FENOFIBRATE 160MG TABLETS

Active substance: 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.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor.
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side-effects get serious, or if you notice any side-effects not
listed in this leaflet, please tell your doctor.
In this leaflet:
1) What Supralip 160 mg is and what it is used for
2) 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) Further information

1) What Supralip 160 mg 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 nonmedical
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) Before you take Supralip 160 mg
Do not take Supralip 160 mg
 If you suffer from severe liver or kidney disease or gallbladder disease
 If you are allergic (hypersensitive) to fenofibrate or any of the other
ingredients of Supralip 160 mg
 If sunlight or UV light have caused an allergic reaction (photoallergy) or
skin damage while you were taking fibrates or an anti-inflammatory drug
called ketoprofen in the past
 If you suffer from acute or chronic pancreatitis (inflammation of the
pancreas which causes abdominal pain) unless it is caused by high levels
of a type of fat in the blood (hypertriglyceridemia)
Take special care with Supralip 160 mg
Tell your doctor before you start to take this medicine:
 If you have any kidney or liver problems
 If you develop symptoms suggestive of hepatitis (inflammation of the liver)
such as mild jaundice (yellowing of the skin and whites of the eyes),
stomach pain and itching
 If you suffer from pancreatitis (inflammation of the pancreas leading to
abdominal pain)
 If you suffer from hypothyroidism (underactive thyroid gland)
 If you are pregnant or breast-feeding
Important advice regarding muscle effects:
Contact your doctor quickly if you experience unexplained muscle pain,
tenderness or weakness. This is because on rare occasions, there is a risk
of muscle problems which may be serious, including muscle breakdown
which can cause kidney damage. Your doctor may perform a blood test to
check the condition of your muscles before and after starting treatment.

The risk of muscle breakdown is greater in certain patients. Tell your doctor
if any of the following applies to you:
 kidney problems
 thyroid problems
 you are more than 70 years old
 you have ever had muscle problems during treatment with cholesterol
lowering medicines called “statins” (such as simvastatin, atorvastatin,
pravastatin, rosuvastatin or fluvastatin) or fibrates (such as fenofibrate,
bezafibrate or gemfibrozil)
 you or close family members have a hereditary muscle disorder
The risk of muscle problems can be greater if Supralip 160 mg is taken with
cholesterol lowering medicines called “statins” (such as simvastatin,
atorvastatin, pravastatin, rosuvastatin, fluvastatin). Tell your doctor if you
are taking any of these medicines.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
In particular please let your doctor know if you already take:
 anti-coagulants to thin your blood (for example, warfarin)
 other drugs used to control lipid (fat) levels in the blood (for example,
drugs known as “statins” or “fibrates”). Taking a “statin” (e.g. simvastatin,
atorvastatin) at the same time as Supralip 160 mg can increase the risk of
muscle problems
 ciclosporin (an immunosuppressant)
Taking Supralip 160 mg with food and drink
Swallow the tablet with a glass of water. It is important to take the tablet
with food, as it will not work as well if your stomach is empty.
Pregnancy and breast-feeding
Pregnancy
Tell your doctor if you are, you think you might be or are planning to
become pregnant. Supralip 160 mg must not be taken if you are pregnant.
Breast-feeding
You must not use Supralip 160 mg if you are breast-feeding or if you are
planning to breast-feed your baby. Ask your doctor for advice before taking
any medicine.
Driving and using machines
This medicine will not affect your ability to drive or use machines.
Important information about some of the ingredients of Supralip 160
mg
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
If you are allergic to soya lecithin, peanuts or arachis oil, do not take
Supralip 160 mg as it contains soya lecithin.

3) How to take Supralip 160 mg
Always take Supralip 160 mg exactly as your doctor has told you.
Also, please read the label on the packet. You should check with your
doctor if you are not sure.
Swallow the tablet with a glass of water. It is important to take the tablet
with food, as it will not work as well as if your stomach is empty.
The usual dose for adults is one tablet of Supralip 160 mg a day.
If you are currently taking one capsule of Lipantil Micro 200mg, you can
change to one tablet of Supralip 160 mg.

Use in children and adolescents
The use of Supralip 160mg is not recommended in children and
adolescents under 18 years of age.

If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.

5) How to store Supralip 160 mg
If you take more Supralip 160 mg than you should
If you accidentally take more Supralip 160mg than you should or if someone
else has taken your medicine, contact your nearest hospital casualty
department or tell your doctor immediately.
If you forget to take Supralip 160 mg
Do not take a double dose to make up for a forgotten tablet. Take the next
dose with your next meal and then carry on taking your tablets as usual. If
you are worried about this talk to your doctor.
If you stop taking Supralip 160 mg
Do not stop taking the medicine unless your doctor tells you to, or the
tablets make you feel unwell. This is because raised cholesterol levels need
treating for a long period of time. Remember you should also continue with
a low-fat diet whilst taking Supralip 160 mg.

 Keep all medicines 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.
 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 protect the environment.

6) Further Information

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
product, ask your doctor.

What Supralip 160 mg contains:
Each film coated tablet contains 160 milligrams (mg) of fenofibrate. This is
the active ingredient.

4) Possible side effects

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.

Like all medicines, Supralip 160 mg can cause side effects, although not
everybody gets them.
Some patients have experienced the following side effects whilst taking
fenofibrate:
Common side effects (experienced by between 1 in 10 and 1 in 100
patients):
 Stomach pain, nausea, vomiting, diarrhoea and flatulence
 Raised levels of various liver enzymes in the blood
Uncommon side effects (experienced by between 1 in 100 and
1 in 1,000 patients):
 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)
 Reactions such as rashes, itching, red patches on the skin
 Slight increase in creatinine (substance excreted by the kidneys)
 Gallstones
 Muscle pain, muscle inflammation, muscle cramps and weakness
 Headache
 Reduced sex drive
Rare side effects (experienced by between 1 in 1,000 and 1 in 10,000
patients):
 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)
 Hair loss
 Decrease in haemoglobin (oxygen carrying pigment in blood) and
decrease in white blood cells
 Increased sensitivity to sunlight, sun lamps and sunbeds
 Slight increase in urea (substance excreted by the kidneys)
During post marketing experience, some patients have also experienced
(the frequency of these side effects is not known):
 Chronic disease of the lung tissues,
 muscle breakdown.
If you develop any unusual discomfort, tell your doctor as soon as possible.

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: 01.10.2012.
Supralip® is a registered trademark of Fournier Industrie et Sante (Société
par Actions Simplifiée), Dijon, 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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