Friday 24 August 2012

Bumetanide Injection 0.5mg / ml, solution for injection. (Leo Laboratories Ltd)






Bumetanide injection 0.5 mg/ml



Solution for injection



Bumetanide



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 Bumetanide injection 0.5 mg/ml, solution for injection, will be called Bumetanide.



In this leaflet:


  • 1. What Bumetanide is and what it is used for

  • 2. Before you have Bumetanide

  • 3. How to use Bumetanide

  • 4. Possible side effects

  • 5. How to store Bumetanide

  • 6. Further information




What Bumetanide Is And What It Is Used For


Bumetanide belongs to a group of medicines called diuretics.


Bumetanide works by removing any excess water from your body. It will make you go to the toilet more.



Bumetanide is used:


  • To treat oedema. Oedema means that there is too much water in your body. Oedema can cause symptoms such as swollen ankles or trouble breathing.




Before You Have Bumetanide



Do not have Bumetanide


  • If you are allergic (hypersensitive) to bumetanide.

  • 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.

  • If you have a problem with your kidneys and you cannot pass water (urine) at all or you are producing less urine than normal.

  • If you have been told that you have high levels of urea in your blood.

  • If you have been told that you have low levels of certain salts in your blood.

  • If you are taking another medicine called lithium for depression.



Take special care with Bumetanide


Before you have Bumetanide tell your doctor


  • If you have diabetes.

  • If you are on a low salt diet.

When you are having Bumetanide your doctor may take regular blood tests. This is very important in the elderly, in diabetics or in patients having high doses.




Taking other medicines


Do not have Bumetanide if you are taking lithium.


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:


  • Medicines for heart conditions, such as digoxin. Your doctor may need to change your dose.

  • Medicines for high blood pressure. Your doctor may need to change your dose.



Pregnancy and breast-feeding


Please ask your doctor or pharmacist for advice before having Bumetanide:


  • If you are pregnant, or think you are pregnant.

  • If you are breast-feeding.

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




Driving and using machines


This medicine may cause dizziness or feeling faint as side effects. You must not drive or use machines if you get these side effects.




Important information about some of the ingredients of Bumetanide


Bumetanide contains:


Sodium. This medicine is nearly "sodium free".
Your medicine contains less than 23 milligrams (mg) of sodium in a dose of 5 milligrams.


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





How To Use Bumetanide


Bumetanide will be given to you by a doctor or nurse. It may be given into your vein or into your muscle.



How much Bumetanide to have


Your doctor will prescribe the right dose for you.


You are likely to need the toilet more often after you have had your medicine.



Adults:


The usual dose for oedema affecting your lungs is 1 to 2 mg injected into a vein. You may be given another injection later if necessary.


If you are given this medicine by a drip into your vein the usual dose is 2 to 5 mg. This may take between 30 and 60 minutes to give.


If you are given your injection into a muscle, the usual dose is 1 mg.


Your doctor may change your dose depending on your test results.



Elderly:


Your doctor may prescribe less medicine than the usual adult dose to start with. Your doctor may then adjust your dose to make sure the dose is right for you.



Children:


This medicine is not recommended for use in children under 12 years of age.




If you have more Bumetanide 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 Bumetanide


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



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




Possible Side Effects


Like all medicines, Bumetanide 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 feel shaky, trembly or faint and your heart starts to beat fast or irregularly.


  • You produce less urine than usual or no urine at all.



Other possible side effects:


Digestive problems:


  • Stomach ache.

Skin problems:


  • Rash.

Other problems:


  • Bruising or bleeding more easily.

  • Swollen or painful breasts (sometimes in men).

  • Muscle cramps in the legs.

  • Muscle and bone pain.

  • Hearing disturbance.

  • You feel dizzy or faint.

  • Changes in blood test results. Your doctor can explain this more.


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 Bumetanide


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

  • Do not use the injection after the expiry date on the label. The expiry date is the last day of that month.

  • Store below 25°C.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.




Further Information



What Bumetanide contains


  • The active ingredient is bumetanide 0.5 milligrams per millilitre.

  • The other ingredients are disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water for injections and xylitol.



What Bumetanide looks like and contents of the pack


Bumetanide is a clear, colourless solution.


This medicine comes in glass ampoules containing 4ml of solution. There are five ampoules in each box.




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 October 2008.


Registered Trade Mark




LEO


018901-01





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