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LIPANTHYL MICRO 67

Active substance(s): FENOFIBRATE MICRONISED

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Lipanthyl® Micro 67
(fenofibrate)
Your medicine is known by the above name but will be referred to as
Lipanthyl Micro throughout this:
Patient Information 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 Lipanthyl Micro is and what it is used for
2) What you need to know before you take Lipanthyl Micro
3) How to take Lipanthyl Micro
4) Possible side effects
5) How to store Lipanthyl Micro
6) Contents of the pack and other information

1) What Lipanthyl Micro is and what it is used for
Lipanthyl 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'.

Effects on muscles
Stop taking Lipanthyl 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 Lipanthyl Micro.

Lipanthyl Micro can often also increase the amount of a 'good' type of
cholesterol, called HDL or high density lipoprotein cholesterol.

Other medicines and Lipanthyl 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 Lipanthyl 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

It is always essential to continue a low-fat diet during treatment with
Lipanthyl Micro.

If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before taking Lipanthyl Micro.

2) What you need to know before you take Lipanthyl Micro

Lipanthyl 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.

Lipanthyl 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.
Lipanthyl 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.

Do not take Lipanthyl 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 Lipanthyl Micro if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Lipanthyl Micro.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking Lipanthyl 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 Lipanthyl Micro.
Your doctor might want to test your blood or urine to check if Lipanthyl
Micro is working properly and also if your kidneys, muscles and liver are
working properly.

Pregnancy, breast-feeding and fertility
• Do not take Lipanthyl Micro and tell your doctor if you are pregnant,
think you might be pregnant or are planning to have a baby
• Do not take Lipanthyl 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 Lipanthyl
Micro
Lipanthyl 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 Lipanthyl 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 (67 mg) three times a
day.

Use in children and adolescents
The usual dose for children is one capsule of Lipanthyl Micro 67mg per
20kg bodyweight per day. Your doctor will work out the dose that is
required.

• 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)

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.

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 gallbladder stones
• Jaundice
• Feeling dizzy (vertigo)
• Feeling exhausted (fatigue)

If you take more Lipanthyl Micro than you should
If you take more Lipanthyl 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 Lipanthyl 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 Lipanthyl Micro
Do not stop taking Lipanthyl 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 Lipanthyl 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 Lipanthyl 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 Lipanthyl 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.

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 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 Lipanthyl Micro





Do not store above 25°C. Keep in the original package.
Keep all medicines out of the reach and sight of children.
Do not take these capsules after the expiry date printed on the packet.
Take any capsules that are out of date, or which you no longer need,
back to your pharmacist.
• If the capsules become discoloured or show signs of any deterioration,
you should seek the advice of your pharmacist.
• Lipanthyl 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) Contents of the pack and other information
What Lipanthyl Micro contain
Your medicine is called Lipanthyl Micro 67. Each capsule contains 67mg of
the active ingredient fenofibrate, micronised.
Lipanthyl Micro 67 also contains the following ingredients: lactose, sodium
lauryl sulphate, pregelatinised maize starch, crospovidone, magnesium
stearate, gelatin, titanium dioxide (E171), quinoline yellow (E104) and
erythrosine (E127).
What Lipanthyl Micro looks like and contents of the pack
The capsules are yellow, hard gelatin capsules with no markings.
Lipanthyl Micro capsules are available as blister packs of 60 capsules.
PL 10383/0643

Lipanthyl Micro 67

POM

Who makes and repackages your medicine?
This product is manufactured by Laboratoires Fournier S.A. 28, boulevard
Clemenceau 2100, France and is procured from within the EU by the
Product Licence holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 08.07.2016
Lipanthyl is a registered trademark of BGP Products Operations GmbH.

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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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