Prospect: information for the user

Hidonac antidote 200 mg/ml concentrate for infusion solution

Acetylcysteine

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1. What is Hidonac antidote and for what it is used

2. What you need to know before starting to use Hidonac antidote

3. How to use Hidonac antidote

4. Possible adverse effects

5. Storage of Hidonac antidote

6. Contents of the package and additional information

Hidonac antídoto is used in the treatment of paracetamol overdose.

This medication contains a derivative of cysteine (acetylcysteine) that is used in the synthesis of glutathione. Glutathione eliminates free radicals that can cause tissue damage and are released in inflammatory processes.

In a paracetamol overdose, a relative deficiency of glutathione occurs in the liver.
Glutathione can bind to toxic degradation products of paracetamol. If acetylcysteine is administered in time after a paracetamol overdose, it may prevent liver damage.

Before starting treatment, blood samples must be taken to analyze paracetamol levels in the blood.

Warnings and precautions

Consult your doctor before starting to use this medication

• If you are asthmatic or have a severe respiratory disease, as this medication may cause respiratory difficulties (bronchospasm).
• If you have previously experienced an adverse reaction to acetylcysteine.
• If you are pregnant or breastfeeding.
• High doses of acetylcysteine may cause alterations in blood coagulation, prolonging bleeding.

The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is in poor condition.

Children and adolescents

The same precautions and warnings apply to children and adolescents.

Interference with analytical tests

• Acetylcysteine may interfere with salicylate determination.
• Acetylcysteine may interfere with ketone determination in urine.

Use of Hidonac antidote with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

• Nitroglycerin, as it may increase its effect of lowering blood pressure (hypotension), potentially causing headaches.
• Carbamazepine, a medication used to combat epilepsy attacks, as it may increase the risk of attacks.

Use of Hidonac antidote with food and beverages

The consumption of food and beverages does not affect the efficacy of the medication.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

No information is available on the use of the medication during pregnancy or breastfeeding, so it is not recommended to use it during these periods.

No data are available on the effect of acetylcysteine on human fertility. Animal studies do not indicate harmful effects on human fertility at recommended doses.

Driving and operating machinery

No evidence exists of effects on the ability to drive and operate machinery.

Hidonac antidote contains sodium

This medication contains 748 mg of sodium (main component of table salt) in each 25 ml vial. This is equivalent to 37.4% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is administered through intravenous infusion under strict medical supervision.

Use in adults and adolescents (with a body weight of more than 40 kg)

Your doctor will determine the treatment to follow (see detailed information in the section for healthcare professionals at the end of this leaflet).

The recommended dose is 300 mg of acetylcysteine per kilogram of body weight, equivalent to 1.5 ml/kg of Hidonac Antidote in the interval of 21 hours, according to the following 3-step schedule:

- 150 mg/kg, equivalent to 0.75 ml/kg, slowly administered intravenously diluted in 200 ml of 5% glucose solution over 60 minutes.

- 50 mg/kg, equivalent to 0.25 ml/kg, in 500 ml of 5% glucose solution administered slowly over 4 hours.

- 100 mg/kg, equivalent to 0.50 ml/kg, in 1000 ml of 5% glucose solution administered slowly over 16 hours.

Use in children

In children, the volume of 5% glucose solution for infusion should be adjusted based on age and weight to avoid the risk of pulmonary vascular congestion. Your doctor will calculate the amounts to be administered.

To be effective, treatment should be initiated as quickly as possible, usually no later than 8-10 hours after paracetamol overdose ingestion; after this time, the protective effect of acetylcysteine decreases progressively and rapidly, and after 15 hours of intoxication, it may not be effective.

Infusion of the medication may be discontinued when blood test results show paracetamol levels below 200 micrograms/ml.

If you use more Hidonac Antidote than you should

If you have used more Hidonac Antidote than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount used.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Acetaminophen adverse reactions typically occur between 15 and 60 minutes after the start of infusion and, in many cases, symptoms improve by stopping the infusion. Antihistamine treatment may be required, and in some cases, corticosteroids. Once an adverse reaction is under control, infusion can usually be restarted at the lowest infusion rate (100 mg/kg in 1 liter over more than 16 hours).

The following adverse effects have been described, although their frequency cannot be established from the available information:

Immune system disorders: Anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, hypersensitivity.

Cardiac disorders: Tachycardia, bradycardia.

