Patient leaflet - Supralip 160 mg film-coated tablets
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 to peanut or arachis oil or soya lecithin or related products
- while taking other medicines (such as other fibrates and an anti-inflammatory medicine called ‘ketoprofen’), you have had an allergic reaction or skin damage from sunlight or UV light
- 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 Supralip 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.
Supralip and effects on muscles
Stop taking Supralip and see a doctor straight away if you get
- unexplained cramps
- painful, tender or weak muscles.
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. In particular, 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 taking Supralip.
Other medicines and Supralip
Tell your doctor or pharmacist 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 levels of fat in the blood (such as, statins or fibrates). This is because taking a statin or another fibrate in addition to 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.
Pregnancy, breast-feeding and fertility
- Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. This is because it is not known how Supralip may affect your unborn baby. You should only use Supralip if your doctor tells you to.
- Do not use Supralip if you are breast-feeding or planning to breast-feed your baby. This is because it is not known whether Supralip passes into human milk
Driving and using machines
This medicine will not affect your ability to drive or use tools or machines.
Supralip contains lactose, sucrose and soya oil
- Supralip contains sugars called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- Supralip contains soya oil. If you are allergic to peanuts, arachis oil or soya, do not take this medicine.
- This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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.
Your doctor will determine the appropriate strength for you, depending on your condition, your current treatment and your personal risk status.
Taking this medicine
Take the tablet with food - it will not work as well if your stomach is empty.
- Swallow the tablet with a glass of water.
- Do not crush or chew the tablet.
Remember that as well as taking Supralip, it is also important that you:
- have a low fat diet
- take regular exercise.
How much to take
The recommended dose is one tablet a day.
If you are already taking one capsule of Lipantil Micro 200 mg, you can change to one tablet of Supralip. You will still receive the same amount of medicine.
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 young people 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 to take a dose, take the next dose with your next meal.
- Then take your next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose.
If you are worried about this talk to your doctor.
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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 you require long-term treatment. If your doctor stops your medicine, do not keep any leftover tablets unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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:
Uncommon: may affect up to 1 in 100 people
- 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)
Rare: may affect up to 1 in 1,000 people
- allergic reaction – the signs may include swelling of the face, lips, tongue or throat, which may cause difficulty in breathing
- 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)
Not known: it is not known how often these happen
- severe skin rash which reddens, peels and swells and looks like a severe burn
- long-term lung problems
Stop taking Supralip and see a doctor straight away, if you notice any of the side effects above.
Other side effects include:
Common may affect up to 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
- increase in homocysteine (too much of this amino acid in the blood has been associated to a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal link has not been established)
Uncommon may affect up to 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
Rare may affect up to 1 in 1,000 people:
- hair loss
- increase in urea (produced by the kidneys) – shown in tests
- skin is more sensitive to sunlight, sun lamps and sunbeds
- drop in haemoglobin (that carries oxygen in blood) and white blood cells – shown in tests
Not known: it is not known how often these happen:
- muscle breakdown
- complications of gallbladder stones
- Feeling exhausted (fatigue).
Tell your doctor or pharmacist if you notice any of the side effects listed above.
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 Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE SUPRALIP
- Keep out of the sight and reach of children.
- Do not store above 30oC
- Store in the original package in order to protect from moisture.
- Do not use Supralip 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.
- If the tablets become discoloured or show any other signs of deterioration, seek the advice of a pharmacist.
- 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 contains
Each film-coated tablet contains 160 mg of fenofibrate.
Each tablet also contains the following inactive ingredients: sodium laurilsulfate, lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E 171), talc, soybean lecithin and xanthan gum.
What Supralip looks like and contents of the pack
Supralip are white, oblong, film-coated tablets engraved ‘160’ on one side and plain on the other side.
Supralip comes in blister packs of 30 tablets.
Manufacturer and product licence holder
Supralip is manufactured by
Delpharm L'Aigle, Zone Industrielle No. 1., Route Crulai, 61300 L'Aigle, France.
Procured from the EU by product licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref.) 27.01.22[19]
Supralip is a trademark of BGP Products Operations GmbH.
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