Package leaflet: Information for the user

Acetylcysteine Sandoz, 100 mg/ml, solution for infusion
Acetylcysteinum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Acetylcysteine Sandoz is and what it is used for
Important information before using Acetylcysteine Sandoz
How to use Acetylcysteine Sandoz
Possible side effects
How to store Acetylcysteine Sandoz
Contents of the pack and other information

1. What Acetylcysteine Sandoz is and what it is used for

Acetylcysteine Sandoz solution for infusion contains the active substance acetylcysteine – a medicine with antioxidant properties that neutralizes harmful factors (e.g. free radicals). Acetylcysteine is a derivative of the natural amino acid L-cysteine. It neutralizes free radicals by binding them through sulfhydryl groups. In paracetamol poisoning, acetylcysteine acts as an antidote by binding to its toxic metabolites. The effectiveness of the antidotal treatment depends on the time elapsed between the overdose and the initiation of Acetylcysteine Sandoz administration.
The indication for using Acetylcysteine Sandoz is paracetamol poisoning.

2. Important information before using Acetylcysteine Sandoz

When not to use Acetylcysteine Sandoz
if the patient is allergic to acetylcysteine, disodium edetate, or any of the other
ingredients of this medicine (listed in section 6).
Symptoms of allergy may include: itching, urticaria, rash, bronchospasm (shortness of breath),
rapid heartbeat, and low blood pressure.
if the patient has a weakened cough reflex (e.g. young children and elderly people) and respiratory
physiotherapy is not ensured.
if the patient is under 2 years of age.

Warnings and precautions
Talk to your doctor before using Acetylcysteine Sandoz.
Exercise particular caution when administering Acetylcysteine Sandoz to:
patients with respiratory insufficiency.
patients with bronchial hyperreactivity or patients who currently suffer or have a history of chronic
bronchial asthma, as the medicine may cause bronchospasm and shortness of breath.
patients with a history of atopy or asthma, as the medicine may cause pseudoprophylactic reactions.
patients who currently have or have previously had gastric or duodenal ulcer disease or oesophageal varices.
patients with body weight less than 40 kg, due to the risk of reduced circulating blood volume, decreased serum sodium concentration, and occurrence of seizures.
patients with impaired expectoration ability, as the medicine may liquefy bronchial secretions and increase their volume. The doctor may then recommend assistance in removing secretions, e.g. by drainage or suction.
Acetylcysteine administered in high doses as an antidote may prolong prothrombin time.
During treatment with Acetylcysteine Sandoz, coagulation parameters should be closely monitored,
especially in patients in whom liver transplantation may be necessary.
Very rare cases of severe skin reactions (i.e. Stevens-Johnson syndrome and Lyell's syndrome) have been reported during acetylcysteine treatment. If skin or mucous membrane changes occur during treatment with Acetylcysteine Sandoz, the patient should immediately consult a doctor or nurse.

Acetylcysteine Sandoz and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use.
There is a risk of physical incompatibility between Acetylcysteine Sandoz and penicillin,
ampicillin, cephalosporins, erythromycin, certain tetracyclines, and amphotericin B. It is especially important to avoid mixing these medicines in the same syringe or infusion, or administering them within a short time interval into the same vein through the same puncture site.
Concomitant use of acetylcysteine and antitussive medicines may lead to dangerous accumulation of secretions due to reduced cough reflex.
Acetylcysteine enhances the vasodilatory effect of nitroglycerin and other nitrates, as well as their inhibition of platelet aggregation (platelet clumping). If the patient receives both medicines parenterally, the patient should report headache to the doctor or nurse, as it may indicate arterial hypotension.
Acetylcysteine may interfere with colorimetric determination of salicylates in plasma, as well as with tests for ketones in plasma and urine using sodium nitroprusside.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Acetylcysteine Sandoz as an antidote in paracetamol poisoning may be used if, in the doctor's opinion, the risk of liver damage to the mother and fetus due to poisoning is greater than the potential risk associated with acetylcysteine use.
The medicine should be used during breastfeeding only if the doctor considers it necessary.

Driving and operating machinery
The effect on the ability to drive and operate machinery is unknown.

