HOSPITALS

PACKAGE LEAFLET: INFORMATION FOR THE USER

ACETYLCYSTEiNE 200 mg/mi iNJECTiON

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor 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.

IN THIS LEAFLET:

What Acetylcysteine Injection is and what it is used for

2.    Before you are given Acetylcysteine Injection

3.    How Acetylcysteine Injection will be given

4.    Possible side effects

5.    How to store Acetylcysteine Injection

6.    Further information

WHAT ACETYLCYSTEiNE iNJECTiON iS AND WHAT iT iS USED FOR

Acetylcysteine Injection contains Acetylcysteine, which is used for the treatment of paracetamol overdose (where you may have taken too much paracetamol).

You will be given Acetylcysteine if you have taken a potentially harmful amount of paracetamol.

Acetylcysteine protects the liver from damage by the high levels of paracetamol. It is very effective when given during the first 8 hours after a paracetamol overdose. The effectiveness is reduced as the time interval increases, but it can still help when given up to 24 hours after the overdose.

©BEFORE YOU ARE GiVEN ACETYLCYSTEiNE iNJECTiON

The level of paracetamol in your blood should be checked before treatment is started.

Tell your doctor if you:

• suffer from asthma or breathing difficulties • have had an adverse reaction to Acetylcysteine or any of the other ingredients of Acetylcysteine before (see list of ingredients in Section 6)

• are pregnant or breast-feeding.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant the doctor will decide if you should receive this medicine. You should not breastfeed during or immediately after being given this medicine. Ask the doctor or nurse if you need further information.

Driving and using machines

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.

HOW ACETYLCYSTEiNE iNJECTiON WiLL BE GiVEN

Acetylcysteine Injection will be diluted in glucose or sodium chloride solution and given as an intravenous infusion (a drip into a vein) by a doctor or

Adults:

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 300 mg Acetylcysteine per kg of your body weight, over a period of 21 hours. The doctor will calculate how much to give you in each stage. Children:

Children will be given Acetylcysteine Injection in Ihree 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.

ACETYLCYSTEiNE 200 mg/mi iNJECTiON FOR INFUSION

ADMiNiSTRATiON INFORMATION FOR THE HEALTHCARE PROFESSiONAL

Acetylcysteine should be administered by intravenous infusion preferably using Glucose 5% as the infusion fluid. Sodium Chloride 0.9% solution may be used if Glucose 5% is not suitable.

The full course of treatment with acetylcysteine comprises of 3 consecutive intravenous infusions. Doses should be administered sequentially with no break between the infusions. The patient should receive a total dose of 300 mg/kg body weight over a 21 hour period.

Adults

•    Weigh the patient to determine the correct weight band.

•    Use the adult dosage table to determine the appropriate volume of acetylcysteine (ampoule volume) to be added to the infusion fluid for each of the 3 infusion periods.

First infusion

Add the appropriate volume of acetylcysteine injection to 200 mL of infusion fluid and infuse over 1 hour.

Second infusion

Add the appropriate volume of acetylcysteine injection to 500 mL of infusion fluid and infuse over the next 4 hours. Third infusion

Add the appropriate volume of acetylcysteine injection to 1 litre of infusion fluid and infuse over the next 16 hours.

Aduit Dosage Tabie

¹Dose calculations are based on the weight in the middle of each band. If the patient weighs less than 40 kg use the paediatric dosage table.

²Ampoule volume has been rounded up to the nearest whole number.

Children

Children are treated with the same doses and regimen as adults. However, the quantity of intravenous fluid used has been modified to take into account age and weight, as fluid overload is a potential danger. Doses should be administered sequentially using an appropriate infusion pump.

Preparation and administration of paediatric infusions Weigh the child to determine the correct weight band.

Read off the table the total infusion volume required for each dose according to the weight of the child and make up the solutions according to the directions below.

^:irst Infusion

Prepare a 50 mg/mL solution by diluting each 10 mL ampoule of acetylcysteine (200 mg/mL) with 30 mL glucose 5% or sodium chloride 0.9% to give a total volume of 40 mL. Prepare the appropriate volume for the weight of the child. The dose is infused over 1 hour at the infusion rate stated in the table.

Second Infusion

Prepare a 6.25 mg/mL solution by diluting each 10 mL ampoule of acetylcysteine (200 mg/mL) with 310 mL glucose 5% or sodium chloride 0.9% to give a total volume of 320 mL.

Prepare the appropriate volume for the weight of the child. The dose is infused over 4 hours at the infusion rate stated in the table.

Third Infusion

Prepare a 6.25 mg/mL solution by diluting each 10 mL ampoule of acetylcysteine (200 mg/mL) with 310 mL glucose 5% or sodium chloride 0.9% to give a total volume of 320 mL.

Prepare the appropriate volume for the weight of the child. The dose is infused over 16 hours at the infusion rate stated in the table.

For example for a child weighing 12 kg, the first infusion would be 38 mL infused at 38 mL/h over 1 hour,the second nfusion would be 100 mL infused at 25 mL/h over 4 hours and the third infusion is 208 mL infused at 13 mL/h over 16 hours.

Paediatric Dosage Table

¹Dose calculations are based on the weight in the middle of each band. If the patient weighs more than 40 kg use the adult dosage table. Figures have been rounded up to the nearest whole number.

Blood tests may be carried out before, during and after treatment with this medicine.

Because the injection will be given to you by a nurse or doctor, 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.

POSSIBLE SIDE EFFECTS

Like all medicines Acetylcysteine Injection can cause side effects particularly when treatment is first started, although not everybody gets them.

All medicines can cause adverse reactions although not everyone gets them. Tell your doctor or nurse immediately if you notice any of the following:

•    swelling of the face, lips or tongue

•    wheezing, difficulty in breathing

•    feeling or being sick

•    irritation at the injection site

•    skin rash, itching

•    flushing (red face or feeling hot)

•    low blood pressure resulting in dizziness

•    very rarely, rapid heart beat or increased blood pressure.

These symptoms often happen 15 to 60 minutes after the start of the infusion, and may be relieved by stopping the infusion. You may need to be treated with antihistamines. Once the reaction is under control the infusion can be restarted.

Other rare side effects:

•    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 Ihe 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.

Reporting of side effects

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.

0HOW TO STORE ACETYLCYSTEINE INJECTION

Keep Acetylcysteine out of the reach and sight of children.

Do not use Acetylcysteine after the expiry date, which is stated on the

The expiry date refers to the last day of that month.

Store below 25°C in its carton.

Once diluted, Acetylcysteine should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.

FURTHER INFORMATION

What Acetylcysteine Injection contains:

The active substance is acetylcysteine 200 mg/ml. The other ingredients are: disodium edetate, water for injections and sodium hydroxide.

What Acetylcysteine Injection looks like and contents of the pack Clear glass ampoules containing 10 ml acetylcysteine 200 mg/ml solution. 10 ampoules are packed per carton.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG.

Manufacturer:

Merckle GmbH, Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany This leaflet was last revised in June 2015 PL 00289/1543