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FENOFIBRATE 160MG TABLETS

Active substance(s): FENOFIBRATE

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Supralip® 160 mg tablets/
Fenofibrate 160mg Tablets
(fenofibrate)

Your medicine is known by either of the above names but will be referred to
as Supralip 160 mg throughout this:

Patient Information 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.

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 Supralip 160 mg.

Supralip 160 mg 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.

Other medicines and Supralip 160 mg
Tell your doctor if you are taking have recently taken or might take any
other medicines.
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 160 mg 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 160 mg.

Supralip 160 mg 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.

Supralip 160 mg 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.

Supralip 160 mg 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

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 160mg during pregnancy, you should use Supralip 160mg
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.

What is in this leaflet:
1) What Supralip 160 mg is and what it is used for
2) What you need to know before you take Supralip 160 mg
3) How to take Supralip 160 mg
4) Possible side effects
5) How to store Supralip 160 mg
6) Contents of the pack and other information

1) What Supralip 160 mg is and what it is used for

2) What you need to know before you take Supralip 160 mg

Do not take Supralip 160 mg if:
• 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 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 160 mg if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Supralip 160 mg.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Supralip 160 mg 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 160 mg.
Effects on muscles
Stop taking Supralip 160 mg 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.

Driving and using machines
This medicine will not affect you being able to drive or use tools or
machines.
Supralip 160 mg 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 160 mg contains soya oil. If you are allergic to peanut or soya, do
not use this medicinal product.

3) How to take Supralip 160 mg
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 200 mg, you can
change to one tablet of Supralip 160 mg.
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 160mg is not recommended in children and
adolescents under 18 years of age.
If you take more Supralip 160 mg than you should
If you take more Supralip 160 mg 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 160 mg
• 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 160 mg
Do not stop taking Supralip 160 mg 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 160 mg 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 t aking Supralip 1 60 mg a nd s ee a doc tor s traight a way, i f 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 160 mg 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 160 mg

• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the carton, label or blister strip.
• Do not store this medicine above 30° C. Store in the original package to
protect from moisture.
• If your doctor tells you to stop taking the tablets, please take them back to
the pharmacist for safe disposal. Only keep them if your doctor tells you
to.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
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 160 mg contains:
Each film coated tablet contains 160 milligrams (mg) of fenofibrate. This is
the active ingredient.
Each tablet also contains the following inactive ingredients:
sodium laurilsulfate, lactose monohydrate, povidone, crospovidone,
microcrystalline cellulose, silica colloidal anhydrous, sodium stearyl
fumarate.
The tablet coating Opadry® consists of the following excipients (inactive)
ingredients: polyvinyl alcohol, titanium dioxide (E 171), talc, soybean
lecithin, xanthan gum.
What Supralip 160 mg looks like and contents of the pack
Supralip 160mg are white, oblong, film-coated tablets engraved “160” on
one side and “fournier logo” on the other side.
Supralip 160mg comes in blister packs of 30 tablets
PL 10383/1669

Supralip® 160mg Tablets/
Fenofibrate 160mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Recipharm Fontaine, Rue des Pres
Potets, 21121 Fontaine-les-Dijon, France. Procured from within the EU and
repackaged by the Product Licence Holder Primecrown Ltd., 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 17.03.2016
Supralip is a registered trademark of Fournier Industrie et Sante (Société
par Actions Simplifiée), France.

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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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