Supralip 160mg Film-Coated Tablets
S0305-30-SP-PIL-03.10.2016
PATIENT INFORMATION LEAFLET
Supralip® 160mg Film-coated Tablets
(fenofibrate)
Your medicine is available using the above name, but will be referred to as Supralip throughout the 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.
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
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. 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: Contents of the pack and other 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.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking 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.
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 taking 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.
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.
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 160mg 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.
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 160mg 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 200mg, 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.
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.
POM
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 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 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
• rash, itching or red patches on the skin
• 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).
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
Do not store above 30° C. Store in the original package.
Protect from moisture.
Keep out of the sight and reach of children.
Do not take these tablets after the expiry date printed on the packet. 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.
Supralip 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.
If your tablets appear to be discoloured or show any other signs of deterioration, please contact your pharmacist who will advise you.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Supralip contains:
Each film-coated tablet contains 160 mg of fenofibrate as the active ingredient.
Each film-coated tablet also contains the following inactive ingredients: lactose monohydrate, sodium laurilsulfate, povidone, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E171), talc, soybean lecithin and xanthan gum.
What Supralip looks like and contents of the pack
The tablets are white, oblong, film-coated tablets engraved with “160” on one side and the “Fournier logo” on the reverse.
They are available in packs of 30 tablets.
Manufacturer
RECIPHARM FONTAINE. RUE DES PRES POTETS. 21121 FONTAINE-LES-DIJON. FRANCE.
Procured from within the EU and repackaged by: Amimed Direct Ltd, Hendon London, NW9 6AQ.
Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
PL No: 33902/0305
Leaflet revision date: 03/10/2016
Supralip® is a registered trademark of BGP Products Operations GmbH.
S0305-30-SP-PIL-03.10.2016