Acetylcysteine Kern Pharma 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylcysteine Kern Pharma 100 mg/ml solution for injection EFG

Read the entire leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Acetylcysteine Kern Pharma is and what it is used for
2. What you need to know before using Acetylcysteine Kern Pharma
3. How to use Acetylcysteine Kern Pharma
4. Possible side effects
5. How to store Acetylcysteine Kern Pharma
6. Contents of the pack and other information

1. What Acetilcisteína Kern Pharma is and what it is used for

Acetilcisteína Kern Pharma contains the active substance acetylcysteine, which belongs to a group of medicines called mucolytics that reduce the viscosity of mucus, making it more fluid and facilitating its removal from the respiratory tract.

Acetilcisteína Kern Pharma is indicated to help eliminate excess mucus and phlegm in adults and children from 2 years of age, in respiratory conditions associated with bronchial hypersecretion such as: acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, pulmonary complications of cystic fibrosis, facilitation of procedures under anesthesia such as bronchoscopy, bronchography, and bronchoalveolar lavage, bronchiectasis, obstructive and infectious complications following tracheostomy, and bronchopulmonary complications due to surgical interventions.

2. What you need to know before using Acetilcisteína Kern Pharma

Do not use Acetilcisteína Kern Pharma:

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use acetylcysteine.

If you have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine, as it may cause breathing difficulties (bronchospasm).

The possible sulfur-like odor (resembling rotten eggs) of the medicine is characteristic of the active substance and does not indicate that its properties have been altered.

During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease over the course of treatment. If you find that you are unable to effectively expectorate, postural drainage and bronchoaspiration should be performed.

Intravenous administration must be carried out under strict medical supervision. Adverse reactions are more likely to occur after intravenous infusion if the drug is administered too rapidly or in excessive amounts. Therefore, it is recommended to strictly follow the instructions provided in section 3. How to use Acetilcisteína Kern Pharma.

Acetylcysteine is incompatible with rubber and certain metals, especially iron, nickel, and copper. Contact with materials containing these substances should be avoided.

Use with caution during long-term treatment in patients with histamine intolerance.

Children and adolescents

The same precautions and warnings apply to children and adolescents.

It is contraindicated in children under 2 years of age.

Use of Acetilcisteína Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If concomitant treatment with nitroglycerin is required, monitor for the development of hypotension (low blood pressure), which may be severe and may be accompanied by headache.

Concomitant use of carbamazepine, a drug used to treat epileptic seizures, may increase the risk of seizures.

Do not administer simultaneously with antitussive (cough-suppressant) medicines or with agents that reduce bronchial secretions (such as antihistamines and anticholinergics), as this could lead to accumulation of bronchial secretions.

Separate administration from antibiotics is recommended.

Dissolving acetylcysteine with other medicines is not recommended.

Use of Acetilcisteína Kern Pharma with food and drink

Taking food and beverages does not affect the efficacy of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Acetylcysteine crosses the placenta. Therefore, the use of acetylcysteine during pregnancy is not recommended.

It is unknown whether acetylcysteine and its metabolites are excreted in human breast milk. Use during breastfeeding should be avoided.

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

Driving and use of machines

There is no evidence of effects on the ability to drive or operate machinery.

Acetilcisteína Kern Pharma contains sodium

This medicine contains 41.2 mg of sodium (the main component of table/cooking salt) in each 3 ml ampoule. This corresponds to 2.06% of the maximum daily sodium intake recommended for an adult.

Interference with diagnostic tests

Acetylcysteine may interfere with the colorimetric assay method for the determination of salicylates.

Acetylcysteine may interfere with urine ketone testing.

3. How to use Acetylcysteine Kern Pharma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Local administration:

Inhalation via nebulizer

Adults and children 12 years and older: one 300 mg ampoule once or twice daily for 5 to 10 days.

Children between 2 and 12 years: up to one 300 mg ampoule once or twice daily for 5 to 10 days in cooperative children.

Endotracheobronchial route

Adults and children 12 years and older: one 300 mg ampoule (60 drops) once or twice daily for 5 to 10 days.

Children between 2 and 12 years: up to one 300 mg ampoule (60 drops) once or twice daily for 5 to 10 days.

Parenteral administration:

This medicine may be administered in bronchial conditions when local treatment is impossible or difficult, or when the physician prefers systemic administration (lack of patient cooperation, enforced bed rest, closed-circuit respiration, etc.).

Intramuscular route

Adults and children 12 years and older: one 300 mg ampoule once or twice daily administered by deep injection.

Children between 2 and 12 years: 150 mg (half an ampoule of 3 ml) once or twice daily administered by deep injection.

Intravenous route

Administration of acetylcysteine by intravenous route must be performed under strict medical supervision.

The medicine should be administered by slow infusion in saline solution or 5% glucose solution.

Adults and children 12 years and older: one 300 mg ampoule once or twice daily.

Children between 2 and 12 years: 150 mg (half an ampoule of 3 ml) once or twice daily.

Opening the ampoule:

• Hold the ampoule as shown in Figure 1;
• Place your thumb on the coloured spot and apply pressure backward as shown in Figure 2.

Duration of treatment

The duration of treatment should be determined according to the clinical course. The average duration is 5–10 days. The high general and local tolerability of acetylcysteine allows prolonged treatment in certain cases.

If you use more Acetylcysteine Kern Pharma than you should

If you have used more acetylcysteine than recommended, you may experience symptoms similar to those described in section 4. Possible side effects, but more intense. In case of overdose or accidental massive administration, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount used.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following adverse effects may occur, although their frequency cannot be determined from the available information:

Local use:

Allergic reactions (hypersensitivity), bronchial constriction and breathing difficulty (bronchospasm), increased nasal discharge (rhinorrhea), mouth ulcers (stomatitis), vomiting, nausea, urticaria, rash or itching.

Parenteral use:

Allergic reactions (hypersensitivity) of varying severity, potentially leading to anaphylactic shock, increased heart rate (tachycardia), bronchial constriction and breathing difficulty (bronchospasm, dyspnea), vomiting, nausea, facial swelling (angioedema), urticaria, flushing, rash, itching, facial edema, decreased blood pressure, reduced blood coagulation (increased prothrombin time, decreased platelet aggregation).

In very rare cases, severe skin reactions (Stevens-Johnson syndrome and Lyell syndrome) have been reported, although in most of these cases at least one other drug suspected of triggering the syndrome could also be identified.

If any skin or mucous membrane changes occur, administration of acetylcysteine must be stopped immediately. The specialist physician will determine the appropriate course of treatment.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Local administration

It is recommended to open the ampoule immediately before use. Opened ampoules may only be used for local administration and must be stored in the refrigerator for a maximum of 24 hours.

Parenteral administration

Use immediately after opening. If not used immediately, the storage times and conditions during use are the responsibility of the user.

The solution, once diluted for use (in 5% glucose solution or 0.9% sodium chloride solution), remains stable for 24 hours at 25°C.

Discard after use.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Acetylcysteine Kern Pharma

The active substance is acetylcysteine. Each 3 ml ampoule contains 300 mg of acetylcysteine.

The other components are: disodium edetate, sodium hydroxide (for pH adjustment), and water for injections.

Appearance of the medicinal product and contents of the container

Appearance: amber glass ampoules with a break point, containing 3 ml of a clear, colourless solution.

Each pack contains 5 ampoules.

Marketing Authorisation Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: December 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es