Tuesday, 24 July 2012

Isotard 25, 40, 50 and 60 mg XL Tablets





Isotard XL Tablets



Isosorbide mononitrate (25, 40, 50 or 60mg)






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 further questions, please 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.




In this leaflet:



1. What Isotard XL is and what it is used for

2. Before you take Isotard XL

3. How to take Isotard XL

4. Possible side effects

5. How to store Isotard XL

6. Further information






What Isotard XL is and what it is used for



Isotard XL modified release tablets are used to prevent attacks of angina (chest pain).



Isotard XL works by opening up blood vessels and reducing the pain.





Before you take Isotard XL




Do not take Isotard XL if:



  • you are allergic (hypersensitive) to isosorbide-5-mononitrate or any of the other ingredients in Isotard XL modified release tablets (see Section 6 Further Information)

  • you recently had a stroke or have a history of stroke

  • you are taking sildenafil or similar products e.g. Viagra for male erectile dysfunction

  • you have problems with your heart or circulation

  • you have a lack of iron in your blood

  • you suffer from closed angle glaucoma (high pressure in the eye)

  • you have low blood pressure

  • you have suffered a head injury causing high pressure within the brain




Take special care with Isotard XL:



Tell your doctor or pharmacist if:



  • you suffer from malnutrition

  • you suffer from hypothermia (body temperature which is lower than normal)

  • you are pregnant, think you might be pregnant, considering becoming pregnant or are breast feeding

  • you have liver or kidney disease

  • your thyroid gland is under active or you are taking thyroxine

  • you have recently suffered from a heart attack

  • you are taking any other medication, even those you may have bought for yourself without prescription

Isotard XL should not be used for the relief of sudden (acute) attacks of angina. If you have an attack of angina you should speak to your doctor or pharmacist who may supply you with other medicines for this.



Treatment with this medicine should not be discontinued suddenly. Withdrawal from Isotard XL should be tapered gradually.





Taking other medicines with Isotard XL



Isotard XL may lower blood pressure (you may experience this as dizziness, tiredness or feeling sick) so take special care when taking other medicines that may also lower blood pressure.



Do not take Isotard XL if you are taking sildenafil or similar products e.g. Viagra for male erectile dysfunction. When taken together a severe and possibly dangerous fall in blood pressure can occur which may result in collapse, unconsciousness and could be fatal.



Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines taken without a prescription.





Taking Isotard XL with food and drink



You are advised NOT to drink alcohol with this medicine, as the effects of alcohol may become worse. Alcohol may also increase the side effects of this medicine and make you feel dizzy or light-headed if you stand up or move suddenly.





Pregnancy and breast-feeding



In pregnancy or when breast feeding, Isotard XL should only be used under medical supervision. Ask your doctor or pharmacist for advice before taking any medicine.





Driving and using machines



Do not drive or operate machinery when taking Isotard XL if you develop low blood pressure (you may experience this as dizziness, tiredness or feeling sick) or if you have blurred vision.





Important information about some of the ingredients of Isotard XL



Isotard XL contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Isotard XL.






How to take Isotard XL



Always take Isotard XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.



Adults, elderly, children and adolescents 12 years of age and over – 1 or 2 tablets daily, ideally in the morning. Isotard XL should be swallowed whole with water. Do not crush or chew.



Children under 12 – Isotard XL must not be given to children under 12 years.



If you take more Isotard XL than you should - You should only take what your doctor recommends. If you take too many Isotard XL tablets contact your doctor or pharmacist if you can do so. If not, go to the nearest hospital casualty department immediately, taking the Isotard XL pack and remaining tablets with you.



If you forget to take Isotard XL - If you forget to take your tablet, take it as soon as possible and continue to take the tablets as normal. Do not take a double dose to make up for a forgotten tablet.



If you stop taking Isotard XL – Angina is a condition which may need treatment for life, always talk to your doctor or pharmacist before stopping using Isotard XL.



If you have any further questions on the use of this product, ask your doctor or pharmacist.





Possible side effects



Like all medicines, Isotard XL can cause side effects, although not everybody gets them.



  • Headaches may occur when treatment is first started but usually disappears after 1 to 2 weeks.

  • Low blood pressure may occasionally occur (you may experience this as dizziness, tiredness and feeling sick).

  • More rarely, becoming flushed and allergic rashes can occur.

  • Increased and decreased heart rate have also been reported.

If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.





How to store Isotard XL



  • Keep out of the reach and sight of children.

  • Do not store above 25°C.

  • Keep the container tightly closed.

  • Do not use Isotard XL after the expiry date which is printed on the carton label has passed.

  • 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 Isotard XL contains



Each tablet contains 25, 40, 50 or 60mg isosorbide-5-mononitrate. It also contains polyethylene glycol, hydroxypropylmethylcellulose, stearic acid, talc, purified siliceous earth, lactose, carnauba wax, magnesium stearate and the colourings titanium dioxide (E171) and yellow iron oxide (E172).





What Isotard XL looks like and contents of the pack



Isotard 25XL, 40XL and 50XL tablets are round and cream in colour with ‘IM25’, ‘IM40’ and ‘IM50’ respectively on one side.



Isotard 60XL tablets are oval and cream in colour with a score line on both sides and ‘60’ on one side.



Isotard XL tablets are provided in packs of 28.





Marketing Authorisation Holder:




ProStrakan Limited

Galabank Business Park

Galashiels

Scotland

TD1 1QH





Manufacturers:




Valpharma s.a.

Via Ranco 47031

Serravalle

Republic of San Marino




Euderma srl1

Via Rigardara 27-29

47040 Cerasolo Di Coriano

(Forli)

Italy




Valpharma International SpA2

Via G. Morgagni

2 - 61016 Pennabilli (PU)

Italy





This leaflet was last approved in 04/2008



1 This site only manufactures 25XL, 40XL and 50XL tablets



2 This site only manufactures 60XL tablets.






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