Package Insert: Information for the Patient

Acetilcisteína Kern Pharma 100 mg/ml Injectable Solution EFG

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Acetilcisteína Kern Pharma contains the active ingredient acetilcisteína, which belongs to a group of medicines called mucolítics that reduce the viscosity of mucus, liquefying it and facilitating its elimination from the respiratory tract.

Acetilcisteína Kern Pharma is indicated to facilitate the elimination of excess mucus and phlegm in adults and children aged 2 years and above, in respiratory processes in the presence of bronchial hypersecretion such as: Acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, pulmonary complications of cystic fibrosis, facilitation of maneuvers in anesthesia in bronchoscopies, bronchographies, and bronchoaspiration, bronchiectasias, obstructive and infectious complications by tracheotomy, and bronchopulmonary complications by surgical intervention.

No use Acetilcisteína Kern Pharma:

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

Advertencias and precautions

Consult your doctor or pharmacist before starting to use acetilcisteína.

If you are asthmatic or have a severe respiratory disease, you must consult with your doctor before taking this medication as it may cause respiratory difficulties (bronchoconstriction).

The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that its characteristics have been altered.

During the first days of treatment, you may observe an increase in mucus and phlegm, which will decrease over the course of treatment. If you are unable to effectively cough up mucus, you should perform postural drainage and bronchial aspiration.

Administration by intravenous route will be carried out under strict medical supervision. It is more likely that adverse reactions will occur after intravenous perfusion if the drug is administered too quickly or in excessive amounts. Therefore, it is recommended to strictly follow the instructions in section 3. How to use Acetilcisteína Kern Pharma.

Acetilcisteína is not compatible with rubber and certain metals, especially iron, nickel, and copper. You should avoid contact with materials that contain them.

It should be administered with caution in 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 old.

Use of Acetilcisteína Kern Pharma with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In case you need simultaneous treatment with nitroglycerin, you should monitor for the appearance of hypotension (low blood pressure), which can be severe, and may cause headaches.

The simultaneous use of carbamazepine, a medication used to combat epilepsy attacks, may increase the risk of seizures.

Do not administer concurrently with cough medications or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may lead to an accumulation of bronchial secretions.

It is recommended to administer antibiotics separately.

Do not dissolve acetilcisteína with other medications.

Use of Acetilcisteína Kern Pharma with food and beverages

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Acetilcisteína crosses the placenta. Therefore, it is not recommended to use acetilcisteína during pregnancy.

The excretion of acetilcisteína and its metabolites in breast milk is unknown. You should avoid its use during lactation.

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

Driving and operating machinery

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

Acetilcisteína Kern Pharma contains sodium

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

Interference with analytical tests

Acetilcisteína may interfere with the colorimetric method for determining salicylates.

Acetilcisteína may interfere with the ketone test in urine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 vial one or two times a day for 5 to 10 days.

Children between 2 and 12 years: up to one 300 mg vial one or two times a day for 5 to 10 days in cooperative children.

Endotracheal-bronchial route

Adults and children 12 years and older: one 300 mg vial (60 drops) one or two times a day for 5 to 10 days.

Children between 2 and 12 years: up to one 300 mg vial (60 drops) one or two times a day for 5 to 10 days.

Parenteral administration:

This medication can be administered in bronchial conditions when local treatment is impossible or difficult or when the doctor prefers the systemic route (lack of patient cooperation, bed rest, closed-circuit breathing, etc.).

Intramuscular route

Adults and children 12 years and older:one 300 mg vial one or two times a day administered by deep injection.

Children between 2 and 12 years:150 mg (half vial of 3 ml) one or two times a day administered by deep injection.

Intravenous route

The administration of acetylcysteine by intravenous route is carried out under strict medical supervision.

The medication must be administered by slow infusion in saline solution or 5% glucose solution.

Adults and children 12 years and older: one 300 mg vial one or two times a day.

Children between 2 and 12 years: 150 mg (half vial of 3 ml) one or two times a day.

Opening the vial:

• Hold the vial as indicated in Figure 1;
• Place the thumb on the colored point and exert pressure backward as indicated in Figure 2.

Treatment duration

The treatment duration should be established according to the clinical evolution. The average duration is 5-10 days. The high general and local tolerability of acetylcysteine allows prolonged treatments in certain cases.

If you use more Acetilcisteína Kern Pharma than you should

If you have used more acetylcysteine than you should, you may notice symptoms similar to those described in section 4, although more intense. In case of overdose or accidental massive administration, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91.562.04.20 indicating the medication and the amount used.

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

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

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

Local Use:

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

Parenteral Use:

Allergic reactions (hypersensitivity) of varying degrees, which may lead to anaphylactic shock, increased heart rate (tachycardia), constriction of the bronchioles and difficulty breathing (bronchospasm, dyspnea), vomiting, nausea, facial swelling (angioedema), urticaria, flushing, rash, itching, facial edema, decreased blood pressure, decreased blood coagulation (increased prothrombin time, decreased platelet aggregation).

In very rare cases, severe skin reactions (Stevens-Johnson syndrome and Lyell syndrome) may occur, although in most cases, another suspected medication was also identified as a trigger for the syndrome.

If any skin or mucous membrane alterations occur, discontinue acetilcysteine administration immediately. A specialist will determine the subsequent treatment.

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 Medicinal Products for Human Use: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.

No special storage conditions are required.

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

Local Administration

It is recommended to open the ampule at the time of use. Open ampules can only be used for local use, and should be stored in the refrigerator for a maximum of 24 hours.

Parenteral Administration

Once opened, use immediately. If not used immediately, storage times and conditions in use are the responsibility of the user.

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

Dispose of after use.

Medications should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Acetilcisteína Kern Pharma

The active ingredient is acetilcisteína. Each 3 ml ampoule contains 300 mg of acetilcisteína.

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

Appearance of the product and contents of the packaging

Appearance: amber glass ampoules with breaking point, containing 3 ml of transparent and colorless solution.

Each package contains 5 ampoules.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:December 2024

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