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OMEGA 3-ACID-ETHYL ESTERS 1000MG SOFT CAPSULES

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

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Package leaflet: Information for the user
Omega 3-acid-ethyl esters 1000mg Soft Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
-

Keep this leaflet. You may need 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.

What is in this leaflet:
1.

What Omega 3-acid-ethyl esters 1000mg Soft Capsules is and what it is used for

2.

What you need to know before you take Omega 3-acid-ethyl esters 1000mg Soft Capsules

3.

How to take Omega 3-acid-ethyl esters 1000mg Soft Capsules

4.

Possible side effects

5.

How to store Omega 3-acid-ethyl esters 1000mg Soft Capsules

6.

Contents of the pack and other information

1. What Omega 3-acid-ethyl esters 1000mg Soft Capsules is and what it is used for
Omega 3-acid-ethyl esters 1000mg Soft Capsules contains highly purified omega-3 polyunsaturated fatty
acids. Omega 3-acid-ethyl esters 1000mg Soft Capsules belongs to a group of so-called reducers of
cholesterol and triglycerides.
Omega 3-acid-ethyl esters 1000mg Soft Capsules 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 1000mg Soft Capsules
Do not take Omega 3-acid-ethyl esters 1000mg Soft Capsules


If you are allergic (hypersensitive) to Omega 3-acid-ethyl esters 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 1000mg Soft Capsules






If you are due to have or have had surgery recently
If you have had a trauma recently
If you have a kidney problem
If you have diabetes which is not controlled
If you have problems with your liver. Your doctor will monitor any effects Omega 3-acid-ethyl
esters 1000mg Soft Capsules may have on your liver with blood tests.

Other medicines and Omega 3-acid-ethyl esters 1000mg Soft Capsules
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.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Omega 3-acid-ethyl esters 1000mg Soft Capsules with food and drink
You may 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 older people
Use Omega 3-acid-ethyl esters 1000mg Soft Capsules with care if you are over 70 years.
Children and adolescents
Children and adolescents should not take this medicine.
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.
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 1000mg Soft Capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.





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 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, 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.
If you take more of Omega 3-acid-ethyl esters 1000mg Soft Capsules 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 1000mg Soft Capsules
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
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):



stomach problems and indigestion (dyspepsia)
feeling sick (nausea)

Uncommon side effects (may affect up to 1 in 100 people):







abdominal and stomach pain
allergic reactions
dizziness
problems with taste
diarrhoea
being sick (vomiting)

Rare side effects (may affect up to 1 in 1,000 people):




headache
acne
itchy rash (pruritus)




high blood sugar levels
liver problems

Very rare side effects (may affect up to 1 in 10,000 people):






blood in your stools
low blood pressure
dry nose
raised red skin rash (hives or urticaria)
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:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Omega 3-acid-ethyl esters 1000mg Soft Capsules

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, bottle and blister. The expiry
date refers to the last day of that month.
Store Omega 3-acid-ethyl esters 1000mg Soft Capsules below 30°C. Do not freeze. Store in the original
package in order to protect from moisture.
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.
HDPE bottle (100 capsules only): The capsules should be used within 100 days of first opening the bottle.

6. Content of the pack and other information
What Omega 3-acid-ethyl esters 1000mg Soft Capsules contains




The active substances are omega-3-acid ethyl esters.
Each soft capsule contains 1,000 mg of omega-3-acid ethyl esters 90 comprising principally 840
mg of eicosapentoenoic acid (EPA) ethyl ester (460 mg) and docosahexaenoic acid (DHA) ethyl
ester (380 mg) (these substances are called omega-3 polyunsaturated fatty acids) including as
antioxidant 4 mg of the inactive ingredient d-alpha- tocopherol.
The other excipients are:
Soft capsule shell is made up of gelatin, glycerol, traces of medium-chain triglycerides.

What Omega 3-acid-ethyl esters 1000mg Soft Capsules looks like and contents of the pack
Omega 3-acid-ethyl esters 1000mg Soft Capsules are transparent soft gelatin capsules containing pale
yellow oil.

Omega 3-acid-ethyl esters 1000mg Soft Capsules is available in the following pack sizes:
Transparent PVC/Aclar® – Aluminium blisters, available in packs of 28 capsules.
HDPE bottles with a tamper-evident HDPE screw cap, pack sizes of 28 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG

OR*

Marketing Authorisation Holder:
Teva UK Limited, Eastbourne BN22 9AG
Manufacturer:
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
This leaflet was last revised in April 2016
PL 00289/1615
* Only the site used for batch release will be listed on the printed mock-up

Expand Transcript

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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