Lipantil Micro 200mg Capsules
LIPANTIL® MICRO 200MG CAPSULES
(fenofibrate)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor, pharmacist or nurse.
■ This medicine has been prescribed for you only. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.
PACKAGE LEAFLET: INFORMATION FOR THE USER
What is in this leaflet:
1. What Lipantil Micro 200mg Capsules are and what they are used for
2. What you need to know 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. Contents of the pack and other 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 (called '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. What you need to know before you take Lipantil Micro 200mg Capsules
Do not take Lipantil Micro 200mg Capsules if:
■ You are allergic to fenofibrate or any of the other ingredients of this medicine (listed in Section 6:
Contents of the pack and other information)
■ While taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and an antiinflammatory medicine called 'ketoprofen')
■ You have severe liver, kidney or gallbladder problems
■ You have pancreatitis (an inflamed pancreas which causes abdominal pain), which is not caused by high levels of fat in the blood
Do not take Lipantil Micro 200mg Capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lipantil Micro 200mg Capsules.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Lipantil Micro 200mg Capsules if:
■ You have any liver or kidney problems
■ You may have an inflamed liver (hepatitis) - signs include yellowing of the skin and the whites of the eyes (jaundice) and an increase in liver enzymes (shown in blood tests)
■ You have an under-active thyroid gland (hypothyroidism)
■ You have diabetes, especially Type 2 diabetes, that is not well controlled
■ You have problems with certain proteins in your blood
■ You have an alcohol problem
■ You are taking other medicines
■ You or your family have had muscle problems
■ 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).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lipantil Micro 200mg Capsules.
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.
Effects on muscles
Stop taking Lipantil Micro 200mg Capsules and see a doctor straight away if you get unexplained cramps or painful, tender or weak muscles while taking this medicine.
■ This is because this medicine may cause muscle problems, which may be serious
■ These problems are rare but include muscle inflammation and breakdown. This can cause kidney damage or even death
Your doctor may do a blood test to check your muscles before and after starting treatment.
The risk of muscle breakdown is higher in some patients.
Tell your doctor if:
■ You are over 70 years old
■ You have kidney problems
■ You have thyroid problems
■ You or a close family member has a muscle problem which runs in the family
■ You drink large amounts of alcohol
■ You are taking medicines called statins to lower cholesterol - such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
■ You have ever had muscle problems during treatment with statins or fibrates - such as fenofibrate, bezafibrate or gemfibrozil
If any of the above apply to you (or you are not sure), talk to your doctor before taking Lipantil Micro 200mg Capsules.
Other medicines and Lipantil Micro 200mg Capsules
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
■ Anti-coagulants to thin your blood (such as warfarin)
■ Other medicines to control fat levels in the blood (such as statins or fibrates). Taking a statin at the same time as Lipantil Micro 200mg Capsules may increase the risk of muscle problems
■ A particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)
■ Cyclosporin - used to suppress your immune system
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lipantil Micro 200mg Capsules.
Lipantil Micro 200mg Capsules with food, drink and alcohol
It is important to take the capsule with food - it will not work as well if your stomach is empty.
Pregnancy, breast-feeding and fertility
■ Do not take Lipantil Micro 200mg Capsules and tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby
■ Do not take Lipantil Micro 200mg Capsules if you are breast-feeding or planning to breast-feed your baby
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine will not affect you being able to drive or use tools or machines.
Important information about some of the ingredients of Lipantil Micro 200mg Capsules
Lipantil Micro 200mg Capsules contains lactose monohydrate (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
3. How to take Lipantil Micro 200mg Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Also, please read the label on the packet. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
■ Swallow the capsule whole with a glass of water
■ Do not open or chew the capsule
■ Take the capsule with food - it will not work as well if your stomach is empty
How much to take
The recommended dose for adults is one capsule of Lipantil Micro 200mg Capsules a day, taken at mealtimes.
Use in children and adolescents
The use of Lipantil Micro 200mg Capsules are not recommended 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 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
■ If you forget a dose, take the next dose with your next meal
■ Then take your next capsule at the normal time
■ Do not take a double dose to make up for a forgotten dose
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 the capsules make you feel unwell. This is because abnormal levels of fats in the blood need treating for a long period of time.
Remember that as well as taking Lipantil Micro 200mg Capsules it is also important that you:
■ Have a low fat diet
■ Take regular exercise
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lipantil Micro 200mg Capsules and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
■ Allergic reaction - the signs may include swelling of the face, lips, tongue or throat, which may cause difficulty in breathing
■ Cramps or painful, tender or weak muscles - these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death
■ Stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis)
■ Chest pain and feeling breathless - these may be signs of a blood clot in the lung (pulmonary embolism)
■ Pain, redness or swelling in the legs - these may be signs of a blood clot in the leg (deep vein thrombosis)
■ Yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes - these may be signs of an inflamed liver (hepatitis)
Stop taking Lipantil Micro 200mg Capsules and see a doctor straight away, if you notice any of the side effects above.
Other side effects include:
Common (affects less than 1 in 10 people):
■ Diarrhoea
■ Stomach pain
■ Wind (flatulence)
■ Feeling sick (nausea)
■ Being sick (vomiting)
■ Raised levels of liver enzymes in the blood - shown in tests
POM
Uncommon (affects less than 1 in 100 people):
■ Headache
■ Gallstones
■ Reduced sex drive
■ Rash, itching or red patches on the skin
■ Increase in 'creatinine' produced by the kidneys - shown in tests
■ Pancreatitis (inflammation of the pancreas leading to abdominal pain)
■ Thromboembolism: pulmonary embolism (blood clot in the lung causing chest pain and breathlessness), deep vein thrombosis (blood clot in the leg causing pain, redness or swelling)
■ Muscle pain, muscle inflammation, muscle cramps and weakness
Rare (affects less than 1 in 1,000 people):
■ Hair loss
■ Increase in 'urea' produced by the kidneys - shown in tests
■ Increased sensitivity of your skin to sunlight, sun lamps and sunbeds
■ Drop in haemoglobin (that carries oxygen in the blood) and white blood cells - shown in tests
■ 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
■ Hypersensitivity (allergic reaction)
Side effect where the chance of it happening are not known
■ Severe form of skin rash with reddening, peeling and swelling of the skin that resembles severe burns
■ Long-term lung problems
■ Muscle breakdown
■ Complications of gallbladder stones
■ Jaundice
■ Feeling dizzy (vertigo)
■ Feeling exhausted (fatigue)
If you get any unusual breathing discomfort, tell your doctor straight away.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
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.
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. Contents of the pack and other 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 (E172) 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 Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0231
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: 26.05.16
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