Omega 3-Acid-Ethyl Esters 1000 Mg Soft Capsules
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.
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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-acid-ethyl 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
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:
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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
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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
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.
The capsule core also contains:
alpha-tocopherol (may contain vegetable oil e.g. soya oil)
The Capsule shell is made up of: gelatin, glycerol, purified water, medium-chain triglycerides and lecithin (sunflower)
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.
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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
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