Ref: LTT0039/260315/1 /F

Lipantil Micro 200mg 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 200mg Capsules and will be referred to as Lipantil throughout this leaflet.

In this leaflet:

[p What Lipantil is and what it is used for

[p Before you take Lipantil

[p How to take Lipantil

[p Possible side effects

[p How to store Lipantil

[p Further information

^ What Lipantil is and what it is used for

Lipantil Micro 200mg 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 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 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 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.

[p Before you take Lipantil

Do not take Lipantil Micro if:

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

_*    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

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 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

_*    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 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 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 must not be taken if you are pregnant.

Breast-feeding

You must not use Lipantil 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

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.

[p How to take Lipantil

Always take Lipantil 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 200mg a day, taken at mealtimes.

(fenofibrate)

Patient Information Leaflet (continued)

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.

If you take more Lipantil than you should

If you accidentally take more Lipantil 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

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

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. 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, Lipantil 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 substances 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

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.

How to store Lipantil

*    Store in the original package.

_*    Do not store above 30°C

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Lipantil after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month.

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.

Lipantil 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.

Further information

What Lipantil contains:

Each hard capsule contains 200 mg of fenofibrate as the active ingredient.

Your medicine also contains the following inactive ingredients: Lactose monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and magnesium stearate.

The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127) and ferric oxide (E 172)

What Lipantil looks like and contents of the pack Lipantil are gelatin, orange capsules containing white powder.

Each pack contains 30 capsules.

Manufacturer and Licence Holder

Lipantil is manufactured by RECIPHARM Fontaine, Rue des Pres Potets F 21121 Fontaine-les-Dijon, France.

Procured from within the EU by the Product Licence Holder LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,

B98 0RE, UK.

POM PL 33723/0039 Lipantil Micro 200mg Capsules Lipantil is a registered trademark of Fournier Industrie et Sante. Revision date: 26/03/15

Blind or partially sighted?

Is this leaflet hard to see or read?

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

(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 200mg Capsules and will be referred to as Lipanthyl throughout this leaflet.

In this leaflet:

What Lipanthyl is and what it is used for

Before you take Lipanthyl

How to take Lipanthyl

Possible side effects

How to store Lipanthyl

Further information

^ What Lipanthyl is and what it is used for

Lipanthyl Micro 200mg 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 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 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.

Lipanthyl 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.

Before you take Lipanthyl

Do not take Lipanthyl Micro if:

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

_*    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

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 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

_*    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 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 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 must not be taken if you are pregnant.

Breast-feeding

You must not use Lipanthyl 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

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

Always take Lipanthyl 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 Lipanthyl Micro 200mg a day, taken at mealtimes.

(fenofibrate)

Patient Information Leaflet (continued)

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.

If you take more Lipanthyl than you should

If you accidentally take more Lipanthyl 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

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

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. 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 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 substances 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 Lipanthyl. 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

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.

How to store Lipanthyl

*    Store in the original package.

_*    Do not store above 30°C

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Lipanthyl after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month.

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.

Lipanthyl 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.

Further information

What Lipanthyl contains:

Each hard capsule contains 200 mg of fenofibrate as the active ingredient.

Your medicine also contains the following inactive ingredients: Lactose monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and magnesium stearate.

The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127) and ferric oxide (E 172)

What Lipanthyl looks like and contents of the pack Lipanthyl are gelatin, orange capsules containing white powder.

Each pack contains 30 capsules.

Manufacturer and Licence Holder

Lipanthyl is manufactured by RECIPHARM Fontaine, Rue des Pres Potets F 21121 Fontaine-les-Dijon, France.

Procured from within the EU by the Product Licence Holder LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,

B98 0RE, UK.

[POM] PL 33723/0039 Lipanthyl Micro 200mg Capsules Lipanthyl is a registered trademark of Fournier Industrie et Sante. Revision date: 26/03/15

Blind or partially sighted?

Is this leaflet hard to see or read?

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

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 Fenofibrate Micro 200mg Capsules and will be referred to as Fenofibrate throughout this leaflet.

In this leaflet:

What Fenofibrate is and what it is used for Before you take Fenofibrate How to take Fenofibrate [p Possible side effects

How to store Fenofibrate ,6 Further information

^ What Fenofibrate is and what it is used for

Fenofibrate Micro 200mg 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.

Fenofibrate 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.

Fenofibrate 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.

Fenofibrate 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 Fenofibrate.

[p Before you take Fenofibrate

Do not take Fenofibrate Micro if:

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

*    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 Fenofibrate

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 Fenofibrate 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

_*    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 Fenofibrate 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 Fenofibrate 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. Fenofibrate must not be taken if you are pregnant.

Breast-feeding

You must not use Fenofibrate 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 Fenofibrate

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.

[p How to take Fenofibrate

Always take Fenofibrate 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 Fenofibrate Micro 200mg a day, taken at mealtimes.

Patient Information Leaflet (continued)

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.

If you take more Fenofibrate than you should

If you accidentally take more Fenofibrate 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 Fenofibrate

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 Fenofibrate

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 Fenofibrate. 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, Fenofibrate 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 inammation, 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 substances 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 Fenofibrate. 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

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.

How to store Fenofibrate

*    Store in the original package.

_*    Do not store above 30°C

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Fenofibrate after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month.

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.

Fenofibrate 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.

Further information

What Fenofibrate contains:

Each hard capsule contains 200 mg of fenofibrate as the active ingredient.

Your medicine also contains the following inactive ingredients: Lactose monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and magnesium stearate.

The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127) and ferric oxide (E 172)

What Fenofibrate looks like and contents of the pack Fenofibrate are gelatin, orange capsules containing white powder.

Each pack contains 30 capsules.

Manufacturer and Licence Holder

Fenofibrate is manufactured by RECIPHARM Fontaine, Rue des Pres Potets F 21121 Fontaine-les-Dijon, France.

Procured from within the EU by the Product Licence Holder LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,

B98 0RE, UK.

[POM] PL 33723/0039 Lipanthyl Micro 200mg Capsules Revision date: 26/03/15

Blind or partially sighted?

Is this leaflet hard to see or read?

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

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.