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PRESTYLON 1G SOFT CAPSULES

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

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PRESTYLON
1 g SOFT CAPSULES
omega 3-acid-ethyl esters
Package leaflet: Information
for the user

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,
pharmacist or nurse.
- 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, pharmacist or
nurse. This includes any
possible side effects not listed
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

• 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 Prestylon 1 g Soft
Capsules may have on your
liver with blood tests
• If you are allergic to fish.
Other medicines and Prestylon
1 g 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.
Taking Prestylon 1 g 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 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.

1 What Prestylon 1 g Soft
Capsules are and what they Driving and using machines
are used for
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.
Prestylon 1 g Soft Capsules 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.

2 What you need to know
before you take Prestylon
1 g Soft Capsules
Do not take Prestylon 1 g 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).

This medicine is not likely to
affect you being able to drive or
use any tools or machines.

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
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
Warnings and precautions
recommended by a doctor.
Talk to your doctor, pharmacist or If the medicine is not working well
nurse before taking Prestylon 1 g enough at this dose, your doctor
Soft Capsules:
may increase this to 4 capsules a
day.
• If you are due to have or have
had surgery recently
• If you have had a trauma
recently

If you take more Prestylon 1 g
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.

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
If you forget to take Prestylon 1 g waste. Ask your pharmacist how
Soft Capsules
to throw away medicines you no
If you miss a dose, take it when
longer use. These measures will
you remember unless it is almost help to protect the environment.
time for your next dose, in which
case take the next dose as usual.
6 Contents of the pack and
Do not take a double dose (twice
other information
the dose recommended by your
What
Prestylon 1 g Soft Capsules
doctor) to make up for a forgotten
contains
dose.
If you have any further questions • The active substances are
omega-3-acid ethyl esters.
on the use of this medicine, ask
Each soft capsule contains
your doctor, pharmacist or nurse.
1,000 mg of omega-3-acid ethyl
esters
90 comprising principally
4 Possible side effects
840 mg of eicosapentoenoic
acid (EPA) ethyl ester (460 mg)
Like all medicines, this medicine
and docosahexaenoic acid
can cause side effects, although
(DHA) ethyl ester (380 mg)
not everybody gets them.
(these substances are called
Common side effects (may affect
omega-3 polyunsaturated fatty
up to 1 in 10 people):
acids) including as antioxidant
• stomach problems and
4 mg of the inactive ingredient
indigestion (dyspepsia)
d-alpha- tocopherol.
• feeling sick (nausea).
• The other excipients are:
Soft capsule shell is made up of
Uncommon side effects (may
gelatin, glycerol and traces of
affect up to 1 in 100 people):
medium-chain triglycerides.
• abdominal and stomach pain
• allergic reactions
What Prestylon 1 g Soft Capsules
• dizziness
looks like and contents of the
• problems with taste
pack
• diarrhoea
Prestylon 1 g Soft Capsules are
• being sick (vomiting).
transparent soft gelatin capsules
Rare side effects (may affect up to containing pale yellow oil.
1 in 1,000 people):
Prestylon 1 g Soft Capsules is
• headache
available in the following pack
• acne
sizes:
• itchy rash
Transparent PVC/Aclar® –
• high blood sugar levels
Aluminium blisters, available in
• liver problems.
packs of 20, 28, 30, 3 x 10, 60, 90,
Very rare side effects (may affect 9 x 10, 100 and 120 capsules.
up to 1 in 10,000 people):
HDPE containers with tamper
• blood in your stools
evident HDPE screw cap, available
• low blood pressure
in packs of 20, 28, 30, 90, 98, 100
• dry nose
and hospital packs of 280 (10 x 28)
• raised red skin, itchy rash
capsules.
(hives or urticaria)
• changes in the results of certain Not all pack sizes may be
blood tests.
marketed.
Not Known
Marketing Authorisation Holder
• itching
and Manufacturer
Reporting of side effects
Marketing Authorisation Holder:
If you get any side effects, talk to TEVA UK Limited, Brampton
your doctor, pharmacist or nurse. Road, Hampden Park, Eastbourne,
This includes any possible side
BN22 9AG.
effects not listed in this leaflet. You
Manufacturer:
can also report side effects
TEVA Pharmaceutical Works
directly via the Yellow Card
Private Limited Company, Pallagi
Scheme at:
út 13, 4042 Debrecen, Hungary.
www.mhra.gov.uk/yellowcard
By reporting side effects you can This leaflet was last revised in
help provide more information on January 2018
the safety of this medicine.
PL 00289/1415

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.

EAS2014a

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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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