- omega-3-acid ethyl esters 90
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 15905/0001 .
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMACOR® 1000 mg 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.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Omacor is and what it is used for
2. What you need to know before you take Omacor
3. How to take Omacor
4. Possible side effects
5. How to store Omacor
6. Contents of the pack and other information
1. WHAT OMACOR IS AND WHAT IT IS USED FOR
Omacor contains highly purified omega-3 polyunsaturated fatty acids.
Omacor belongs to a group of so called reducers of cholesterol and triglycerides.
Omacor is used:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMACOR
Do not take Omacor:
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 Omacor.
Other medicines and Omacor
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.
Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines including medicines obtained without prescription.
Omacor with food and 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 gastrointestinal area).
Use Omacor with care if you are over 70 years.
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.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
Omacor contains soya oil
Omacor contains soya 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 or pharmacist if you are not sure.
Dose after a heart attack
The usual dose is one capsule a day.
Dose to treat high blood triglyceride levels (high levels of fat in the blood or hypertriglyceridaemia)
The usual 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 Omacor 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. However, you should contact your doctor or pharmacist for further advice.
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omacor 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):
Uncommon side effects (occur in 1 to 10 users in 1,000):
Rare side effects (occur in 1 to 10 users in 10,000):
Other side effects have occurred in a very small number of people but their exact frequency is unknown
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.
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 national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.
In the UK:
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Reports may be made via freepost, to the following address:
5. HOW TO STORE OMACOR
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 Omacor contains
The active substances are omega-3-acid ethyl esters, 1000 mg of omega-3-acid ethyl esters 90 comprising 460 mg eicosapentaenoic acid (EPA), 380 mg docosahexaenoic acid (DHA) ethyl esters (these substances are called omega-3 polyunsaturated fatty acids) and including also 4 mg d-alpha-tocopherol (mixed with a vegetable oil e.g. soya oil) as antioxidant.
The soft capsule shell is made up of gelatine, glycerol, medium-chain triglycerides, lecithin (soya) and purified water.
What Omacor looks like and contents of the pack
Omacor capsules are transparent soft gelatin capsules containing pale yellow oil.
Omacor is available in the following pack sizes:
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer of Omacor is:
This leaflet was last updated: September 2018
Omacor is supplied in the UK by
Omacor is supplied in Ireland by
® Registered Trademark
20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
+44 (0)1707 853000
+44 (0)1707 853 000