PACKAGE LEAFLET: INFORMATION FOR THE USER    C*****

Magnesium Sulphate Injection 50%w/v

Magnesium Sulphate Heptahydrate BP

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

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

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

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

In this leaflet:

1.    What Magnesium Sulphate Injection is and what it is used for

2.    Before you are given Magnesium Sulphate Injection

3.    How Magnesium Sulphate Injection will be given

4.    Possible side effects

5.    How to store Magnesium Sulphate Injection

6.    Further information

1.    What Magnesium Sulphate Injection is and what it is used for

Magnesium Sulphate Injection is used to treat low levels of magnesium in the blood.

It may also be used to treat seizures (fits) caused by a serious complication of pregnancy known as eclampsia.

2.    Before you are given Magnesium Sulphate Injection

You should not be given Magnesium Sulphate Injection if:

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

•    you suffer from a heart problem known as heart block

•    you suffer from liver or kidney failure

Take special care with Magnesium Sulphate Injection if:

•    you suffer from any liver or kidney problems

•    you suffer from a disorder that causes muscle weakness known as myasthenia gravis

If any of the above apply to you or your child please tell your doctor or nurse before you are given Magnesium Sulphate Injection

Taking other medicines

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

Medicines which may interact with Magnesium Sulphate Injection include:

•    CNS depressants (medicines that act on the nervous system to cause drowsiness)

•    digitalis glycosides (a medicine used to treat heart problems)

•    muscle relaxants e.g. tubocurarine

•    nifedipine (a medicine used to treat high blood pressure)

Pregnancy and breast-feeding

Magnesium Sulphate may be used to treat the fits associated with eclampsia, a serious complication of pregnancy. Tell your doctor if you think you may be pregnant or if you are breast-feeding before being given Magnesium Sulphate Injection.

Driving and using machines

There are no known effects of Magnesium Sulphate Injection on driving and using machines.

3.    How Magnesium Sulphate Injection will be given

Your doctor will give Magnesium Sulphate Injection to you into a vein (intravenous) or into the muscle (intramuscular) either by injection or infusion (drip). Your doctor will decide how much Magnesium Sulphate you should be given.

For the treatment of low magnesium levels:

Up to 40g (equivalent to 160 mmols of magnesium ions) by slow intravenous infusion (in glucose 5%) over a period of up to 5 days.

To prevent fits associated with eclampsia:

An initial intravenous dose is followed for 24 hours by either regular intramuscular injections or an intravenous infusion.

Patients with kidney failure will be given a reduced dose.

Continued overleaf

If you are given more Magnesium Sulphate Injection than you should be

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 if you have any concerns.

4.    Possible side effects

Like all medicines, Magnesium Sulphate Injection can cause side effects, although not everybody gets them.

Possible side effects include:

•    watery diarrhoea

•    stomach pains

•    feeling or being sick

•    flushing of the skin

•    feeling thirsty

•    slowed reflexes

•    temporarily low blood pressure

•    drowsiness

•    confusion

•    muscle weakness

•    slowed breathing

•    low body temperature

•    irregular heartbeat

•    heart attack

•    coma

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

5.    How to store Magnesium Sulphate Injection

Keep out of the reach and sight of children.

This Magnesium Sulphate Injection should not be used 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 been passed before administering the injection to you. The expiry date refers to the last day of that month.

Store below 25°C. Protect from light.

6.    Further Information

What Magnesium Sulphate Injection contains

The active substance is Magnesium Sulphate Heptahydrate 5g.

The other ingredients are water for injections, dilute hydrochloric acid and sodium hydroxide.

What Magnesium Sulphate Injection looks like and contents of the pack

Magnesium Sulphate Injection is a clear, colorless solution supplied in a 10ml prefilled syringe.

Marketing Authorisation Holder

Aurum Pharmaceuticals Ltd Bampton Road Harold Hill Romford RM3 8UG England

Manufacturer

Federa SC

Avenue Jean Jaureslaan, 71 B-1030 Brussels Belgium

This leaflet was last approved in 06/2008.

PL 012064/0045

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

Au RU M