PACKAGE LEAFLET: INFORMATION FOR THE USER

Sterile Potassium Phosphate Solution Solution for Injection

Potassium Phosphate

Read all of this leaflet carefully before you are given this medicine.

•    Keep this leaflet. You may need to read it again.

.. • If you have any further questions, ask your doctor or nurse.

•    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 nurse.

In this leaflet:

1.    What Sterile Potassium Phosphate Solution is and what it is used for

2.    Before you are given Sterile Potassium Phosphate Solution

3.    How Sterile Potassium Phosphate Solution is given

4.    Possible side effects

5.    How to store Sterile Potassium Phosphate Solution 5. Further information

3.    How Sterile Potassium Phosphate Solution is given

Your doctor or nurse will give you Sterile Potassium Phosphate Solution into a vein (intravenously) by slow infusion (drip) once it has been diluted. You should be aware that your doctor may need to monitor your heartbeat during your treatment.

Your doctor will decide the amount of Sterile Potassium Phosphate Solution you need.

Adults (including the elderly)

The usual dose is the equivalent of 310mg of phosphorus daily after dilution.

Children

The usual dose is the equivalent of 46.5 to 62mg of phosphorus daily after dilution

If you think you have been given too much Sterile Potassium Phosphate Solution

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.

4.    Possible side effects

1.    What Sterile Potassium Phosphate Solution is and what it is used for

Potassium Phosphate belongs to a group of medicines called electrolytes. Electrolytes are needed by the body to carry out all of its normal functions.

Sterile Potassium Phosphate Solution, when diluted, is used to out electrolytes back into your body if you have lost them through too much sweating or prolonged diarrhoea and sickness (dehydration).

2.    Before you are given Sterile Potassium Phosphate Solution

You should not be given Sterile Potassium Phosphate Solution if:

•    you are allergic (hypersensitive) to potassium or phosphate or any of the other ingredients of this medicine, listed in section 6 of this leaflet.

•    you have too much phosphate in your body

•    you have severe kidney problems

•    you suffer from kidney stones

•    you suffer from problems with your parathyroid

•    you suffer from softening of the bones (osteomalacia or rickets)

•    you are suffering from a sudden swelling of the pancreas (acute pancreatitis)

•    you suffer from heart disease

•    you suffer from a problem with your adrenal glands known as Addison's disease

•    you are suffering from dehydration

•    you have suffered from severe burns

•    you suffer from a disease of the muscles known as myotonia congenita

f you are unsure about being given this medicine or you have any questions, talk to your doctor or nurse.

Taking other medicines

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

Medicines that may interact with Sterile Potassium Phosphate Solution include:

•    medicines containing potassium

•    medicines that make you pass more urine but stop you passing potassium in that urine (potassium sparing diuretics)

•    medicines used to treat heart problems and high blood pressure e.g. captopril, enalapril and lisinopril

•    steroids such as the adrenocorticoids, glucocorticoids, mineralocorticoids, corticotrophin and anabolic steroids.

•    medicines that make you pass more urine (thiazides and other diuretics)

•    medicines used to treat an irregular heartbeat such as quinidine, digitalis and mexiletine

•    medicines containing salicylates such as aspirin

f you have any doubts about whether this medicine should be administered to you, consult your doctor or nurse.

Pregnancy and breast-feeding

f you are pregnant, trying for a baby or breast-feeding ask your doctor for advice before you are given this medicine.

Driving and using machines

There are no known effects of having Sterile Potassium Phosphate Solution on driving or using machines

Like all medicines, Sterile Potassium Phosphate Solution can cause side effects, although not everybody gets them.

Possible side effects include:

•    water retention (swelling of the feet or lower legs and weight gain)

•    confusion

•    tiredness or weakness

•    irregular or slow heartbeat

•    numbness, tingling, pain or weakness around lips, hands or feet

•    unexplained anxiety

•    weakness or heaviness of legs

•    shortness of breath or trouble breathing.

•    fits

•    decrease in amount of urine or in frequency of urination

•    fast heartbeat,

•    headache or dizziness

•    increased thirst

•    muscle cramps

Some of these side effects may be caused by having too many or too few electrolytes in your body. Your doctor may have to do tests to check this.

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

5.    How to store Sterile Potassium Phosphate Solution

Keep all medicine out of the reach and sight of children.

You should not be given Sterile Potassium Phosphate Solution after the expiry date which is printed on the carton and ampoule label. The doctor or nurse will check that the expiry date on the label has not passed before administering the injection to you. The expiry date refers to the last day of that month.

6.    Further Information

What Sterile Potassium Phosphate Solution contains

The active substance is potassium phosphate 17.42% w/v The other ingredients are disodium edetate and water for injections

What Sterile Potassium Phosphate Solution looks like and contents of the pack

Sterile Potassium Phosphate Solution is a clear, colourless solution supplied in clear glass ampoules containing 5ml or 10ml of the solution. Each carton contains 10 ampoules.

Marketing Authorisation Holder and Manufacturer

Martindale Pharmaceuticals

Bampton Road

Harold Hill

Romford

Essex, RM3 8UG

UK

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

This leaflet was last revised in March 2009.

Product licence number:

PL 01883/0011

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

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