Patient leaflet - Omacor 1000 mg capsule soft
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:
- 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 Omacor
Do not take Omacor:
- if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Omacor (listed in Section 6: Contents of the pack and other information).
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.
- 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 Omacor may have on your liver with blood tests.
- if you are allergic to fish
- if you have, or have had, heart problems
- if 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).
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 gastro- intestinal area).
Elderly
Use Omacor with care if you are over 70 years.
Children
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.
- 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 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 (May affect up to 1 in 10 people):
- irregular, rapid rhythm of the heart
- 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
Rare side effects (May affect up to 1 in 1000 people):
- allergic reactions
- itchy rash (hives or urticaria)
- liver disorders, with possible changes in the results of certain blood tests
Other side effects have occurred in a very small number of people but their exact frequency is unknown
- itching
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, 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 or search for MHRA Yellow Card in the
Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5) How to store Omacor
- Keep out of the sight and reach of children.
- Do not use Omacor 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 above 25°C. Do not freeze.
- 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.
- If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6) Contents of the pack and other information
What Omacor contain
Each capsule contains 1000 mg of omega-3-acid ethyl esters 90 comprising 460 mg eicosapentaenoic acid (EPA) and 380 mg docosahexaenoic acid (DHA) ethyl esters (these substances are called omega-3 polyunsaturated fatty acids) including as antioxidant 4 mg d-alpha- tocopherol (mixed with a vegetable oil e.g. soya-bean oil).
The soft capsule shell is made up of gelatin, glycerol, medium-chain triglycerides, lecithin soya and purified water.
What Omacor looks like and the contents of the pack
Omacor capsules are transparent soft gelatin capsules containing pale yellow oil.
Omacor capsules are available in a plastic bottle containing 28 and 100 capsules.
PL 46420/0271 Omacor 1000mg Soft Capsules P
Product Licence Holder and Manufacturer
Your medicine is manufactured by Pronova BioPharma Norge AS, P.O.Box 420 N-1327 Lysaker, Norway or BASF AS, Framnesveien 41, NO-3222 Sandefjord, Norway. Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 02.04.2025
Omacor is a registered trademark of BASF AS, Norway.
For any information about the medicine, or to request for a copy of this leaflet in Braille, large print or audio, please call the PL holder Suerte Pharma Limited on 020 8839 3000.
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. This includes any possible side effects not listed in this leaflet. See section 4.