Omega 3-Acid-Ethyl Esters 1000mg Soft Capsules
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Omega 3-acid-ethyl esters 1000mg Soft Capsules
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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.
In this leaflet:
1. What Omega 3-acid-ethyl esters 1000mg Soft Capsules is and what it is used for
2. 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. Further 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. 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 the main ingredient or any of the other ingredients of Omega 3-acid-ethyl esters 1000mg Soft Capsules (see Section 6: Further Information).
If any of the above applies to you, do not take this medicine, and talk to your doctor.
Take special care with 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.
If any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
Using 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.
Please tell your doctor or pharmacist if you are using or have recently used other medicines including medicines obtained without prescription.
Taking Omega 3-acid-ethyl esters 1000mg Soft Capsules with food or 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 elderly
Use Omega 3-acid-ethyl esters 1000mg Soft Capsules with care if you are over 70 years.
Use in children and teenagers
Children and teenagers 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.
HOW TO TAKE OMEGA 3-ACID-ETHYL ESTERS 1000MG SOFT CAPSULES
3.
Always take Omega 3-acid-ethyl esters 1000mg Soft Capsules 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 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 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omega 3-acid-ethyl esters 1000mg Soft Capsules 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):
• 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
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
If any of the side effects gets serious, or if you notice any side effects not listed in this leafl et, please tell your doctor or pharmacist.
5. HOW TO STORE OMEGA 3-ACID-ETHYL ESTERS 1000MG SOFT CAPSULES
Keep out of the reach and sight of children.
Do not use Omega 3-acid-ethyl esters 1000mg Soft Capsules after the expiry date which is printed on the carton, bottle and blister. The expiry date refers to the last day of the month.
Store Omega 3-acid-ethyl esters 1000mg Soft Capsules below 30°C. Do not freeze. Keep in the original package in order to protect from moisture.
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.
HDPE bottle (100 capsules only): The capsules should be used within 100 days of first opening the bottle.
6. FURTHER 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 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 and100 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 October 2014
PL 00289/1615 * Only the site used for batch release will be listed on the printed mock-up