Lipantil 200 Micronised
Out of date information, search another6. Further information
Each hard orange, gelatin capsule contains 200mg of the active ingredient fenofibrate micronised.
The capsules also contain lactose, magnesium stearate, pregelatinised maize starch, sodium lauryl sulphate, crospovidone, gelatin, titanium dioxide (E171), iron oxide (E172) and erythrosine (E127).
Each pack contains 30 capsules.
PL 20774/0130 Lipanthyl 200 Micronised / Lipantil 200 Micronised
POM
This medicine is manufactured by: Recipharm Fontaine, rue de pres potets21121 Fontaine, Les-Dijon, France and is procured from within the ELI and repackaged on behalf of the Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA
Leaflet prepared 20th January 2014
Lipanthyl is a registered trademark of Fournier Industrie et Sante.
PP6/0130/V2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lipanthyl® 200 Micronised / Lipantil 200 Micronised (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.
Your medicine is available in the above two names but will be referred to as Lipanthyl 200 Micronised throughout the leaflet.
Your medicine is also available in the following strengths 267and 67 Micronised.
In this leaflet:
1. What Lipanthyl 200 Micronised is and what it is used for
2. Before you take Lipanthyl 200 Micronised
3. Howto take Lipanthyl 200 Micronised
4. Possible side effects
5. How to store Lipanthyl 200 Micronised
6. Further information
1. What Lipanthyl 200 Micronised is and what it is used for
Lipanthyl 200 Micronised 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 200 Micronised 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 200 Micronised 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.
It is always essential to continue a low-fat diet during treatment with Lipanthyl 200 Micronised.
2. Before you take Lipanthyl 200 Micronised Do not take Lipanthyl 200 Micronised if:
• You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Lipanthyl 200 Micronised.
• 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 Lipanthyl 200 Micronised
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.
Lipanthyl 200 Micronised can often also increase the amount of a “good” type of cholesterol, called HDL or high density lipoprotein cholesterol.
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 200 Micronised 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 “statin” or “fibrates”). Taking a “statin” (e.g. simvastain, atorvastatin) at the same time as Lipanthyl 200 Micronised 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 200 Micronised must not be taken if you are pregnant.
Breast-feeding
You must not use Lipanthyl 200 Micronised 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 200 Micronised
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. Howto take Lipanthyl 200 Micronised
Always take Lipanthyl 200 Micronised 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 200 Micronised a day, taken at mealtimes.
Use in children and adolescents
Lipanthyl 200 Micronised 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 Lipanthyl 200 Micronised than you should
If you accidentally take more Lipanthyl 200 Micronised 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 200 Micronised
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 200 Micronised
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 fora long period of time. Remember you should also continue with a low-fat diet whilst taking Lipanthyl 200 Micronised. 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, Lipanthyl 200 Micronised 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 200 Micronised. 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 Lipanthyl 200 Micronised
Do not store above 30°C.
Keep this medicine in its original package.
Keep out of the sight and reach of children.
If your doctor decides to stop treatment return any tablets you have left to the pharmacist for safe disposal. Only keep them if your doctor tells you to.
Do not use after the expiry date shown on the packaging. If the tablets show any signs of deterioration or discolouration, seek the advice of your pharmacist who will show you what to do.
Lipanthyl 200 Micronised should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.