Bronquidiazina cr oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bronquidiazina CR oral suspension

(trimethoprim/sulfamethoxazole/bromhexine hydrochloride/fluid extract of Balsamum Tolui)

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 must not be given to other people, even if they have the same symptoms as you, because it may 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 Bronquidiazina CR is and what it is used for
2. What you need to know before taking Bronquidiazina CR
3. How to take Bronquidiazina CR
4. Possible adverse effects
5. How to store Bronquidiazina CR
6. Contents of the pack and other information

1. What Bronquidiazina CR is and what it is used for

Bronquidiazina CR contains four different active substances. Two of them (trimethoprim/sulfamethoxazole) belong to a group of medicines called antibiotics that eliminate bacteria causing infections. These two antibiotics are combined with bromhexine and Tolú balsam syrup, which have 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 of age, adolescents, and adults, for the oral treatment of infections caused by microorganisms sensitive to the trimethoprim/sulfamethoxazole combination, such as: acute bronchitis and acute exacerbations of chronic bronchitis, pneumonias, middle ear infections, and sinusitis.

Official recommendations regarding the appropriate use of antibacterial agents should be taken into account.

2. What you need to know before starting Bronquidiazina CR

Do not take Bronquidiazina CR

• If you are allergic to the active substances in this medicine: trimethoprim, sulfamethoxazole, bromhexine, Tolu balsam syrup, or to any of the other components of this medicine (listed in section 6).

• If you are allergic to sulfonamides; medicines containing sulfonamides include antidiabetic sulfonylureas (e.g., gliclazide, glyburide) or diuretics of the thiazide group (hydrochlorothiazide).

• In children under 2 years of age.

• If you have or suspect you have acute porphyria (a blood disorder in which hemoglobin is not properly produced).

• If you are or think you may be pregnant or breastfeeding.

• In combination with dofetilide (a drug used to control irregular or rapid heartbeats).

• If you have advanced hepatic or renal failure.

• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking trimethoprim.

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

Warnings and precautions

Severe, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and acute febrile neutrophilic dermatosis or Sweet’s syndrome) have been reported with the use of this medicine.

The highest risk of serious skin reactions occurs during the first weeks of treatment. These reactions typically begin as red spots or circular lesions, often with a central blister. Additional symptoms may include mouth sores, sore throat, nasal ulcers, genital lesions, and conjunctivitis (swollen, red eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

If you have previously experienced Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute febrile neutrophilic dermatosis with cotrimoxazole (trimethoprim/sulfamethoxazole) or bromhexine, you must never use this medicine again.

Stop taking Bronquidiazina CR and seek immediate medical attention, informing the doctor that you have taken this medicine, if you develop red, scaly skin lesions with lumps under the skin and blisters, or experience any of the symptoms listed above.

Hemophagocytic lymphohistiocytosis

Very rare cases of excessive immune reactions due to uncontrolled activation of white blood cells leading to inflammation (hemophagocytic lymphohistiocytosis) have been reported. These reactions can be potentially fatal if not diagnosed and treated early.

Contact your doctor immediately if you experience multiple symptoms such as fever, swollen lymph nodes, weakness, dizziness, shortness of breath, unexpected worsening of cough, and/or concurrent or slightly delayed bruising or skin rash.

Consult your doctor or pharmacist before starting Bronquidiazina CR:

• In elderly patients, those with renal impairment, or those with HIV infection, as they may be more likely to experience severe side effects.
• If you have asthma or a history of asthma, suffer from a serious respiratory disease, or have difficulty coughing.
• If you have conditions predisposing you to gastrointestinal bleeding, such as gastric or duodenal ulcer.
• If you have kidney problems (known renal insufficiency). Your doctor should take special precautions. To ensure adequate renal elimination, ensure adequate fluid intake and maintain urinary pH within normal limits, avoiding urine acidification or alkalization.
• If you have liver problems (severe hepatic parenchymal damage).
• If you have severe blood disorders, except under close medical supervision.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).
• If you take this medicine for a prolonged period, have folate deficiency, or are elderly, your doctor may request blood tests to monitor blood counts.
• If you are at risk of hyperkalemia (high potassium levels) or hyponatremia (low sodium levels), your doctor may consider monitoring blood potassium and sodium levels.
• If you have phenylketonuria (a metabolic disorder affecting the phenylalanine enzyme), as trimethoprim administration alters phenylalanine metabolism. This is not a concern if you follow an appropriate restrictive diet.
• This medicine may interfere with the results of certain laboratory tests.

