Ciprofibrate 100 Mg Tablets
2. Before you take Modalim
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Modalim® 100 mg Tablets
(ciprofibrate)
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 non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood.
Do not take Modalim if:
X You are allergic (hypersensitive) to Modalim 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
X You are pregnant, might become pregnant or think you may be pregnant (see “Pregnancy and breast-feeding” section below)
X You are breast-feeding (see “Pregnancy and breast-feeding” section below)
X You have severe liver or kidney problems X You are taking 'fibrates' (such as dofibrate, 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.
A Take special care with Modalim. Check with your doctor or pharmacist before taking Modalim if:
A You have unexpected muscle pains, tenderness or weakness
A You have liver or kidney problems A You have an under-active thyroid gland A You are over 70 years of age A You ora 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 rosuvastatinj- 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.
a 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. Modalim contains castor oil which may cause stomach upset and diarrhoea. Also contains soya, if you are allergic to peanut or soya, do not use this medicinal product.
Turn
Over
3. How to take Modalim
5. How to store ciprofibrate
) 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
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.
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 Modalimjust 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.
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.
Keep out of the reach and sight of children.
Do not store above 25oC.
Store in the original package.
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.
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 (hydrogenated vegetable oil) and sodium laryl sulphate.
What Modalim looks like and contents of the pack
Modalim tablets are white to off white round tablets with a breakline on one side and embossed 'S170' on the other.
They are supplied in calendar blister packs of 28 tablets-Marketing Authorisation Holder and Manufacturer
Manufacturer Sanofi-Aventis Sp. z o.o. ul. Lubelska 52 35-233 Rzeszow Poland
Procured from within the EU by the Licence Holder: Expono Ltd, Cornwall Road,West Midlands, B66 2JT, UK. Repackaged by: N.G. Ltd, West Midlands, B66 2JT, UK.
| POM I PL: 22961/0117 - Modalim 100 mg Tablets
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.
Leaflet revision date: 25.08.2015 Ref: 867
Modalim® is a registered trademark of sanofi-aventis
| PAN REFLEX BLUE
client NG Ltd contact Randeep Nandra
AMENDMENTS HOURS
26/2/15
26/2/15
29/5/15
Client Approval
Please check this proof carefully to ensure that we have interpreted all your instructions correctly before signing and returning this copy. No liability can be accepted for errors or omissions once this proof has been approved.
O Approved O Plate making authorised O Amendments, Further visual required
PRODUCT CODE 867 description Modalim 100mg tablets
DIMENSIONS
barcodespec 210x148mm DATE 26/8/2015
PROOF NO. 5
Customer Signature_
Date _
proof created by Anthony Duru
|
PLEASE CONFIRM PRINT FINISHING |
MACHINE GLOSS VARNISH O MACHINE MATT VARNISH O |
HIGH GLOSS U.V. VARNISH O SPOT HIGH GLOSS U.V. VARNISH O |
MATT LAMINATION O GLOSS LAMINATION O |
|
SPECIAL REQUIREMENTS foiling O |
EMBOSSING O |
BRAILLE O | |
2. Before you take ciprofibrate
a 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.
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Ciprofibrate 100 mg Tablets
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. H ow to sto re ci p rofi b rate
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 non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood.
Do not take ciprofibrate if:
X 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
X You are pregnant, might become pregnant or think you may be pregnant (see “Pregnancy and breast-feeding” section below)
X You are breast-feeding (see “Pregnancy and breast-feeding” section below)
X You have severe liver or kidney problems X You are taking 'fibrates' (such as dofibrate, 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.
A Take special care with ciprofibrate. Check with your doctor or pharmacist before taking ciprofibrate if:
A You have unexpected muscle pains, tenderness or weakness
A You have liver or kidney problems A You have an under-active thyroid gland A You are over 70 years of age A You ora 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 rosuvastatinj- 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.
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. Ciprofibrate contains castor oil which may cause stomach upset and diarrhoea. Also contains soya, if you are allergic to peanut or soya, do not use this medicinal product.
Turn
Over
) 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
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.
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
Keep out of the reach and sight of children.
Do not store above 25oC.
Store in the original package.
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 100 mg of ciprofibrate
• The other ingredients are maize starch, lactose, microcrystalline cellulose, hypromellose, sterotex K (hydrogenated vegetable oil) and sodium laryl sulphate.
What ciprofibrate looks like and contents of the pack
Ciprofibrate tablets are white to off white round tablets with a breakline on one side and embossed 'S170' on the other.
They are supplied in calendar blister packs of 28 tablets. Marketing Authorisation Holder and Manufacturer
Manufacturer Sanofi-Aventis Sp. z o.o. ul. Lubelska 52 35-233 Rzeszow Poland
Procured from within the EU by the Licence Holder: Expono Ltd, Cornwall Road,West Midlands, B66 2JT, UK. Repackaged by: N.G. Ltd, West Midlands, B66 2JT, UK.
| POM I PL: 22961/0117 - Ciprofibrate 100 mg Tablets
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.
Leaflet revision date: 25.08.2015 Ref: 868
| PAN REFLEX BLUE
Client Approval
Please check this proof carefully to ensure that we have interpreted all your instructions correctly before signing and returning this copy. No liability can be accepted for errors or omissions once this proof has been approved.
O Approved O Plate making authorised O Amendments, Further visual required
client NG Ltd contact Randeep Nandra
PRODUCT CODE 868 AMENDMENTS HOURS
description Ciprofibrate 100mg 18/2/15
tablets 26/2/15
dimensions 29/5/15
barcodespec 210x148mm
Customer Signature Date
DATE 26/8/2015
PROOF NO. 5 PROOF CREATED by Anthony Duru
|
PLEASE CONFIRM PRINT FINISHING |
MACHINE GLOSS VARNISH O MACHINE MATT VARNISH O |
HIGH GLOSS U.V. VARNISH O SPOT HIGH GLOSS U.V. VARNISH O |
MATT LAMINATION O GLOSS LAMINATION O |
|
SPECIAL REQUIREMENTS foiling O |
EMBOSSING O |
BRAILLE O | |
This is a low resolution proof and should be used only as a guide to layout, content and colour separation.
IT SHOULD NOT BE USED TO ASSESS IMAGE QUALITY OR COLOUR ACCURACY. ALL COLOURS MATCH TO PMS NUMBERS WHERE SUPPLIED.