Bronsal solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bronsal injectable solution

(Betamethasone, Diprophylline, Guaifenesin)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Bronsal injectable solution is and what it is used for
2. What you need to know before using Bronsal injectable solution
3. How to use Bronsal injectable solution
4. Possible adverse effects
5. How to store Bronsal injectable solution
6. Contents of the pack and other information

1. What Bronsal injectable solution is and what it is used for

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

It is indicated in the acute phase of respiratory tract diseases that impair adequate pulmonary ventilation.

This medicine is intended for the symptomatic treatment of these acute conditions, which should resolve within a short period of time (6–10 days). In chronic diseases, specific treatment should be continued.

2. What you need to know before using Bronsal injectable solution

Do not use Bronsal injectable solution

• If you are allergic to betamethasone, diprophylline, guaifenesin, or any of the other components of this medicine (listed in section 6).
• If you have a fungal infection (caused by fungi).
• If you have been diagnosed with idiopathic thrombocytopenic purpura (a blood disorder characterized by low platelet count).
• If you have severe hepatic or renal insufficiency.
• In children under 2 years of age.

Warnings and precautions

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

• Patients with uremia (uremia is the accumulation in the blood of waste products normally eliminated by the kidneys).
• Whenever an infectious process is present or suspected. Your doctor will prescribe oral or parenteral antibiotics.
• If treatment periods exceed the recommended duration, side effects associated with systemic corticosteroid use may occur.
• Elderly patients.
• Patients with a history of tuberculosis.
• Patients with severe myocardial or coronary lesions, or severe hypertension.
• Patients with hyperthyroidism.
• Patients with hepatic or renal diseases.
• Patients with diabetes mellitus.
• Patients with gastric ulcer.
• Patients with osteoporosis.
• Patients with epilepsy.
• Patients with myasthenia gravis (a chronic autoimmune neuromuscular disease characterized by variable weakness of skeletal (voluntary) 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 medicine contains betamethasone, which may cause a positive result in doping control tests.

Use of Bronsal injectable solution with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

• Medicines of the xanthine type (e.g., theophylline), as they may enhance the effect of Bronsal.
• Probenecid (a medicine used in the treatment of gout).
• Medicines that induce liver enzymes (barbiturates, phenytoin, and rifampicin).
• Enzyme inhibitors (of the CYP3A4 enzyme) such as ketoconazole and itraconazole (used for fungal infections) may increase the effect of corticosteroids. Therefore, your doctor will perform careful monitoring if you are taking these medicines (including some for HIV: ritonavir, cobicistat).
• Aspirin (salicylates). Caution is advised when using Bronsal concomitantly with salicylates in patients with hypoprothrombinemia (deficiency of a substance (prothrombin) necessary for blood clotting).
• Diuretics that increase potassium excretion.
• Isoproterenol (a medicine used in the treatment of 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 medicine.

The use of this medicine during pregnancy and breastfeeding is not recommended unless clearly indicated by a physician.

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

Driving and use of machines

Not reported.

This medicine contains sodium, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and sodium metabisulfite.

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of suffocation) due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate.

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

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.

3. How to use Bronsal injectable solution

Follow exactly the administration instructions for Bronsal provided 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 by intramuscular route.

If you use more Bronsal injectable solution than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses.

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

4. Possible adverse effects

Like all medicines, Bronsal may cause adverse effects, although not everyone experiences them.

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

Frequent (may affect between 1 and 10 out of 100 patients): gastrointestinal disorders (nausea, vomiting, abdominal pain, diarrhoea), headache, excitation, insomnia or somnolence, osteoporosis, bone fragility, hyperglycaemia, polyphagia (abnormally increased appetite), delayed wound healing, susceptibility to infections (oropharyngeal candidiasis), signs of adrenal hyperactivity (Cushing's syndrome), hirsutism (excessive growth of body and facial hair in women), cutaneous hyperpigmentation, gastric ulcer.

Uncommon (may affect between 1 and 10 out of 1,000 patients): oedema (swelling), hypertension, cardiac failure, hypokalaemia (decreased potassium levels), amenorrhoea (temporary or permanent absence of menstrual periods), sweating, neurological disturbances, intracranial hypertension, acute pancreatitis (inflammation of the pancreas), thromboembolism, myasthenia (chronic autoimmune neuromuscular disease characterised by variable degrees of weakness of the skeletal (voluntary) muscles).

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

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

5. Storage of Bronsal injectable solution

No special storage conditions are required.

Keep this medicine out of the sight and reach 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.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bronsal injectable solution

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

The other components are: sodium metabisulfite (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 pack

Bronsal is a clear, colourless solution. Each pack contains 5 vials of 4 ml.

Marketing Authorisation 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 most recent revision of this leaflet: April 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/