Thursday, October 13, 2016

Sodium Fusidate 500mg for Intravenous Infusion (Leo Laboratories Ltd)





Sodium fusidate 500 mg for intravenous infusion



sodium fusidate




Please 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.


  • In this leaflet sodium fusidate 500 mg for intravenous infusion will be called sodium fusidate infusion.




In this leaflet:



  • 1. What sodium fusidate infusion is and what it is used for


  • 2. Before you have sodium fusidate infusion


  • 3. How to use sodium fusidate infusion


  • 4. Possible side effects


  • 5. How to store sodium fusidate infusion


  • 6. Further information





What Sodium Fusidate Infusion Is And What It Is Used For



This medicine contains sodium fusidate. It is a type of antibiotic.



Sodium fusidate infusion works by killing germs (bacteria) that cause infections.




Sodium fusidate infusion is used to treat infections such as:



  • Infections of the skin and wounds


  • Infections of the blood such as septicaemia


  • Infections of the bone and heart tissue


  • Infections of the lungs such as pneumonia


  • Infections connected with the condition cystic fibrosis.





Before You Have Sodium Fusidate Infusion




Do not have sodium fusidate infusion



  • If you are allergic (hypersensitive) to fusidic acid or its salts.


  • If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.




Take special care with sodium fusidate infusion



Before you have sodium fusidate infusion, tell your doctor:



  • If you have problems with your liver


  • If you have recently been jaundiced.

When you are having sodium fusidate infusion your doctor may take regular blood tests in patients on high doses, with liver problems or taking the medicine for a long time.





Taking other medicines



Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.



You must tell your doctor or pharmacist if you are taking any of the following medicines:



  • Other antibiotics, such as lincomycin and rifampicin.


  • Oral anti-coagulants (medicines to "thin" your blood). You may be likely to bleed more easily. Your
    doctor may need to change your dose.


  • Medicines to lower blood cholesterol, such as statins. Rarely, this may lead to muscle weakness, tenderness or pain.


  • Ciclosporin. This medicine is used to reduce the body's immune reactions.




Pregnancy and breast-feeding



Please ask your doctor or pharmacist for advice before having sodium fusidate infusion:



  • If you are pregnant, or think you are pregnant


  • If you are breast-feeding.

Tell your doctor if you become pregnant while having this medicine.





Driving and using machines



Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.





Important information about some of the ingredients of sodium fusidate infusion



Sodium fusidate infusion contains:



  • Sodium. Each reconstituted vial contains 71.3 milligrams (mg) sodium. You should take this into
    consideration if you are on a controlled sodium diet.



Please ask your doctor if you are worried about any of the ingredients in this medicine.





How To Use Sodium Fusidate Infusion



Sodium fusidate infusion will be given to you into your vein by a doctor or nurse.




How much sodium fusidate infusion to have



Your doctor will prescribe the right dose for you.





If you have received more sodium fusidate infusion than you should



Your doctor or nurse will give you this medicine. If you think you may have been given too much, tell your
doctor or nurse straight away.





If you have missed a dose of sodium fusidate infusion



Your doctor or nurse will give you this medicine. If you think that you have missed a dose then tell your
doctor or nurse.




If you have any further questions about using this medicine, please ask your doctor or pharmacist.





Possible Side Effects



Like all medicines, sodium fusidate infusion can cause side effects, although not everybody gets them.




Important side effects to look out for:



You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:



  • You have difficulty breathing


  • Your face or throat swell


  • Your skin develops a severe rash.

You should tell your doctor straight away if you have any of the following symptoms. You may be having problems with your liver or kidneys:



  • Your skin or the whites of your eyes appear yellow


  • You are not passing water.

You should tell your doctor straight away if you have any of the following symptoms. The level of some cells in your blood may be changed.



  • You develop any unexplained bruising or bleeding


  • You develop persistent or repeated mouth ulcers, sore throats or other infections.




Other possible side effects:



Inflammation of the veins.




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





How To Store Sodium Fusidate Infusion



  • Keep out of the reach and the sight of children.


  • Do not use sodium fusidate infusion after the expiry date on the carton. The expiry date is the
    last day of that month.




Further Information




What sodium fusidate infusion contains



  • The active ingredient is sodium fusidate. A vial of powder contains 500 mg of sodium fusidate.


  • The other ingredients are citric acid, disodium edetate, disodium hydrogen phosphate and water for injections.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.





What sodium fusidate infusion looks like and contents of the pack



Sodium fusidate infusion comes in packs of 2 vials. One vial contains sodium fusidate (powder) and the other vial the solution for the infusion.





Marketing Authorisation Holder and Manufacturer



Marketing Authorisation Holder:




LEO Laboratories Limited

Princes Risborough

Bucks.

HP27 9RR

UK



Manufacturer:




LEO Pharmaceutical Products

DK 2750 Ballerup

Denmark





This leaflet was last revised in March 2008.









LEO



021327-03






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