Tuesday, September 6, 2016

Modalim





Modalim 100mg Tablets



Ciprofibrate







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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





What Modalim is and what it is used for





Modalim contains a medicine called ciprofibrate. This belongs to a group of medicines called ‘fibrates’. It works by lowering the amount of fat in your blood.



Modalim is used to treat something called ‘hyperlipidaemia’.



  • This is where you have high levels of fat in your blood

  • It is usually given after a low fat diet has failed to reduce these high levels

  • People with high levels of fat in their blood have a higher chance of getting the early signs of heart disease




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

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

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.






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.





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.





Modalim 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

  • Feeling breathless

  • Liver problems. This may cause the eyes or skin to go yellow (jaundice)




Other side effects are:



  • Hair loss, balding

  • Headache, balance problems

  • Feeling dizzy, drowsy or tired

  • Impotence




The following side effects can happen at the start of your treatment. You are less likely to get them as treatment continues:



  • Feeling sick (nausea) or being sick (vomiting)

  • Diarrhoea, indigestion or stomach pains



Tell your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days.
Also tell them if you notice any side effects not listed in this leaflet





How to store Modalim



Keep out of the reach and sight 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.





Further information




What Modalim contains



  • The active substance is ciprofibrate

  • The other ingredients are maize starch, lactose monohydrate, microcrystalline cellulose, hypromellose, powdered vegetable stearine, sodium laurilsulfate




What Modalim looks like and contents of the pack



Modalim tablets are long and white with MODALIM stamped on one side. They are supplied in cartons of 28 tablets.





Marketing Authorisation Holder and Manufacturer



Marketing Authorisation Holder




Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com



Manufacturer




Fawdon Manufacturing Centre

Edgefield Avenue

Fawdon

Newcastle-upon-Tyne

NE3 3TT




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.



This leaflet was last revised in



April 2008.



31301405






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