PACKAGE LEAFLET: INFORMATION FQRTHE USER

Magnesium Sulphate Injection 50%w/v

Magnesium Sulphate Heptahydrate

If you are given too much or too little Magnesium Sulphate Injection

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

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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 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 5. 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.

t may also be used to prevent 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 liver or kidney failure

Take special care with Magnesium Sulphate Injection if:

•    you suffer from any liver or kidney problems

f any of the above apply to you 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 ecently taken any other medicines, including medicines obtained without a prescription.

Medicines which may interact with Magnesium Sulphate njection include:

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

•    digitalis (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

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. Please speak to your doctor before driving or operating machinery.

4.    Possible side effects

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

Possible side effects include:

•    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

•    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 after EXP. 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.

Do not store above 25°C.

The ampoule containing the injection will only be used for you and if any injection is left over the doctor/nurse will dispose of it

6.    Further Information

What Magnesium Sulphate Injection contains

The active substance is Magnesium Sulphate Heptahydrate 2ml contains 1g Magnesium Sulphate Heptahydrate (4mmol Mg²+)

5ml contains 2.5g Magnesium Sulphate Heptahydrate (10mmol Mg²+)

10ml contains 5g Magnesium Sulphate Heptahydrate (20mmol Mg²+)

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

What Magnesium Sulphate Injection looks like and contents of the pack

Magnesium Sulphate sterile solution for injection/concentrate for solution for infusion is a clear, solution supplied in 2ml, 5ml and 10ml glass ampoules. 10 ampoules are packed in each carton.

Marketing Authorisation Holder

Aurum Pharmaceuticals Ltd Bampton Road Harold Hill Romford RM3 8UG United Kingdom

MARTJNDALE PHARMA

DEVELOPMENT ARTWORK

Component Code: D02410

Paper size: 170 x 296mm

Grand Fromage Creative Ltd

Amherst House, 22 London Road Sevenoaks, Kent TN13 2BT t:+44 (0)1732 456 187 ^^■@grand-fromage.co.uk www.grand-fromage.co.uk

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 njection or infusion (drip). Your doctor will decide how much Magnesium Sulphate should be given to you.

For the treatment of low magnesium levels:

You will be given up to 40g by slow intravenous infusion (drip) over a period of up to 5 days.

To prevent fits associated with eclampsia:

After an initial intravenous dose you will be monitored for 24 hours and then you may be given either an intravenous infusion (drip) or regular intramuscular injections.

Patients with kidney problems will be given a reduced dose.

Manufacturer

Macarthys Laboratories Ltd Bampton Road Harold Hill Romford RM3 8UG United Kingdom

This leaflet was last revised in October 2012. PL 12064/0013

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

A U R U M

D0241 0 10

100mm Measurement Verification Bar