Ref: 0511/061213/1/F

Lipantil Micro 67mg Capsules

(fenofibrate)

Patient Information Leaflet

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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Your medicine is called Lipantil Micro 67mg Capsules but will be referred to as Lipantil Micro throughout this leaflet.

In this leaflet:

™ What Lipantil Micro is and what it is used for Before you take Lipantil Micro How to take Lipantil Micro Possible side effects How to store Lipantil Micro Further information

^ What Lipantil Micro is and what it is used for

Lipantil Micro 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.

Lipantil Micro 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.

Lipantil Micro 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.

Lipantil Micro can often also increase the amount of a“good” type of cholesterol, called HDL or high density lipoprotein cholesterol.

It is always essential to continue a low-fat diet during treatment with Lipantil Micro.

rp Before you take Lipantil Micro

Do not take Lipantil Micro if:

*    You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Lipantil Micro.

*    You suffer from liver or kidney disease or gallbladder disease.

*    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.

*    You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain) unless it is caused by high levels of fat in the blood (hypertriglyceridemia).

Take special care with Lipantil Micro

Tell your doctor before you start to take this medicine:

*    If you have any kidney problems.

*    If you suffer from an under active thyroid gland (hypothyroidism).

*    If you have diabetes, especially Type 2 diabetes, that is not well controlled.

*    If you have liver problems.

*    If you have problems with certain proteins in your blood

*    If you have an alcohol problem.

*    You are taking other medicines.

*    If you or your family have had muscle problems

*    If you are over 70 years of age (some of the above conditions can lead to high levels of lipids in your blood and need to be corrected before you start therapy with fenofibrate).

Your doctor might want to test your blood or urine to check if Lipantil Micro is working properly and also if your kidneys, muscles and liver are working properly.

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:

*    You have any kidney problems.

*    You have an under active thyroid.

*    You often drink large amounts of alcohol.

*    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 Lipantil Micro 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:

*    Anticoagulants to thin your blood (for example, warfarin).

*    Other drugs 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 Lipantil Micro can increase the risk of muscle problems.

*    Ciclosporin (an immunosuppressant).

*    Drugs to control Type 2 diabetes (glitazones).

Pregnancy and breast-feeding Pregnancy

Tell your doctor if you are, you think you might be or are planning to become pregnant. Lipantil Micro must not be taken if you are pregnant.

Breast-feeding

You must not use Lipantil Micro if you are breast-feeding or if you are planning to breastfeed your baby.

Driving and using machines

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

Important information about some of the ingredients of Lipantil Micro

This medicine contains lactose which is a type of sugar.

If you have been told by your doctor that you have a intolerance to some sugars, contact your doctor before taking this medicinal product.

^3) How to take Lipantil Micro

Always take Lipantil Micro 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 capsule whole with a glass of water. It is important to take the capsule with food, as it will not work as well if your stomach is empty.

The usual dose for adults is one capsule of Lipantil Micro 67 three times a day, taken at mealtimes.

Use in children and adolescents

The usual dose for children is one capsule of Lipantil Micro 67 per 20kg bodyweight per day. Your doctor will work out the dose that is required.

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.

Lipantil ® Micro 67mg Capsules

(fenofibrate)

Patient Information Leaflet (continued)

If you take more Lipantil Micro than you should

If you accidentally take more Lipantil Micro 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 Lipantil Micro

Do not take a double dose to make up for a forgotten capsule.

Take the next dose with your next meal and then carry on taking your capsules as usual. If you are worried about this talk to your doctor.

If you stop taking Lipantil Micro

Do not stop taking the medicine unless your doctor tells you to, or your medicine makes 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 Lipantil Micro. If your doctor stops your medicine, do not keep any left over capsules unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor.

rp How to store Lipantil Micro

*    Store in the original package.

*    Do not store above 3o°C

*    KEEP OUT OF SIGHT AND REACH OF CHILDREN

*    Do not use this medicine after the expiry date shown on the carton label. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

*    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

*    Remember this medicine is for you. A doctor can only prescribe it. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours.

*    This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.

