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MAGNESIUM SULFATE 1G/10ML INJECTION

Active substance(s): MAGNESIUM SULFATE / MAGNESIUM SULFATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Magnesium Sulfate 1g/10ml Injection
Magnesium Sulfate Heptahydrate10%

D03307

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.
2.
3.
4.
5.
6.

What Magnesium Sulfate Injection is and what it is used for
What you need to know before you are given Magnesium
Sulfate Injection
How Magnesium Sulfate Injection will be given
Possible side effects
How to store Magnesium Sulfate Injection
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,
Emergency treatment of serious arrhythmias, especially in the
presence of hypokalaemia (when hypomagnesaemia may also
be present) and in torsade de pointes
It is used in the treatment of acute hypomagnesaemia and can
be used to treat severe acute asthma.

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.

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
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. 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: January 2017

Driving and using machines
There are no known effects of Magnesium Sulfate Injection on
driving and using machines.
D03307

100mm Measurement Verification Bar

3307-C

DEVELOPMENT ARTWORK
D03307
PIL MAGNESIUM SULFATE 10%
W/V
170 x 296mm

12/04/16

BM

3/05/16

BM

30/01/17

BM

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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