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FENOFIBRATE 200MG CAPSULES

Active substance(s): FENOFIBRATE / FENOFIBRATE MICRONISED

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Ref: 1562/051115/1/F

®

Lipantil Micro 200mg Capsules
(fenofibrate)
Patient Information Leaflet
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.
Your medicine is called Lipantil Micro 200mg Capsules and will be referred
to as Lipantil Micro throughout this leaflet.
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 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.
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

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.
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.

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).

Driving and using machines
This medicine should not affect your ability to drive or use machines.

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).

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.

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

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.

Ref: 1562/051115/1/B

®

Lipantil Micro 200mg Capsules
(fenofibrate)
Patient Information Leaflet (continued)
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 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 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.
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:
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
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)
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.

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 in the original package in order to protect from moisture.
Do not store above 30°C
Do not use Lipantil Micro after the expiry date which is stated on the blister
label or carton. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking this medicine, return any unused
capsules to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.
6

Further information

What Lipantil Micro contains:
Each hard capsule contains 200mg of fenofibrate.
The other ingredients are lactose monohydrate, sodium laurilsulfate,
pregelatinised maize starch, crospovidone and magnesium stearate.
The capsule is made of titanium dioxide (E171), red iron oxide (E172) and
gelatin.
What Lipantil Micro looks like and contents of the pack
Lipantil Micro are orange, hard gelatin capsules.
Each blister pack contains 30 capsules.
Manufacturer and Licence Holder
Manufactured by Recipharm Fontaine., Rue des Prés Potets. 21121
Fontaine-les-Dijon, France and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1562 Lipantil Micro 200mg Capsules

Lipantil is a registered trademark of Fournier Industrie et Santé S.A.S.
Revision date: 05/11/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1562/051115/2/F

Fenofibrate 200mg Capsules
Patient Information Leaflet
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.
Your medicine is called Fenofibrate 200mg Capsules and will be referred to
as Fenofibrate throughout this leaflet.
In this leaflet:
1 What Fenofibrate is and what it is used for
2 Before you take Fenofibrate
3 How to take Fenofibrate
4 Possible side effects
5 How to store Fenofibrate
6 Further information

1

What Fenofibrate is and what it is used for

Fenofibrate 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.
Fenofibrate 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.
Fenofibrate 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.
Fenofibrate 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
Fenofibrate.

2

Before you take Fenofibrate

Your doctor might want to test your blood or urine to check if Fenofibrate is
working properly and also if your kidneys, muscles and liver are working
properly.
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 Fenofibrate 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 Fenofibrate 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. Fenofibrate must not be taken if you are pregnant.
Breast-feeding
You must not use Fenofibrate if you are breast-feeding or if you are
planning to breastfeed your baby.

Do not take Fenofibrate if:
* You are allergic (hypersensitive) to fenofibrate, or any of the other
ingredients of Fenofibrate 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).

Driving and using machines
This medicine should not affect your ability to drive or use machines.

Take special care with Fenofibrate
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).

Always take Fenofibrate 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.

Important information about some of the ingredients of Fenofibrate
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 Fenofibrate

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 Fenofibrate 200 mg a day,
taken at mealtimes.
Use in children and adolescents
Fenofibrate is not recommended for use in children under the age of 18.

Ref: 1562/051115/2/B

Fenofibrate 200mg Capsules
Patient Information Leaflet (continued)
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 Fenofibrate than you should
If you accidentally take more Fenofibrate 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 Fenofibrate
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.
If you stop taking Fenofibrate
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
Fenofibrate. 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, Fenofibrate 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):
- 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):
- 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)
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
Fenofibrate. 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.

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 Fenofibrate

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in the original package in order to protect from moisture.
Do not store above 30°C
Do not use Fenofibrate after the expiry date which is stated on the blister
label or carton. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking this medicine, return any unused
capsules to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.
6

Further information

What Fenofibrate contains:
Each hard capsule contains 200mg of fenofibrate.
The other ingredients are lactose monohydrate, sodium laurilsulfate,
pregelatinised maize starch, crospovidone and magnesium stearate.
The capsule is made of titanium dioxide (E171), red iron oxide (E172) and
gelatin.
What Fenofibrate looks like and contents of the pack
Fenofibrate are orange, hard gelatin capsules.
Each pack contains 30 capsules.
Manufacturer and Licence Holder
Manufactured by Recipharm Fontaine., Rue des Prés Potets. 21121
Fontaine-les-Dijon, France and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1562 Fenofibrate 200mg Capsules

Revision date: 05/11/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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