What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL46302/0024.


Supralip 160mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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

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

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.

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

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

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: Contents of the pack and other further information)
  • you are allergic to peanut or arachis oil or soya lecithin or related products
  • while taking other medicines (such as other fibrates or 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 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)

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

Supralip 160 mg and effects on muscles

Stop taking Supralip 160 mg 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 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 160 mg.

Other medicines and Supralip 160 mg

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 160 mg may increase the risk of muscle problems
  • a particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)
  • cyclosporin (an immunosuppressant)

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

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 160 mg may affect your unborn baby. You should only use Supralip 160 mg if your doctor tells you to.
  • Do not use Supralip 160 mg if you are breast-feeding or planning to breast-feed your baby. This is because it is not known whether Supralip 160 mg passes into human milk

Driving and using machines

This medicine will not affect your ability to drive or use tools or machines.

Supralip 160 mg contains lactose, sucrose and soya oil

  • Supralip 160mg contains sugars called lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance), talk to your doctor before taking this medicine.
  • Supralip 160 mg contains soya oil. If you are allergic to peanuts, arachis oil or soya, do not take this medicine.

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.

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 160 mg, 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 160 mg. 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 bout this.

Use in children and adolescents

The use of Supralip 160 mg is not recommended in children and young people under 18 years.

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 to take a dose, take the next dose with your next meal.
  • Then take the 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.

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 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, [though 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:

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 160 mg 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 or pharmacist. 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.

Store in the original package in order to protect from moisture.

Keep this medicine below 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 160 mg tablet contains 160 milligrams (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® also contains: 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

Mylan Products Ltd.
20 Station Close
Potters Bar
Herts
EN6 1TL
UK

For further information in the UK contact:

BGP Products Ltd.
Abbott House
Vanwall Business Park
Vanwall Road
Maidenhead
SL6 4XE
UK

Manufacturer

Famar L'Aigle
Zone Industrielle No. 1
Route Crulai
61300 L'Aigle
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 February 2017.

FM-H8033217