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OMEGA 3-ACID-ETHYL ESTERS 1000 MG 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.
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-acidethyl 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

1. WHAT OMEGA 3-ACID-ETHYL ESTERS IS
AND WHAT IT IS USED FOR

Omega 3-acid-ethyl esters contain highly purified omega-3
polyunsaturated fatty acids. Omega 3-acid-ethyl esters
belong 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 the main ingredient or any of the
other ingredients of this medicine (listed in section 6).
• This medicine may contain soya oil. If you are allergic to
peanut or soya, do not use this medicine.
• If any of the above applies to you, do not take this
medicine, and talk to your doctor.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Omega
3-acid-ethyl esters if:
• you are due to have or have had surgery recently
• you have had a trauma recently (physical injury)
• 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
Children should not take this medicine.

Use in elderly
If you are over 70 years of age, your doctor will decide if you
should receive 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
You should not take this medicine if you are pregnant or
breast-feeding, unless your doctor decides it is absolutely
necessary.
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.
Driving and using machines
This medicine is not likely to affect you being able to drive or
use any tools or machines.

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.
• You should 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 this is unlikely to need special
treatment.
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 have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

The capsule core also contains:
alpha-tocopherol (may contain vegetable oil e.g. soya oil)

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 (occur in 1 to 10 users in 100):
• stomach problems and indigestion (dyspepsia)
• feeling sick (nausea)
Uncommon side effects (occur in 1 to 10 users in 1,000):
• abdominal and stomach pain
• allergic reactions
• dizziness
• problems with taste
• diarrhoea
• being sick (vomiting)
Rare side effects (occur in 1 to 10 users in 10,000):
• headache
• acne
• itchy rash (pruritus)
• high blood sugar levels
• liver problems
Very rare side effects (occur in less than 1 in 10,000 users):
• blood in your stools
• low blood pressure
• dry nose
• raised red skin rash (hives or urticaria)
• changes in the results of certain blood tests

The Capsule shell is made up of: gelatin, glycerol, purified
water, medium-chain triglycerides and lecithin (sunflower)

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.

What Omega 3-acid-ethyl esters looks like and contents of
the pack
Omega 3-acid-ethyl esters capsules are transparent soft gelatin
capsules containing slightly yellow oil.
Omega 3-acid-ethyl esters are available in the following pack
sizes:
– 1 x 20 soft gelatin capsules
– 1 x 28 soft gelatin capsules
– 1 x 30 soft gelatin capsules
– 1 x 60 soft gelatin capsules
– 1 x 100 soft gelatin capsules
– 10 x 28 soft gelatin capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton,
Middlesex, HA3 0BU
United Kingdom
Manufacturer
One-Pharma S.A.
60th km National Road Athens-Lamia
320 09 Schimatari, Viotia
GREECE
This leaflet was last updated in September 2014

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. The expiry date
refers to the last day of the month.
Do not store Omega 3-acid-ethyl esters above 25°C. Do not
freeze.
Omega 3-acid-ethyl esters 1000mg Soft Capsules should be
used within 100 days of opening the bottle.
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. CONTENTS OF THE PACK AND OTHER
INFORMATION

What Omega 3-acid-ethyl esters contains
Each capsule contains 1000 mg Omega-3-Acid Ethyl
Esters 90, comprising principally 840 mg ethyl esters of
eicosapentaenoic acid (EPA) 460 mg and docosahexaenoic
acid (DHA) 380 mg.

GM009 D8

PRODUCT:

Amends:

Omega 3-acid-ethyl esters
1000mg Soft Capsules ALL

Cutter Guide
Black

Times New Roman ALL 10.5 pts
body copy (min)

8
3-9-14

Signed (digitally)

GC

GM009

Artwork Signoff(digitally):

6-11-12
Leaflet (PIL)
210x297 mm (A4)

Approval:
Internal proof approval

Y

Indesign CS 5

External proof approval
Signed (digitally)

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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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