Respiratory, thoracic, and mediastinal disorders: Bronchospasm, dyspnea, stridor, cough.

Gastrointestinal disorders: Vomiting, nausea.

Dermatological and subcutaneous tissue disorders: Angioedema, urticaria, erythema, rash, pruritus.

General disorders and administration site conditions: Facial edema, discomfort.

Complementary examinations: Decreased blood pressure, increased prothrombin time.

In rare cases, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been described in temporal connection with acetaminophen administration. In most cases, at least another suspected medication could be identified as triggering the mucocutaneous syndrome.In case of any new change in the skin or mucous membranes, acetaminophen administration should be stopped immediately. The specialist doctor will determine the subsequent treatment.

In some cases, a decrease in blood coagulation (decreased platelet aggregation) has been described.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and the medications you no longer need. In this way, you will help protect the environment.

Composition of Hidonac Antidote

The active principle is acetylcysteine. Each vial of 25 ml contains 5 g of acetylcysteine.

The other components are: sodium edetate, sodium hydroxide (E524) (for pH adjustment) and water for injectable preparations.

Aspect of the product and content of the packaging

Aspect: transparent glass vials containing 25 ml of transparent and colorless solution and provided with a rubber stopper and an aluminum seal.

Each package contains 1 vial.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization

Zambon S.A.U.

Maresme, 5. Pol. Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Responsible for the manufacture

Alfasigma S.p.A.

Via Enrico Fermi, 1

65020 Alanno (PE) Italy

Last review date of this leaflet: October 2019

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .

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This information is intended solely for healthcare professionals:

Acetylcysteine is administered by intravenous infusion preferably using a glucose 5% solution as infusion solution, although it is possible to use sodium chloride 0.9% if the glucose 5% solution is not recommended.

The infusion should be performed slowly to reduce the risk of adverse effects.

Dosage

The dose should be calculated using the patient's actual weight to determine the total volume of solution.

For more information, consult the technical data sheet of the medicine, which includes tables of dosage, both for adults and children, detailing by weight ranges, doses, volume to infuse and infusion rate.

Adults and adolescents (> 40 kg of body weight)

The complete treatment cycle with acetylcysteine consists of 3 consecutive intravenous infusions:

First infusion : Initial dose of 150 mg/kg of body weight in 200 ml of solution over 1 hour.

Second infusion : 50 mg/kg of body weight in 500 ml over the next 4 hours.

Third infusion : 100 mg/kg of body weight in 1 l over the next 16 hours.

Therefore, the patient should receive a total of 300 mg/kg of body weight over a period of 21 hours.

Children

Children should be treated with the same doses and regimen as adults. However, the volume of solution to be infused should be adjusted taking into account the patient's age and body weight due to the possible risk of pulmonary vascular congestion due to fluid overload.

The complete treatment cycle with acetylcysteine consists of 3 consecutive intravenous infusions:

First infusion :

Initial dose of 150 mg/kg of body weight in infusion over 1 hour (150 mg/kg/h), administered as a solution of 50 mg/ml at a rate of 3 ml/kg/h.

Second infusion :

Dose: 50 mg/kg of body weight in infusion over 4 hours (12.5 mg/kg/h), administered as a solution of 6.25 mg/ml at a rate of 2 ml/kg/h.

Third infusion :

Dose: 100 mg/kg of body weight in infusion over 16 hours (6.25 mg/kg/h), administered as a solution of 6.25 mg/ml at a rate of 1 mg/kg/h.

Preparation of the solution

1st dose

Prepare a solution of 50 mg/ml. Dilute 10 ml of acetylcysteine (200 mg/ml) with 30 ml of glucose 5% or sodium chloride 0.9% to obtain a total volume of 40 ml.

2nd dose

Prepare a solution of 6.25 mg/ml. Dilute 10 ml of acetylcysteine (200 mg/ml) with 310 ml of glucose 5% or sodium chloride 0.9% to obtain a total volume of 320 ml.

3rd dose

Prepare a solution of 6.25 mg/ml. Dilute 10 ml of acetylcysteine (200 mg/ml) with 310 ml of glucose 5% or sodium chloride 0.9% to obtain a total volume of 320 ml.

• Incompatibilities :

It is not recommended to administer acetylcysteine concomitantly with other medications, particularly do not mix with medications to treat infections (antibiotics), due to the possible inactivation of the antibiotic (mainly beta-lactam antibiotics).