Prospect: information for the user

Bronquidiazina CR oral suspension

(trimetroprima/ sulfametoxazol/ bromhexina hidrocloruro/ extracto fluido de bálsamo de Tolú)

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

• Keep this prospect, 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 should not be given to other people, even if they 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 prospect.See section 4.

Bronquidiazina CR contains four active principles. Two of them (trimetoprima/sulfametoxazol) belong to a group of medications called antibiotics that eliminate the bacteria that cause infections. These two antibiotics are associated with bromhexina and balsam of Tolú syrup, with mucolytic and balsamic-expectorant activity, respectively, reducing the viscosity of mucous secretions and facilitating their elimination.

Bronquidiazina CR is indicated in children over 2 years old, adolescents, and adults, for the treatment and prevention of pneumonia caused by Pneumocystis jirovecii.

This medication may also be useful for the oral treatment of other infections produced by sensitive microorganisms to the trimetroprima/sulfametoxazol association, such as: acute bronchitis and exacerbation of chronic bronchitis, pneumonias, middle ear infections, and sinusitis.

Official recommendations on the proper use of antibacterial agents should be taken into account.

Do not take Bronquidiazina CR

• If you are allergic to the active ingredients of this medication: trimetoprima, sulfametoxazol, bromhexina, Tolú balsam syrup, or to any of the other components of this medication (listed in section 6).
• If you are allergic to sulfamidas, medications that contain sulfamidas, such as antidiabetic medications of the sulfonilurea group (e.g., gliclazida, glibenclamida), or diuretics of the thiazide group (hidroclorotiazida).
• In children under 2 years old.
• If you have or think you have acute porphyria (a blood disorder in which hemoglobin is not produced adequately).
• If you are or think you may be pregnant or breastfeeding.
• In combination with dofetilida (a medication used to control irregular or rapid heartbeats).
• If you have advanced liver or kidney insufficiency.

• Do not take Bronquidiazina CR if any of the above points apply to you.If you are unsure, speak with your doctor or pharmacist before starting treatment.

Warnings and precautions

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis, generalized acute pustular exanthema, and acute febrile neutrophilic dermatosis or sweet syndrome) have been described with the use of this medication.

The highest risk of severe skin reactions is during the first weeks of treatment. Initially, they appear as red, circular spots with a central blister. Other signs that may appear include mouth, throat, nose, genital, and conjunctivitis (swollen and red eyes) lesions. These life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to generalized blistering or skin peeling.

If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute febrile neutrophilic dermatosis with the use of cotrimoxazol (trimetoprima/sulfametoxazol) or bromhexina, do not use this medication again at any time.

Stop taking Bronquidiazina CR and immediately see a doctor, informing them of the use of this medication,if you develop red, scaly lesions with subcutaneous nodules and blisters, or experience any of the previously mentioned symptoms.

Lymphohistiocytosis hemophagocytosis

Very rarely, cases of excessive immune reactions due to unregulated activation of white blood cells, causing inflammation (lymphohistiocytosis hemophagocytosis), which can be potentially fatal if not diagnosed and treated promptly.

Immediately contact your doctor,if you experience multiple symptoms such as fever, lymph node swelling, feeling weak, dizziness, shortness of breath, unexpected worsening of cough, hematomas, or concurrent or slightly delayed skin rash.

Consult your doctor or pharmacist before starting to take Bronquidiazina CR:

