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SUPRALIP 160 FILM-COATED TABLETS

Active substance(s): FENOFIBRATE

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606863F

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

Supralip® 160 mg Film-coated tablet
Fenofibrate
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.

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.
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)

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

If any of the above apply to you (or you are not sure), talk to your doctor
or pharmacist before taking Supralip 160 mg.

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

Effects on muscles

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.

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.

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

Your doctor may do a blood test to check your muscles before and after
starting treatment.

606863F_d1
Affiliate Originator: UK Affiliate
Recipharm

COLORS

SERVICE PACKAGING
BAT réalisé par:

MOCKUP REQUEST NUMBER:

D.Margueritte

LCR-03589-2014-DEV

DATE

BLACK
MOCKUP CODE

PROS SUPRALIP M 160 MG 28 COMP UK

FONT TYPE:
HELVETICA NEUE

606863F

FONT SIZE:
9 PT

NAME (REGULATORY PERSON)

SIGNATURE
SIZE

170 x 428

DATE

15/04/14

DRAFT N°:

1

MAQ.
EXÉ.

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.
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)

• 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

If any of the above apply to you (or you are not sure), talk to your doctor
or pharmacist before taking Supralip 160 mg.

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.

Supralip 160 mg with food, drink and alcohol

People with kidney problems

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

If you have kidney problems, your doctor may tell you to take a lower
dose. Ask your doctor or pharmacist about this.

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.

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.

• 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:

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 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)

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

606863F_d1
Affiliate Originator: UK Affiliate
Recipharm

COLORS

SERVICE PACKAGING
BAT réalisé par:

MOCKUP REQUEST NUMBER:

D.Margueritte

LCR-03589-2014-DEV

DATE

BLACK
MOCKUP CODE

PROS SUPRALIP M 160 MG 28 COMP UK

FONT TYPE:
HELVETICA NEUE

606863F

FONT SIZE:
9 PT

NAME (REGULATORY PERSON)

SIGNATURE
SIZE

170 x 428

DATE

15/04/14

DRAFT N°:

1

MAQ.
EXÉ.

• 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 this medicine out of the sight and reach of children.
Keep this medicine in the original package in order to protect from
moisture. Do not store above 30°C.
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.
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. Content of the pack and other information
What Supralip 160 mg contains
• The active substance is fenofibrate. Each Supralip 160mg tablet
contains 160 miligrams (mg) of fenofibrate.
• The other ingredients are: lactose monohydrate, sodium laurilsulfate,
povidone, crospovidone, microcrystalline cellulose, silica colloidal
anhydrous, and sodium stearyl fumarate.

The tablet coating Opadry® consists of the following 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 160 mg film-coated tablets are white tablets.
The film-coated tablets are provided in blister packs of 10, 20, 28, 30, 50,
84, 90, 98, 100, 280, 300.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Abbott Healthcare Products Ltd
Mansbridge Road, West End,
Southampton SO18 3JD, UK
For further information contact:
Abbott Healthcare Products Limited
Mansbridge Road, Southampton, SO18 3JD, UK
TEL+44(0)23 8046 7000
Manufacturer
Recipharm Fontaine
Rue des Prés Potets
21121 Fontaine-lès-Dijon, FRANCE
This medicinal product is authorised in the Member States of the
EEA under the following names:
For MRP No. DE/H/0235/001:
• Germany:
Lipidil-Ter 160 mg
• France:
Lipanthyl 160 mg
• Spain:
Secalip Supra 160 mg
• UK:
Supralip 160 mg
For MRP No. DE/H/0236/001:
• Germany:
Apteor 160 mg
• France:
Fenofibrate Fournier 160mg
• Italy:
Fulcrosupra 160 mg
This leaflet was last revised in July 2013.

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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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