Teromeg 1000mg Capsules
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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.
What is in this leaflet:
1. What Teromeg capsules are and what they are used for
2. What you need to know before you take Teromeg capsules
3. How to take Teromeg capsules
4. Possible side effects
5. How to store Teromeg capsules
6. Contents of the pack and other information
Teromeg capsules contain highly purified omega-3 polyunsaturated fatty acids and belong to a group of so called reducers of cholesterol and triglycerides. They are 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.
• you have had a trauma recently
• you have a kidney problem
• you have diabetes which is not controlled
• you have problems with your liver. Your doctor will monitor any effects this medicine may have on your liver with blood tests.
Children
Children should not take this medicine.
Use in elderly
Use Teromeg capsules with care if you are over 70 years.
Other medicines and Teromeg capsules
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.
Teromeg capsules 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, breast-feeding and fertility
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.
You should not take this medicine if you are pregnant or breast-feeding; unless your doctor decides it is absolutely necessary.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
Do not take Teromeg capsules and tell your doctor if:
• you are allergic to omega-3-acid ethyl esters 90 or any of the other ingredients of this medicine (listed in section 6).
• you are allergic to peanut or soya, since this medicine may contain soya oil.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Teromeg
capsules if:
• you are due to have or have had surgery recently
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 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.
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 Teromeg 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 Teromeg 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.
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.
Like all medicines, Teromeg capsules can cause side effects, although not everybody gets them. The following are side effects that may happen with this medicine:
Common (occur in 1 to 10 users in 100):
• stomach problems and indigestion (dyspepsia)
• feeling sick (nausea)
Uncommon (occur in 1 to 10 users in 1,000):
• abdominal and stomach pain
• allergic reactions
• dizziness
• problems with taste
• diarrhoea
• being sick (vomiting)
Rare (occur in 1 to 10 users in 10,000):
• headache
• acne
• itchy rash (pruritus)
• high blood sugar levels
• liver problems
Very rare (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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet
What Teromeg capsules contain:
The active substance is omega-3-acid ethyl esters 90, comprising principally 840 mg ethylesters of eicosapentaenoic acid (EPA) 460 mg and docosahexaenoic acid (DHA) 380 mg. The capsule core is made of alpha-tocopherol (which 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 Teromeg capsules look like and the contents of the pack
Teromeg capsules are transparent soft gelatin capsules containing slightly yellow oil.
Teromeg capsules are available in the following pack sizes:
- 1 x 28 soft gel capsules
- 1 x 30 soft gel capsules
- 1 x 60 soft gel capsules
- 1 x 100 soft gel capsules
- 10 x 28 soft gel capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd.,
No. 1 Croydon 12-16 Addiscombe Road Croydon CR0 0XT UK
Manufacturer:
One-Pharma S.A
60th km National RoadAthens-Lamia 320 09 Schimatari, Viotia GREECE
This leaflet was last updated in August 2012.
101994/LF/1, 101995/LF/2
Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use Teromeg capsules after the expiry date which is printed on the carton and the label. The expiry date refers to the last day of the month.
Teromeg capsules should be used within 100 days of opening the bottle.
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