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LIPANTIL MICRO 200 CAPSULES

Active substance(s): FENOFIBRATE MICRONISED

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534 LEAFLET Lipantil 20160419

Effects on muscles

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.

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



Keep this leaflet. You may need to read it again.

Your doctor may do a blood test to check your muscles before and
after starting treatment.



If you have any further questions, ask your doctor or pharmacist
or nurse.

The risk of muscle breakdown is higher in some patients. Tell your
doctor if:



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.



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

What is in this leaflet:



You drink large amounts of alcohol

1. What Lipantil Micro is and what it is used for



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 side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, or
pharmacist or nurse.

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

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

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.

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)



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

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



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

A particular class of medicines to treat diabetes (such as
rosiglitazone or pioglitazone)



Cyclosporin - used to suppress your immune system

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIPANTIL
MICRO

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

Do not take Lipantil Micro if:

Lipantil Micro with food, drink and alcohol



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)

It is important to take the capsule with food - it will not work as well
if your stomach is empty.



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

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.

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:

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



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)

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.



You have diabetes, especially Type 2 diabetes, that is not well
controlled

3. HOW TO TAKE LIPANTIL MICRO



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.

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

Rare (affects less than 1 in 1,000 people):

The use of Lipantil Micro 200mg is not recommended in children
under the age of 18.



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)

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.

Side effect where the chance of it happening are not known
If you forget to take Lipantil Micro



Severe form of skin rash with reddening, peeling and swelling of
the skin that resembles severe bums

Then take your next capsule at the normal time



Long-term lung problems

Do not take a double dose to make up for a forgotten dose



Muscle breakdown



Complications of gallbladder stones



Jaundice

If you stop taking Lipantil Micro



Feeling dizzy (vertigo)

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.



Feeling exhausted (fatigue)



If you forget a dose, take the next dose with your next meal




If you are worried about this talk to your doctor.

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:

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.



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)

6. CONTENT OF THE PACK AND OTHER INFORMATION



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)



Each capsule contains 200 milligrams (mg) of micronised
fenofibrate.



Each capsule also contains lactose, sodium lauryl sulphate,
pregelatinised starch, crospovidone and magnesium stearate.

Stop taking Lipantil Micro and see a doctor straight away, if you
notice any of the side effects above.

What Lipantil Micro contains





Diarrhoea

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



Stomach pain

Lipantil Micro capsules are orange coloured capsules.



Wind (flatulence)



Feeling sick (nausea)

The capsules are available as blister packs of 30 capsules.
Product Licence holder



Being sick (vomiting)



Raised levels of liver enzymes in the blood - shown in tests

Other side effects include:
Common (affects less than 1 in 10 people):

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.
Manufacturer

Uncommon (affects less than 1 in 100 people):

This product is manufactured by Recipharm Fontaine, Rue des
Prés Potets, 21121 Fontaine Les Dijon, France.



Headache



Gallstones



Reduced sex drive



Rash, itching or red patches on the skin

Leaflet revision date: 19 April 2016



Increase in 'creatinine' produced by the kidneys - shown in tests



Pancreatitis (inflammation of the pancreas leading to abdominal
pain)

Lipantil® is a registered trade mark of BGP Products Operations
GmbH, Switzerland.



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

POM

PL 08747/0534

534 LEAFLET Lipantil 20160419

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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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