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MODALIM TABLETS 100MG

Active substance(s): CIPROFIBRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ciprofibrate 100mg Tablets/ Modalim® 100mg Tablets
This product is available in the above names but will be referred
to as ciprofibrate throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this
medicine
 Keep this leaflet. You may need to read it again
 If you have any further questions, ask your doctor or
pharmacist
 This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist
 Your doctor may have given you this medicine before from
another company. It may have looked slightly different.
However, either brand will have the same effect.
In this leaflet:
1. What ciprofibrate is and what it is used for
2. Before you take ciprofibrate
3. How to take ciprofibrate
4. Possible side effects
5. How to store ciprofibrate
6. Further information
1. What ciprofibrate is and what it is used for
The name of your medicine is Ciprofibrate 100mg
Tablets (called ciprofibrate throughout this leaflet).
This 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.
Ciprofibrate 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.
2. Before you take ciprofibrate
Do not take ciprofibrate if:
 You are allergic (hypersensitive) to ciprofibrate or any of the
other ingredients of ciprofibrate (see Section 6: Further
information)
 Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue
 You are pregnant, might become pregnant or think you may
be pregnant (see “Pregnancy and breast-feeding” section
below)
 You are breast-feeding (see “Pregnancy and breast-feeding”
section below)
 You have severe liver or kidney problems
 You are taking 'fibrates' (such as clofibrate, bezafibrate,
fenofibrate or gemfibrozil)- used to treat high blood fat levels
Do not take this medicine if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking
ciprofibrate.
Take special care with ciprofibrate. Check with your doctor
or pharmacist before taking ciprofibrate if:
 You have unexpected muscle pains, tenderness or weakness
 You have liver or kidney problems
 You have an under-active thyroid gland
 You are over 70 years of age
 You or a member of your family have had muscle problems in
the past.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking ciprofibrate.
Blood Tests
 Taking ciprofibrate may affect the results of some blood tests.
During treatment your doctor may do blood tests to check how
your liver is working

 If you are going to have any other blood tests, it is important
to tell the person taking the test that you are taking
ciprofibrate
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines. This includes medicines you
buy without a prescription, including herbal medicines. This is
because ciprofibrate can affect the way some other medicines
work. Also some medicines can affect the way ciprofibrate works.
Tell your doctor if you are taking any of the following medicines:
 Statins (such as simvastatin, atorvastatin, pravastatin,
fluvastatin and rosuvastatin)- used to treat high blood fat
levels
 Warfarin - used for thinning the blood
 Insulin or Metformin - used for diabetes
 Contraceptive medicines (such as 'The Pill) or hormone
replacement therapy (HRT)
Taking ciprofibrate with alcohol
One of the side effects of this medicine is muscle problems.
Drinking a lot of alcohol may increase the chance of muscle
problems. This means that you must limit the amount of alcohol
you drink while you are taking ciprofibrate. Ask your doctor for
more advice.
Pregnancy and breast-feeding
Do not take ciprofibrate if you are:
 Pregnant, might become pregnant, or think you may be
pregnant
 Breast-feeding or planning to breast-feed. This is because
small amounts of ciprofibrate may pass into the mother’s milk
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Driving and using machines
If you get dizzy, drowsy and tired while taking ciprofibrate, then
you should not drive or use any tools or machinery.
Important information about some of the ingredients of
ciprofibrate
If you have been told by your doctor that you cannot tolerate
some sugars, contact your doctor before taking ciprofibrate.
3. How to take ciprofibrate
Always take ciprofibrate exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Taking this medicine
 Take this medicine by mouth
 Do not give to children under 12 years
 It is important while you are taking ciprofibrate to keep to any
special diet you have been given
 If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor
How much to take
 The usual dose for adults is 1 tablet every day
 Do not take any more than 1 tablet each day
 If you have kidney problems, only take 1 tablet every other
day
If you take more ciprofibrate than you should
If you take more of this medicine than you should, talk to a doctor
or go to a hospital straight away. Take the medicine pack with
you.
If you forget to take ciprofibrate
 If you forget a dose, take it as soon as you remember it
 However, if it is time for the next dose, skip the missed dose
 Do not take a double dose to make up for a forgotten dose

If you stop taking ciprofibrate
Keep taking your medicine until your doctor tells you to stop. Do
not stop taking ciprofibrate just because you feel better. If you
stop, your illness may get worse.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, ciprofibrate can cause side effects, although
not everybody gets them.
Stop taking your medicine and see a doctor or go to a
hospital straight away - you may need urgent medical
treatment.
 Muscle problems, such as cramps, pain or tenderness. This
can lead to kidney failure
Tell your doctor as soon as possible if you have any of the
following side effects:
 An allergic reaction. The signs may include: a rash (which
may be itchy and lumpy), itching and being more sensitive to
the sun than usual
 Inflammation of the lungs which causes breathlessness,
cough and raised temperature.
 Scarring of the lungs which causes shortness of breath.
 Liver problems. This may cause the eyes or skin to go yellow
(jaundice)
 Severe pain in the upper right corner of your stomach, which
could reach through to your back.
 You may also have a fever and feel or be sick. This could be
a sign of biliary colic or gallstones.
Other side effects are:
Common: may affect up to 1 in 10 people.
 Hair loss, balding
 Headache, balance problems
 Feeling dizzy, drowsy or tired
 Feeling sick (nausea) or being sick (vomiting)
 Diarrhoea, indigestion or stomach pains
 Pain in your muscles
Not known: frequency cannot be estimated from
the available data.
 Impotence
 You may bruise more easily than usual. This could be
because of a blood disorder (thrombocytopenia).
 Muscle weakness, cramps, stiffness and spasm.
 Inflammation of your muscles
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 ciprofibrate
 Do not store above 25°C. Store in the original package.
 Keep out of the sight and reach of children.
 Do not use ciprofibrate after the expiry date which is stated
on the carton. The expiry date refers to the last day of that
month.
 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. Further information
What ciprofibrate contains
 Each tablet contains 100mg of ciprofibrate
 The other ingredients are corn starch, lactose,
microcrystalline cellulose, methylhydroxypropyl cellulose,
sodium lauryl sulphate and K Sterotex (hydrogenated
vegetable oil).
What ciprofibrate looks like and contents of the pack
A white, round tablet scored through the middle on one side and
‘S170’ on the other side.
They are supplied in cartons of 28 tablets.
Manufacturer
Sanofi-Aventis Sp.z.o.o., Ul. Lubelska 52, 35-233 Rzeszow,
Poland.
Procured from within the EU. Parallel Import Product Licence
holder: G Pharma Ltd, Dakota Ave, Salford, M50 2PU.
PL 16369/1590

POM
Revision date: 30/07/2015

This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.

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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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