PATIENT INFORMATION LEAFLET

Mucofluid 200 mg/ml solution for nebulization and for endotracheal and pulmonary instillation

Mesna

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1.What Mucofluid is and what it is used for

2.Before using Mucofluid

3.How to use Mucofluid

4.Possible side effects

5.Storage of Mucofluid

6.Further information

Mucofluid is a mucolytic medication that binds to proteins in mucus fragments and dissolves them, facilitating their elimination.

By nebulization, it is used for:

• cystic fibrosis,
• obstructive respiratory tree pathologies due to mucous plugs.

By endotracheal instillation, it is used:

• to facilitate aspiration and drainage of retained respiratory tract secretions and exudates during anesthesia or intensive care,

in bronchoscopy, to ensure better visualization of areas to be examined.

Do not use Mucofluid

• If you are allergic (hypersensitive) to mesna, other compounds with thiol group or sulfonamides, or any of the other components of Mucofluid.
• If you have asthma without mucosal obstruction. Or in case of asthmatic status.
• If you have severe renal insufficiency.
• If you present intolerance to aerosols.
• If you cannot cough or expectorate adequately.
• In children under 2 years.

Be especially careful with Mucofluid

• Mucofluid is exclusively for use through nebulizer or endotracheal instillation and must be administered only under medical supervision.
• It is not recommended for use in children under 12 years.
• In asthmatic patients, the product will be administered only if there is retention of mucosities and bronchial exudates, and always in the presence of a doctor or in a healthcare center.
• Any type of device can be used, provided that the circuit through which the product must pass is made of plastic, glass, or stainless steel. Mucofluid must not be in direct contact with rubber or unprotected metal.
• A white deposit may form in the devices or circuits, which can be removed by rinsing with water.
• The solution should ideally be administered at room temperature.
• As it is an easily oxidizable product, it is preferable to open the ampoule at the time of using its content. The solution can be used up to 24 hours after opening, stored below25°C.
• Accidental intravenous injection or oral absorption does not pose a risk to the patient. However, accidental intramuscular injection may cause local tissue necrosis (death of tissue due to lack of blood supply).

Use of other medications

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

Mucofluid can be used simultaneously through local application with other medications such as antibiotics (to treat infections), bronchodilators (to treat asthmatic respiratory disorders), corticosteroids (to treat inflammatory processes), and anesthetics when administered intravenously.

It is recommended not to mix Mucofluid with aminoglycosides (streptomycin, kanamycin, neomycin, gentamicin) in the same solution, as they are inactivated. However, there is no inconvenience for the use of all these antibiotics through systemic administration and Mucofluid through local application.

Due to physical-chemical incompatibility, it is recommended not to mix Mucofluid in the same solution with:

• Certain types of antibiotics (oxytetracycline, carbenicillin, and erythromycin)
• Aminophylline (medication for treating asthma)
• Lipiodol (radiological contrast medium)
• Cisplatin (medication for treating certain tumors)
• Nitrogen gas

If you undergo a urine analysis, false positive results may appear in the determination of certain components (sulfites or ketones) due to the presence in the urine of some substances (disulfides or free thiol groups) after administration of mesna.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

There are insufficient data on the use of mesna in pregnant women.

Mucofluid should not be used during pregnancy except if it is clearly necessary.

Mucofluid should be avoided during lactation or lactation should be interrupted while receiving Mucofluid treatment.

Driving and operating machines

The influence of Mucofluid on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the administration instructions for Mucofluid as indicated by your doctor. Consult your doctor if you have any doubts.

Mucofluid can be administered:

Through nebulization:The solution can be used pure, or it can be diluted to equal parts with distilled water or physiological serum. The solution can be administered preferably with a nasal piece, with a mask, or under a chamber.

The usual therapeutic dose is 3 ml (600 mg) to 6 ml (1200 mg) of the undiluted product per day, divided into3 to4 times a day.

The maximum dose is 24 ml (4.8 g) of pure product per day.

Through endotracheal instillation:The solution must be diluted to equal parts, with distilled water or physiological serum. The solution can be administered via endotracheal tube or tracheotomy cannula.

The usual therapeutic dose is 1 ml or 2 ml of diluted solution at 10% every hour.

The maximum dose is 24 ml (4.8 g) per day.

Treatment should be reduced to the shortest possible period and, in case of no sufficiently rapid improvement, the clinical situation should be reevaluated with a possible adjustment of the treatment. In cystic fibrosis, Mucofluid will be administered according to symptoms.

If you use more Mucofluid than you should:

No cases of overdose have beenreported.

After using large volumes of solution and sudden liquefaction of mucus, partial pulmonary edema (partial accumulation of fluid in the lungs) may occur, causing transient respiratory disturbances. The patient should be strictly monitored and symptomatic treatment should be performed.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone (91) 562 04 20.

If you forgot to use Mucofluid:

Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with Mucofluid:

Do not interrupt the treatment with Mucofluid without first consulting your doctor.

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

Like all medications, Mucofluid may have adverse effects, although not everyone will experience them.

The adverse effects described with Mucofluid are:

-Chest pain.

-Hypersensitivity (allergy).

-Cough.

-Bronchospasm (contraction of the bronchi, causing narrowing and difficulty breathing).

-Dysgeusia (alteration in the sense of taste (bad taste, bitter taste, etc.)).

-Angioneurotic edema (hives or welts due to swelling under the skin).

-Erythematous rash (red, itchy skin eruption).

-Urticaria (itching).

There is a possibility of bronchospasm, particularly in sensitive asthmatic patients. Vomiting and digestive discomfort may occur, especially in children, due to excessive fluidification and ingestion of mucus.

Occasionally, a burning sensation in the retrosternal area (central chest area, behind the sternum) may occur with the solution at a concentration of 200 mg/ml (in this case, the solution should be diluted to 100 mg/ml).

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

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

This medication does not require special conservation conditions.

Due to its easily oxidizable nature, it is preferable to open the ampule at the time of using its contents. The solution can be used up to 24 hours after opening, preserved below25°C.

Medicines should not be disposed of through drains or trash.Deposit the packaging and unused medications at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of Mucofluid

- The active ingredient is mesna. Eachml of Mucofluid contains 200mg of mesna. Each ampule of 3 ml contains 600 mg of mesna.

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

Appearance of the product and contents of the package

Mucofluid is a transparent and colorless solution.

The solution is supplied in a colorless glass ampule.

Mucofluid is marketed in packages with 6 ampules of 3ml of solution.

Holder of the marketing authorization and responsible manufacturer

Holder:

IONFARMA, S.L.

Peru, 228

08020 Barcelona-Spain

Manufacturer:

Laboratorios Reig Jofré, S.A.

Gran Capitan, 10

08970 Sant Joan Despí (Barcelona)

This prospectus was approved in September 2023.

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