3 Possible side effects

Like all medicines, Lipantil Micro can cause side effects, although not everybody gets them. Some patients have experienced the following side effects whilst taking fenofibrate:

Common (in less than 1 in 10, but more than 1 in 100 patients treated):

-    Stomach pain, being sick, feeling sick, diarrhoea and wind (flatulence)

-    Raised levels of various liver enzymes in the blood

Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients treated):

-    Pancreatitis (inflammation of the pancreas leading to stomach pain)

-    Blood clot in the lung causing chest pain and breathlessness (pulmonary embolism); blood clot in the leg causing pain, redness or swelling (deep vein thrombosis)

-    Gallstones (cholelithiasis)

-    Headache

-    Reactions such as rashes, itching or red patches on the skin

-    Muscle pain, muscle inflammation, muscle cramps, spasms or weakness

-    Reduced sex drive

-    Slight increases in blood levels of substances normally excreted by the kidneys (creatinine)

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):

-    Slight increases in blood levels of substances normally excreted by the kidneys (urea)

-    Hair loss

-    Increased sensitivity to light

-    Decrease in haemoglobin (oxygen carrying pigment in blood) and decrease in white blood cells

-    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

In addition to those events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of Lipantil Micro. A precise frequency cannot be estimated from the available data and is therefore classified as "not known”:

-    Muscle breakdown

-    Chronic disease of the lung tissues

-    Fatigue

-    Vertigo

If you develop any unusual discomfort, tell your doctor as soon as possible.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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 help provide more information on the safety of this medicine.

|POM| PL 15184/0511 Lipantil Micro 67mg Capsules Lipantil is a registered trademark of Fournier Industrie et Sante. Revision date: 06/12/13

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Lipanthyl Micro 67mg Capsules

(fenofibrate)

Patient Information Leaflet

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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Your medicine is called Lipanthyl Micro 67mg Capsules but will be referred to as Lipanthyl Micro through out this leaflet.

In this leaflet:

^ What Lipanthyl Micro is and what it is used for [a Before you take Lipanthyl Micro How to take Lipanthyl Micro [4 Possible side effects

How to store Lipanthyl Micro ,4 Further information

^ What Lipanthyl Micro is and what it is used for

Lipanthyl Micro 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.

Lipanthyl Micro 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.

Lipanthyl Micro can be used in addition to othermedicines [statins] in some circumstances when levels of fats in the blood are not controlled with a statin alone.

Lipanthyl Micro can often also increase the amount of a“good” type of cholesterol, called HDL or high density lipoprotein cholesterol.

It is always essential to continue a low-fat diet during treatment with Lipanthyl Micro.

Before you take Lipanthyl Micro

Do not take Lipanthyl Micro if:

*    You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Lipanthyl Micro.

*    You suffer from liver or kidney disease or gallbladder disease.

*    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.

*    You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain) unless it is caused by high levels of fat in the blood (hypertriglyceridemia).

Take special care with Lipanthyl Micro

Tell your doctor before you start to take this medicine:

*    If you have any kidney problems.

*    If you suffer from an under active thyroid gland (hypothyroidism).

*    If you have diabetes, especially Type 2 diabetes, that is not well controlled.

*    If you have liver problems.

*    If you have problems with certain proteins in your blood

*    If you have an alcohol problem.

*    You are taking other medicines.

*    If you or your family have had muscle problems

*    If you are over 70 years of age (some of the above conditions can lead to high levels of lipids in your blood and need to be corrected before you start therapy with fenofibrate).

Your doctor might want to test your blood or urine to check if Lipanthyl Micro

is working properly and also if your kidneys,muscles and liver are working

properly.

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:

*    You have any kidney problems.

*    You have an under active thyroid.

*    You often drink large amounts of alcohol.

*    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 Lipanthyl Micro 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:

*    Anticoagulants to thin your blood (for example, warfarin).

*    Other drugs 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 Lipanthyl Micro can increase the risk of muscle problems.

*    Ciclosporin (an immunosuppressant).

*    Drugs to control Type 2 diabetes (glitazones).

Pregnancy and breast-feeding Pregnancy

Tell your doctor if you are, you think you might be or are planning to become pregnant. Lipanthyl Micro must not be taken if you are pregnant.

