Lipantil Micro 200
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Lipantil*1 Micro 200 mg 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.
In this leaflet:
1. What Lipantil Micro is and what it is used for
2. Before you take Lipantil Micro
3. How to take Lipantil Micro
4. Possible side effects
5. How to store Lipantil Micro
6. Further information
1. WHAT LIPANTIL MICRO 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 Micro is used, alongside a low fat diet and other nonmedical 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.
2. 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 200 mg.
• 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
• 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 200 mg a day, taken at mealtimes.
Use in children and adolescents
Lipantil Micro is 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 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.
4. 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 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
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.
5. HOWTO STORE LIPANTIL MICRO
Keep this medicine in the original package in order to protect from
moisture. Do not store above 30°C
Keep out of the reach and sight of children.
Do not use Lipantil Micro 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.
Lipantil Micro 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 contains
Each Lipantil Micro 200 capsule contains the active ingredient: 200 milligrams (mg) of fenofibrate.
Each capsule also contains the following inactive ingredients: lactose monohydrate, magnesium stearate, sodium laurilsulfate, pregelatinised starch and crospovidone.
The capsule is made of gelatin, titanium dioxide (E171), erythrosine (El 27), and ferrous oxide (E 172).
What Lipantil Micro looks like and contents of the pack Lipantil Micro 200 mg is supplied to you as orange, hard gelatin capsules. Lipantil Micro 200 mg is provided in blister packs of 10, 28 or 30 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
BGP Products Ltd.
Abbott House Vanwall Business Park Vanwall Road Maidenhead, SL64XE.UK.
Rue des Pres Potets - 21121 Fontaine Les Dijon - France (p
Q_
This leaflet was last revised in February 2015. s
If you wish to receive this PIL in Braille, large font or audio format please contact 023 8046 7000
p] Abbott
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
Lipantil® Micro 200 mg capsules
(fenofibrate)
In this leaflet:
1. What Lipantil Micro is and what it is used for
2. Before you take Lipantil Micro
3. How to take Lipantil Micro
4. Possible side effects
5. How to store Lipantil Micro
6. Further information
1. WHAT LIPANTIL MICRO 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 Micro is used, alongside a low fat diet and other nonmedical 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.
2. 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 200 mg.
• 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 antiinflammatory 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
• 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 200 mg a day, taken at mealtimes.
Use in children and adolescents
Lipantil Micro is 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.
MKP-00024-2015
|[fpo
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.
4. 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 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
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.
5. HOW TO STORE LIPANTIL MICRO
Keep this medicine in the original package in order to protect from moisture. Do not store above 30°C
Keep out of the reach and sight of children.
Do not use Lipantil Micro 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.
Lipantil Micro 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 contains
Each Lipantil Micro 200 capsule contains the active ingredient:
200 milligrams (mg) of fenofibrate.
Each capsule also contains the following inactive ingredients: lactose monohydrate, magnesium stearate, sodium laurilsulfate, pregelatinised starch and crospovidone.
The capsule is made of gelatin, titanium dioxide (E171), erythrosine (E127), and ferrous oxide (E 172).
What Lipantil Micro looks like and contents of the pack Lipantil Micro 200 mg is supplied to you as orange, hard gelatin capsules. Lipantil Micro 200mg is provided in blister packs of 10, 28 or 30 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
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