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MODALIM 100 MG TABLETS

Active substance(s): CIPROFIBRATE

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500011/PL1b

Ciprofibrate 100 mg tablets
Patient Information 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 100 mg 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 nonmedical 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 breastfeeding” 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.
Continued overleaf

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

5. HOW TO STORE CIPROFIBRATE
• Do not store above 25ºC.
• 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.
• If you notice any sign of discolouration or deterioration,
contact your pharmacist immediately.
6. FURTHER INFORMATION
What ciprofibrate contains
• Each tablet contains 100 mg of ciprofibrate.
• The other ingredients are maize starch, lactose,
microcrystalline cellulose, hypromellose, Sterotex K
and sodium laurilsulfate
What ciprofibrate looks like and contents of the pack
Ciprofibrate tablets are round and white with a breakline on
one side and S170 stamped on the other.
They are supplied in cartons of 28 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Sanofi-Aventis Sp. z.o.o. Ul. Lubelska 52, 35-233 Rzeszów,
Poland.
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.
Ciprofibrate 100 mg tablets
PL No: 18067/0468

POM
th

This leaflet was last revised on 17 March 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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.

500011/PL1b

504511/PL1b

®

Modalim 100 mg tablets
(ciprofibrate)
Patient Information 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 Modalim is and what it is used for
®
2) Before you take Modalim
®
3) How to take Modalim
4) Possible side effects
®
5) How to store Modalim
6) Further information
®

1. WHAT MODALIM IS AND WHAT IT IS USED FOR
®
The name of your medicine is Modalim 100 mg tablets
®
(called Modalim 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.
®

Modalim is used alongside a low fat diet and other nonmedical treatments such as exercise and weight loss, to lower
levels of fats in the blood.
®

2. BEFORE YOU TAKE MODALIM
®
Do not take Modalim if:
• You are allergic (hypersensitive) to ciprofibrate or any
®
of the other ingredients of Modalim (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 breastfeeding” 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 Modalim .
®

Take special care with Modalim . Check with your doctor
®
or pharmacist before taking Modalim 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 Modalim .

Blood Tests
®
• Taking Modalim 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 Modalim
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 Modalim can affect the way some other
medicines work. Also some medicines can affect the way
®
Modalim 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 Modalim 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 Modalim . Ask your
doctor for more advice.
Pregnancy and breast-feeding
®
Do not take Modalim 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 Modalim 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 Modalim , then
you should not drive or use any tools or machinery.
Important information about some of the ingredients of
®
Modalim
If you have been told by your doctor that you cannot tolerate
®
some sugars, contact your doctor before taking Modalim .
®

3. HOW TO TAKE MODALIM
®
Always take Modalim 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 Modalim 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 Modalim 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.
Continued overleaf

®

If you forget to take Modalim
• 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 Modalim
Keep taking your medicine until your doctor tells you to stop.
®
Do not stop taking Modalim 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, Modalim 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

®

5. HOW TO STORE MODALIM
• Do not store above 25ºC.
• Store in the original package.
• Keep out of the sight and reach of children.
®
• Do not use Modalim 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.
• If you notice any sign of discolouration or deterioration,
contact your pharmacist immediately.
6. FURTHER INFORMATION
®
What Modalim contains
• Each tablet contains 100 mg of ciprofibrate.
• The other ingredients are maize starch, lactose,
microcrystalline cellulose, hypromellose, Sterotex K
and sodium laurilsulfate
®

What Modalim looks like and contents of the pack
®
Modalim tablets are round and white with a breakline on one
side and S170 stamped on the other.
They are supplied in cartons of 28 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Sanofi-Aventis Sp. z.o.o. Ul. Lubelska 52, 35-233 Rzeszów,
Poland.
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.
®

Modalim 100 mg tablets
PL No: 18067/0468

POM

®

Modalim is a registered trademark of Sanofi.
th

This leaflet was last revised on 17 March 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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.

504511/PL1b

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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