Patient leaflet - Magnesium Sulfate injection BP 20%w/v

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

Magnesium Sulfate Injection is used to treat low levels of magnesium in the blood where it is not possible for the medicine to be taken by mouth.

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

It is used in the treatment of acute hypomagnesaemia

2.What you need to know before you are given Magnesium Sulfate Injection

You must not be given Magnesium Sulfate Injection if:

you are allergic to Magnesium Sulfate, its salts or any of the other ingredients of this medicine listed in section 6.
you suffer from severe kidney failure

Warnings and Precautions

Talk to your doctor, pharmacist or nurse before receiving Magnesium Sulfate if you:

suffer from any kidney problem.
suffer from severe liver problems
suffer from a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs known as myasthenia gravis

During treatment

Your blood calcium levels will be routinely monitored whilst taking Magnesium Sulfate

Other medicines and Magnesium Sulfate Injection

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

Medicines which may interact with Magnesium Sulfate

Injection include:

Digitalis glycosides e.g. digoxin (a medicine used to treat heart problems)
Barbiturates (e.g. amobarbital)
Opioids ( e.g. morphine)
Hypnotics ( e.g. nitrazepam)
muscle relaxants e.g. tubocurarine
Calcium channel blockers e.g. nifedipine or nimodipine (medicines used to treat high blood pressure) which could result in calcium ion imbalance causing abnormal muscle function.
Aminoglycoside antibacterials (such as Streptomycin)

Pregnancy, fertility and breast-feeding

Tell your doctor if you are pregnant or trying to become pregnant. Magnesium Sulfate Injection will only be given to you if your doctor considers the benefit of treatment outweighs the risk to the developing baby. Low blood calcium levels and effects

on the bones, such a reduced bone density, have been reported in babies whose mothers were given magnesium sulphate continuously for more than 5-7 days during pregnancy.

Driving and using machines

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

3. How Magnesium Sulfate Injection will be given

Your doctor will give Magnesium Sulfate Injection to you into a vein (intravenous) or muscle either by injection or infusion (drip).

Adults

For the treatment of low magnesium levels:

Up to 160 mmols of magnesium ions (200ml of a 20% solution) by 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 mmol/20ml of magnesium ions intravenously (20ml of a 20% solution) or in some cases 5g/25ml or 20 mmol/25ml

intravenously, as described above, is followed by an infusion of 1g per hour continued for 24h after the last fit.

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

Renal Failure:

Doses must be reduced in renal failure. Caution must be observed to prevent exceeding the renal excretory capacity. The dosage should not exceed 20g in 48 hours (100ml of a 20% solution or 80mmol of magnesium ions).

e Heptahydrate

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse
If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet, Magnesium Sulfate 20% w/v Solution for Injection will be called Magnesium Sulfate Injection.

Package leaflet: Information for the User

Magnesium Sulfate 20%

/v Solution for Injection

Magnesium Sulf

100mm Measurement Verification Bar

Elderly

No special recommendation except in patients with kidney problems

Use in children and adolescents

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 6 - 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 Sulfate 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, this medicine can cause side effects, although not everybody gets them. Serious side effects are:

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

Contact your doctor or nurse immediately if you get any of the following:

Problems with the balance of salts and water in the blood. This may lead to thirst (which may be severe), dry mouth, tiredness, restlessness and muscle weakness.

There have been isolated reports of low blood calcium levels in mothers and their new-born babies following prolonged use and high doses of magnesium sulfate during pregnancy.

Other side effects:

Feeling or being sick
Flushing of the skin
Loss/slowed reflexes
Hypotension
Confusion
Irregular or slowed heartbeat
Double vision
Slurred speech
Respiratory depression
ECG changes (prolonged PR, QRS and QT intervals)
D05027
Reporting of side effects
If you or your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Magnesium Sulfate Injection

Keep this medicine out of the sight and reach of children. This Magnesium Sulfate 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. Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Protect from light. Keep in outer carton.

6. Contents of the pack and other Information

What Magnesium Sulfate Injection contains

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

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

What Magnesium Sulfate Injection looks like and contents of the pack

Magnesium Sulfate Injection is a clear, colourless solution supplied in 20ml ampoules.

Marketing Authorisation Holder

Aurum Pharmaceuticals Ltd

T/A Martindale Pharma

Bampton Road

Harold Hill

Romford RM3 8UG

England

Manufacturers

Macarthys Laboratories Ltd