Below is a text only representation of the Patient Information Leaflet (ePIL).
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.
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
Martindale Pharma, an Ethypharm Group Company
Address
Jupiter House, Mercury Park, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0HH, UK