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1. Magnesium Sulphate Injection 50%W/V
2. Magnesium Sulphate Injection 50%W/V

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 nurse.

•    In this leaflet, Magnesium Sulphate 50% w/v Solution for Injection will be called Magnesium Sulphate Injection.

In this leaflet:

1.    What Magnesium Sulphate Injection is for

2.    Before you are given Magnesium Sulphate Injection

3.    How you will be given Magnesium Sulphate Injection

4.    Possible side effects

5.    How to store Magnesium Sulphate Injection

6.    Further information.

1. What Magnesium Sulphate Injection is for

Magnesium Sulphate belongs to a group of medicines called mineral supplements. Magnesium is important for many systems in the body, especially the muscles and nerves. Magnesium Sulphate Injection is given to increase the amount of magnesium in the body where the blood levels of magnesium are lower than normal (hypomagnesaemia), and where it is not possible for the medicine to be taken by mouth. This can be due to problems with absorption of magnesium, severe diarrhoea, chronic alcoholism, malnutrition or having to have all nutrients by injection.

Before you are given Magnesium lphate Injection

You should not be given Magnesium Sulphate Injection if:

•    You are allergic to the active ingredient, magnesium sulphate

•    You are allergic to the other ingredients of Magnesium Sulphate Injection (see section 6.)

•    You are suffering from any form of heart disease, for example, you have had a heart attack of heart block (where your heart beat signals are delayed)

•    You have kidney failure.

If the above applies to you talk to your doctor or nurse.

Check with your doctor before being given Magnesium Sulphate Injection if:

•    You are pregnant, planning to become pregnant or breast-feeding

•    You have kidney problems.

•    You have myasthenia gravis (a condition causing muscle weakness)

Magnesium sulphate injection will not be given to you if you are in a coma resulting from liver problems if there is a risk of kidney failure.

Tell your doctor if you are taking any of the following medicines:

•    Medicines for heart disease called cardiac glycosides (such as digoxin, digitoxin)

•    Muscle relaxants, used during anaesthesia, as using these medicines with Magnesium Sulphate may cause their effect to be increased

•    Medicines called opioids (such as morphine), barbiturates (such as amylobarbitone) or hypnotics (such as nitrazepam), as using these medicines with Magnesium Sulphate can cause slow and/or shallow breathing

•    Nifedipine or nimodipine, which may be used to treat high blood pressure or angina, as using this medicine with Magnesium Sulphate can cause problems with muscle function

•    Aminoglycoside antibacterials (such as streptomycin)

•    Any other medicine, including medicines obtained without a prescription.

If any of the above applies to you talk to your doctor or nurse.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or are breast-feeding, ask your doctor or nurse for advice before being given Magnesium Sulphate.

Driving and using machines

Magnesium Sulphate may cause drowsiness. If this happens to you, do not drive or use machinery.

Magnesium Sulphate Injection will be given to you by your doctor or nurse.

Important:

Your doctor will choose the dose that is right for you.

You will be given Magnesium Sulphate Injection by your doctor or nurse as an injection into a muscle or, after dilution, into a vein, depending on your condition and how much your body needs.

For injection into a vein, the solution should be diluted to 20% or less, and the rate of injection should be less than 1.5 ml per minute of a 10% solution.

Adults and the Elderly • T reatment of mild magnesium deficiency: - 1 gram (g) every 6 hours for 4 doses, injected into a muscle.

• Treatment of severe magnesium deficiency:

- Up to 250 milligrams (mg) per kilogram (kg) of body weight injected into a muscle over 4 hours or 5 g per litre of infusion solution given intravenously over 3 hours Children

•    The solution should be diluted to 20% if being injected into a muscle.

•    If it is injected into a vein the solution should be diluted to 1% and given over 1 hour.

•    In severe conditions half the dose may be given in the first 15 - 20 minutes.

•    Up to a 3% solution may be used in sever conditions

•    The usual dose for babies is 25 - 50 mg per kg every 8 to 12 hours for 2 to 3 doses

•    The usual dose for children is 25 - 50 mg per kg every 4 to 6 hours for 3 to 4 doses.

Patients with kidney problems

Your doctor may give you a lower dose.

Medical check-ups

While you are receiving this medicine, your doctor will want you to have regular blood tests to check your condition. This is to make sure that your medicine is working properly and that the dose you are receiving is right for you.

If you are given more Magnesium Sulphate Injection than you should

If you think you have been given too much Magnesium Sulphate Injection you should tell your doctor.

Too much Magnesium Sulphate can lead to raised levels of magnesium in the blood (hypermagnaesemia), with symptoms of flushing, feel thirsty, low blood pressure, drowsiness, feeling or being sick, confusion, slurred speech, double vision, loss of knee jerk reflex, muscle weakness, slow and/or shallow breathing and irregular heart beat. If treatment is not stopped or attempts not made to lower the blood levels of magnesium, this could eventually lead to coma or heart attack. You may be given an injection of a calcium salt to help to lower very high levels of magnesium. If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Seek immediate medical help if you have an allergic reaction. This includes any of the following symptoms:

•    Difficulties in breathing

•    Swelling of your eyelids, face or lips

•    Rash or itching especially those covering your whole body

Other side effects:

Effects on the heart and blood

•    Low blood pressure

•    Irregular or slow heart beat

•    Heart attack

•    low levels of Calcium in your blood. (This may cause you to have pins & needles or twitching muscles)

Effects on respiration

•    Slow and/or shallow breathing Effects on the stomach and bowel

•    Feeling sick or being sick Effects on the nervous system

•    Loss of knee jerk reflex

•    Coma Other effects

•    Slurred speech or double vision.

•    Flushing

•    Drowsiness

•    Confusion

•    Muscle weakness

•    Feeling thirsty.

If any of the side effects gets 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.

Do not use it after the expiry date on the label. The expiry date refers to the last day of that month.

Store below 25°C.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

6.    Further information

What Magnesium Sulphate Injection contains

In active ingredient is Magnesium Sulphate BP 50% w/v.