Lipantil Micro 200mg Capsules
Out of date information, search anotherLIPANTIL® MICRO 200MG CAPSULES
(fenofibrate)
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
In this leaflet:
1. What Lipantil Micro 200mg Capsules are and what they are used for
2. Before you take Lipantil Micro 200mg Capsules
3. How to take Lipantil Micro 200mg Capsules
4. Possible side effects
5. How to store Lipantil Micro 200mg Capsules
6. Further information
1. What Lipantil Micro 200mg Capsules are and what they are used for
Lipantil Micro 200mg Capsules belong 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 200mg Capsules are 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 200mg Capsules 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 200mg Capsules 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 200mg Capsules.
2. Before you take Lipantil Micro 200mg Capsules
Do not take Lipantil Micro 200mg Capsules if:
■ You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Lipantil Micro 200mg Capsules.
■ 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 200mg Capsules:
Tell your doctor before you start to take Lipantil Micro 200mg Capsules:
■ 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 200mg Capsules are 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 Micro 200mg Capsules are 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 200mg Capsules 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 200mg Capsules must not be taken if you are pregnant.
Breast-feeding
You must not use Lipantil Micro 200mg Capsules if you are breastfeeding or if you are planning to breast-feed your baby.
Driving and using machines
Lipantil Micro 200mg Capsules should not affect your ability to drive or use machines.
Important information about some of the ingredients of Lipantil Micro 200mg Capsules
Lipantil Micro 200mg Capsules contain lactose monohydrate which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Lipantil Micro 200mg Capsules.
3. How to take Lipantil Micro 200mg Capsules
Always take Lipantil Micro 200mg Capsules 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 Capsules a day, taken at mealtimes.
Use in children and adolescents
Lipantil Micro 200mg Capsules are not recommended for use in children under the age of 18.
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 Micro 200mg Capsules than you should
If you accidentally take more Lipantil Micro 200mg Capsules 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 200mg Capsules
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 200mg Capsules
Do not stop taking Lipantil Micro 200mg Capsules 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 200mg Capsules. 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 Lipantil Micro 200mg Capsules, ask your doctor.
4. Possible side effects
Like all medicines, Lipantil Micro 200mg capsules 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 increase 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 200mg Capsules. 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.
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. Website: 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 Lipantil Micro 200mg Capsules
Do not store above 30°C. Store in the original package. KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last day of that month.
If your doctor decides to stop treatment, return any leftover capsules to the pharmacist. Only keep them if your doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.
Medicines 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.
6. Further information
What Lipantil Micro 200mg Capsules contain
Each capsule contains 200mg of the active ingredient fenofibrate.
Lipantil Micro 200mg Capsules also contain the following ingredients: lactose monohydrate, sodium lauryl sulphate, pregelatinised starch, crospovidone, magnesium stearate, gelatin, titanium dioxide (E171), ferrous oxide (El72) and erythrosine (E127).
What Lipantil Micro 200mg Capsules look like and contents of the pack
The capsules are orange hard gelatin capsules with no markings. Lipantil Micro 200mg Capsules are available as blister packs of 30 capsules.
Manufacturer
Your medicine is manufactured by: RECIPHARM Fontaine,
Rue des Pres Potets, F 21121 Fontaine-les-Dijon, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceutical Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0231 | POM
Lipantil® is a registered trademark of Fournier Industrie et Sante.
If you wish to receive this leaflet in Braille, large font or audio format please contact 01302 365000 and ask for the Regulatory Department.
Leaflet revision date: 23.01.15
LIPANTHYL® MICRO 200MG CAPSULES
(fenofibrate)
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
In this leaflet:
1. What Lipanthyl Micro 200mg Capsules are and what they are used for
2. Before you take Lipanthyl Micro 200mg Capsules
3. How to take Lipanthyl Micro 200mg Capsules
4. Possible side effects
5. How to store Lipanthyl Micro 200mg Capsules
6. Further information
1. What Lipanthyl Micro 200mg Capsules are and what they are used for
Lipanthyl Micro 200mg Capsules belong 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 200mg Capsules are 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 200mg Capsules 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 Micro 200mg Capsules 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 200mg Capsules.
2. Before you take Lipanthyl Micro 200mg Capsules
Do not take Lipanthyl Micro 200mg Capsules if:
■ You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Lipanthyl Micro 200mg Capsules.
■ 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 200mg Capsules:
Tell your doctor before you start to take Lipanthyl Micro 200mg Capsules:
■ 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 200mg Capsules are 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 Micro 200mg Capsules are 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 200mg Capsules 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 200mg Capsules must not be taken if you are pregnant.
Breast-feeding
You must not use Lipanthyl Micro 200mg Capsules if you are breast-feeding or if you are planning to breast-feed your baby.
Driving and using machines
Lipanthyl Micro 200mg Capsules should not affect your ability to drive or use machines.
Important information about some of the ingredients of Lipanthyl Micro 200mg Capsules
Lipanthyl Micro 200mg Capsules contain lactose monohydrate which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Lipanthyl Micro 200mg Capsules.
3. How to take Lipanthyl Micro 200mg Capsules
Always take Lipanthyl Micro 200mg Capsules 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 Capsules a day, taken at mealtimes.
Use in children and adolescents
Lipanthyl Micro 200mg Capsules are not recommended for use in children under the age of 18.
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 Micro 200mg Capsules than you should
If you accidentally take more Lipanthyl Micro 200mg Capsules 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 200mg Capsules
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 200mg Capsules
Do not stop taking Lipanthyl Micro 200mg Capsules 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 200mg Capsules. 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 Lipanthyl Micro 200mg Capsules, ask your doctor.
4. Possible side effects
Like all medicines, Lipanthyl Micro 200mg Capsules 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 Micro 200mg Capsules. 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
■ Fatique
■ Vertigo
If you develop any unusual discomfort, tell your doctor as soon as possible.
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. Website: 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 Lipanthyl Micro 200mg Capsules
Do not store above 30°C. Store in the original package. KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last day of that month.
If your doctor decides to stop the treatment, return any leftover capsules to the pharmacist. Only keep them if your doctor tells you to.
If the capsules appear discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.
Medicines 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.
6. Further information
What Lipanthyl Micro 200mg Capsules contain
Each capsule contains 200mg of the active ingredient fenofibrate.
Lipanthyl Micro 200mg Capsules also contain the following ingredients: lactose monohydrate, sodium lauryl sulphate, pregelatinised starch, crospovidone, magnesium stearate, gelatin, titanium dioxide (E171), ferrous oxide (E172) and erythrosine (E127).
What Lipanthyl Micro 200mg Capsules look like and contents of the pack
The capsules are orange hard gelatin capsules with no markings. Lipanthyl Micro 200mg Capsules are available as blister packs of 30 capsules.
Manufacturer
Your medicine is manufactured by: RECIPHARM Fontaine,
Rue des Pres Potets, F 21121 Fontaine-les-Dijon, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceutical Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0231 I POM |
Lipanthyl® is a registered trademark of Fournier Industrie et Sante.
If you wish to receive this leaflet in Braille, large font or audio format please contact 01302 365000 and ask for the Regulatory Department.
Leaflet revision date: 23.01.15
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