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TEROMEG 1000MG CAPSULES

Active substance(s): OMEGA-3-ACID ETHYL ESTERS 90

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Package Leaflet: Information for the user

Teromeg® 1000 mg Capsules
Omega-3-Acid Ethyl Esters 90
• 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
• you are allergic to fish.
If any of the above applies to you, talk to your doctor or
pharmacist before taking this medicine.

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.

Children
Children should not take this medicine.
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.

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 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).

1. WHAT TEROMEG CAPSULES ARE AND WHAT
THEY ARE USED FOR

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.

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.

Driving and using machines
This medicine is not likely to affect you being able to drive
or use any tools or machines.
Teromeg contains soya bean oil.
Teromeg may contain soya-bean oil. If you are allergic to
peanut or soya, do not use this product.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TEROMEG CAPSULES

3. HOW TO TAKE TEROMEG CAPSULES

Do not take Teromeg capsules and tell your doctor if:
• you are allergic (hypersensitive) to omega-3-acid
ethyl esters 90 or any of the other ingredients of this
medicine (listed in section 6).
If any of the above applies to you, do not take this
medicine, and talk to your doctor.

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.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Teromeg
capsules if:
• you are due to have or have had surgery recently
• you have had a trauma recently
• you have a kidney problem

Dose after a heart attack
The recommended dose is one capsule a day.

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continued overleaf

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.

United Kingdom
Yellow Card Scheme
Freephone: 0808 100 3352 (available from 10 a.m. to 2
p.m. Mondays to Fridays)
Website: www.mhra.gov.uk/yellowcard

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. However, you should contact your doctor or
pharmacist for further advice.

5. HOW TO STORE TEROMEG CAPSULES
Keep this medicine out of the sight and reach of children.
Do not store Teromeg above 25°C. Do not freeze.
Do not use this medicine after the expiry date which is
stated on the carton and the label after EXP. The expiry
date refers to the last day of the month.
Teromeg capsules should be used within 100 days of
opening the bottle.
Do not throw away any medicine via wastewater or
household waste. Ask your pharmacist how to throw
away medicines no longer use. These measures will help
protect the environment.

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.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION

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:

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).

Common side effects (may affect up to 1 in 10 people):
• stomach problems like abdominal distension, pain,
constipation, diarrhoea and 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.

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 20 soft gel capsules
– 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.

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.

Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd
Capital House, 85 King William Street,
London EC4N 7BL UK

Not known (frequency cannot be estimated from the
available data):
• Itching
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.

Manufacturer:
One-Pharma S.A
60th km National Road Athens-Lamia
320 09 Schimatari, Viotia
GREECE
This leaflet was last updated in January 2018.
LF-104204-01
TERO.LEAF.3
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