MUCOFLUID 200 mg/ml SOLUTION FOR NEBULIZATION AND SOLUTION FOR ENDOTRACHEOPULMONARY INSTILLATION

2. Before you use Mucofluid

Do not use Mucofluid

• if you are allergic (hypersensitive) to mesna, other compounds with a thiol group or sulfonamides, or any of the other components of Mucofluid.
• if you have asthma without mucous obstruction. Or in case of asthmatic status.
• if you have severe renal insufficiency.
• if you have intolerance to aerosols.
• if you are unable to cough or expectorate properly.
• in children under 2 years of age.

Take special care with Mucofluid

• Mucofluid is exclusively for use via a nebuliser or endotracheal instillation and should only be administered under medical supervision.
• Its use is not recommended in children under 12 years of age.
• In asthmatic patients, the product should only be administered if there is retention of mucus and bronchial secretions and always in the presence of a doctor or in a healthcare centre.
• 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 should not come into direct contact with rubber or unprotected metal.
• A white deposit may form in the devices or circuits, which can be eliminated by rinsing with water.
• The solution should ideally be administered at room temperature.
• As it is a readily oxidisable product, it is preferable to open the ampoule at the time of use. The solution can be used up to 24 hours after opening, stored below 25°C.
• Accidental intravenous injection or oral absorption does not pose a risk to the patient. However, accidental intramuscular injection can cause local tissue necrosis (tissue death due to lack of blood supply).

Using other medicines

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

Mucofluid can be used simultaneously with other medicines, such as antibiotics (to treat infections), bronchodilators (to treat respiratory disorders of an asthmatic type), corticosteroids (to treat inflammatory processes), and anaesthetics when these are administered intravenously.

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

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

• certain types of antibiotics (oxytetracycline, carbenicillin, and erythromycin)
• aminophylline (a medicine for treating asthma)
• lipiodol (a radiological contrast medium)
• cisplatin (a medicine for treating certain tumours)
• nitrogen gas

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

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

Mucofluid should be avoided during breastfeeding or breastfeeding should be interrupted while receiving treatment with Mucofluid.

Driving and using machines

The influence of Mucofluid on the ability to drive and use machines is nil or insignificant.

3. How to use Mucofluid

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

Mucofluid can be administered:

Via nebulisation:The solution can be used undiluted or diluted to an equal extent with distilled water or physiological serum. The solution can be administered preferably with a nasal piece, 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 into 3 to 4 administrations per day.

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

Via endotracheal instillation:The solution should be diluted to an equal extent with distilled water or physiological serum. The solution can be administered via an endotracheal tube or tracheotomy cannula.

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

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

Treatment should be reduced to the shortest possible period, and if there is no sufficiently rapid improvement, the clinical situation should be reassessed with possible adjustment of treatment. In cystic fibrosis, Mucofluid will be administered according to symptoms.

If you use more Mucofluid than you should:

No cases of overdose have been reported.

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

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

If you forget to use Mucofluid:

Do not use a double dose to make up for forgotten doses.

If you stop using Mucofluid:

Do not stop using Mucofluid without consulting your doctor first.

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

4. Possible side effects

Like all medicines, Mucofluid can cause side effects, although not everybody gets them.

The side effects described with Mucofluid are:

- Chest pain.

- Hypersensitivity (allergy).

- Cough.

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

• Disgeusia (alteration in the sense of taste (bad taste, bitter taste,...)).

- Angioneurotic oedema (hives or swelling under the skin).

- Erythematous rash (red skin rash).

- Urticaria (itching).

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

Sometimes, a sensation of retrosternal burning (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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storing Mucofluid

Keep out of the reach and sight of children.

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

This medicine does not require any special storage conditions.

As it is a readily oxidisable product, it is preferable to open the ampoule at the time of use. The solution can be used up to 24 hours after opening, stored below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Mucofluid

• The active ingredient is mesna. Each ml of Mucofluid contains 200 mg of mesna. Each 3 ml ampoule contains 600 mg of mesna.

• The other ingredients are: disodium edetate, sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance and packaging of the product

Mucofluid is a clear, colourless solution.

The solution is supplied in a colourless glass ampoule.

Mucofluid is marketed in packs of 6 ampoules of 3 ml of solution.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

IONFARMA, S.L.

Peru, 228

08020 Barcelona-Spain

Manufacturer:

Laboratorios Reig Jofré, S.A.

Gran Capitan, 10

08970 Sant Joan Despí (Barcelona)

This leaflet was approved in September 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/