What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 01883/6136.


Magnesium Sulfate 1g/10ml Solution for Injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

Magnesium Sulfate 1g/10ml Solution for Injection

Magnesium Sulfate Heptahydrate10%

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, please ask your doctor, pharmacist.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Magnesium Sulfate Injection is and what it is used for
2. What you need to know before you are given Magnesium Sulfate Injection
3. How Magnesium Sulfate Injection will be given
4. Possible side effects
5. How to store Magnesium Sulfate Injection
6. Contents of the pack and other information

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 should not be given Magnesium Sulfate Injection if:

  • you are allergic (hypersensitive) to Magnesium Sulfate 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 Sulfate Injection if:

  • you suffer from any breathing problems
  • you suffer from kidney problems

A risk-benefit assessment should be performed in individual cases prior to initiation of treatment.

If any of the above apply to you or your child please tell your doctor or nurse before you are given Magnesium Sulfate Injection

Other medicines and Magnesium Sulfate Injection

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Medicines which may interact with Magnesium Sulfate Injection include:

  • 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.
  • 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
  • neuromuscular blocking drugs (medicines used to stop movement during surgery)
  • barium (a medicine used when having an X-ray)
  • Antibacterials (such as Streptomycin)

Pregnancy, fertility and breast-feeding

Tell your doctor if you think you may be pregnant or if you are breast-feeding before being given Magnesium Sulfate Injection. Magnesium Sulfate may be used to treat the fits associated with eclampsia, a serious complication of pregnancy. It is not advisable to administer magnesium sulfate during pregnancy or breastfeeding unless considered essential, and it must be administered under medical supervision. If used in pregnant women the babies heart rate should be monitored and use within 2 hours of delivery should be avoided.

The benefit risk should be decided before this drug is administered.

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).

Adults, children and the elderly

The usual dose is 35-50 mmol diluted in 1 litre of 5% Glucose Intravenous Infusion or 0.9%w/v Sodium Chloride Injection , given over a period of 12-24 hours.

Patients suffering from kidney problems will need a reduced dose.

If you are given too much or too little 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, Magnesium Sulfate Injection can cause side effects, although not everybody gets them.

Possible side effects include:

  • shock, symptoms of which include sweating, fainting and a fluttering heartbeat
  • slowed reflexes
  • flushing of the skin
  • temporarily low blood pressure
  • low body temperature
  • slow or irregular heartbeat
  • feeling or being sick
  • feeling thirsty
  • drowsiness
  • confusion
  • muscle weakness
  • slowed breathing
  • heart attack
  • coma
  • hypersensitivity reactions
  • Hypocalcaemia
  • dehydration (hypertonic)
  • low phosphate levels in the blood (hypophosphataemia)

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 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 passed before administering the injection to you. The expiry date refers to the last day of that month.

Do not store above 25°C.

6. Contents of the pack and other Information

What Magnesium Sulfate Injection contains

The active substance is Magnesium Sulfate 10%w/v.

The other ingredient is Water for Injection.

What Magnesium Sulfate Injection looks like and contents of the pack

Magnesium Sulfate Injection is a clear, colorless solution supplied in 2ml or 10ml ampoules. Each pack contains 10 ampoules.

Marketing Authorisation Holder and Manufacturer

Macarthys Laboratories Ltd
T/A Martindale Pharma
Bampton Road
Harold Hill
Romford
RM3 8UG
United Kingdom

Product Licence No: PL 01883/6136R

This leaflet was last revised in: July 2019

MARTINDALE PHARMA
Bampton Road
Harold Hill
Romford
RM3 8UG
UK

D05029