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

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

• are allergic to magnesium sulfate or any other ingredients of this medicine (listed in section 6)
• have or had kidney failure
• have or had liver problems and failure
• have or had heart problems

Talk to your doctor if you are concerned about any of the above.

Talk to your doctor, pharmacist or nurse before being given Magnesium Sulfate Solution for Injection or Infusion if you:

• have or had liver disease or have kidney disease as your doctor may need to adjust your dose
• have any breathing difficulties or lung diseases
• have a disease causing muscle weakness and fatigue (myasthenia gravis)

There is no relevant use of Magnesium Sulfate Solution for Injection or Infusion in children for the treatment of hypomagnesaemia. Magnesium sulfate can be used with caution in female adolescents with pre-eclampsia and eclampsia.

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This includes medicines bought without a prescription, including herbal medicines. In particular, tell your doctor if you are using any of the following medicines:

• Muscle relaxants, for example rocuronium or vecuronium
• Calcium-channel blockers, e.g. nifedipine, lercanidipine or amlodipine, may result in abnormal muscle function and low blood pressure
• Central nervous system depressants (medicines which act on the brain to cause drowsiness), such as drugs used in anxiety called benzodiazepines (e.g. diazepam) or medicines to help with sleeping called hypnotics (e.g. zopiclone)
• Aminoglycoside antibacterial (used to treat infections), for example gentamicin and tobramycin
• Heart medicines such as digitalis glycosides and digoxin
• Intravenously administered calcium
• Diuretic agents e.g. furosemide
• Antacids and laxatives
• Vasodilator agents such as non-selective alpha-adrenergic blockers e.g. phentolamine
• Cisplatin, amphotericin B and ciclosporin.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine. Tell your doctor if you are pregnant or trying to become pregnant.

Magnesium Sulfate Solution for Injection or Infusion is used to treat serious complications in pregnancy. Your doctor will only give you Magnesium Sulfate Solution for Injection or Infusion if the benefit of treatment outweighs the risk to you and the developing baby. Low blood calcium levels and effects on the bones, such as reduced bone density, have been reported in babies whose mothers were given magnesium sulfate continuously for more than 5-7 days during pregnancy. If used repeatedly or for longer periods during pregnancy, monitoring of mineral levels and skeletal side effects in the newborn baby should be considered.

Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking this medicine.

The recommended dose for the treatment of magnesium deficiency is up to 200 mL of a 20% w/v solution by slow intravenous infusion given over a period of up to 5 days.

The recommended dose is an initial dose of 20 mL of a 20% w/v solution given slowly over a period of 5-15 minutes, followed by an infusion of 5 mL of a 20% w/v solution per hour for 24 hours after the last seizure.

The recommended dose is an initial dose of 20 mL of a 20% w/v solution given slowly over a period of 5-15 minutes, followed by an infusion of 5 mL of a 20% w/v solution per hour, continued for 24 hours after the last seizure.

If seizures recur, a further 10-20 mL of magnesium can be given over 5 minutes via IV route.

You may be given a different dose by your doctor if you have problems with your kidneys or liver.

As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much of this medicine, however, tell your doctor as soon as possible if you have any concerns.

In the unlikely event of an overdose your doctor will monitor your side effects. If you are a medical practitioner administering this medicine an overdose may be reversed with calcium salts which should be administered slowly intravenously in a dose equivalent to 2.5 to 5 mmol of calcium (please refer to the Summary of Product Characteristics).

• Hypersensitivity, for example an itchy rash, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing) or a feeling that you are going to faint.

Excessive administration of magnesium leads to the development of symptoms of hypermagnesaemia. This can include the side effects as listed below.

• heart attack (shortness of breath, chest pain, feeling faint and/or dizzy)
• coma
• hypermagnesaemia

• problems with the balance of salts and water in the blood. This may lead to thirst (which may be severe)
• flushing of the skin
• tiredness
• skin rashes
• loss of knee jerk reflex
• muscle weakness
• abnormal heartbeats
• shallow or slow breathing
• feeling or being sick
• sweating
• high temperature
• headache, dizziness, confusion
• double vision, blurred vision and drooping eyelid
• slurred speech
• pain, burning, inflammation and bruising at injection site

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

If you get 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.

The active substance is magnesium sulfate heptahydrate at a strength of 200 g per litre (approximately 0.8 mmol magnesium per mL).

The other ingredients are sulfuric acid and Water for Injections.

This medicine is a clear and colourless solution.

This medicine is available in 20 mL and 50 mL vials, packed into cartons containing 1 vial or 10 vials.

Not all pack sizes may be marketed.