Norway.
If you get any side effects, talk to your doctor or
This
leaflet was last updated: August 2017
pharmacist. This includes any possible side
smm effects not listed in this leaflet. You can also report Omacor is supplied in the United Kingdom by
side effects directly via the national reporting Mylan UK Healthcare Limited., 20 Station Close,
system. By reporting side effects you can help Potters Bar, Hertfordshire, EN6 1TL, UK.
provide more information on the safety of this
Omacor is supplied in Ireland by Mylan IRE
medicine.
Healthcare Limited., Newenham Court, Northern
In the UK:
Cross, Malahide Road, Dublin 17, Ireland.
The Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard
® Registered Trademark
In Ireland:
Reports may be made via freepost, to the
following address:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
5. HOW TO STORE OMACOR
• Keep out of the reach and sight of 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.

[fil]Mylan
MKP- 0620-2017
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