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FENOFIBRATE 200MG CAPSULES

Active substance: FENOFIBRATE MICRONISED

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lipantil® Micro 200mg capsules
(fenofibrate)
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 name of your medicine is Lipantil Micro 200mg capsules but will
be referred to as Lipantil Micro throughout this leaflet.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Lipantil Micro is and what it is used for
Before you take Lipantil Micro
How to take Lipantil Micro
Possible side effects
How to store Lipantil Micro
Further information

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 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

Do not take Lipantil Micro if:
You are allergic (hypersensitive) to fenofibrate, or any of the
other ingredients of Lipantil Micro
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:
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.
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 breast-feed 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.
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 200mg
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 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

What Lipantil Micro looks like and contents of the pack
Lipantil Micro are orange, hard gelatin capsules.
Lipantil Micro is available in blister packs of 30 capsules.

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

Lipantil® Micro 200mg capsules, PL No: 18799/2430

If you develop any unusual discomfort, tell your doctor as soon as
possible.
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 LIPANTIL MICRO
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use your capsule after the expiry date which is stated on the
carton and the blister label after „Exp‟. The expiry date refers to the
last day of that month.
Medicine 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
What Lipantil Micro contains
The active ingredient is fenofibrate.
Each capsule contains 200mg fenofibrate.
The other ingredients are: lactose monohydrate, sodium lauryl
sulphate, pregelatinised starch, povidone and magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E171) and ferric
oxide (E172).

Manufactured by: Recipharm Fontaine., Rue des Prés Potets,
21121, Fontaine Les Dijon, France.
Procured from within the EU & repackaged by Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.

Leaflet date: 21.01.2015

POM

Lipantil® is a registered trademark of Fournier Pharmaceuticals.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fenofibrate 200mg capsules
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 name of your medicine is Fenofibrate 200mg capsules but will be
referred to as Fenofibrate throughout this leaflet.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Fenofibrate is and what it is used for
Before you take Fenofibrate
How to take Fenofibrate
Possible side effects
How to store Fenofibrate
Further information

1. WHAT FENOFIBRATE IS AND WHAT IT IS USED FOR
Fenofibrate 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

Do not take Fenofibrate if:
You are allergic (hypersensitive) to fenofibrate, or any of the
other ingredients of Fenofibrate
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 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).
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.
Driving and using machines
This medicine should not affect your ability to drive or use machines.
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

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.
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 200mg
a day, taken at mealtimes.
Use in children and adolescents
Fenofibrate 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 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

What Fenofibrate looks like and contents of the pack
Fenofibrate are orange, hard gelatin capsules.
Fenofibrate is available in blister packs of 30 capsules.

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

Fenofibrate 200mg capsules, PL No: 18799/2430

If you develop any unusual discomfort, tell your doctor as soon as
possible.
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 FENOFIBRATE

Keep out of the sight and reach of children.
Do not store this medicine above 30°C.
Store in the original package in order to protect from moisture.
Do not use your capsules after the expiry date which is stated on the
carton and the blister label after „Exp‟. The expiry date refers to the
last day of that month.
Medicine 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

What Fenofibrate contains
The active ingredient is fenofibrate.
Each capsule contains 200mg fenofibrate.
The other ingredients are:lactose monohydrate, sodium lauryl
sulphate, pregelatinised starch, povidone and magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E171) and ferric
oxide (E172).

Manufactured by: Recipharm Fontaine., Rue des Prés Potets,
21121, Fontaine Les Dijon, France.
Procured from within the EU & repackaged by Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.

Leaflet date: 21.01.2015

POM

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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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