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OMEGA 3-ACID-ETHYL ESTERS 1000MG SOFT CAPSULES

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

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Package Leaflet: Information for the user

Omega 3-acid-ethyl esters
1000mg Soft Capsules
Omega-3-Acid Ethyl Esters 90
Read all of this leaflet carefully before
you start taking this medicine, because it
contains important information for you.
 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 only.
Do not pass it on to others. It may harm
them, even if their signs of illness are
the same as yours.
 If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

1. What Omega 3-acid-ethyl esters is and
what it is used for
Omega 3-acid-ethyl esters contains highly
purified omega-3 polyunsaturated fatty
acids. Omega 3-acid-ethyl esters belongs
to a group of so called ‘reducers of
cholesterol and triglycerides’.
Omega 3-acid-ethyl esters 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. What you need to know before you
take Omega 3-acid-ethyl esters
Do not take Omega 3-acid-ethyl esters:
 if you are allergic to omega-3-acid ethyl
esters, soya, peanut or any of the other
ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Omega 3-acid-ethyl esters if:
 you are due to have or have recently had
surgery;
 you have recently had a trauma;
 you have a kidney problem;
 you have diabetes which is not
controlled;
 you have problems with your liver. Your
doctor will monitor any effects Omega
3-acid-ethyl esters 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.
Children and adolescents
In the absence of efficacy and safety data,
children and adolescents should not take
this medicine.

Other medicines and Omega 3-acid-ethyl
esters
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any 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.
Omega 3-acid-ethyl esters with food
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).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
You should not take this medicine if you
are pregnant or breast-feeding, unless your
doctor decides it is absolutely necessary.

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What is in this leaflet
1. What Omega 3-acid-ethyl esters is and
what it is used for.
2. What you need to know before you take
Omega 3-acid-ethyl esters
3. How to take Omega 3-acid-ethyl esters
4. Possible side effects
5. How to store Omega 3-acid-ethyl esters
6. Contents of the pack and other
information

Older people
There is limited data on the use of Omega3-acid ethyl esters in older people above 70
years of age.
Use Omega 3-acid-ethyl esters with care if
you are over 70 years.

Driving and using machines
This medicine is not likely to affect you
being able to drive or use any tools or
machines.
Omega-3-acid ethyl esters Capsules
contains lecithin (soya)
This product may contain traces of soya. If
you are allergic to peanut or soya, do not
take this medicinal product.
3. How to take Omega 3-acid-ethyl esters
Always take this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
 Swallow the capsules with a drink of
water.
 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 recommended dose is one capsule a
day.
Dose to treat high blood triglyceride
levels (high levels of fat in the blood or
hypertriglyceridaemia)
The recommended dose is 2 capsules a day.
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 Omega 3-acid-ethyl
esters than you should
If you accidentally take more of this
medicine than you should, do not worry,
as it is unlikely that you will need special
treatment. However, you should contact
your doctor or pharmacist for further
advice.

Dimension - 135 x 295 mm

Front Side
Font: Times New Roman
Font size: 9 points
No. of Columns: 2 Columns

If you forget to take Omega 3-acid-ethyl
esters
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 stop using Omega-3-acid ethyl
esters
Do not stop the treatment without
consulting your doctor. Talk to your doctor
if you are not satisfied with the effects of
Omega-3-acid ethyl esters.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
The following are side effects that may
happen with this medicine:
Common side effects (may affect up to 1
in 10 people):
 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 (may affect up to
1 in 100 people):
 high blood sugar levels
 gout
 dizziness
 problems with taste
 headache
 low blood pressure
 nose bleed
 blood in your stools
 rash

6. Contents of the pack and other
information
What Omega 3-acid-ethyl esters contains
 The active substance is Omega-3-Acid
Ethyl Esters 90. Each capsule contains
1000 mg of omega-3-acid ethyl esters
90 comprising principally 840 mg
ethylesters of eicosapentaenoic acid
(EPA) (465 mg) and docosahexaenoic
acid (DHA) (375 mg).
 The other ingredients are alphatocopherol, gelatin, glycerol, purified
water, medium-chain triglycerides,
isopropyl alcohol and opacode
white ink (composition of opacode
white ink is shellac glaze, titanium
dioxide, purified water,
N-butyl alcohol, lecithin (soya),
simeticone).
What Omega 3-acid-ethyl esters looks
like and contents of the pack
Omega 3-acid-ethyl esters is a soft, oblong,
transparent gelatin capsule containing pale
yellow colored oily liquid, imprinted with
‘740’.
Omega 3-acid-ethyl esters is available in
the following pack sizes:
 White opaque HDPE container with
white opaque HDPE screw closure with
induction sealing.
Each bottle contains 20, 28, 100 or 120
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS,
United Kingdom.
Manufacturer & Distributor:
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire WD18 9SS,
United Kingdom.

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.

The leaflet was last revised on {08/2015}

1xxxxxx

5. How to store Omega 3-acid-ethyl
esters
Keep this medicine out of the sight and
reach of children.
Do not use Omega 3-acid-ethyl esters after
the expiry date which is printed on the
carton and the label after EXP. The expiry
date refers to the last day of that month.
Store Omega 3-acid-ethyl esters capsules
below 30°C. Shelf life after first opening of
HDPE container is 120 days.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

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Rare side effects (may affect up to 1 in
1,000 people):
 allergic reactions
 raised red skin rash (hives or urticaria)
 liver disorders, with possible changes in
the results of certain blood tests

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Dimension - 135 x 295 mm

Back Side
Font: Times New Roman
Font size: 9 points
No. of Columns: 2 Columns

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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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