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SUPRALIP 160MG TABLETS

Active substance: FENOFIBRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

SUPRALIP 160MG TABLETS
(fenofibrate)
This leaflet is for Supralip® 160mg Tablets which will be referred
to as Supralip throughout this leaflet.

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 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, or
pharmacist or nurse. This includes any possible side effects
not listed in this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Supralip is and what it is used for
What you need to know before you take Supralip
How to take Supralip
Possible side effects
How to store Supralip
Contents of the pack and other information

1. What Supralip is and what it is used for
Supralip belongs to a group of medicines, commonly known as
fibrates. These medicines are used to lower the level of fats
(lipids) in the blood. For example the fats known as triglycerides.
Supralip is used, alongside a low fat diet and other non-medical
treatments such as exercise and weight loss, to lower levels of
fats in the blood.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Supralip
if:
you have any liver or kidney problems
you may have an inflamed liver (hepatitis) - signs include
yellowing of the skin and the whites of the eyes (jaundice),
an increase in liver enzymes (shown in blood tests),
stomach pain and itching
you have an under-active thyroid gland (hypo-thyroidism)
If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Supralip.

Effects on muscles

Stop taking Supralip and see a doctor straight away if you get
unexplained cramps or painful, tender or weak muscles while
taking this medicine.
This is because this medicine may cause muscle problems,
which may be serious.
These problems are rare but include muscle inflammation
and breakdown. This can cause kidney damage or even
death.
Your doctor may do a blood test to check your muscles before and
after starting treatment.
The risk of muscle breakdown is higher in some patients. Tell your
doctor if:
you are over 70 years old
you have kidney problems
you have thyroid problems
you or a close family member has muscle problems which
runs in the family
you drink large amounts of alcohol
you are taking medicines called statins to lower cholesterol
such as simvastatin, atorvastatin, pravastatin, rosuvastatin
or fluvastatin
you have ever had muscle problems during treatment with
statins or fibrates such as fenofibrate, bezafibrate or
gemfibrozil.

Supralip can be used in addition to other medicines (statins) in
some circumstances when levels of fats in the blood are not
controlled with a statin alone.

If any of the above apply to you (or you are not sure), talk to
your doctor before Supralip.

2. What you need to know before you take
Supralip

Tell your doctor if you are taking have recently taken or might
take any other medicines.

Do not take Supralip if:

you are allergic to fenofibrate or any of the other ingredients
of this medicine (listed in Section 6: Further information)
you are allergic (hypersensitive) to peanut or arachis oil or
soya lecithin or related products
while taking other medicines, you have had an allergic
reaction or skin damage from sunlight or UV light (these
medicines include other fibrates and an anti-inflammatory
medicine called ‘ketoprofen’)
you have severe liver, kidney or gallbladder problems
you have pancreatitis (an inflamed pancreas which causes
abdominal pain) which is not caused by high levels of fat in
the blood

Do not take Supralip if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Supralip.

Other medicines and Supralip

In particular tell your doctor or pharmacist if you are taking any of
the following medicines:
anti-coagulants to thin your blood (such as warfarin)
other medicines to control fat levels in the blood (such as,
statins or fibrates). Taking a statin at the same time as
Supralip may increase the risk of muscle problems
a particular class of medicines to treat diabetes (such as
rosiglitazone or pioglitazone)
ciclosporin (an immunosuppressant)
If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Supralip.

Supralip with food, drink and alcohol

It is important to take the tablet with food - it will not work as
well if your stomach is empty.

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Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant, think you may be
pregnant or are planning to have a baby. As there is not
enough experience with the use of Supralip during
pregnancy, you should use Supralip only, if your doctor
considers it absolutely necessary.
It is not known, whether the active substance in Supralip
160mg passes into breast-milk. Therefore, you should not
use Supralip 160mg if you are breast-feeding or planning to
breast-feed your baby.

Ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines

This medicine will not affect you being able to drive or use tools or
machines.
Supralip contains lactose (a type of sugar). If you have been
told by your doctor that you cannot tolerate or digest some sugars
(have an intolerance to some sugars), talk to your doctor before
taking this medicine.
Supralip contains soya oil. If you are allergic to peanut or soya,
do not use this medicinal product.

3. How to take Supralip
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.

Taking this medicine

Swallow the tablet with a glass of water.
Do not crush or chew the tablet.
Take the tablet with food - it will not work as well if your
stomach is empty.

How much to take

The recommended dose is one tablet a day.
If you are currently taking one capsule of Lipantil Micro 200mg,
you can change to one tablet of Supralip.

People with kidney problems

If you have kidney problems, your doctor may tell you to take a
lower dose. Ask your doctor or pharmacist about this.

