Skip to Content

UK Edition. Click here for US version.

FENOFIBRATE MICRO 200MG CAPSULES

Active substance(s): FENOFIBRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Ref: LTT0039/010816/1/F

®

Lipantil Micro 200mg Capsules
(fenofibrate)
Patient Information Leaflet
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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, or pharmacist or nurse.
Your medicine is called Lipantil Micro 200mg Capsules but will be referred to
as Lipantil Micro throughout this leaflet.
What is in this leaflet
1

What Lipantil Micro is and what it is used for

2

What you need to know before you take Lipantil Micro

3

How to take Lipantil Micro

4

Possible side effects

5

How to store Lipantil Micro

6

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 ‘ ketopofen
* 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 Lipantil Mirco 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 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
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 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 200 mg 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.

Ref: LTT0039/010816/1/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 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

* Store in the original package.
* Do not store above 30°C
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Lipantil after the expiry date which is stated on the carton and
the blister pack after EXP. The expiry date refers to the last day of that
month.
If your doctor tells you to stop taking this medicine, return any unused
tablets 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.
Lipantil 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 contains:
Each hard capsule contains 200 mg of fenofibrate as the active ingredient.
Your medicine also contains the following inactive ingredients: Lactose
monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and
magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127)
and ferric oxide (E 172)
What Lipantil looks like and contents of the pack
Lipantil are gelatin, orange capsules containing white powder.
Each pack contains 30 capsules.
Manufacturer and Licence Holder
Lipantil is manufactured by RECIPHARM Fontaine, Rue des Prés Potets
F 21121 Fontaine-les-Dijon, France.
Procured from within the EU by the Product Licence Holder LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,
B98 0RE, UK.

POM

PL 33723/0039

Lipantil Micro 200mg Capsules

Lipantil is a registered trademark of Fournier Industrie et Sante.
Revision date: 01/08/16

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

Ref: LTT0039/010816/2/F

®

Lipanthyl Micro 200mg Capsules
(fenofibrate)
Patient Information Leaflet
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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, or pharmacist or nurse.
Your medicine is called Lipanthyl Micro 200mg Capsules but will be referred
to as Lipanthyl Micro throughout this leaflet.
What is in this leaflet
1

What Lipanthyl Micro is and what it is used for

2

What you need to know before you take Lipanthyl Micro

3

How to take Lipanthyl Micro

4

Possible side effects

5

How to store Lipanthyl Micro

6

Contents of the pack and other information

1

What Lipanthyl Micro is and what it is used for

Lipanthyl 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’.
Lipanthyl 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.
Lipanthyl 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.
Lipanthyl 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
Lipanthyl Micro.

Your doctor might want to test your blood or urine to check if Lipanthyl Micro
is working properly and also if your kidneys, muscles and liver are working
properly.
Effects on muscles
Stop taking Lipanthyl 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 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 Lipanthyl Micro.
Other medicines and Lipanthyl Micro
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 Lipanthyl 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 Lipanthyl Micro
Lipanthyl 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.

2

What you need to know before you take Lipanthyl
Micro

Do not take Lipanthyl 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 ‘ ketopofen
* 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 Lipanthyl Mirco if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Lipanthyl Micro.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking Lipanthyl 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 Lipanthyl Micro

Pregnancy, breast-feeding and fertility
* Do not take Lipanthyl Micro and tell your doctor if you are pregnant, think
you might be pregnant or are planning to have a baby
* Do not take Lipanthyl 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 Lipanthyl Micro
Lipanthyl 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 Lipanthyl 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 Lipanthyl Micro 200 mg
a day, taken at mealtimes.
Use in children and adolescents
The use of Lipanthyl Micro 200mg is not recommended in children under the
age of 18.

