PROSPECTO: INFORMATION FOR THE USER

Mesna Altan 200mg/ml solution for nebulization and for endotracheopulmonary instillation

Mesna

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

• Keep this prospectus, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section 4.

1. What is Mesna Altan and for what it is used

2. What you need to know before starting to take Mesna Altan

3. How to take Mesna Altan

4. Possible adverse effects

5. Storage of Mesna Altan

6. Contents of the package and additional information

Mesna is a mucolytic medication that binds to proteins of 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.

No use Mesna Altan

If you are allergic (hypersensitive) to mesna, to other compounds with thiol group or sulfonamides or to any of the other components of Mesna.

If you have asthma without mucous 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.

Tenga especial cuidado con Mesna Altan

Mesna 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. Mesna 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.

Since it is a product easily oxidizable, it is preferable to open the ampoule at the time of using its content. The solution can be used up to 12 hours after opening, kept at room temperature.

Accidental intravenous injection or oral absorption does not pose a risk to the patient. However, accidental intramuscular injection may cause local tissue necrosis (tissue death due to lack of blood supply).

Uso de otros medicamentos

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

Mesna 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 Mesna with aminoglycosides (streptomycin, kanamycin, neomycin, gentamicin) in the same solution, as these are inactivated. However, there is no problem with the use of all these antibiotics through systemic administration and Mesna through local application.

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

- certain types of antibiotics (oxitetraciclina, carbenicilina and eritromicina)

- aminophylline (medication for asthma)

- lipiodol (radiological contrast medium)

- cisplatino (medication for certain tumors)

- nitrous oxide

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

Embarazo y lactancia

Consult your doctor or pharmacist before using any medication.

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

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

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

Conducción y uso de máquinas

The influence of Mesna on the ability to drive and use machines is negligible or insignificant.

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

Mesna 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 into 3 to 4 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 tracheostomy cannula.

The usual therapeutic dose is 1 ml or 2 ml of diluted solution to 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 sufficient rapid improvement, the clinical situation should be reevaluated with a possible adjustment of the treatment. In cystic fibrosis, Mesna will be administered based on symptoms.

If you use more Mesna Altan than you should:

No cases of overdose have been reported.

After the use of large volumes of solution and the sudden liquefaction of mucus, a partial pulmonary edema (partial accumulation of fluid in the lungs) may occur, causing transient disturbances in ventilation. 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 Mesna Altan:

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

If you interrupt the treatment with Mesna Altan:

Do not interrupt the treatment with Mesna 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, Mesna Altan may have adverse effects, although not everyone will experience them.

The adverse effects described with Mesna Altan are:

-Chest pain

-Hypersensitivity (allergy)

-Cough

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

-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 caused by excessive fluidification and ingestion of mucosities may occur, especially in children.

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 ease of oxidation, it is preferable to open the ampule at the time of using its content. The solution can be used up to 12 hours after opening, kept at room temperature.

Medicines should not be thrown down the drains or in the trash. Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Mesna Altan

- The active ingredient is mesna. Each ml of Mesna contains 200 mg of mesna. Each ampoule of 3 ml contains 600 mg of mesna.

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

Appearance of the product and contents of the packaging

Mesna is a transparent and colorless solution.

The solution is supplied in a colorless glass ampoule.

Mesna is marketed in packaging with 6 ampoules of 3 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.Cólquide, 6 Portal 2, 1st-Office F

28230 Las Rozas (Madrid)

Spain

Responsible for manufacturing:

Altan Pharmaceuticals S.A.

Avda. de la Constitución, 198-199,

Polígono Industrial Monte Boyal, Casarrubios del Monte, 45950 Toledo-Spain

Altan Pharmaceuticals, S.A.

Poligono Industrial s/nº (Bernedo) - 01118 – Spain

This leaflet was approved in July 2022

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