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LIPANTIL 200 MICRONISED

Active substance(s): FENOFIBRATE MICRONISED / FENOFIBRATE MICRONISED / FENOFIBRATE MICRONISED

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lipanthyl® 200 Micronised /
Lipantil 200 Micronised
(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.
Your medicine is available in the above two names but will be
referred to as Lipanthyl 200 Micronised throughout the leaflet.
Your medicine is also available in the following strengths 267
and 67 Micronised.
What is in this leaflet:
1. What Lipanthyl 200 Micronised is and what it is used for
2. What you need to know before you take Lipanthyl 200
Micronised
3. How to take Lipanthyl 200 Micronised
4. Possible side effects
5. How to store Lipanthyl 200 Micronised
6. Contents of the pack and other information.
1. What Lipanthyl 200 Micronised is and what it is used for
Lipanthyl 200 Micronised 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 200 Micronised 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 200 Micronised 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 200 Micronised 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 200 Micronised.
2. What you need to know before you take Lipanthyl 200
Micronised
Do not take Lipanthyl 200 Micronised 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 Lipanthyl 200 Micronised if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist before
taking Lipanthyl 200 Micronised.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking
Lipanthyl 200 Micronised 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 200 Micronised.
Your doctor might want to test your blood or urine to check if
Lipanthyl 200 Micronised is working properly and also if your
kidneys, muscles and liver are working properly.
Effects on muscles
Stop taking Lipanthyl 200 Micronised 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 200 Micronised.
Other medicines and Lipanthyl 200 Micronised
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 200 Micronised may increase the risk of muscle
problems.

A particular class of medicines to treat diabetes (such as
rosiglitazone or pioglitazone)

Ciclosporin – 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 200 Micronised.
Lipanthyl 200 Micronised 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 Lipanthyl 200 Micronised and tell your doctor if
you are pregnant, think you might be pregnant or are
planning to have a baby

Do not take Lipanthyl 200 Micronised if you are breastfeeding 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 200 Micronised
Lipanthyl 200 Micronised 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 200 Micronised
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.
Your doctor will determine the appropriate strength for you,
depending on your condition, your current treatment and your
personal risk status.

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
200 Micronised a day, taken at mealtimes.
Use in children and adolescents
The use of Lipanthyl 200 Micronised 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 Lipanthyl 200 Micronised than you should
If you take more Lipanthyl 200 Micronised 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 200 Micronised

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 200 Micronised
Do not stop taking Lipanthyl 200 Micronised 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 200 Micronised 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 200 Micronised 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 200 Micronised and see a doctor straight
away, if you notice any of the side effects above.





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 effects 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 200 Micronised
Do not store above 30°C.
Keep this medicine in its original package.
Keep out of the sight and reach of children.
If your doctor decides to stop treatment return any tablets you
have left to the pharmacist for safe disposal. Only keep them if
your doctor tells you to.
Do not use after the expiry date shown on the packaging. If the
tablets show any signs of deterioration or discolouration, seek
the advice of your pharmacist who will show you what to do.
Lipanthyl 200 Micronised 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
Each hard ochre, gelatin capsule contains 200mg of the active
ingredient fenofibrate micronised.
The capsules also contain lactose, magnesium stearate,
pregelatinised maize starch, sodium lauryl sulphate,
crospovidone, gelatin, titanium dioxide (E171), red iron oxide
(E172) and yellow iron oxide (E172).
Each blister pack contains 30 capsules.

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

Increase in homocysteine (too much of this amino acid in the
blood has been associated to a higher risk of coronary heart
disease, stroke and peripheral vascular disease, although a
casual link has not been established)
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)

POM

PL 20774/0130 Lipanthyl 200 Micronised / Lipantil 200
Micronised
This medicine is manufactured by: Recipharm Fontaine, rue de
pres potets 21121 Fontaine, Les-Dijon, France and is procured
from within the EU and repackaged on behalf of the Product
Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by
Maxearn Ltd, Bolton, BL6 4SA.
Leaflet prepared 26th June 2017
Lipanthyl is a registered trademark of Fournier Industrie et Sante.

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact: Quadrant Pharmaceuticals
Ltd, Tel: 01204 473081
PP10/0130/V3

Expand Transcript

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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