This medicine should not be used to treat pharyngitis caused by β-hemolytic Streptococcus Group A (S. pyogenes).

During treatment with this medicine, avoid excessive exposure to sunlight or use of sunlamps.

Bronquidiazina CR should not be taken together with antitussive (cough-suppressant) medicines or those that reduce bronchial secretions, as this may lead to accumulation of liquefied mucus.

Severe skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with trimethoprim therapy. Discontinue Bronquidiazina CR and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Other medicines and Bronquidiazina CR

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Bronquidiazina CR may enhance the effect and/or toxicity of certain drugs. It is important to inform your doctor if you are taking or have recently taken any of the following:

• Medicines used to control heart rhythm (class III antiarrhythmics), such as dofetilide.

• Folic acid antagonists, such as phenytoin (used in epilepsy treatment) and methotrexate (used to treat certain cancers and rheumatoid arthritis). If trimethoprim/sulfamethoxazole and phenytoin are administered together, excessive phenytoin effects should be monitored. If Bronquidiazina CR is used with methotrexate, folic acid supplementation should be considered.

• Medicines used to increase urine output: diuretics (especially thiazides).

• Oral anticoagulants such as warfarin. Close monitoring of anticoagulant therapy is advised during treatment with Bronquidiazina CR.

• Certain medicines used to control blood glucose: oral hypoglycemics or antidiabetics (sulfonylureas).

• Medicines used to treat heart conditions (digoxin).

• Medicines used to treat certain parasitic infections (pyrimethamine).

• Certain antiretroviral medicines used to treat human immunodeficiency virus (HIV): (lamivudine, zidovudine). Blood parameter monitoring should be considered.

• Immunosuppressants used in transplant patients (cyclosporine).

• Medicines that may cause hyperkalemia (increased blood potassium).

• Drugs such as procainamide, amantadine.

Taking Bronquidiazina CR with food and drink

It is recommended to take this medicine with food or drink to minimize possible gastrointestinal disturbances (nausea or diarrhea). It is also recommended to drink plenty of water while taking Bronquidiazina CR.

Pregnancy, breastfeeding, and fertility

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.

Trimethoprim, sulfamethoxazole, and bromhexine cross the placenta, and their safety in pregnant women has not been established. This medicine should be avoided during pregnancy.

Trimethoprim should not be taken during the first three months of pregnancy. Treatment with trimethoprim during the first trimester may increase the risk of spontaneous abortion. Children born to mothers treated with trimethoprim during the first trimester may have an increased risk of congenital malformations, particularly neural tube defects (where the spine and spinal cord do not form properly), oral clefts (where the lip and palate do not form correctly), and heart defects.

When administered to the mother before delivery, there is a theoretical risk of kernicterus (a serious neurological complication due to elevated blood bilirubin) in the newborn. This theoretical risk is particularly relevant in infants at higher risk of hyperbilirubinemia, such as preterm infants or those with glucose-6-phosphate dehydrogenase deficiency. Administration of this medicine should be avoided in late pregnancy and in breastfeeding mothers when either the mother or infant has or is at particular risk of developing hyperbilirubinemia.

Trimethoprim, sulfamethoxazole, and bromhexine are excreted in breast milk; therefore, this medicine should be avoided during breastfeeding.

Driving and using machines

During treatment with this medicine, dizziness may occur due to bromhexine. If you feel dizzy, do not drive or operate machinery.

Bronquidiazina CR contains sucrose, sodium benzoate, sodium, methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), and ethanol.

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 1 mg of sodium benzoate per ml of suspension.

This medicine may cause allergic reactions (possibly delayed) as it contains methylparahydroxybenzoate (E-218) and propylparahydroxybenzoate (E-216).

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

The small amount of alcohol in this medicine does not produce any noticeable effect.

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

3. How to take Bronquidiazina CR

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Treatment of acute infections:

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

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

Children 6–11 years: 7.5 ml every 12 hours.

If there is no clinical improvement after 7 days of treatment, the patient should be reassessed.

The total daily dose must not exceed 320 mg of trimethoprim and 1600 mg of sulfamethoxazole.

The total daily dose of bromhexine must not exceed 6 mg per day in children aged 2–5 years, 12 mg per day in children aged 6–11 years, and 48 mg per day in adults and adolescents aged 12 years and older.

Special dosage recommendations

Elderly patients: (see section 2: Warnings and precautions). If not otherwise indicated, the standard dose should be used.

