BRONSAL Injectable Solution

2. What you need to know before taking Bronsal Injectable Solution

Do not use Bronsal Injectable Solution

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

Warnings and Precautions

Consult your doctor or pharmacist before taking Bronsal Injectable Solution if you are in any of the following situations:

• Uremic patients (uremia is the concentration in the blood of waste products that are normally eliminated by the kidneys).
• Whenever there is or is suspected to be an infectious process. Your doctor will prescribe oral or parenteral antibiotics.
• If the recommended treatment periods are exceeded, the side effects of systemic corticosteroids may appear.
• Elderly patients.
• Patients with a history of tuberculosis.
• Patients with severe myocardial or coronary lesions, or severe hypertension.
• Patients with hyperthyroidism.
• Patients with liver or kidney disease.
• Patients with diabetes mellitus.
• Patients with gastric ulcers.
• Patients with osteoporosis.
• Patients with epilepsy.
• Patients with myasthenia gravis (a chronic autoimmune neuromuscular disease characterized by variable degrees of weakness of the skeletal muscles).
• Patients with glaucoma (an eye disease in which the optic nerve is damaged).
• If you experience blurred 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 tests.

Using Bronsal Injectable Solution with Other Medications

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

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

• Xanthine-type medications (e.g., theophylline), as they may enhance 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 for fungal infections) may increase the effect of corticosteroids. Therefore, your doctor will closely monitor you if you are taking these medications (including some for HIV: ritonavir, cobicistat).
• Aspirin (salicylates). Caution should be exercised if Bronsal is used concomitantly with salicylates in patients with hypoprothrombinemia (deficiency of a substance necessary for blood coagulation).
• Diuretics that increase potassium elimination.
• Isoproterenol (a medication used to treat asthma).

Pregnancy and Breastfeeding

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

The use of this medication is not recommended during pregnancy and breastfeeding, except on explicit medical indication.

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

Driving and Using Machines

Not described.

This medication contains sodium, methylparaben, propylparaben, and sodium metabisulfite.

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation) because it contains methylparaben and propylparaben.

It may cause severe allergic reactions or bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.

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

3. How to Use Bronsal Injectable Solution

Follow your doctor's instructions for administering Bronsal exactly. Consult your doctor or pharmacist if you have any questions.

The recommended dose in adults is one injection 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Bronsal Injectable Solution

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

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

4. Possible Side Effects

Like all medications, Bronsal can cause side effects, although not everyone will experience them.

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

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

Uncommon (may affect 1 to 10 in every 1,000 patients): edema (swelling), hypertension, heart failure, hypokalemia (decreased potassium levels), amenorrhea (temporary or permanent absence of menstrual flow), sweating, neurological disorders, intracranial hypertension, acute pancreatitis, thromboembolism, myasthenia (a chronic autoimmune neuromuscular disease characterized by variable degrees of weakness of the skeletal muscles).

Frequency unknown: hypoaesthesia, blurred vision (see also section 4.4).

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Bronsal Injectable Solution

No special storage conditions are required.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bronsal Injectable Solution

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

The other ingredients are: sodium metabisulfite (E-223), disodium edetate, anhydrous disodium hydrogen phosphate, methylparaben (E-218), propylparaben (E-216), and water for injectable preparations.

Appearance of the Product and Package Contents

Bronsal is a clear and colorless solution. Each package contains 5 ampoules of 4 ml.

Marketing Authorization Holder and Manufacturer

Holder

IONFARMA, S.L.U.

Perú, 228

08020 Barcelona, Spain.

Manufacturer

LABORATORIOS REIG JOFRÉ, S.A.

Gran Capitán, 10

08970 Sant Joan Despí, Barcelona, Spain.

Date of the Last Revision of this Package Leaflet:April 2022.

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