LIPANTIL MICRO 200 CAPSULES

Active substance: FENOFIBRATE MICRONISED

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Important advice regarding muscle effects:

534 LEAFLET Lipantil 20130207

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.

Contact your doctor quickly if you experience unexplained muscle
pain, tenderness or weakness. This is because on rare occasions,
there is a risk of muscle problems which may be serious, including
muscle breakdown which can cause kidney damage. Your doctor
may perform a blood test to check the condition of your muscles
before and after starting treatment.
The risk of muscle breakdown is greater in certain patients.
Tell your doctor if any of the following applies to you:

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



You have any kidney problems

-

If you have any further questions, ask your doctor.



An under active thyroid

-

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



You often drink large amounts of alcohol



You have ever had muscle problems during treatment with
cholesterol lowering medicines called “statins” (such as
simvastatin, atorvastatin, pravastatin, rosuvastatin or
fluvastatin) or fibrates (such as fenofibrate, bezafibrate or
gemfibrozil)



you or close family members have a hereditary muscle disorder

-

-

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

In this leaflet:
1. What Lipantil Micro is and what it is used for
2. Before you take Lipantil Micro
3. How to take Lipantil Micro
4. Possible side effects
5. How to store Lipantil Micro
6. Further information
1. WHAT LIPANTIL MICRO IS AND WHAT IT IS USED FOR
Lipantil Micro 200mg 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 [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. BEFORE YOU TAKE LIPANTIL MICRO
Do not take Lipantil Micro if:


You are allergic (hypersensitive) to fenofibrate, or any of the
other ingredients of Lipantil Micro 200 mg.



You suffer from liver or kidney disease or gallbladder disease.



Sunlight or UV light have caused an allergic reaction
(photoallergy) or skin damage while you were taking fibrates or
an anti-inflammatory drug called ketoprofen in the past.



You suffer from pancreatitis (inflammation of the pancreas
leading to abdominal pain) unless it is caused by high levels of
fat in the blood (hypertriglyceridemia).
Take special care with Lipantil Micro
Tell your doctor before you start to take this medicine:

The risk of muscle problems can be greater if Lipantil Micro is taken
with cholesterol lowering medicines called “statins” (such as
simvastatin, atorvastatin, pravastatin, rosuvastatin, fluvastatin). Tell
your doctor if you are taking any of these medicines.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a
prescription.
In particular please let your doctor know if you already take:


Anticoagulants to thin your blood (for example, warfarin).



Other drugs to control lipid (fat) levels in the blood (for example,
drugs known as “statins” or “fibrates”). Taking a “statin” (e.g.
simvastatin, atorvastatin) at the same time as Lipantil Micro can
increase the risk of muscle problems.



Ciclosporin (an immunosuppressant).

 Drugs to control Type 2 diabetes (glitazones).
Pregnancy and breast-feeding
Pregnancy
Tell your doctor if you are, you think you might be or are planning to
become pregnant. Lipantil Micro must not be taken if you are
pregnant.
Breast-feeding
You must not use Lipantil Micro if you are breast-feeding or if you
are planning to breastfeed your baby.
Driving and using machines
This medicine should not affect your ability to drive or use
machines.
Important information about some of the ingredients of Lipantil
Micro
This medicine contains lactose which is a type of sugar.
If you have been told by your doctor that you have a intolerance to
some sugars, contact your doctor before taking this medicinal
product.
3. HOW TO TAKE LIPANTIL MICRO
Always take Lipantil Micro exactly as your doctor has told you.



If you have any kidney problems



If you suffer from an under active thyroid gland (hypothyroidism)



If you have diabetes, especially Type 2 diabetes, that is not well
controlled.



If you have liver problems.



If you have problems with certain proteins in your blood



The usual dose for adults is one capsule of Lipantil Micro 200 mg a
day, taken at mealtimes.

If you have an alcohol problem.

Use in children and adolescents



You are taking other medicines.



If you or your family have had muscle problems

Lipantil Micro is not recommended for use in children under the age
of 18.



If you are over 70 years of age

People with kidney problems

Also, please read the label on the packet. You should check with
your doctor if you are not sure.
Swallow the capsule whole with a glass of water. It is important to
take the capsule with food, as it will not work as well if your stomach
is empty.

(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 you have kidney problems, your doctor may tell you to take a
lower dose. Ask your doctor or pharmacist about this.

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.

If you accidentally 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 take more Lipantil Micro than you should

If you forget to take Lipantil Micro

5. HOW TO STORE LIPANTIL MICRO

Do not take a double dose to make up for a forgotten capsule. Take
the next dose with your next meal and then carry on taking your
capsules as usual. If you are worried about this talk to your doctor.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store the capsules below 25°C in a dry place. Protect from light.

If you stop taking Lipantil Micro



Do not stop taking the medicine unless your doctor tells you to, or
your medicine makes you feel unwell. This is because raised
cholesterol levels need treating for a long period of time.

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.

Remember you should also continue with a low-fat diet whilst taking
Lipantil Micro. If your doctor stops your medicine, do not keep any
left over capsules unless your doctor tells you to. If you have any
further questions on the use of this product, ask your doctor.

6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS

What Lipantil Micro contains

Like all medicines, Lipantil Micro can cause side effects, although
not everybody gets them. Some patients have experienced the
following side effects whilst taking fenofibrate:
Common (in less than 1 in 10, but more than 1 in 100 patients
treated):



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



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

-

Stomach pain, being sick, feeling sick, diarrhoea and wind
(flatulence)

-

Raised levels of various liver enzymes in the blood

Uncommon (in less than 1 in 100, but more than 1 in 1,000
patients treated):



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.

-

Pancreatitis (inflammation of the pancreas leading to stomach
pain)

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

-

Blood clot in the lung causing chest pain and breathlessness
(pulmonary embolism); blood clot in the leg causing pain,
redness or swelling (deep vein thrombosis)

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

-

Gallstones (cholelithiasis)

Manufacturer

-

Headache

-

Reactions such as rashes, itching or red patches on the skin

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

-

Muscle pain, muscle inflammation, muscle cramps, spasms or
weakness

-

Reduced sex drive

Leaflet revision date: 07 February 2013

-

Slight increases in blood levels of substances normally excreted
by the kidneys (creatinine)

Lipantil is a registered trade mark of Fournier Industrie et Sante,
France.

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients
treated):
-

Slight increases in substances excreted by the kidneys (urea)

-

Hair loss

-

Increased sensitivity to light

-

Decrease in haemoglobin (oxygen carrying pigment in blood)
and decrease in white blood cells

-

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

In addition to those events reported during clinical trials, the
following side effects have been reported spontaneously during
postmarketing use of Lipantil Micro. A precise frequency cannot be
estimated from the available data and is therefore classified as “not
known”:
-

Muscle breakdown

-

Chronic disease of the lung tissues

-

Fatigue

-

Vertigo

If you develop any unusual discomfort, tell your doctor as soon as
possible.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

POM

PL No: 08747/0534

534 LEAFLET Lipantil 20130207

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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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