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LIPANTHYL 267MG MICRONISED CAPSULES

Active substance(s): FENOFIBRATE MICRONISED

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LIPANTIL® MICRO 267mg CAPSULES/
LIPANTHYL 267mg MICRONISED 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 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.
The name of your medicine is LIPANTIL MICRO 267mg CAPSULES/LIPANTHYL
267mg MICRONISED CAPSULES but will be referred to as Lipantil micro
throughout this leaflet
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 non-medical 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 gall bladder 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 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 Lipantil 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, and 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 200mg a day,
taken at mealtimes. However, your doctor may want you to take one capsule of
Lipantil micro 267mg a day (a higher dose).
Use in children and adolescents
The use of Lipantil micro 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 capsule
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
increases 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 effects 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 gall bladder 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.
Do not store above 30°C. Store in the original package.
Do not take capsules after the expiry date which is stated on the carton and
blister label after ‘Exp’. The expiry date refers to the last day of that month.
If the capsules become discoloured or show any signs of deterioration, seek
the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine, return any
unused capsules to your pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
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 contains
The active ingredient in Lipantil micro is fenofibrate.
Each capsule contains 267mg fenofibrate.
The other ingredients are: lactose, magnesium stearate, pregelatinised maize
starch, sodium laurilsulfate, crospovidone, titanium dioxide (E171), red iron oxide
(E172), yellow iron oxide (E172) and gelatin.
What Lipantil micro looks like and contents of the pack
Lipantil micro is in an orange cap and pale yellow body.
Lipantil micro is available as blister packs of 30 capsules.
Manufactured by: Recipharm Fontaine, Rues des Prets Potets, 21121
Fontaine-les-Dijon, France.
Procured from within the EU and repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
®

LIPANTIL MICRO 267mg CAPSULES/LIPANTHYL 267mg MICRONISED
CAPSULES
PL 18799/2773
POM
Leaflet date: 27.04.2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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