Breast-feeding

You must not use Lipanthyl Micro if you are breast-feeding or if you are planning to breastfeed your baby.

Driving and using machines

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

Important information about some of the ingredients of Lipanthyl Micro

This medicine contains lactose which is a type of sugar.

If you have been told by your doctor that you have a intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Lipanthyl Micro

Always take Lipanthyl Micro 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 capsule whole with a glass of water. It is important to take the capsule with food, as it will not work as well if your stomach is empty.

The usual dose for adults is one capsule of Lipantil Micro 67 three times a day, taken at mealtimes.

Use in children and adolescents

The usual dose for children is one capsule of Lipantil Micro 67 per 20kg bodyweight per day. Your doctor will work out the dose that is required.

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.

Lipanthyl Micro 67mg Capsules

(fenofibrate)

Patient Information Leaflet (continued)

If you take more Lipanthyl Micro than you should

If you accidentally take more Lipanthyl Micro 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 Lipanthyl Micro

Do not take a double dose to make up for a forgotten capsule.

Take the next dose with your next meal and then carry on taking your capsules as usual. If you are worried about this talk to your doctor.

If you stop taking Lipanthyl Micro

Do not stop taking the medicine unless your doctor tells you to, or your medicine makes 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 Lipanthyl Micro. If your doctor stops your medicine, do not keep any left over capsules unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor.

Possible side effects

Like all medicines, Lipanthyl Micro can cause side effects, although not everybody gets them. Some patients have experienced the following side effects whilst taking fenofibrate:

Common (in less than 1 in 10, but more than 1 in 100 patients treated):

-    Stomach pain, being sick, feeling sick, diarrhoea and wind (flatulence)

-    Raised levels of various liver enzymes in the blood

Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients treated):

-    Pancreatitis (inflammation of the pancreas leading to stomach pain)

-    Blood clot in the lung causing chest pain and breathlessness (pulmonary embolism); blood clot in the leg causing pain, redness or swelling (deep vein thrombosis)

-    Gallstones (cholelithiasis)

-    Headache

-    Reactions such as rashes, itching or red patches on the skin

-    Muscle pain, muscle inflammation, muscle cramps, spasms or weakness

-    Reduced sex drive

-    Slight increases in blood levels of substances normally excreted by the kidneys (creatinine)

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):

-    Slight increases in blood levels of substances normally excreted by the kidneys (urea)

-    Hair loss

-    Increased sensitivity to light

-    Decrease in haemoglobin (oxygen carrying pigment in blood) and decrease in white blood cells

-    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

In addition to those events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of Lipantil Micro. A precise frequency cannot be estimated from the available data and is therefore classified as "not known”:

-    Muscle breakdown

-    Chronic disease of the lung tissues

-    Fatigue

-    Vertigo

If you develop any unusual discomfort, tell your doctor as soon as possible.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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 help provide more information on the safety of this medicine.

[m How to store Lipanthyl Micro

*    Store in the original package.

*    Do not store above 3o°C

*    KEEP OUT OF SIGHT AND REACH OF CHILDREN

*    Do not use this medicine after the expiry date shown on the carton label. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

*    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

*    Remember this medicine is for you. A doctor can only prescribe it. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours.

*    This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.

3 Further information

What this medicine contains:

Each capsule contains 67mg of fenofibrate (micronised) as the active ingredient. Fenofibrate is one of a group of medicines known as lipid modifying drugs (see below).

Your medicine also contains the following inactive ingredients: Lactose, sodium laurilsulfate, pregelatinised starch, crospovidone and magnesium stearate. The capsule is made of gelatin, titanium dioxide (E171), quinoline yellow (E104) and erythrosine (E127).

Your medicine contains 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.

What this medicine looks like and contents of the pack

Lipanthyl Micro are hard gelatin yellow capsules. Each blister pack contains 60 or 90 capsules.

Manufacturer and Licence Holder

This medicine is manufactured by Recipharm Fontaine, Rue des Pres Potets, 21121 Fontaine Les Dijon, France and procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|PQM| PL 15184/0511 Lipanthyl Micro 67mg Capsules Lipanthyl is a registered trademark of Fournier Industrie et Sante Revision date: 06/12/13

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.