Patients with renal impairment

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 use. For proper administration of this medicine, it is recommended to shake well before use.

Duration of treatment

Your doctor will determine how long you should take Bronquidiazina CR. Do not stop treatment prematurely. If you need to take Bronquidiazina CR for long periods of time, your doctor may request blood tests and prescribe folic acid supplements (vitamin) during the time you are taking this medicine.

If you take more Bronquidiazina CR than you should

Symptoms of overdose include: nausea, vomiting, dizziness, and confusion.

In acute trimethoprim overdose, bone marrow depression has been observed.

If vomiting does not occur, it should be induced. Gastric lavage should be performed. Depending on renal function status, administration of fluids is recommended if urinary elimination is low.

Both substances, trimethoprim and sulfamethoxazole, are dialyzable by hemodialysis. Peritoneal dialysis is not effective.

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

If you forget to take Bronquidiazina CR

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

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

Serious adverse effects

Call emergency services immediately if you experience multiple symptoms such as fever, very low blood pressure, or increased heart rate after taking this medicine, as these may be symptoms of shock.

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

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

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

• Severe skin reactions that may be life-threatening (frequency not known: cannot be estimated from available data): painful, raised plum-colored lesions on the limbs, sometimes also on the face and neck, accompanied by fever (Sweet's syndrome); as well as red, scaly rashes with bumps under the skin and blisters (acute generalized exanthematous pustulosis) (see section 2: Warnings and precautions).

• Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Drug hypersensitivity reactions accompanied by systemic symptoms (DRESS), which occur rarely (may affect up to 1 in 1,000 people) but may be life-threatening. In this type of reaction, you may develop flu-like symptoms: fever, rash, swollen lymph nodes, and abnormal blood test results.

• Skin rashes that may occur very rarely (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 reported with this medicine, classified by frequency:

• Very common (may affect more than 1 in 10 people): hyperkalaemia (elevated potassium levels).
• Common (may affect up to 1 in 10 people): candidiasis (overgrowth of Candida fungus), headache, nausea, diarrhoea, and skin rashes.
• Uncommon (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): leucopenia, neutropenia, and agranulocytosis (decrease in total white blood cells or certain types of white blood cells); megaloblastic anaemia or immune haemolytic anaemia (decrease in red blood cells with or without increased cell size); aplastic anaemia (bone marrow failure to produce various types of blood cells); methaemoglobinaemia (inability of haemoglobin to carry oxygen); eosinophilia (abnormally high levels of a certain type of white blood cells); purpura (reddish spots on the skin); haemolysis (breakdown of red blood cells); serum sickness (hypersensitivity reaction similar to an allergy); anaphylaxis (severe allergic reaction); allergic myocarditis (allergic reaction affecting the heart); angioedema (fluid retention in skin and mucous membranes); fever; allergic vasculitis (inflammation mainly affecting small veins); nodular periarteritis (a vascular disease); systemic lupus erythematosus (an immune-type disease); hypoglycaemia (low blood glucose); hyponatraemia (low blood sodium); anorexia (metabolic disorder); depression; hallucinations; aseptic meningitis; seizures; peripheral neuritis (damage and deterioration of peripheral nerves); ataxia (loss of coordination); dizziness; 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 abnormalities); photosensitivity (skin reaction caused by interaction with light); exfoliative dermatitis (severe inflammation of the entire skin surface); fixed drug eruption (allergic reaction); erythema multiforme (allergic reaction affecting the skin); arthralgia (joint pain); myalgia (muscle pain); renal function impairment; uveitis (eye inflammation).

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bronquidiazina CR

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 refers to 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 properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bronquidiazina CR

• The active substances are trimethoprim, sulfamethoxazole, bromhexine, and fluid extract of balsam of Peru. Each 7.5 ml of suspension contains 80 mg of trimethoprim, 400 mg of sulfamethoxazole, 4 mg of bromhexine hydrochloride, and 32.5 mg of fluid extract of balsam of Peru.
• The other components are: glycerol, sucrose, xanthan gum, sodium saccharin, methyl 4-hydroxybenzoate (E-218), sodium benzoate, propyl 4-hydroxybenzoate (E-216), simethicone, anise flavor, ethanol (derived from the fluid extract of balsam of Peru), and water.

Nature of the product and pack contents

White, homogeneous oral suspension with anise scent.

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

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the most recent review of this leaflet: July 2025