Acetylcysteine Sandoz contains sodium
The medicine contains approximately 49 mg of sodium (main component of table salt) in each 3 ml ampoule.
This corresponds to 2.45% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Acetylcysteine Sandoz

This medicine should be used as directed by the physician. In case of doubts, consult your
doctor.
Antidotal treatment should be initiated as soon as possible after ingestion of a toxic dose of
paracetamol. Treatment must be carried out under hospital conditions.
Acetylcysteine Sandoz should be administered intravenously within 4 to 8 hours after poisoning,
and no later than within the first 14 hours. During the first 24 hours after poisoning, the daily
dose of acetylcysteine should be approximately 300 mg/kg body weight (about 20 g per day for
an adult).
To reduce the risk of adverse reactions, the medicine should be diluted in 5% glucose solution
or 0.9% sodium chloride solution and administered by slow intravenous infusion.
In children and patients with body weight less than 40 kg, the volume of glucose or sodium
chloride solution should be proportionally reduced (but not below 50 ml).
Dosing in adults:

Acetylcysteine dose	Volume of solution administered by intravenous infusion	Infusion duration
150 mg/kg body weight	200 ml of 5% glucose solution or 0.9% sodium chloride solution	15 minutes
50 mg/kg body weight	500 ml of 5% glucose solution or 0.9% sodium chloride solution	4 hours
100 mg/kg body weight	1000 ml of 5% glucose solution or 0.9% sodium chloride solution	16 hours

Total: intravenous 300 mg acetylcysteine/kg body weight over the first 20 hours of treatment.
Dosing in children:
In the treatment of paracetamol poisoning in children, the same doses adjusted to body weight and the same administration regimen as in adults should be used. The volume of intravenous fluid should be adjusted according to the child's age and body weight. Fluid overload poses a potential risk of circulatory failure.
Children with body weight of 20 kg and above:

Dose of acetylcysteine	Volume of solution administered by intravenous infusion	Duration of infusion
150 mg/kg body weight	100 ml of 5% glucose solution or 0.9% sodium chloride solution	15 minutes
50 mg/kg body weight	250 ml of 5% glucose solution or 0.9% sodium chloride solution	4 hours
100 mg/kg body weight	500 ml of 5% glucose solution or 0.9% sodium chloride solution	16 hours

Children with body weight less than 20 kg:
The volume for infusions (when using the same doses) is determined by the attending physician.
In patients at higher risk of liver damage following high-dose paracetamol (e.g. patients with AIDS, malnourished patients, those undergoing long-term treatment with rifampicin, phenytoin, carbamazepine, phenobarbital, and alcohol-dependent individuals), treatment with Acetylcysteine Sandoz should be initiated as early as possible and at a lower serum paracetamol concentration than in other individuals.

Method of administration and duration of treatment:
Acetylcysteine Sandoz is administered by slow intravenous infusion in 5% glucose solution or 0.9% sodium chloride solution.
The ampoules do not require scoring with a file. After shaking the contents from the neck, hold the ampoule with the white dot facing upwards and snap off the top portion.

Notes:
The characteristic sulphurous odour of the medicinal product does not indicate decomposition but is due to the presence of sulphur in the molecule of the active substance.
Acetylcysteine may react with rubber and metals (including iron, nickel, copper); therefore, it is essential that the solution comes into contact only with glass or plastic materials.

Use of a higher than recommended dose of Acetylcysteine Sandoz
If a higher than recommended dose of the medicinal product is administered, seek immediate medical advice.
Symptoms of overdose may resemble the adverse reactions listed in section 4.
If necessary, symptomatic treatment should be administered.

Missed dose of Acetylcysteine Sandoz
Do not administer a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Not common (may occur in less than 1 in 100 people):
headache, fever, allergic reactions with itching, urticaria, rash, angioedema (swelling of the skin and/or mucous membranes, e.g. in the face, limbs, joints),
increased heart rate, nausea, vomiting, inflammation of the oral mucosa, abdominal pain, diarrhoea.

Rare (may occur in less than 1 in 1,000 people):
shortness of breath, bronchospasm, dyspepsia.

Very rare (may occur in less than 1 in 10,000 people):
anaphylactic reaction (a type of sudden allergic reaction) up to anaphylactic shock, anaphylactoid reactions; bleeding, decreased blood pressure, severe skin reactions (with blistering of the skin and mucous membranes [mainly in the oral cavity and genital organs], erosions, skin peeling, accompanied by fever and joint pain).

Frequency not known (cannot be estimated from the available data):
hot flushes, facial swelling.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301 / fax: +48 22 49 21 309 / website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store Acetylcysteine Sandoz

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and on the ampoule after EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Acetylcysteine Sandoz contains

The active substance is acetylcysteine. 1 ml of solution contains 100 mg of acetylcysteine. One ampoule (3 ml) contains 300 mg of acetylcysteine.
Other components of the medicine are: edetate disodium, sodium hydroxide (10% solution), ascorbic acid, water for injections.

What Acetylcysteine Sandoz looks like and contents of the pack
The infusion solution is supplied in 3 ml ampoules made of amber glass, packed in a cardboard box.
Pack sizes contain 5, 10 or 50 ampoules.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00