• In elderly patients, with renal insufficiency, or with HIV infection, as they may be more likely to experience severe effects.
• If you are asthmatic or have a history of asthma, have a severe respiratory disease, or have difficulty coughing.
• If you have conditions that predispose you to gastrointestinal bleeding, such as stomach or duodenal ulcers.
• If you have kidney problems (known renal insufficiency). Your doctor should take special measures. To ensure adequate renal elimination, the patient should receive adequate fluid intake and the urine pH should be maintained within normal limits, avoiding acidification or alkalization of the urine.
• If you have liver problems (severe liver parenchymal damage).
• If you have severe blood disorders, except in cases where close medical supervision is provided.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).
• If you take this medication for a long time or have folate deficiency or are elderly, your doctor may request that you undergo blood tests to perform blood counts.
• If you have a risk of hyperpotasemia (high potassium levels) and hyponatremia (low sodium levels), your doctor will consider the need to perform a potassium and sodium blood test.
• If you have phenylketonuria (a metabolic disorder affecting the phenylalanine enzyme), as trimetoprima alters phenylalanine metabolism. This is not a problem in patients with an adequate restrictive diet.
• This medication may interfere with the results of some analytical tests.

This medication should not be used to treat streptococcal pharyngitis (S. pyogenes).

During treatment with this medication, exposure to excessive sunlight or the use of sunlamps should be avoided.

Bronquidiazina CR should not be taken with antitussives (cough medications) or with medications that reduce bronchial secretions, as it may cause a buildup of fluidified mucus.

Other medications and Bronquidiazina CR

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Bronquidiazina CR may potentiate the effect and/or toxicity of some medications. It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Medications used to control irregular heartbeats (antiarrhythmic class III), such as dofetilida.

• Medications that antagonize folic acid, such as phenytoin (used to treat epilepsy) and methotrexate (used to treat various types of cancer and also to treat rheumatoid arthritis). If trimetoprima/sulfametoxazol and phenytoin are administered, the excessive effect of phenytoin should be considered. If Bronquidiazina CR is administered with methotrexate, the administration of a folate supplement should be considered.

• Diuretics (especially thiazides) used to increase urine elimination.

• Oral anticoagulants, such as warfarin. A careful control of anticoagulant treatment is recommended during the use of Bronquidiazina CR.

• Some medications used to control blood sugar or blood glucose levels: hypoglycemics or oral antidiabetics (sulfonilurea).

• Medications used to treat heart problems (digoxin).

• Medications used to treat some parasites (pirimetamina).

• Certain medications used to treat HIV: antiretrovirals (lamivudina, zidovudina). A follow-up of blood parameters should be considered.

• Medications used in transplants: immunosuppressants (ciclosporina).

• Medications that cause hyperpotasemia (elevated potassium levels).

• Medications such as procainamide, amantadina.

Taking Bronquidiazina CR with food and drinks

It is recommended to take this medication with food or a drink to minimize any possible gastrointestinal alteration (nausea or diarrhea). It is recommended to drink plenty of water while taking Bronquidiazina CR.

Pregnancy, lactation, and fertility

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

Trimetoprima, sulfametoxazol, and bromhexina cross the placenta, and their safety in pregnant women has not been established. This medication should be avoided during pregnancy.

When this medication is administered to the mother before birth, there is a theoretical risk of kernicterus (a severe neurological complication due to increased bilirubin in the blood) in the newborn. This theoretical risk is particularly important in premature infants or those with a higher risk of hyperbilirubinemia, such as those with glucose-6-phosphate dehydrogenase deficiency. Administration of this medication should be avoided in the final stages of pregnancy and in lactating mothers, especially when mothers or infants have or are at risk of developing hyperbilirubinemia.

Trimetoprima, sulfametoxazol, and bromhexina are excreted in breast milk, so this medication should be avoided during lactation.

Driving and operating machines

During treatment with this medication, dizziness may occur due to bromhexina, so if you feel dizzy, do not drive or operate machines.

Bronquidiazina CR contains sacarose, benzoate sodium, sodium, parahydroxybenzoate of methyl (E-218), parahydroxybenzoate of propyl (E-216), and ethanol.

This medication contains sacarose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 1 mg of benzoate sodium in each ml of suspension.

This medication may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl (E-218) and parahydroxybenzoate of propyl (E-216).

This medication contains 0.0014 mg of alcohol (ethanol) in each ml of dose. The amount in 1 ml of this medication is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol in this medication does not produce any perceptible effect.

