Phosphates solution for infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

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

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

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Phosphates solution for infusion is and what it is used for

2.    What you need to know before you are given Phosphates solution for infusion

3.    How you are given Phosphates solution for infusion

4.    Possible side effects

5.    How Phosphates solution for infusion is stored

6.    Contents of the pack and other information

1. What Phosphates infusion is and what it is used for

In this leaflet this medicines is referred to as Phosphates infusion.

Phosphates infusion is used when there are low levels of phosphate in the blood.

Phosphate is the most common form of phosphorus. Phosphorus is a mineral found in many foods, such as milk, cheese, dried beans, peas, nuts, and peanut butter. In the body, phosphate is critical for energy storage and metabolism, for the utilisation of many B-complex vitamins, to buffer body fluids, for proper muscle and nerve function, and for maintaining calcium balance. Phosphorus is vital to the formation of bones and teeth, and healthy bones and soft tissues require calcium and phosphorus to grow and develop throughout life.

2. What you need to know before you are given Phosphates infusion

You should not receive Phosphates infusion if you have:

•    kidney problems

•    have abnormal levels of electrolytes (e g. phosphate, potassium, sodium or calcium) in your blood or excessive levels of water in your body

Your doctor will check this.

Warnings and precautions

Talk to your doctor or pharmacist before being given Phosphates infusion if you have:

•    high blood pressure

•    heart failure or heart disease

•    too much flu id in body tissues

•    fluid in the lungs

•    convulsions

•    conditions associated with poor kidney or adrenal gland function

•    severe dehydration (water loss)

•    severe burns or extensive tissue damage

You will be carefully monitored during treatment for serum electrolyte levels, kidney function, ECC, fluid and acid-base-balance. Your doctor will explain this to you.

Other Medicines and Phosphates infusion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking or have been taking

•    potassium-sparing diuretics (water pills) such as amiloride, spironolactone and triamterene

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Phosphates infusion has no effect on driving or using machines.

3.    How you are given Phosphates infusion

Phosphates infusion will be given to you in hospital.

You will receive your medicine by infusion (IV drip). The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you to receive.

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

If you receive too much Phosphates infusion

It is very unlikely that you will receive more infusion that you should as your doctor or nurse will monitor you during treatment. However, if you think you received too much inform your doctor immediately.

See section 4, Possible side effects, for symptoms of overdose.

4.    Possible side effects

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

Prolonged infusion of Phosphates infusion may result in raised phosphate levels in the blood (hyperphosphataemia). This may lead to reduced calcium levels in the blood (hypocalcaemia) with muscle spasm (tetany), fits (convulsions) or nervous excitability and to deposition of insoluble calcium in soft tissue. This tissue calcification may cause low blood pressure (hypotension) and organ damage and result in kidney failure.

If too much Phosphates infusion is administered, it may cause raised potassium (hyperkalaemia) and sodium (hypernatraemia) electrolyte levels.

Symptoms associated with increased potassium levels include:

•    muscle weakness • lack of energy    • mental confusion

•    numbness/pins & needles of the extremities • paralysis

•    abnormal heart rhythms and blood pressure.

Symptoms associated with increased sodium levels include:

•    loss of water from the brain resulting in sleepiness and confusion, which could progress to convulsions, coma and breathing failure

•    reduced amounts of saliva and tears • restlessness

•    increased heart rate and blood pressure • irritability and weakness

•    thirst • fever • dizziness • headache Intravenous administration may also be associated with pain and inflammation at the injection site.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Phosphates infusion

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Phosphates solution.

Phosphates solution should be stored between 2°C and 25°C.

The solution must not be used after the expiry date shown on the label. Any solution remaining after treatment should be disposed of via approved hospital procedures.

Keep out of the sight and reach of children.

6.    Contents of the pack and other information

What Phosphates infusion contains

Phosphates infusion contains a mixture of two phosphates, 0.259% Monopotassium Phosphate BPC 1949 and 2.9% Sodium Phosphate BP dissolved in water for injection.

What Phosphates infusion looks like and contents of the pack

The solution is contained in a sealed tube-shaped plastic container, known as a Polyfusor® container and is available in a 500ml pack only. Marketing Authorisation Holder Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1NT. UK.

Manufacturer:

Terumo BCT Limited,

Old Belfast Road, Millbrook,

Larne, Co. Antrim, BT40 2SH. UK

This leaflet was last revised in September 2014.

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