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CIPROFIBRATE 100MG TABLETS

Active substance: CIPROFIBRATE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is known as the above name but will be referred to as Modalim throughout this leaflet.

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

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 400

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

1. What Modalim is and what it is used for
Modalim 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 non-medical treatments such as exercise and weight loss,
to lower levels of fats in the blood.

WARNING!

PROOF HISTORY:
v.1 - waymade - 18/02/14

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 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

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.

DATE:

CUSTOMER
APPROVED:

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.

18/02/14

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.

DATE OF PROOF:

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.
UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

06464/3053D
CODE:

DT

DATE:

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.

ARTWORKER:

Modalim 100mg tabs
PRODUCT:

CUSTOMER:

Waymade

PRE-PRESS NO.:

05-0269

Q.A.
APPROVED:

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

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.

Colour
Swatch

Black

WARNING!

27mm

Modalim® 100mg Tablets
(ciprofibrate)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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.

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






DATE:

CUSTOMER
APPROVED:




WARNING!

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 Modalim
Modalim 100mg tablets should not be stored above 25°C. Store in the original package.
Do not use after the expiry date printed on the carton, label or blister strip. The expiry date refers to
the last day of that month.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking your medicine, please take it back to the pharmacist for safe
disposal. Only keep your medicine if your doctor tells you to.
If the tablets show any visible signs of deterioration, you should seek the advice of your pharmacist,
who will tell you what to do.
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.

DATE:

The other ingredients are:
maize starch, lactose, microcrystalline cellulose, methylhydroxypropylcellulose, Sterotex K (hydrogenated
vegetable oil) and sodium lauryl sulphate.
What Modalim looks like and contents of the pack
Modalim 100mg tablets are white, round tablets with a breakline on one side and ‘S170’ stamped on the
other.

18/02/14

DT

05-0269

Q.A.
APPROVED:

6. Further information
What Modalim contains
Your medicine is called Modalim 100mg tablets. Each tablet contains 100mg of ciprofibrate.

DATE OF PROOF:

ARTWORKER:

PRE-PRESS NO.:

Modalim 100mg tablets are available as blister packs of 28 tablets.
POM

PL No: 06464/3053

This product is manufactured by Sanofi-Synthelabo UK Ltd., Edgefield Avenue, Fawdon, Newcastle, UK.
and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex. SS14 3FR

Waymade

Modalim 100mg tabs

06464/3053D

CUSTOMER:

PRODUCT:

CODE:

Leaflet Reference (revision and issue date) 11.2.2014

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

Modalim is a registered trademark of Sanofi-aventis

Colour
Swatch

Black

000-0000D

WARNING!

PROOF HISTORY:
v.1 - waymade - 18/02/14

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 400

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

Ciprofibrate® 100mg Tablets
Patient Information Leaflet
This product is known as the above name but will be referred to as Ciprofibrate throughout this leaflet.

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
Ciprofibrate 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.

WARNING!

PROOF HISTORY:
v.1 - waymade - 18/02/14

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

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.

DATE:

CUSTOMER
APPROVED:

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.

18/02/14

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)

DATE OF PROOF:

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.

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

CODE:

06464/3053D

DT

Ciprofibrate 100mg tabs
PRODUCT:

ARTWORKER:

Waymade
CUSTOMER:

05-0269

DATE:

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.

PRE-PRESS NO.:

Q.A.
APPROVED:

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

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.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 400

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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.

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






DATE:

CUSTOMER
APPROVED:




WARNING!

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
Ciprofibrate 100mg tablets should not be stored above 25°C. Store in the original package.
Do not use after the expiry date printed on the carton, label or blister strip. The expiry date refers to
the last day of that month.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking your medicine, please take it back to the pharmacist for safe
disposal. Only keep your medicine if your doctor tells you to.
If the tablets show any visible signs of deterioration, you should seek the advice of your pharmacist,
who will tell you what to do.
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.

DATE:

The other ingredients are:
maize starch, lactose, microcrystalline cellulose, methylhydroxypropylcellulose, Sterotex K (hydrogenated
vegetable oil) and sodium lauryl sulphate.
What Ciprofibrate looks like and contents of the pack
Ciprofibrate 100mg tablets are white, round tablets with a breakline on one side and ‘S170’ stamped on the
other.

18/02/14

DT

05-0269

Q.A.
APPROVED:

6. Further information
What Ciprofibrate contains
Your medicine is called Ciprofibrate 100mg tablets. Each tablet contains 100mg of ciprofibrate.

DATE OF PROOF:

ARTWORKER:

PRE-PRESS NO.:

Ciprofibrate 100mg tablets are available as blister packs of 28 tablets.
POM

PL No: 06464/3053

This product is manufactured by Sanofi-Synthelabo UK Ltd., Edgefield Avenue, Fawdon, Newcastle, UK.
and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex. SS14 3FR

Ciprofibrate 100mg tabs

06464/3053D

PRODUCT:

CODE:

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

Waymade
CUSTOMER:

Leaflet Reference (revision and issue date) 11.2.2014

Colour
Swatch

Black

000-0000D

WARNING!

PROOF HISTORY:
v.1 - waymade - 18/02/14

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 400

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

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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