This medication contains less than 23 mg of sodium (1 mmol) per 7.5 ml of suspension, which is essentially "sodium-free".

Follow exactly the medication administration instructions provided by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will prescribe the most appropriate dose and duration based on the type and severity of the infection. The standard recommended dose is:

Pneumocystis Jiroveci Pneumonia

Treatment

Adults and children (≥2 years):1.9 ml of oral suspension per kg of body weight per day in two or more divided doses, for 2 weeks.

The maximum dose of bromhexine is 6 mg in children 2-5 years, 12 mg in children 6-11 years, and 48 mg in adults. If a dose of trimetoprima/sulfametoxazol is needed that exceeds the maximum dose of bromhexine, other presentations may be necessary.

Prophylaxis

Adults and adolescents (>12 years):

The following dosing regimens may be used:

Children (≥2 years):

The following dosing regimens may be used:

• Children 2-5 years:
• • 3.8 ml, twice a day, 7 days a week,
  • 3.8 ml, twice a day, three times a week on alternate days,
  • 3.8 ml, twice a day, three times a week on consecutive days.

• Children 6-12 years:
• • 7.5 ml, twice a day, 7 days a week,
  • 7.5 ml, twice a day, three times a week on alternate days
  • 7.5 ml, twice a day, three times a week on consecutive days.

The above doses may also be administered as a single dose, three times a week on consecutive days.

The total daily dose should not exceed 320 mg of trimetoprima and 1600 mg of sulfametoxazol.

Treatment of acute infections:

Adults and children over 12 years:15 ml every 12 hours.

Children 2-5 years:3.8 ml every 12 hours.

Children 5-11 years:7.5 ml every 12 hours.

If after 7 days of treatment no clinical improvement is observed, the patient will be reevaluated.

The daily dose of bromhexine should not exceed 6 mg in children 2-6 years and 12 mg in children 6-12 years.

Special dosages

Geriatric patients:(see section 2: Warnings and precautions). If no other dosage is indicated, the standard dose will be used.

Patients with renal insufficiency

Adults and adolescents (>12 years):

Your doctor may perform blood tests every 2-3 days to measure the amount of medication in your blood.

Route and method of administration

Oral route. For proper administration of this medication, it is recommended to shake well before use.

Duration of treatment

Your doctor will indicate the duration of your treatment with Bronquidiazina CR. Do not discontinue treatment before.If you must take Bronquidiazina CR for long periods of time,your doctor may request blood tests and prescribe folic acid supplements (vitamin) during the time you take this medication.

If you take more Bronquidiazina CR than you should

The symptoms of overdose include: nausea, vomiting, dizziness, and confusion.

In acute overdose with trimetoprima, bone marrow depression has been observed.

In case of acute overdose, vomiting should be induced. Gastric lavage should be performed. Depending on the state of renal function, administration of fluids should be performed if urine elimination is low.

Both substances, trimetoprima and sulfametoxazol, are dialyzable by hemodialysis. Peritoneal dialysis is not effective.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Tel.: 91 562 04 20.

If you forgot to take Bronquidiazina CR

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

Like all medicines, Bronquidiazina CR may cause side effects, although not everyone will experience them.

Stop taking Bronquidiazina CR and contact your doctor immediately if you experience any of the following signs that may be related to an allergic reaction. The possibility of a severe allergic reaction is very rare (it may affect up to 1 in 10,000 people).

• Difficulty breathing
• Dizziness
• Swelling of the face
• Swelling of the mouth, tongue, or throat that may be painful and cause difficulty swallowing
• Chest pain
• Red patches on the skin

Contact your doctor as soon as possible if you experience any of the following adverse reactions:

• Severe skin reactions that may be life-threatening (frequency unknown: cannot be estimated from available data): purple-colored, elevated, and painful blisters on the extremities and sometimes on the face and neck, with fever (Sweet syndrome); as well as red, scaly, and blistering skin rash (acute generalized exanthematous pustulosis), (see section 2: Warnings and precautions).

