Document: leaflet MAH BRAND_PL 46302-0024 change

• leaflet MAH BRAND_PL 43900-0053
• leaflet MAH BRAND_PL 46302-0024

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Supralip® 160 mg Film-coated tablet

Fenofibrate

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: Further 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 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.

Effects on muscles

Stop taking Supralip 160 mg 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 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 160 mg.

Other medicines and Supralip 160 mg

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 160 mg 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 160 mg.

Supralip 160 mg 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 160mg during pregnancy, you should use Supralip 160mg 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 160mg 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 160 mg 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 160 mg contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

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.

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 200 mg, you can change to one tablet of Supralip 160 mg.

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 160mg is not recommended in children and adolescents under 18 years of age.

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FOR POSITION ONLY

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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 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.

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 abnormal levels of fats in the blood need treating for a long period of time.

Remember that as well as taking Supralip 160 mg 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 160 mg 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)

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•    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 160 mg 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 160 mg

Keep this medicine out of the sight and reach of children.

Keep this medicine in the original package in order to protect from moisture. Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXR 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 160mg tablet contains 160 miligrams (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® consists of the following inactive ingredients: 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 August 2016.

Ml Mylan