Package Insert: Information for the User

Bronsal Injectable Solution

(Betametasona, Diprofilina, Guaifenesina)

Read this package insert carefully before starting to take 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 to you alone, 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.

Bronsal injectable solution contains the active principles betamethasone, diprophylline and guaifenesin.

It is indicated in the acute phase of respiratory system diseases that compromise adequate pulmonary ventilation.

This medication is designed for symptomatic treatment of these acute processes that must resolve in a short period of time (6-10 days). In chronic diseases, specific treatment should be continued.

Do not use Bronsal injectable solution

• If you are allergic to betamethasone, diprophylline, guaifenesin, or any of the other components of this medication (listed in section 6).
• If you have a fungal infection.
• If you have been diagnosed with idiopathic thrombocytopenic purpura (a blood disorder characterized by a lack of platelets).
• If you have severe liver or kidney failure.
• In children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bronsal injectable solution if you are in any of the following situations:

• Patients with uremia (the concentration in the blood of waste products that are usually eliminated by the kidneys).
• Whenever there is or is suspected to be an infectious process. Your doctor will prescribe antibiotics orally or parenterally.
• If the recommended treatment periods are exceeded, side effects from the use of systemic corticosteroids may appear.
• Older patients.
• Patients with a history of tuberculosis.
• Patients with severe myocardial or coronary injuries, or severe hypertension.
• Patients with hyperthyroidism.
• Patients with liver or kidney diseases.
• Patients with diabetes mellitus.
• Patients with gastric ulcers.
• Patients with osteoporosis.
• Patients with epilepsy.
• Patients with myasthenia gravis (a chronic autoimmune and neuromuscular disorder characterized by variable degrees of weakness of the skeletal muscles (voluntary) of the body).
• Patients with glaucoma (a disease in which the optic nerve is damaged).
• If you experience blurry vision or other visual disturbances.
• If you have pheochromocytoma (a tumor of the adrenal gland).

This medication contains betamethasone, which may produce a positive result in doping control tests.

Use of Bronsal injectable solution with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription.

The following medications may interact with Bronsal. Inform your doctor if you are taking any of them:

• Medications of the xanthine type (e.g., theophylline), which may potentiate the effect of Bronsal.
• Probenecid (a medication used to treat gout).
• Medications that induce liver enzymes (barbiturates, phenytoin, and rifampicin).
• Enzyme inhibitors (CYP3A4) such as ketoconazole and itraconazole (used to treat fungal infections) may increase the effect of corticosteroids. Your doctor will perform thorough controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).
• Aspirin (salicylates). Be cautious when using Bronsal with salicylates in patients with hypoprothrombinemia (a deficiency of a substance (prothrombin) necessary for blood coagulation).
• Diuretics that increase the elimination of potassium.
• Isoproterenol (a medication used to treat asthma).

Pregnancy and lactation

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

This medication is not recommended for use during pregnancy and lactation, except for express medical indication.

Newborn babies of mothers who received betamethasone near the end of pregnancy may have low blood sugar levels after birth.

Driving and operating machinery

Not described.

This medication contains sodium, methylparahydroxybenzoate, propylparahydroxybenzoate, and sodium metabisulfite.

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) due to methylparahydroxybenzoate and propylparahydroxybenzoate.

It may cause severe allergic reactions or bronchospasm (sudden sensation of choking) due to sodium metabisulfite.

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

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

The recommended dose in adults is one injectable every 12-24 hours via intramuscular route.

If you use more Bronsal injectable solution than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Bronsal injectable solution

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

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

Like all medications, Bronsal can produce adverse effects, although not all people will experience them.

The severity of adverse effects associated with prolonged treatment increases with doses and treatment duration. Short-term treatments usually do not produce adverse reactions.

Frequent (may affect between 1 and 10 of every 100 patients): gastrointestinal disorders (nausea, vomiting, abdominal pain, diarrhea), headache, excitement, insomnia or somnolence, osteoporosis, bone fragility, hyperglycemia, polyphagia (abnormal increase in the need to eat), delayed wound healing, propensity to infections (oropharyngeal candidiasis), signs of hyperadrenal activity (Cushing's Syndrome), hirsutism (excessive hair growth in women, on the face and body), skin hyperpigmentation, gastric ulcer.

Rare (may affect between 1 and 10 of every 1,000 patients): edema (swelling), hypertension, heart failure, hypokalemia (decrease in potassium levels), amenorrhea (temporary or permanent absence of menstrual flow), sweating, neurological alterations, intracranial hypertension, acute pancreatitis (inflammation of the pancreas), thromboembolism, myasthenia (chronic autoimmune and neuromuscular disease characterized by variable degrees of weakness of skeletal muscles (voluntary) of the body).

Unknown frequency: hypotension, blurred vision (see section 4.4).

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

This product does not require special conditions for conservation.

Keep this medication out of the sight and reach 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bronsal injectable solution

The active principles are (per 4 ml ampoule): betamethasone 2 mg (sodium phosphate of betamethasone), dipyridamole 250 mg and guaifenesin 200 mg.

The other components are: sodium metabisulphite (E-223), disodium edetate, anhydrous disodium hydrogen phosphate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216) and water for injectable preparations.

Appearance of the product and contents of the packaging

Bronsal is a transparent and colourless solution. Each package contains 5 ampoules of 4 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder

IONFARMA, S.L.U.

Perú, 228

08020 Barcelona. Spain.

Responsible for manufacturing

LABORATORIOS REIG JOFRÉ, S.A.

Gran Capitán, 10

08970 Sant Joan Despí, Barcelona. Spain.

Date of the last review of this prospectus:April 2022.

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