Magnesium Sulfate 50%w/v Solution for Injection or Infusion

• 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 50% w/v Solution for Injection or Infusion is and what it is used for
2. What you need to know before you are given Magnesium Sulfate 50% w/v Solution for Injection or Infusion
3. How Magnesium Sulfate 50% w/v Solution for Injection or Infusion is given
4. Possible side effects
5. How to store Magnesium Sulfate 50% w/v Solution for Injection or Infusion
6. Contents of the pack and other information

• If you are allergic to magnesium sulfate, its salts or any of the other ingredients of this medicine (listed in section 6);
• you have liver failure or condition known as ‘hepatic encephalopathy’ (impaired brain function due to liver disease);
• you have kidney failure or severe kidney problems, or you cannot make or pass urine;
• you have heart problems or a disease causing muscle weakness and fatigue called ‘myasthenia gravis’ (in these cases you should not be given magnesium sulfate by injection).

If any of the above apply to you please tell your doctor or nurse before you are given Magnesium Sulfate 50% w/v Solution for Injection or Infusion.

Talk to your doctor, pharmacist or nurse before you are given Magnesium Sulfate 50% w/v Solution for Injection or Infusion:

• if you have kidney problems (you will need reduced dose);
• if you have liver problems.

Tell your doctor or nurse if flushing and sweating occurs.

Your magnesium and calcium blood levels will be monitored during treatment.

Your reflexes, breathing and urine output will also be checked while receiving magnesium sulfate.

Tell your doctor or pharmacist or nurse if you are using, have recently used or might use any other medicines. Medicines which may interact with magnesium sulfate include:

• Muscle relaxants e.g. vecuronium
• Nifedipine (used to treat high blood pressure or chest pain)
• Calcium channel blockers (medicines to treat high blood pressure and chest pain)
• Diuretics (medicines that increase the passage of urine) such as thiazides and furosemide
• Calcium salts
• Digitalis glycosides e.g. digoxin (a medicine used to treat heart problems)
• Aminoglycoside antibacterial agents (medicines used to treat bacterial infections)
• Barbiturates (medicines for treating anxiety, insomnia)
• Opioids (medicines for treating chronic pain) such as morphine
• Hypnotics (medicines for sleep disorders).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. Magnesium Sulfate 50% w/v Solution for Injection or Infusion may be used to treat the fits associated with pre-eclampsia and eclampsia, a serious complication of pregnancy.

If you are pregnant and you are given Magnesium Sulfate 50% w/v Solution for Injection or Infusion, your baby’s heart rate will be thoroughly monitored and use within 2 hours of delivery will be avoided. Magnesium sulfate can cause foetal skeletal adverse effects when given continuously for more than 5 to 7 days to pregnant women. In case of prolonged or repeated use of magnesium sulfate during pregnancy, your baby will be monitored for abnormal calcium or magnesium levels and skeletal adverse effects. You will not receive Magnesium Sulfate 50% w/v Solution for Injection or Infusion during pregnancy or breast-feeding unless considered essential by your doctor, and it will be given to you under medical supervision. Your doctor will assess that the potential benefits outweigh the risks before giving this medicine to you.

Magnesium sulfate has no effects on fertility.

Magnesium Sulfate 50% w/v Solution for Injection or Infusion is unlikely to affect the ability to drive and use machines. However, some people may feel dizzy or drowsy after receiving Magnesium Sulfate injection. If you experience these side effects, do not drive or use machines.

For magnesium deficiency, you will be given

8-12 g of magnesium sulfate in the first 24 hours followed by 4-6 g/day for 3 or 4 days, to replete body stores.

Alternatively, 2-4 ml of undiluted Magnesium Sulfate 50% w/v solution can be injected into a muscle (may be painful) every 6 hours for 24 hours (4 doses in total).

For the control and prevention of seizures in severe pre-eclampsia or eclampsia:

An initial loading dose of 4-5 g magnesium sulfate diluted to an appropriate volume will be given into your vein. It will be followed by either an infusion into a vein of 1-2 g/hour or regular injections into a muscle of undiluted Magnesium Sulfate 50% w/v solution, until seizures cease.

Patients with kidney problems will be given a reduced dose.

There are no special dosage instructions.

Caution should be observed as kidney and/or liver disorders and side effects are more likely in this age group.

In children, Magnesium Sulfate 50% w/v solution, appropriately diluted prior to use, may be given as an injection into a muscle.

As this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too much. However, tell your doctor or nurse if you have any concerns.

It is unlikely that you will miss a dose as your doctor or nurse will be giving it to you. You should not receive a double dose if you have missed one. Ask your doctor or nurse when you should have the next dose.

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: Website: 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
  Each 2 ml ampoule contains 4 mmol Mg²⁺
  (equivalent to 1 g magnesium sulfate heptahydrate).
  Each 5 ml ampoule contains 10 mmol Mg²⁺
  (equivalent to 2.5 g magnesium sulfate heptahydrate).
  Each 10 ml ampoule contains 20 mmol Mg²⁺
  (equivalent to 5 g magnesium sulfate heptahydrate).
  Each 20 ml vial contains 40 mmol Mg²⁺
  (equivalent to 10 g magnesium sulfate heptahydrate).
  Each 50 ml vial contains 100 mmol Mg²⁺
  (equivalent to 25 g magnesium sulfate heptahydrate).
  Each 100 ml vial contains 200 mmol Mg²⁺
  (equivalent to 50 g magnesium sulfate heptahydrate).
• The other ingredients are Sulfuric Acid (for pH adjustment) and Water for Injections.

This medicine is a clear and colourless solution. This medicine is available in 2mL, 5mL and 10mL ampoules, and 20mL, 50mL and 100mL vials. The medicine is packed into cartons containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same time.