LIPANTHYL 200 MICRONISED CAPSULES

Active substance: FENOFIBRATE MICRONISED

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

LIPANTIL MICRO 200/LIPANTHYL 200 MICRONISED CAPSULES
(fenofibrate)
Patient Information Leaflet
27mm

This product is known as the above names but will be referred to as Lipantil Micro throughout this leaflet.

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 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 [statins] in some circumstances when levels of fats
in the blood are not controlled with a statin alone.

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

DATE:
12/03/13

UK PIL DATED NOVEMBER 2012

6464/0476D

DT
ARTWORKER:

DATE OF PROOF:
CODE:

Q.A.
APPROVED:

Important advice regarding muscle effects:
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:
• You have any kidney problems
• An under active thyroid
• 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
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 an intolerance to some sugars, contact your doctor before
taking this medicinal product.

Colour
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Black

WARNING!

DATE:

Take special care with Lipantil Micro
Tell your doctor before you start to take this medicine:
• 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
• If you have an alcohol problem.
• You are taking other medicines.
• If you or your family have had muscle problems
• If 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).
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.

05-0440

CUSTOMER: Waymade
PRODUCT: Lipantil micro 200 caps

WARNING!

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
200mg.
• 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).

PRE-PRESS NO.:

CUSTOMER
APPROVED:

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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

PROOF HISTORY:
v.1 - waymade - 12/03/13

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• 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.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

3. How to take Lipantil Micro
Always take Lipantil Micro exactly as your doctor has told you. 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.
The usual dose for adults is one capsule of Lipantil Micro 200 mg a day, taken at mealtimes.
Use in children and adolescents
Lipantil Micro is not recommended for use 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 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. 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.
4. Possible side effects
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:

DATE:
12/03/13





UK PIL DATED NOVEMBER 2012

6464/0476D



CODE:

DT



DATE OF PROOF:

ARTWORKER:

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.



5. How to store Lipantil Micro.
Lipantil micro 200/Lipanthyl 200 micronised capsules should be stored in a dry place below 25°C,
protected from light.
Keep out of the sight and reach of children.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe
disposal. Only keep the capsules if your doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist before taking them.
Do not use Lipantil Micro after the expiry date which is stated on the carton and the blister after
EXP. The expiry date refers to the last day of that month.
Lipantil 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. Further Information
Each capsule contains 200mg of the active ingredient fenofibrate in a plain orange capsule.
Lipantil micro 200/Lipanthyl 200 micronised capsules also contain the following: lactose, magnesium
stearate, pregelatinised maize starch, sodium lauryl sulphate, crospovidone, titanium dioxide (E171), iron
oxide (E172) erythrosine (E127) and gelatin.
Lipantil micro 200/Lipanthyl 200 micronised capsules are available as blister packs of 30 capsules.
POM

PL No: 6464/0476

This product is manufactured by Recipharm Fontaine, Rues des Prets Potets, 21121 Fontaine-les-Dijon,
France and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 6.3.2013
Lipantil ® is a registered trademark of FOURNIER INDUSTRIE

Colour
Swatch

Black

000-0000D

WARNING!

DATE:

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

Q.A.
APPROVED:
PRE-PRESS NO.:

CUSTOMER: Waymade
PRODUCT: Lipantil micro 200 caps

WARNING!

Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients treated):
• Pancreatitis (inflammation of the pancreas leading to stomach pain)
• 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)
• Gallstones (cholelithiasis)
• Headache
• Reactions such as rashes, itching or red patches on the skin
• Muscle pain, muscle inflammation, muscle cramps, spasms or weakness
• Reduced sex drive
• Slight increases in blood levels of substances normally excreted by the kidneys (creatinine)

05-0440

CUSTOMER
APPROVED:

Common (in less than 1 in 10, but more than 1 in 100 patients treated):
• Stomach pain, being sick, feeling sick, diarrhoea and wind (flatulence)
• Raised levels of various liver enzymes in the blood

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

If you forget to take 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.

PROOF HISTORY:
v.1 - waymade - 12/03/13

Leaflet Flat Size = 148 x 400

If you take more Lipantil Micro than you should
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.

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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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