Patient leaflet - Omega 3-acid-ethyl Esters 1000 mg soft capsules
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:
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 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.
- you are allergic to fish.
- you have, or have had, heart problems
you develop light-headedness, asthenia
(feeling of weakness), palpitations or shortness of breath as these may be symptoms of an irregular and often very rapid heart rhythm (atrial fibrillation).
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.
Older people
There is limited data on the use of Omega-3-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.
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.
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.
- 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 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 that you will need special treatment.
However, you should contact your doctor or pharmacist for further advice.
Front Side Dimension - 135 x 295 mm
Back Side Dimension - 135 x 295 mm
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)
- Irregular, rapid rhythm of the heart
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
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
Frequency not known:
Other side effects have occurred in a very small number of people but their exact frequency is unknown
- Itching
- Itchy rash (hives or urticaria)
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.
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.
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 alpha-tocopherol, gelatin, glycerol, medium-chain triglycerides and ink (composition of ink is dewaxed bleach shellac resin, isopropyl alcohol, propylene glycol, titanium dioxide, sodium lauryl sulphate, twin 80.
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 and Manufacturer
Strides Pharma UK Ltd.
Unit 4, The Metro Centre
Dwight Road, Watford,
WD 189 SS
United Kingdom
The leaflet was last revised on 01/2024.