PACKAGE LEAFLET: INFORMATION FOR THE USER

Magnesium Sulphate Injection BP 20%w/v

Magnesium Sulphat

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 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 treat seizures (fits) caused by a serious omplication 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 heart problems 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

f 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 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 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

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 breastfeeding 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) either by injection or infusion (drip)

Adults and the elderly

For the treatment of low magnesium levels:

Up to 160 mmols of magnesium ions (200ml of a 20% solution) oy slow intravenous infusion (in glucose 5%) over a period of up to 5 days.

To prevent fits associated with eclampsia:

An initial dose of 4g/20ml or 16 mmols/20ml of magnesium ons intravenously (20ml of a 20% solution) or in some cases 5g/25ml or 20 mmols/25ml intravenously, as described above, s followed by an infusion of 1g per hour continued for 24h after the last fit.

f fits recur, a further 2-4g/10-20ml or 8-16 mmols/10-20ml of magnesium ions (depending on your weight, 2g if you are less than 70Kg) is given intravenously over 5 min.

Heptahydrate Ph Eur

Children

For the treatment of low magnesium levels:

The usual dose is 100mg/kg (0.5ml/kg of 20% solution or 0.4mmols/kg of magnesium ions) as a single dose, repeated every 12 hours as necessary.

To prevent fits associated with low magnesium levels:

The usual dose is 20-40mg/kg (0.1-0.2ml/kg of a 20% solution or 0.08-0.16 mmols/kg of magnesium ions) repeated every 4-6 hours as necessary.

Patients with kidney failure will be given a reduced dose. The dose will not be more than 20g in 48 hours (100ml of a 20% solution or 80mmols of magnesium ions).

If you are given too much or too little of 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.

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.

Protect from light. Keep in outer carton.

6.    Further Information

What Magnesium Sulphate Injection contains

The active substance is Magnesium Sulphate Heptahydrate 20%w/v.

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 20ml ampoules.

Marketing Authorisation Holder and Manufacturer

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

Date of last revision: August 2012 PL 012064/0048

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

Aurum