• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Talk to your doctor or nurse before using Acetylcysteine Injection if:

• you suffer from asthma or breathing difficulties
• you have had an adverse reaction to Acetylcysteine before
• you are pregnant or breast-feeding

If you have any doubts about whether this medicine should be given to you, discuss things more fully with the doctor or nurse.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or nurse for advice before being given this medicine.

It is unlikely that after using Acetylcysteine Injection, your ability to drive and use machines will be affected. However, if you feel unwell you must speak to your doctor before driving or operating machinery.

This medicinal product contains 32.26mg of sodium per ml of infusion (a total of 322.6mg of sodium in each 10ml ampoule for infusion). This amount must be taken into consideration by patients on a salt-restricted diet.

Acetylcysteine Injection is given in three stages. During each stage a different dose of Acetylcysteine will be given. You will be given a total dose of 300mg of Acetylcysteine per kg of your body weight, over a period of 21 hours. Some patients may require longer treatment with acetylcysteine. The doctor will calculate how much to give you in each stage.

Children should be given Acetylcysteine Injection in three stages, like adults. However, the amount of fluid used to dilute Acetylcysteine Injection will be calculated to take into consideration the age and weight of the child, as too much fluid can be harmful. Blood tests may be carried out before, during and after treatment with this medicine.

Acetylcysteine Injection will be given to you by a doctor or nurse, therefore it is unlikely that you will be given too much or that you will miss a dose. However, if you are concerned about your treatment, please talk to your doctor.

• coughing, noisy breathing
• respiratory arrest (stop breathing)
• chest tightness or pain,
• puffy eyes, blurred vision, pain in the face or eyes
• sweating, feeling unwell
• raised temperature, hot, red face and skin
• liver problems
• slow heart beat, cardiac arrest (heart stops beating)
• fainting, collapsing, fits
• reduction in blood platelets, which increases the risk of bleeding or bruising
• a condition called acidosis, which may cause weariness, vomiting, thirst or restlessness
• anxiety
• joint pain or disease
• bluish skin from low oxygen levels in the blood

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

By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is Acetylcysteine 200 mg/1 ml.

The other ingredients are disodium edetate, nitrogen gas, sodium hydroxide and water for injection.

Acetylcysteine Injection is a clear colourless solution for infusion.

The product is available in (Type I) clear glass ampoules in pack sizes of 10x 10ml, 10x 20ml or 5x 20ml ampoules.

Not all pack sizes may be marketed.