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LIPANTIL MICRO 200MG CAPSULES

Active substance(s): FENOFIBRATE / FENOFIBRATE MICRONISED

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Assessed against UK PIL dated
January
2016 LEAFLET: INFORMATION FOR THE USER
PACKAGE

Lipantil® Micro 200mg capsules
(fenofibrate)
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist
or nurse.
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.
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.
The name of your medicine is Lipantil Micro 200mg capsules but will
be referred to as Lipantil Micro throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Lipantil Micro is and what it is used for
What you need to know before you take Lipantil Micro
How to take Lipantil Micro
Possible side effects
How to store Lipantil Micro
Contents of the pack and other 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 (called
‘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. What you need to know before you take Lipantil Micro
Do not take Lipantil Micro if:
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’)
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

MOCK UP
You have pancreatitis (an inflamed pancreas which causes
abdominal pain), which is not caused by high levels of fat in the
blood
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:
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)
You have diabetes, especially Type 2 diabetes, that is not well
controlled
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.
Effects on muscles
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
Your doctor may do a blood test to check your muscles before and
after starting treatment.
The risk of muscle breakdown is higher in some patients. Tell your
doctor if:
You are over 70 years old
You have any kidney problems
You have thyroid problems
You or a close family member has a muscle problem which runs
in the family
You drink large amounts of alcohol
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 above apply to you (or you are not sure), talk to your
doctor before taking Lipantil Micro.

Other medicines and Lipantil Micro
By
Selvam
at 5:57
pm,
Aug
17, 2016
Please
tell Siva
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)
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
A particular class of medicines to treat diabetes (such as
rosiglitazone or pioglitazone)
Cyclosporin - used to suppress your immune system
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Lipantil Micro.
Lipantil Micro with food, drink and alcohol
It is important to take the capsule with food - it will not work as well if
your stomach is empty.
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.
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
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.

3. How to take Lipantil Micro
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
200mg a day, taken at mealtimes.
Use in children and adolescents
The use of Lipantil Micro 200mg is not recommended 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 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
If you forget a dose, take the next dose with your next meal
Then take your next capsule at the normal time
Do not take a double dose to make up for a forgotten dose
If you are worried about this talk to your doctor.
If you stop taking Lipantil Micro
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.
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:
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)
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)
Stop taking Lipantil Micro and see a doctor straight away, if you
notice any of the side effects above.
Other side effects include:
Common (affects less than 1 in 10 people):
Diarrhoea
Stomach pain
Wind (flatulence)
Feeling sick (nausea)
Being sick (vomiting)
Raised levels of liver enzymes in the blood - shown in tests

Uncommon (affects less than 1 in 100 people):
Headache
Gallstones
Reduced sex drive
Rash, itching or red patches on the skin
Increase in 'creatinine' produced by the kidneys - shown in tests
Pancreatitis (inflammation of the pancreas leading to abdominal
pain)
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
Rare (affects less than 1 in 1,000 people):
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)
Side effect where the chance of it happening are not known
Severe form of skin rash with reddening, peeling and swelling of
the skin that resembles severe burns
Long-term lung problems
Muscle breakdown
Complications of gallbladder stones
Jaundice
Feeling dizzy (vertigo)
Feeling exhausted (fatigue)
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.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not take the 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. Contents of the pack and other information
What Lipantil Micro contains
The active ingredient in Lipantil Micro 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).
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.
Manufactured by: Recipharm Fontaine., Rue des Prés Potets,
21121, Fontaine Les Dijon, France.
Procured from within the EU & repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Lipantil® Micro 200mg capsules
PL 18799/2430

POM

Leaflet date: 20.06.2016
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 because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist
or nurse.
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.
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.
The name of your medicine is Fenofibrate 200mg capsules but will be
referred to as Fenofibrate throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Fenofibrate is and what it is used for
What you need to know before you take Fenofibrate
How to take Fenofibrate
Possible side effects
How to store Fenofibrate
Contents of the pack and other 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 (called
‘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. What you need to know before you take Fenofibrate
Do not take Fenofibrate if:
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’)
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
Do not take Fenofibrate if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Fenofibrate.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking Fenofibrate
if:
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)
You have diabetes, especially Type 2 diabetes, that is not well
controlled
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 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.
Effects on muscles
Stop taking Fenofibrate 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
Your doctor may do a blood test to check your muscles before and
after starting treatment.
The risk of muscle breakdown is higher in some patients. Tell your
doctor if:
You are over 70 years old
You have any kidney problems
You have thyroid problems
You or a close family member has a muscle problem which runs
in the family
You drink large amounts of alcohol
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 above apply to you (or you are not sure), talk to your
doctor before taking Fenofibrate.

Other medicines and Fenofibrate
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)
Other medicines to control fat levels in the blood (such as statins
or fibrates). Taking a statin at the same time as Fenofibrate may
increase the risk of muscle problems
A particular class of medicines to treat diabetes (such as
rosiglitazone or pioglitazone)
Cyclosporin - used to suppress your immune system
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Fenofibrate.
Fenofibrate with food, drink and alcohol
It is important to take the capsule with food - it will not work as well if
your stomach is empty.
Pregnancy, breast-feeding and fertility
Do not take Fenofibrate and tell your doctor if you are pregnant,
think you might be pregnant or are planning to have a baby
Do not take Fenofibrate if you are breast-feeding or planning to
breast-feed your baby.
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
Fenofibrate
Fenofibrate 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.

3. How to take Fenofibrate
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 Fenofibrate
200mg a day, taken at mealtimes.
Use in children and adolescents
The use of Fenofibrate 200mg is not recommended 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 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
If you forget a dose, take the next dose with your next meal
Then take your next capsule at the normal time
Do not take a double dose to make up for a forgotten dose
If you are worried about this talk to your doctor.
If you stop taking Fenofibrate
Do not stop taking Fenofibrate 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.
Remember that as well as taking Fenofibrate 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 Fenofibrate and see a doctor straight away, if you
notice any of the following serious side effects - you may need
urgent medical treatment:
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)
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)
Stop taking Fenofibrate and see a doctor straight away, if you notice
any of the side effects above.
Other side effects include:
Common (affects less than 1 in 10 people):
Diarrhoea
Stomach pain
Wind (flatulence)
Feeling sick (nausea)
Being sick (vomiting)
Raised levels of liver enzymes in the blood - shown in tests

Uncommon (affects less than 1 in 100 people):
Headache
Gallstones
Reduced sex drive
Rash, itching or red patches on the skin
Increase in 'creatinine' produced by the kidneys - shown in tests
Pancreatitis (inflammation of the pancreas leading to abdominal
pain)
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
Rare (affects less than 1 in 1,000 people):
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)
Side effect where the chance of it happening are not known
Severe form of skin rash with reddening, peeling and swelling of
the skin that resembles severe burns
Long-term lung problems
Muscle breakdown
Complications of gallbladder stones
Jaundice
Feeling dizzy (vertigo)
Feeling exhausted (fatigue)
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 Fenofibrate
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 take the 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. Contents of the pack and other information
What Fenofibrate contains
The active ingredient in Fenofibrate 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).
What Fenofibrate looks like and contents of the pack
Fenofibrate are orange, hard gelatin capsules.
Fenofibrate is available in blister packs of 30 capsules.
Manufactured by: Recipharm Fontaine., Rue des Prés Potets,
21121, Fontaine Les Dijon, France.
Procured from within the EU & repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Fenofibrate 200mg capsules
PL 18799/2430
Leaflet date: 20.06.2016

POM

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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