Supralip 160mg Tablets
Variation 0008: To change the name of the manufacturer from Laboratoires FOURNIER S.A ‘ to ‘Recipharm Fontaine’, with consequential changes to the label and leaflet. No other changes approved
Supralip 160mg Tablets
(fenofibrate)
g Tablets
Previouul y asse ssed ag ai n^tUK ^iL dated Ma rch 201l
By Naresh Beeharry at 10:24 am, Jan 31, 2012
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Supralip 160m
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 is and what it is used for
2. Before you take Supralip
3. How to take Supralip
4. Possible side effects
5. How to store Supralip
6. Further information
1. What Supralip is and what it is used for
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 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 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
Do not take Supralip:
■ 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
■ 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 are under 18 years of age
■ 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
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 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 can increase the risk of muscle problems
■ ciclosporin (an immunosuppressant)
Taking Supralip 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.
APPROVED
Pregnancy and brea.
Pregnancy
Tell your doctor if you are, you think you might be or are planning to become pregnant. Supralip must not be taken if you are pregnant.
Breast-feeding
You must not use Supralip if you are breast-feeding or if you are planning to breast-feed your baby. Ask you 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
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 as it contains soya lecithin.
3. How to take Supralip
Always take Supralip 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 if your stomach is empty.
The usual dose for adults is one tablet of Supralip a day. If you are currently taking one capsule of Lipantil Micro 200mg, you can change to one tablet of Supralip.
If you take more Supralip than you should
If you accidentally take more Supralip 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
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
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.
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.
4. Possible side effects
Like all medicines, Supralip 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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. How to store Supralip
■ Store in the original package. Do not store above 30°C.
■ Keep your medicine in a safe place out of the reach and sight of children.
■ Do not take these tablets after the expiry dated printed on the packaging. The expiry date refers to the last day of that month.
■ Take any tablets that are out of date, or which you no longer need, back to your pharmacist. Only keep them if your doctor tells you to.
■ If you tablets appear to be discoloured or show any other signs of deterioration, please contact your pharmacist who will advise you.
■ 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. Further information
What Supralip contains
Each film-coated tablet contains 160mg of fenofibrate, micronised as the active ingredient.
Each film-coated tablet also includes the following inactive ingredients: sodium laurilsuIfate, lactose monohydrate, povidone, microcrystalline cellulose, silica colloidal anhydrous, crospovidone and sodium stearyl fumarate.
The tablet coating consists of Opadry® OY-B-28920, polyvinyl alcohol, titanium dioxide (E171), talc, soybean lecithin and xanthan gum.
What Supralip looks like and contents of the pack
Supralip are white, oblong, film-coated tablets engraved with '160' on one side and the Fournier logo on the reverse.
They are available in blister packs containing 30 film-coated tablets.
Manufacturer
Manufactured by: RECIPHARM FONTAINE, Fontaine les Dijon, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
iPOMl PL No: 08929/0292
Leaflet revision 8i issue date (Ref): 24.01.12
Supralip® is a registered trademark of Fournier Industrie et Sante.
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