HEALTHCARES

MAGNESIUM SULFATE 50% W/V Patient Information Leaflet

PLEASE READ THIS LEAFLET CAREFULLY. IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE, YOU MAY WISH TO READ IT AGAIN.

1.    WHAT IS MAGNESIUM SULFATE 50% W/V AND WHAT IS IT USED FOR?

Magnesium Sulfate, the active ingredient, plays a number of important roles in the body, and is involved in the regulation of the nervous and blood systems. Magnesium Sulfate 50% w/v is a solution for injection or infusion and is used for magnesium deficiency and prevention (and control) of seizures in patients with severe pre-eclampsia (high blood pressure associated with pregnancy) or eclampsia (convulsions as a result of preeclampsia).

2.    BEFORE USING MAGNESIUM SULFATE 50%W/V

Magnesium Sulfate 50% w/v should NOT BE USED if you:

•    Are allergic to magnesium or its salts

•    Have suffered from a disease of the brain associated with cirrhosis of the liver

•    Have had liver failure

•    Have had kidney failure

•    Have myasthenia gravis (a chronic progressive muscular weakness disease)

•    Suffer from heart disease

Check with your doctor if you are concerned about any of the above.

Magnesium Sulfate 50%w/v should be used with caution in patients who are:

•    Suffering from impaired kidney function Taking other medicines:

Please tell your doctor if you are taking any other medication especially digitalis glycosides, nifedipine, muscle relaxants or central nervous system depressants such as sedatives.

Check with your doctor if you are concerned about any of the above.

3.    HOW TO USE MAGNESIUM SULFATE 50% W/V

The doctor will decide what dose of Magnesium Sulfate 50%w/v you should take. Check the label carefully. If you are not sure about anything, ask your doctor, nurse or pharmacist.

The usual dose for the treatment of magnesium deficiency is:

Up to 160mmol of magnesium given by slow intravenous infusion (using concentrations not higher than 20% w/v) over a maximum of 5 days. If further treatment is required, for example during prolonged feeding by drip, the usual daily dose is about 12mmol of magnesium.

The usual dose for the prevention and control of fits associated with severe preeclampsia and eclampsia is:

An initial intravenous dose of 4g, given slowly over a period of 20 minutes or so, is followed by an infusion of 1g/hour. If necessary, regular injections of 5g can be made into the buttocks every 4 hours, for at least 24 hours after the last fit. If fits recur a further 2-4g is given intravenously over 5 minutes.

You may be given (prescribed) a different dose by your doctor if you have problems with your kidneys.

If swallowed Magnesium Sulfate 50% w/v may cause stomach irritation and watery diarrhoea.

If any of this medicine is swallowed tell your doctor immediately.

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If a dose of Magnesium Sulfate 50%w/v is not given at the correct time - the dose should be given as soon as it is remembered. The next dose should be given at the usual time.

If more Magnesium Sulfate 50%w/v is given than should be - tell the doctor as soon as possible. If you are a medical practitioner administering this medicine an overdose may be reversed with calcium salts which should be administered slowly intravenously in a dose equivalent to 2.5 to 5mmol of calcium (please refer to the Summary of Product Characteristics).

4.    POSSIBLE SIDE EFFECTS OF MAGNESIUM SULFATE 50% W/V

As with all medicines, there may be some side effects with Magnesium Sulfate 50%w/v. The most common side effects are:-

•    respiratory depression (slow or shallow breathing) and abnormal heart beats

•    nausea (feeling sick) and/or vomiting

•    lowering of blood pressure

•    sweating and high temperature

•    thirst

•    confusion

•    drowsiness

•    muscle weakness

Very rare side effects are:

•    Heart attack (shortness of breath, chest pain, feeling faint and/or dizzy)

•    Coma

Tell your doctor, nurse or pharmacist, immediately, if you think you have any of these or other problems with Magnesium Sulfate 50%w/v.

5.    HOW TO STORE MAGNESIUM SULFATE 50% W/V

The medicine has an expiry date stated on the ampoule, vial and carton. Before use the doctor or nurse will check the product has not passed this date and that there is no sign of deterioration.

After the expiry date, any unused product should be returned to a pharmacy.

Keep the container in the original outer carton.

Do not freeze.

Store this medicine in a safe place where children cannot see or reach it.

6.    FURTHER INFORMATION

This medicine contains Magnesium Sulfate at a strength of 500g per litre as the active ingredient. It also contains the inactive ingredient: Water for Injection.

The following packs are available:

•    2ml, 5ml and 10ml ampoules

•    20ml and 50ml vials

The manufacturer and marketing authorisation holder is:

South Devon Healthcare, Torbay PMU, Long Road, Paignton, Devon, TQ4 7TW The leaflet was revised in: 03/2012 PL 13079/0004 PIL/4/4