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LIPANTHYL MICRO 200MG CAPSULES

Active substance(s): FENOFIBRATE

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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 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,
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, pharmacist or nurse.

What is in this leaflet:
1.

2.
3.
4.
5.
6.

What Lipantil Micro 200mg Capsules are and what they
are used for
What you need to know before you take Lipantil Micro
200mg Capsules
How to take Lipantil Micro 200mg Capsules
Possible side effects
How to store Lipantil Micro 200mg Capsules
Contents of the pack and other information

1. What Lipantil Micro 200mg Capsules are
and what they are used for
Lipantil Micro 200mg Capsules belong 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 200mg Capsules are 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 200mg Capsules 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 200mg Capsules 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 200mg Capsules.

2. What you need to know before you take
Lipantil Micro 200mg Capsules
Do not take Lipantil Micro 200mg Capsules 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 antiinflammatory 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 Lipantil Micro 200mg Capsules if any of the above
apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Lipantil Micro 200mg Capsules.

Warnings and Precautions

Talk to your doctor, pharmacist or nurse before taking Lipantil
Micro 200mg Capsules 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
(hypothyroidism)

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).

3. How to take Lipantil Micro 200mg
Capsules

If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Lipantil Micro 200mg
Capsules.

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 might want to test your blood or urine to check if
Lipantil Micro 200mg Capsules are working properly and also
if your kidneys, muscles and liver are working properly.

Effects on muscles

Stop taking Lipantil Micro 200mg Capsules 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 200mg Capsules.

Other medicines and Lipantil Micro 200mg Capsules

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 200mg Capsules 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 200mg
Capsules.

Lipantil Micro 200mg Capsules 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 200mg Capsules 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 200mg Capsules 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 200mg Capsules

Lipantil Micro 200mg Capsules contains lactose monohydrate
(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.

Taking this medicine





How much to take

The recommended dose for adults is one capsule of Lipantil
Micro 200mg Capsules a day, taken at mealtimes.

Use in children and adolescents

The use of Lipantil Micro 200mg Capsules are 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 200mg Capsules
than you should

If you take more Lipantil Micro 200mg Capsules 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 200mg Capsules
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 200mg Capsules

Do not stop taking Lipantil Micro 200mg Capsules 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 200mg
Capsules 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, 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 200mg Capsules 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 200mg Capsules 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):







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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

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)

What Lipantil Micro 200mg Capsules look like and
contents of the pack

The capsules are orange hard gelatin capsules with no
markings.
Lipantil Micro 200mg Capsules are available as blister packs
of 30 capsules.

Manufacturer

Your medicine is manufactured by: RECIPHARM Fontaine,
Rue des Prés Potets, F 21121 Fontaine-les-Dijon, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0231

POM

Lipantil® is a registered trademark of Fournier Industrie et
Sante.
If you wish to receive this leaflet in Braille, large font or audio
format please contact 01302 365000 and ask for the
Regulatory Department.
Leaflet revision date: 26.05.16

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, 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 200mg
Capsules










Do not store above 30°C. Store in the original package.
KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
Do not use after the expiry date printed on the carton or
blister strip. The expiry date refers to the last day of
that month.
If your doctor decides to stop treatment, return any
leftover capsules to the pharmacist. Only keep them if
your doctor tells you to.
If the capsules become discoloured or show any other
signs of deterioration, take them to your pharmacist
who will advise you.
Medicines 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 200mg Capsules contain

Each capsule contains 200mg of the active ingredient
fenofibrate.
Lipantil Micro 200mg Capsules also contain the following
ingredients: lactose monohydrate, sodium lauryl sulphate,
pregelatinised starch, crospovidone, magnesium stearate,
gelatin, titanium dioxide (E171), ferrous oxide (E172) and
erythrosine (E127).

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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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