Use in children and adolescents

The use of Supralip is not recommended in children and
adolescents under 18 years of age.

If you take more Supralip than you should

If you take more Supralip than you should or if someone else has
taken your medicine, tell your doctor or contact your nearest
hospital.

If you forget to take Supralip

If you forget a dose, take the next dose with your next
meal.
Then take your next tablet at the normal time.
Do not take a double dose to make up for a forgotten dose.

If you are worried about this talk to your doctor.

If you stop taking Supralip

Do not stop taking Supralip unless your doctor tells you to, or the
tablets make you feel unwell. This is because abnormal levels of
fats in the blood need treating for a long period of time.
Remember that as well as taking Supralip it is also important that
you:
have a low fat diet
take regular exercise.
If your doctor stops your medicine, do not keep any left over
tablets unless your doctor tells you to. If you have any further
questions on the use of this medicine, ask your doctor or
pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop taking Supralip and see a doctor straight away, if you
notice any of the following serious side effects – you may
need urgent medical treatment:
allergic reaction - the signs may include swelling of the face,
lips, tongue or throat, which may cause difficulty in
breathing
cramps or painful, tender or weak muscles - these may be
signs of muscle inflammation or breakdown, which can
cause kidney damage or even death
stomach pain - this may be a sign that your pancreas is
inflamed (pancreatitis)
chest pain and feeling breathless - these may be signs of a
blood clot in the lung (pulmonary embolism)
pain, redness or swelling in the legs - these may be signs of
a blood clot in the leg (deep vein thrombosis)
yellowing of the skin and whites of the eyes (jaundice), or
an increase in liver enzymes - these may be signs of an
inflamed liver (hepatitis).
Stop taking Supralip and see a doctor straight away, if you notice
any of the side effects above.

Other side effects include:
Common (affects less than 1 in 10 people):

diarrhoea
stomach pain
wind (flatulence)
feeling sick (nausea)
being sick (vomiting)
raised levels of liver enzymes in the blood – shown in tests.

Uncommon (affects less than 1 in 100 people):

headache
gallstones
reduced sex drive
increase in creatinine (produced by the kidneys) – shown in
tests
pancreatitis (inflammation of the pancreas leading to
abdominal pain)
thromboembolism: pulmonary embolism (blood clot in the
lung causing chest pain and breathlessness), deep vein
thrombosis (blood clot in the leg causing pain, redness or
swelling)
muscle pain, muscle inflammation, muscle cramps and
weakness.

Rare (affects less than 1 in 1,000 people):

hair loss
feeling dizzy (vertigo)
feeling exhausted (fatigue)
increase in urea (produced by the kidneys) – shown in tests
increased sensitivity of your skin to sunlight, sun lamps and
sunbeds
drop in haemoglobin (that carries oxygen in blood) and
white blood cells – shown in tests
hepatitis (inflammation of the liver), symptoms of which
may be mild jaundice (yellowing of the skin and whites of
the eyes), stomach pain and itching
hypersensitivity (allergic reaction).

Side effect where the chance of it happening are
not known

severe form of skin rash with reddening, peeling and
swelling of the skin that resembles severe burns
long-term lung problems
muscle breakdown
complications of gallbladder stones.
If you get any unusual breathing discomfort, tell your doctor
straight away.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. 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.

5. How to store Supralip
Do not store above 30°C. Store in the original package.
Keep out of the sight and reach of children.
Do not take these tablets after the expiry date printed on
the packaging. The expiry date refers to the last day of that
month.
Take any tablets that are out of date, or which you no longer
need, back to your pharmacist. Only keep them if your
doctor tells you to.
If your tablets appear to be discoloured or show any other
signs of deterioration, please contact your pharmacist who
will advise you.
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.

6. Contents of the pack and other
information
What Supralip contain

Each Supralip 160mg tablet contains 160mg of micronised
fenofibrate. This is the active ingredient.
Each tablet also contains the following inactive ingredients:
sodium laurilsulfate, lactose monohydrate, povidone,
crospovidone, microcrystalline cellulose, colloidal anhydrous silica,
sodium stearyl fumarate.
The tablet coating consists of polyvinyl alcohol,
titanium dioxide (E171), talc, soybean lecithin and xanthan gum.
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What Supralip looks like and contents of the pack

Supralip are white, oblong, film-coated tablets engraved “160” on
one side and “Fournier logo” on the reverse.
Supralip are available in packs of 30 tablets.

Manufacturer

Supralip are manufactured by:
Recipharm Fontaine, 21121 Fontaine les Dijon, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0284

POM

Leaflet revision & issue date (Ref): 09.05.14
Supralip® is a registered trademark of Fournier Industrie et Sante.

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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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