Medication Guide App

SUPRALIP 160MG FILM-COATED TABLETS

Active substance: FENOFIBRATE

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

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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

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 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

PROOF HISTORY:
v.2 - waymade - 27/06/14

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: 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 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.

DATE:

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.

27/06/14
DATE OF PROOF:
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REPORTING OF SIDE EFFECTS

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.

UK PIL DATED JULY 2013

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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.

6464/2057F

04-1957

Supralip 160mg tabs
PRODUCT:

CUSTOMER:

Waymade

ARTWORKER:

DATE:

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 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 Supralip 160 mg.

PRE-PRESS NO.:

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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.

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.
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.

WARNING!

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 COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is known by the above name but will usually be referred to as Supralip 160 mg in this leaflet.

WARNING!

27mm

SUPRALIP® 160 mg film-coated TABLETS
(fenofibrate)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000F

Remember that as well as taking Supralip 160 mg it is also important that you:
• have a low fat diet
• take regular exercise.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Supralip 160 mg 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 160 mg and see a doctor straight away, if you notice any of the side effects above.

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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.

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.

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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).

DATE:

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.

27/06/14

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.


DATE OF PROOF:

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ARTWORKER:

PRE-PRESS NO.:

04-1957

Q.A.
APPROVED:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.2 - waymade - 27/06/14

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.





REPORTING OF SIDE EFFECTS

UK PIL DATED JULY 2013

6464/2057F



CODE:

Supralip 160mg tabs
PRODUCT:

CUSTOMER:

Waymade



5. How to store Supralip
Do not use after the expiry date printed on the carton label or blister label EXP. The expiry date refers to the last day of
that month.
Supralip 160mg film-coated tablets should not be stored above 30°C. Store in the original package.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the
tablets 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
before taking them.
Supralip 160 mg film-coated tablets 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
Your medicine is called Supralip 160mg film-coated tablets.
Each white, oval, film-coated tablet marked ‘160’ on one side and a logo on the other side, contains 160mg of the active ingredient
fenofibrate, in a modified release, micronised formulation.
Supralip 160mg film-coated tablets also contain the following: lactose monohydrate, sodium laurilsulfate, povidone, microcrystalline
cellulose, anhydrous colloidal silica, crospovidone, sodium stearyl fumarate, and Opadry OYB 28920 (which contains polyvinyl
alcohol, titanium dioxide (E171), talc, soya lecithin and xanthan gum).
Supralip 160mg film-coated tablets are available as blister packs of 30 tablets.
POM

PL No: 6464/2057

This product is manufactured by Recipharm Fontaine, Rue des Préts Potets, 21121 Fontaine-les-Dijon, France and is procured
from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 26.06.2014
Supralip is a registered trademark of FOURNIER INDUSTRIE

WARNING!

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

27mm

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

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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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