• Drug hypersensitivity reactions with systemic symptoms (DRESS), which occur with a rare frequency (may affect up to 1 in 1,000 people) but may be life-threatening. In this type of reaction, you may develop symptoms similar to the flu: fever, skin rash, lymph node inflammation, and altered blood test results.

• Skin rashes that may appear with a very rare frequency (may affect up to 1 in 10,000 people) but may be life-threatening: Stevens-Johnson syndrome, toxic epidermal necrolysis (see section 2: Warnings and precautions).

In addition, the following adverse effects have been described with this medication, classified by frequency:

• Very common (may affect more than 1 in 10 people): hyperkalemia (elevated potassium levels).
• Common (may affect up to 1 in 10 people): candidiasis (overgrowth of the fungus Candida), headache, nausea, diarrhea, and skin rash.
• Rare (may affect up to 1 in 100 people): vomiting, upper abdominal pain.
• Rare (may affect up to 1 in 1,000 people): bronchospasm, exanthema, urticaria.
• Very rare (may affect up to 1 in 10,000 people): leukopenia, neutropenia, and agranulocytosis (decreased total or specific type of white blood cells), megaloblastic anemia or immune hemolytic anemia (decreased red blood cell count with or without increased cell size), aplastic anemia (bone marrow insufficiency), methemoglobinemia (inability of hemoglobin to transport oxygen), eosinophilia (abnormally high count of a specific type of white blood cell), purpura (red patches on the skin), hemolysis (rupture of red blood cells), serum disease (hypersensitivity reaction similar to an allergy), anaphylaxis (severe allergic reaction), allergic myocarditis (allergic reaction affecting the heart), angioedema (retention of fluids in the skin and mucous membranes), fever, allergic vasculitis (inflammation affecting mainly small veins), periarteritis nodosa (vascular disease), systemic lupus erythematosus (immune system disease), hypoglycemia (decreased blood glucose), hyponatremia (decreased sodium levels), anorexia (metabolic disorder), depression, hallucinations, aseptic meningitis, seizures, peripheral neuritis (nerve damage and deterioration), ataxia (loss of coordination), vertigo, tinnitus (ringing in the ears), dizziness, cough, difficulty breathing, pulmonary infiltrates, glossitis (inflammation of the tongue), stomatitis (mouth lesions), pseudomembranous colitis (inflammation of the colon), pancreatitis (inflammation of the pancreas), hepatobiliary disorders (liver function alteration), photosensitivity (skin reaction caused by interaction with light), exfoliative dermatitis (severe skin inflammation), fixed drug eruption (allergic reaction), erythema multiforme (allergic reaction affecting the skin), arthralgia (joint pain), myalgia (muscle pain), renal function impairment, uveitis (inflammation of the eye).

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

This medication 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 the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bronquidiazina CR

• The active principles are trimetroprima, sulfametoxazol, bromhexina, and fluid extract of Tolú balsam. Each 7.5 ml of suspension contains 80 mg of trimetroprima, 400 mg of sulfametoxazol, 4 mg of bromhexina hydrochloride, and 32.5 mg of fluid extract of Tolú balsam.
• The other components are: glycerin, sacarose, xanthan gum, sodium saccharin, methyl parahydroxybenzoate (E-218), sodium benzoate, propyl parahydroxybenzoate (E-216), simethicone, anise essence, ethanol (from the fluid extract of Tolú balsam), and water.

Appearance of the product and contents of the packaging

White, homogeneous oral suspension with an anise odor.

Glass bottle with a high-density polypropylene/polyethylene (PP/HDPE) cap with a child-proof closure, containing 150 ml of oral suspension and a dosing measurer.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940-Leioa (Bizkaia)

Spain

Responsible for Manufacturing

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet:June 2022