Lipantil Micro 200 Capsules
534 LEAFLET Lipantil 20160419
PACKAGE LEAFLET: INFORMATION FOR THE USER LIPANTIL® MICRO 200 CAPSULES (fenofibrate)
Your medicine is known as Lipantil Micro 200 Capsules but will be referred to as Lipantil Micro throughout the following leaflet.
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 or 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, or pharmacist or nurse.
What is in this leaflet:
1. What Lipantil Micro is and what it is used for
2. What you need to know before you take Lipantil Micro
3. How to take Lipantil Micro
4. Possible side effects
5. How to store Lipantil Micro
6. Contents of the pack and other information
1. WHAT LIPANTIL MICRO IS AND WHAT IT IS USED FOR
Lipantil Micro 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 (called ‘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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIPANTIL MICRO
Do not take Lipantil Micro 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 anti-inflammatory 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 if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lipantil Micro.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking Lipantil Micro 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 (hypo-thyroidism)
• 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.
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.
Effects on muscles
Stop taking Lipantil Micro 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 Lipantn Micro.
Other medicines and Lipantil Micro
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 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.
Lipantil Micro 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 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 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
Lipantil Micro contains lactose (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
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 200 mg a day, taken at mealtimes.
Use in children and adolescents
The use of Lipantil Micro 200mg is 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 than you should
If you 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
• 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
Do not stop taking Lipantil Micro 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 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 or 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 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 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
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 bums
• 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, or 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
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Store the capsules below 25°C in a dry place. Protect from light.
• Do not take these capsules after the expiry date printed on the packet.
• If the capsules show any signs of deterioration, or are out of date, check with your pharmacist who will tell you what to do.
• If your doctor tells you to stop taking these capsules, take any which you have left back to your pharmacist for safe disposal. Only keep the capsules if the doctor tells you to.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Lipantil Micro contains
• Each capsule contains 200 milligrams (mg) of micronised fenofibrate.
• Each capsule also contains lactose, sodium lauryl sulphate, pregelatinised starch, crospovidone and magnesium stearate.
• The capsule shell is made of gelatin, and is coloured with titanium dioxide (E 171), and erythrosine (E 127) and iron oxide (E172).
What Lipantil Micro looks like and contents of the pack
Lipantil Micro capsules are orange coloured capsules.
The capsules are available as blister packs of 30 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Recipharm Fontaine, Rue des Pres Potets, 21121 Fontaine Les Dijon, France.
| POM | PL 08747/0534 Leaflet revision date: 19 April 2016
Lipantil® is a registered trade mark of BGP Products Operations GmbH, Switzerland.
534 LEAFLET Lipantil 20160419