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PRESTYLON 1G SOFT CAPSULES

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

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TEVA UK Ref:

231-30-11915-E LEA OMEGA 3 (PRESTYLON) 1000mg TAB TUK Dimensions:
Length:
Width:

PRESTYLON
1 g SOFT CAPSULES
omega 3-acid-ethyl esters

• If you have problems with your
liver. Your doctor will monitor
any effects Prestylon 1 g Soft
Capsules may have on your
liver with blood tests.

Package leaflet: Information
for the user

Other medicines and Prestylon
1 g Soft Capsules
If you are using a medicine to
Read all of this leaflet carefully
stop blood clotting in your
before you start taking this
arteries, such as warfarin, you
medicine because it contains
may need extra blood tests and
important information for you.
- Keep this leaflet. You may need your usual dose of your blood
thinning medicine may have to be
to read it again.
changed.
- If you have any further
questions, ask your doctor,
Tell your doctor or pharmacist if
pharmacist or nurse.
you are using, have recently used
- This medicine has been
or might use any other medicines.
prescribed for you only. Do not
Taking Prestylon 1 g Soft
pass it on to others. It may
harm them, even if their signs Capsules with food and drink
of illness are the same as yours. You may take the capsules at
- If you get any side effects, talk meal times. This is to help lower
the chances of side effects that
to your doctor, pharmacist or
affect the area in and around the
nurse. This includes any
possible side effects not listed stomach (the gastro-intestinal
area).
in this leaflet. See section 4.
What is in this leaflet

1. What Prestylon 1 g Soft
Capsules are and what they
are used for
2. What you need to know before
you take Prestylon 1 g Soft
Capsules
3. How to take Prestylon 1 g Soft
Capsules
4. Possible side effects
5. How to store Prestylon 1 g Soft
Capsules
6. Contents of the pack and other
information

Use in older people
Use Prestylon 1 g 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
1 What Prestylon 1 g Soft
Capsules are and what they affect you being able to drive or
are used for
use any tools or machines.
Prestylon 1 g Soft Capsules
contain highly purified omega-3
polyunsaturated fatty acids.
Prestylon 1 g Soft Capsules
belong to a group of so-called
reducers of cholesterol and
triglycerides.

3 How to take Prestylon 1 g
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
Prestylon 1 g Soft Capsules are
drink of water.
used:
• together with other medicines • You may take the capsules at
meal times to help reduce
for treatment after a heart attack
gastro-intestinal side effects.
• to treat certain forms of
increased triglycerides (fats) in • Your doctor will decide how
long you should take this
the blood after changes to the
medicine.
diet have not worked.
Dose after a heart attack
2 What you need to know
The recommended dose is one
before you take Prestylon
capsule a day.
1 g Soft Capsules

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
Warnings and precautions
Talk to your doctor, pharmacist or may increase this to 4 capsules a
nurse before taking Prestylon 1 g day.
Soft Capsules:
If you take more Prestylon 1 g
Do not take Prestylon 1 g Soft
Capsules
• If you are allergic
(hypersensitive) to Omega-3acid ethyl esters or any of the
other ingredients of this
medicine (listed in Section 6).

• 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

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.

400 mm
160 mm

Version:

1

15 April 2016

Colours Used:

Template
PANTONE® GREEN C
BLACK

If you forget to take Prestylon 1 g 6 Contents of the pack and
Soft Capsules
other information
If you miss a dose, take it when
you remember unless it is almost What Prestylon 1 g Soft Capsules
time for your next dose, in which contains
case take the next dose as usual. • The active substances are
Do not take a double dose (twice
omega-3-acid ethyl esters.
the dose recommended by your
Each soft capsule contains
doctor) to make up for a forgotten
1,000 mg of omega-3-acid ethyl
dose.
esters 90 comprising principally
840 mg of eicosapentoenoic
If you have any further questions
acid (EPA) ethyl ester (460 mg)
on the use of this medicine, ask
and docosahexaenoic acid
your doctor, pharmacist or nurse.
(DHA) ethyl ester (380 mg)
Possible
side
effects
(these substances are called
4
omega-3 polyunsaturated fatty
Like all medicines, this medicine
acids) including as antioxidant
can cause side effects, although
4 mg of the inactive ingredient
not everybody gets them.
d-alpha- tocopherol.

The other excipients are:
Common side effects (may affect
Soft capsule shell is made up of
up to 1 in 10 people):
gelatin,
glycerol and traces of
• stomach problems and
medium-chain
triglycerides.
indigestion (dyspepsia)
• feeling sick (nausea).
What Prestylon 1 g Soft Capsules
looks like and contents of the
Uncommon side effects (may
pack
affect up to 1 in 100 people):
• abdominal and stomach pain
Prestylon 1 g Soft Capsules are
• allergic reactions
transparent soft gelatin capsules
• dizziness
containing pale yellow oil.
• problems with taste
Prestylon 1 g Soft Capsules is
• diarrhoea
available in the following pack
• being sick (vomiting).
sizes:
Rare side effects (may affect up to Transparent PVC/Aclar® –
1 in 1,000 people):
Aluminium blisters, available in
• headache
packs of 20, 28, 30, 3 x 10, 60, 90,
• acne
9 x 10, 100 and 120 capsules.
• itchy rash (pruritus)
HDPE containers with tamper
• high blood sugar levels
evident HDPE screw cap, available
• liver problems.
in packs of 20, 28, 30, 90, 98, 100
Very rare side effects (may affect and hospital packs of 280 (10 x 28)
up to 1 in 10,000 people):
capsules.
• blood in your stools
Not all pack sizes may be
• low blood pressure
marketed.
• dry nose
• raised red skin rash (hives or
Marketing Authorisation Holder
urticaria)
and Manufacturer
• changes in the results of certain
Marketing Authorisation Holder:
blood tests.
TEVA UK Limited, Brampton
Reporting of side effects
Road, Hampden Park, Eastbourne,
If you get any side effects, talk to BN22 9AG.
your doctor, pharmacist or nurse.
Manufacturer:
This includes any possible side
TEVA Pharmaceutical Works
effects not listed in this leaflet. You
Private Limited Company, Pallagi
can also report side effects directly
út 13, 4042 Debrecen, Hungary.
via the Yellow Card Scheme at:
This leaflet was last revised in
www.mhra.gov.uk/yellowcard
By reporting side effects you can April 2016
help provide more information on PL 00289/1415
the safety of this medicine.

5 How to store Prestylon 1 g
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 Prestylon 1 g 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 to protect the environment.

11915-E

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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