Acetilcisteine Sandoz

Package Leaflet: Information for the User

Acetylcysteine SANDOZ, 100 mg/ml, Solution for Infusion

Acetylcysteine

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Acetylcysteine SANDOZ and What is it Used For
• 2. Important Information Before Using Acetylcysteine SANDOZ
• 3. How to Use Acetylcysteine SANDOZ
• 4. Possible Side Effects
• 5. How to Store Acetylcysteine SANDOZ
• 6. Package Contents and Other Information

1. What is Acetylcysteine SANDOZ and What is it Used For

The solution for infusion Acetylcysteine SANDOZ contains the active substance acetylcysteine, an antioxidant 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 the case of paracetamol poisoning, acetylcysteine acts as an antidote by binding to its toxic metabolites. The effectiveness of the antidote treatment depends on the time elapsed between the overdose and the start 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 you are allergic to acetylcysteine, disodium edetate, or any of the other ingredients of this medicinal product (listed in section 6). Symptoms of an allergic reaction may include: itching, hives, rash, bronchospasm (shortness of breath), rapid heartbeat, and decreased blood pressure. if you have a weakened cough reflex (e.g., in small children and the elderly) and do not have ensured respiratory physiotherapy. if you are under 2 years of age.

Warnings and Precautions

Before using Acetylcysteine SANDOZ, discuss it with your doctor. Be particularly cautious when administering Acetylcysteine SANDOZ to: patients with respiratory failure. patients with bronchial hyperreactivity or patients who have had or currently have chronic asthma, as the medicinal product may cause bronchospasm and shortness of breath. patients with atopy or a history of asthma, as the medicinal product may cause a pseudo-anaphylactic reaction. patients with a current or past history of gastric or duodenal ulcer, or esophageal varices. patients with a body weight of less than 40 kg, as there is a risk of decreased blood volume, decreased sodium levels in the blood, and seizures. patients with reduced ability to cough, as the medicinal product may cause thinning of bronchial secretions and increase their volume. The doctor may then recommend assisted removal of secretions, e.g., by drainage or suction. Acetylcysteine, when 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 who may require liver transplantation. Rarely, severe skin reactions (e.g., Stevens-Johnson syndrome and Lyell's syndrome) have been reported during treatment with acetylcysteine. If skin or mucous membrane changes occur during treatment with Acetylcysteine SANDOZ, seek medical attention immediately.

Acetylcysteine SANDOZ and Other Medicinal Products

Inform your doctor about all medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to use. There is a risk of physical incompatibility between Acetylcysteine SANDOZ and penicillin, ampicillin, cephalosporins, erythromycin, some tetracyclines, and amphotericin B. Avoid mixing these medicinal products in a syringe or infusion, and do not administer them at short intervals through the same vein or using the same cannula. Concomitant use of acetylcysteine and antitussives may cause dangerous accumulation of secretions due to reduced cough reflex. Acetylcysteine enhances the effects of nitroglycerin and other nitrates, which involve vasodilation and inhibition of platelet aggregation. If you are receiving both medicinal products parenterally, inform your doctor or nurse about any headache, as it may indicate hypotension. Acetylcysteine may interfere with the determination of salicylates in serum by colorimetry and ketones in serum and urine using sodium nitroprusside.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicinal product. Acetylcysteine SANDOZ can be used as an antidote in case of paracetamol poisoning when, 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 the use of acetylcysteine. The medicinal product should be used during breastfeeding only if the doctor considers it necessary.

Driving and Using Machines

No effects on the ability to drive and use machines have been observed.

Acetylcysteine SANDOZ Contains Sodium

The medicinal product contains approximately 49 mg of sodium (the main component of common salt) in each 3 ml ampoule. This corresponds to 2.45% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Use Acetylcysteine SANDOZ

This medicinal product should be used in accordance with the doctor's recommendations. In case of doubts, consult your doctor. Antidote treatment should be started as soon as possible after taking a toxic dose of paracetamol. Treatment is carried out in a hospital setting. Acetylcysteine SANDOZ should be administered intravenously within 4 to 8 hours after poisoning, but no later than within the first 14 hours. On the first day after poisoning, the daily dose of acetylcysteine should be approximately 300 mg/kg body weight (approximately 20 g per day for an adult). To minimize the risk of side effects, the medicinal product should be diluted in a 5% glucose solution or 0.9% sodium chloride solution and administered in a slow intravenous infusion. In children and patients with a body weight of less than 40 kg, the volume of glucose or sodium chloride solution should be proportionally reduced (but not below 50 ml). Dosing in Adults:Total: intravenous 300 mg of 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 per body weight and the same treatment regimen as in adults are used. The volume of fluid administered intravenously should be modified depending on the age and body weight of the child. Fluid overload is a potential risk of circulatory failure. Children with a body weight of 20 kg or more: Children with a body weight of less than 20 kg: The volume for infusions (using the same doses) is determined by the attending physician.

Notes:
The specific, sulfur-like smell of the medicinal product does not indicate its decomposition but is due to the presence of sulfur in the molecule. Acetylcysteine may react with rubber and metals (including iron, nickel, copper), so it is essential to ensure that the solution comes into contact only with glass or plastic materials.

Using a Higher Dose of Acetylcysteine SANDOZ Than Recommended

In case of administration of a higher dose of the medicinal product than recommended, seek medical attention immediately. Possible symptoms of overdose of Acetylcysteine SANDOZ are similar to the side effects listed in section 4. If necessary, symptomatic treatment should be applied.

Missing a Dose of Acetylcysteine SANDOZ

Do not use a double dose to make up for a missed dose. If you have any further doubts about using this medicinal product, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Acetylcysteine SANDOZ can cause side effects, although not everybody gets them. Uncommon (may affect up to 1 in 100 people): headache, fever, allergic reactions with itching, hives, rash, angioedema (swelling of the skin and/or mucous membranes, e.g., in the face, limbs, joints), rapid heartbeat, nausea, vomiting, oral mucositis, abdominal pain, diarrhea. Rare (may affect up to 1 in 1,000 people): shortness of breath, bronchospasm, indigestion. Very rare (may affect up to 1 in 10,000 people): anaphylactic reaction (a type of severe allergic reaction), including shock; bleeding, decreased blood pressure, severe skin reactions (with blistering of the skin and mucous membranes, mainly in the mouth and genital area, ulcers, skin peeling, with fever and joint pain). Frequency not known (cannot be estimated from the available data): hot flashes, facial swelling.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Acetylcysteine SANDOZ

Store the medicinal product out of the sight and reach of children. Do not store above 25°C. Do not use this medicinal product after the expiry date stated on the carton and ampoule after EXP. The expiry date refers to the last day of the month. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Acetylcysteine SANDOZ Contains

• The active substance of the medicinal product is acetylcysteine. 1 ml of solution contains 100 mg of acetylcysteine. 1 ampoule (3 ml) contains 300 mg of acetylcysteine.
• The other ingredients of the medicinal product are: disodium edetate, sodium hydroxide (10% solution), ascorbic acid, water for injections.

What Acetylcysteine SANDOZ Looks Like and Contents of the Package

The solution for infusion is available in orange glass ampoules in a cardboard box. The packages contain 5, 10, or 50 ampoules of 3 ml each.

Marketing Authorization Holder

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia. For more detailed information, please contact: Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, tel. 22 209 70 00. Date of Last Revision of the Package Leaflet:12/2021. Sandoz Logo