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FENOFIBRATE 160MG TABLETS

Active substance(s): 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 nonmedical treatments such as exercise and weight loss, to lower
levels of fats in the blood.
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.

2. What you need to know before you take
Supralip

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

Other medicines and Supralip

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







you are allergic to fenofibrate or any of the other
ingredients of this medicine (listed in Section 6:
Contents of the pack and other 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 antiinflammatory 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.

Warnings and precautions

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

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Supralip with food, drink and alcohol

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).

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

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 passes into breast-milk. Therefore, you should
not use Supralip 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 monohydrate (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.

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

How much to take

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.

If you take more Supralip than you should

If your doctor stops your medicine, do not keep any leftover
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.

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).

Effects on muscles

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

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).

Do not take Supralip if:


Use in children and adolescents

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.

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 160mg.

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.

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4. Possible side effects

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
rash, itching or red patches on the skin
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 effects 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.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name:
Supralip 160mg Tablets
Reference No: 08929/0284

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 use this medicine after the expiry date which is
stated on the carton and the blister after EXP. 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.
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.

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

Each 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.

What Supralip looks like and contents of the pack

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

Manufacturer

Supralip are manufactured by:
Famar L'Aigle, Zone lndustrielle No. 1, Route Crulai,
61300 L'Aigle, 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): 06.03.17
Supralip® is a registered trademark of BGP Products
Operations GmbH.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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