Omega-3-Acid-Ethyl Esters 1000mg Soft Capsules
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 ut 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