Ref: LTT0039/010816/2/B

®

Lipanthyl 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 Lipanthyl Micro than you should
If you take more Lipanthyl 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 Lipanthyl 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 Lipanthyl Micro
Do not stop taking Lipanthyl 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 Lipanthyl 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 Lipanthyl 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 Lipanthyl 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 Lipanthyl Micro

* Store in the original package.
* Do not store above 30°C
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Lipanthyl after the expiry date which is stated on the carton and
the blister pack after EXP. The expiry date refers to the last day of that
month.
If your doctor tells you to stop taking this medicine, return any unused
tablets 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.
Lipanthyl 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 Lipanthyl contains:
Each hard capsule contains 200 mg of fenofibrate as the active ingredient.
Your medicine also contains the following inactive ingredients: Lactose
monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and
magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127)
and ferric oxide (E 172)
What Lipanthyl looks like and contents of the pack
Lipanthyl are gelatin, orange capsules containing white powder.
Each pack contains 30 capsules.
Manufacturer and Licence Holder
Lipanthyl is manufactured by RECIPHARM Fontaine, Rue des Prés Potets
F 21121 Fontaine-les-Dijon, France.
Procured from within the EU by the Product Licence Holder LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,
B98 0RE, UK.

POM

PL 33723/0039

Lipanthyl Micro 200mg Capsules

Lipanthyl is a registered trademark of Fournier Industrie et Sante.
Revision date: 01/08/16

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

Ref: LTT0039/010816/3/F

Fenofibrate Micro 200mg Capsules
Patient Information Leaflet
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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, or pharmacist or nurse.
Your medicine is called Fenofibrate Micro 200mg Capsules but will be
referred to as Fenofibrate Micro throughout this leaflet.
What is in this leaflet
1

What Fenofibrate Micro is and what it is used for

2

What you need to know before you take Fenofibrate Micro

3

How to take Fenofibrate Micro

4

Possible side effects

5

How to store Fenofibrate Micro

6

Contents of the pack and other information

1

What Fenofibrate Micro is and what it is used for

Fenofibrate 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’.
Fenofibrate 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.
Fenofibrate 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.
Fenofibrate 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
Fenofibrate Micro.

Your doctor might want to test your blood or urine to check if Fenofibrate
Micro is working properly and also if your kidneys, muscles and liver are
working properly.
Effects on muscles
Stop taking Fenofibrate 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 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 Micro.
Other medicines and Fenofibrate Micro
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 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 Fenofibrate Micro
Fenofibrate 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.

2

What you need to know before you take Fenofibrate
Micro

Do not take Fenofibrate 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 ‘ ketopofen
* 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 Mirco if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Fenofibrate Micro.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking Fenofibrate 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 Fenofibrate Micro

Pregnancy, breast-feeding and fertility
* Do not take Fenofibrate Micro and tell your doctor if you are pregnant,
think
you might be pregnant or are planning to have a baby
* Do not take Fenofibrate 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 Fenofibrate
Micro
Fenofibrate 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 Fenofibrate 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 Fenofibrate Micro 200
mg a day, taken at mealtimes.
Use in children and adolescents
The use of Fenofibrate Micro 200mg is not recommended in children under
the age of 18.

Ref: LTT0039/010816/3/B

Fenofibrate Micro 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 Micro than you should
If you take more Fenofibrate 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 Fenofibrate 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 Fenofibrate Micro
Do not stop taking Fenofibrate 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 Fenofibrate 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 Fenofibrate 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 Fenofibrate 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 Fenofibrate Micro

* Store in the original package.
* Do not store above 30°C
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Fenofibrate after the expiry date which is stated on the carton
and the blister pack after EXP. The expiry date refers to the last day of that
month.
If your doctor tells you to stop taking this medicine, return any unused
tablets 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.
Fenofibrate 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:
Each hard capsule contains 200 mg of fenofibrate as the active ingredient.
Your medicine also contains the following inactive ingredients: Lactose
monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and
magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127)
and ferric oxide (E 172)
What Fenofibrate looks like and contents of the pack
Fenofibrate are gelatin, orange capsules containing white powder.
Each pack contains 30 capsules.
Manufacturer and Licence Holder
Fenofibrate is manufactured by RECIPHARM Fontaine, Rue des Prés Potets
F 21121 Fontaine-les-Dijon, France.
Procured from within the EU by the Product Licence Holder LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,
B98 0RE, UK.

POM

PL 33723/0039

Fenofibrate Micro 200mg Capsules

Revision date: 01/08/16

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.

Hide