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SECALIP SUPRA 160MG TABLETS

Active substance(s): FENOFIBRATE

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Ref: 0831/240414/1/F

Supralip® 160mg Tablets / Secalip® Supra 160mg Tablets
(fenofibrate)
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.
Your medicine is called Supralip 160mg Tablets / Secalip Supra 160mg
Tablets and will be referred to as Supralip throughout the leaflet.
What is in this leaflet:
1 What Supralip is and what it is used for
2 What you need to know before you take Supralip
3 How to take Supralip
4 Possible side effects
5 How to store Supralip
6 Contents of the pack and other information

1

What Supralip is and what it is used for

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.
Other medicines and Supralip
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 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 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 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 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.

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.

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

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 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.
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.

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 200 mg, 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.

Ref: 0831/240414/1/B

®

Supralip 160mg Tablets / Secalip® Supra 160mg Tablets
(fenofibrate)
Patient Information Leaflet (continued)
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 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.

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
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).

How to store Supralip

* Do not store above 30°C. Store in original package.
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not use this medicine after the expiry date shown on the carton label or

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to anyone, it may harm them, even if their symptoms
are the same as yours. This leaflet does not tell you everything about this
medicine. If you have any questions or are not sure about anything then
ask your doctor or pharmacist.

6

Further information

What this medicine contains:
Each film-coated tablet contains 160mg fenofibrate as the active ingredient.
Your medicine also contains the following inactive ingredients: sodium
laurilsulfate, lactose monohydrate, povidone, crospovidone, microcrystalline
cellulose, silica colloidal anhydrous, sodium stearyl fumarate, polyvinyl
alcohol, titanium dioxide (E171), talc, soybean lecithin and xanthan gum.
What this medicine looks like and contents of the pack
Supralip are white, oblong, film-coated tablets engraved with “160” on one
side and “Fournier logo” on the other side. Each blister strip contains 10
tablets. They are available in packs of 30 tablets
Manufacturer and Licence Holder
This medicine is manufactured by Recipharm Fontaine, Rue des
Prés-Potets, 21121 Fontaine Les Dijon, France and is procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0831

Supralip 160mg Tablets

Supralip and Secalip are registered trademarks of Fournier Industrie et
Sante.
Revision date: 24/04/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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