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SUPRALIP 160MG FILM-COATED TABLETS

Active substance(s): FENOFIBRATE / FENOFIBRATE / FENOFIBRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SUPRALIP® 160mg FILM-COATED TABLETS
(fenofibrate)
This medicine is available as the above name but will be referred to as Supralip 160mg throughout the
following 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. What Supralip 160mg is and what it is used for
2. What you need to know before you take Supralip 160mg
3. How to take Supralip 160mg
4. Possible side effects
5. How to store Supralip 160mg
6. Contents of the pack and other information
1. WHAT SUPRALIP 160mg IS AND WHAT IT IS USED FOR
Supralip 160mg 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 160mg 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 160mg 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 160mg
Do not take Supralip 160mg if:
• you are allergic to fenofibrate or any of the other ingredients of this medicine (Iisted in Section 6:
Contents of the pack and other further information)
• you are allergic to peanut or arachis oil or soya lecithin or related products
• while taking other medicines (such as other fibrates or an anti-inflammatory medicine called 'ketoprofen'),
you have had an allergic reaction or skin damage from sunlight or UV light
• 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 Suprilip 160mg if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Supralip 160mg.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Supralip 160mg 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 160mg.
Supralip 160mg and effects on muscles
Stop taking Supralip 160mg and see a doctor straight away if you get
− unexplained cramps
− painful, tender or weak muscles.
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. In particular, 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 problem 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 160mg.
Other medicines and Supralip 160mg
Tell your doctor or pharmacist 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 levels of fat in the blood (such as, statins or fibrates). This is because taking a
statin or another fibrate in addition to Supralip 160mg may increase the risk of muscle problems
• a particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporin (an immunosuppressant)
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Supralip 160mg.
Pregnancy, breast-feeding and fertility
• Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. This is
because it is not known how Supralip 160mg may affect your unborn baby. You should only use Supralip
160mg if your doctor tells you to.
• Do not use Supralip 160mg if you are breast-feeding or planning to breast-feed your baby. This is
because it is not known whether Supralip 160mg passes into human milk
Driving and using machines
This medicine will not affect your ability to drive or use tools or machines.
Supralip 160mg contains lactose monohydrate, sucrose and soya oil
− Supralip 160mg contains sugars called lactose monohydrate. If you have been told by your doctor that
you cannot tolerate or digest some sugars (have an intolerance), talk to your doctor before taking this
medicine.
− Supralip 160mg contains soya oil. If you are allergic to peanuts, arachis oil or soya, do not take this
medicine.
3. HOW TO TAKE SUPRALIP 160mg
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will determine the appropriate strength for you, depending on your condition, your current
treatment and your personal risk status.
Taking this medicine
Take the tablet with food - it will not work as well if your stomach is empty.
− Swallow the tablet with a glass of water.
− Do not crush or chew the tablet.
Remember that as well as taking Supralip 160mg it is also important that you:
− have a low fat diet
− take regular exercise.
How much to take
The recommended dose is one tablet a day.
It you are already taking one capsule of Lipantil Micro 200 mg, you can change to one tablet of Supralip
160mg. You will still receive the same amount of medicine.

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 young people under 18 years.
If you take more Supralip 160mg than you should
If you take more Supralip 160mg 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 160mg
• If you forget to take a dose, take the next dose with your next meal.
• Then take the next dose at the usual 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 160mg
Do not stop taking Supralip 160mg unless your doctor tells you to, or the tablets make you feel unwell. This
is because you require long-term treatment. 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine ·can cause side effects, although not everybody gets them.
Stop taking Supralip 160mg and see a doctor straight away, if you notice any of the following
serious side effects - you may need urgent medical treatment:
Uncommon: may affect up to 1 in 100 people
− 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)
Rare: may affect up to 1 in 1,000 people
− allergic reaction - the signs may include swelling of the face, lips, tongue or throat, which may cause
difficulty in breathing
− 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)
Not known: it is not known how often these happen
− severe skin rash which reddens, peels and swells and looks like a severe bum
− long-term lung problems
Stop taking Supralip 160mg and see a doctor straight away, if you notice any of the side effects above.
Other side effects include:
Common may affect up to 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
• increase in homocysteine (too much of this amino acid in the blood has been associated to a higher risk
of coronary heart disease, stroke and peripheral vascular disease although a causal link has not been
established).
Uncommon may affect up to 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
Rare may affect up to 1 in 1,000 people:
• hair loss
• increase in urea (produced by the kidneys) - shown in tests
• skin is more sensitive to sunlight, sun lamps and sun beds
• drop in haemoglobin (that carries oxygen in blood) and white blood cells - shown in tests
Not known: it is not known how often these happen:
• muscle breakdown
• complications of gallbladder stones
• feeling exhausted (fatigue).
Tell your doctor or pharmacist if you notice any of the side effects listed above.
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 160mg
• Supralip 160mg should not be stored 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.
• If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or
pharmacist who will advise you what to do.
• 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 160mg contains
Your medicine is called Supralip 160mg. Each tablet contains 160mg of the active ingredient, fenofibrate.
Each white oblong, film-coated tablet is engraved ‘160’ on one side and ‘Fournier Logo’ on the reverse.
Supralip 160mg also contain the following inactive ingredients:
Sodium lauril sulfate, lactose monohydrate, crospovidone, microcrystalline cellulose, silica colloidal
anhydrous, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E171), talc, soybean lecithin,
povidone and xanthan gum.
Supralip 160mg are available as blister packs of 30 tablets.
POM

PL No: 17805/0221

This product is manufactured by Laboratoires Fournier S.A., 42 rue de Longvic 21300, Chenove, France
and procured from within the EU by the Product Licence holder: Delta Pharma (Europe) Ltd., 1 Colonial
Way, P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by O.P.D. Laboratories Ltd., Watford,
Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 11.07.2017.
Supralip is a registered Trade Mark of BGP Products Operations GmbH, Switzerland.

To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.

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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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