BRONQUIDIAZINA CR SUSTAINED-RELEASE ORAL SUSPENSION

2. What you need to know before taking Bronquidiazina CR

Do not take Bronquidiazina CR

• If you are allergic to the active ingredients of this medication: trimethoprim, sulfamethoxazole, bromhexine, Tolu balsam syrup, or any of the other components of this medication (listed in section 6).
• If you are allergic to sulfonamides, medications that contain sulfonamides are antidiabetic medications of the sulfonylurea group (e.g., gliclazide, glibenclamide) or diuretics of the thiazide group (hydrochlorothiazide).
• In children under 2 years.
• If you have or think you have acute porphyria (a blood disease in which hemoglobin is not produced properly).
• If you are or think you may be pregnant or breastfeeding.
• In combination with dofetilide (a medication used to control irregular or rapid heartbeats).
• If you have advanced liver or kidney failure.

• Do not take Bronquidiazina CR if anyof the above points apply to you. If you are not sure, before starting treatment, talk to your doctor or pharmacist.

Warnings and precautions

Life-threatening skin rashes have been described (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and acute febrile neutrophilic dermatosis or Sweet's syndrome) with the use of this medication.

The period of highest risk of severe skin reactions is during the first few weeks of treatment. Initially, they appear as red spots or circular patches, often with a central blister. Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes). These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can 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 cotrimoxazole (trimethoprim/sulfamethoxazole) or bromhexine, you should not use this medication again at any time.

Stop taking Bronquidiazina CR and go immediately to a doctor, informing them of the use of this medication, if you develop red and scaly lesions with bumps under the skin and blisters, or experience any of the above symptoms.

Haemophagocytic lymphohistiocytosis

Very rare cases of excessive immune reactions have been reported due to unregulated activation of white blood cells, causing inflammation (haemophagocytic lymphohistiocytosis), which can be potentially fatal if not diagnosed and treated early.

Contact your doctor immediatelyif you experience multiple symptoms such as fever, swollen lymph nodes, weakness, dizziness, shortness of breath, unexpected worsening of cough, bruising, or skin rash with or without a slight delay.

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

• In elderly patients, with kidney failure, 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 diseases that predispose you to gastrointestinal bleeding, such as stomach or duodenal ulcers.
• If you have kidney problems (known kidney failure). Your doctor should take special measures. To ensure adequate renal elimination, the patient should receive adequate fluid intake and the urinary 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 there is close medical supervision.
• 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 if you have a folate deficiency or are an elderly patient, your doctor may request that you have blood tests to perform blood counts.
• If you are at risk of hyperkalemia (high potassium levels) and hyponatremia (low sodium levels), your doctor will consider the need to monitor potassium and sodium levels in the blood.
• If you have phenylketonuria (a metabolic disease that affects the enzyme phenylalanine), as the administration of trimethoprim alters phenylalanine metabolism. This is not a problem in patients with an adequate restrictive diet.
• This medication may interfere with the results of some laboratory tests.

This medication should not be used to treat streptococcal pharyngitis (Group A beta-hemolytic S. pyogenes).

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

Bronquidiazina CR should not be taken with antitussive medications (for cough) or those that reduce bronchial secretions, as this may cause an accumulation of fluidized mucus.

Other medications and Bronquidiazina CR

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

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

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

• Medications used to increase urine elimination: diuretics (especially thiazides).

• Oral anticoagulant medications such as warfarin. Careful monitoring of anticoagulant treatment is recommended during the use of Bronquidiazina CR.

• Certain medications used to control blood sugar levels: oral hypoglycemics or antidiabetics (sulfonylurea).

• Medications used to treat heart problems (digoxin).

• Medications used to treat infections caused by certain parasites (pyrimethamine).

• Certain medications used to treat the human immunodeficiency virus (HIV): antiretrovirals (lamivudine, zidovudine). Monitoring of blood parameters should be considered.

• Medications used in transplants: immunosuppressants (cyclosporine).

• Medications that produce hyperkalemia (increased potassium in the blood).

• Drugs such as procainamide, amantadine.

Taking Bronquidiazina CR with food and drinks

4. Possible Adverse Effects

Like all medicines, Bronquidiazina CR can produce adverse effects, although not all people suffer from them.

Severe 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 medication, as it may be a symptom of shock.

Stop taking Bronquidiazina CR and contact your doctor immediatelyif you have the following signs compatible with an allergic reaction. The possibility of having a severe allergic reaction is very rare (it can affect up to 1 in 10,000 people).

• Difficulty breathing
• Dizziness
• Facial swelling
• Swelling of the mouth, tongue, or throat that can 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 can threaten the patient's life (frequency not known: cannot be estimated from available data): purple-colored, raised, and painful blisters on the extremities and sometimes on the face and neck, with fever (Sweet's syndrome); as well as red and scaly eruptions with bumps under the skin and blisters (acute generalized exanthematous pustulosis), (see section 2: Warnings and Precautions).

• Drug hypersensitivity reactions accompanied by systemic symptoms (DRESS), which occur with a rare frequency (can affect up to 1 in 1,000 people) but can 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 eruptions that can appear with a very rare frequency (can affect up to 1 in 10,000 people) but can 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 order of frequency:

• Very frequent (can affect more than 1 in 10 people): hyperkalemia (elevated potassium level).
• Frequent (can affect up to 1 in 10 people): candidiasis (overgrowth of the Candida fungus), headache, nausea, diarrhea, and skin eruptions.
• Infrequent (can affect up to 1 in 100 people): vomiting, pain in the upper abdomen.
• Rare (can affect up to 1 in 1,000 people): bronchospasm, exanthema, urticaria.
• Very rare (can affect up to 1 in 10,000 people): leukopenia, neutropenia, and agranulocytosis (decrease in the total number or a certain type of white blood cells), megaloblastic or immune hemolytic anemia (decrease in the number of red blood cells with or without an increase in their size), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), methemoglobinemia (inability of hemoglobin to transport oxygen), eosinophilia (abnormally high amount of a certain type of white blood cells), purpura (red spots on the skin), hemolysis (breakdown of red blood cells), serum sickness (hypersensitivity reaction similar to an allergy), anaphylaxis (severe allergic reaction), allergic myocarditis (allergic reaction that affects the heart), angioedema (fluid retention in the skin and mucous membranes), fever, allergic vasculitis (inflammation that affects mainly small veins), polyarteritis nodosa (vascular disease), systemic lupus erythematosus (immune system disease), hypoglycemia (decrease in blood glucose), hyponatremia (decrease in sodium in the blood), anorexia (metabolic disorder), depression, hallucinations, aseptic meningitis, convulsions, peripheral neuritis (lesion and deterioration of peripheral nerves), ataxia (loss of coordination), vertigo, tinnitus (ringing in the ears), dizziness, cough, difficulty breathing, pulmonary infiltrates, glossitis (inflammation of the tongue), stomatitis (lesions in the mouth), pseudomembranous colitis (inflammation of the colon), pancreatitis (inflammation of the pancreas), hepatobiliary disorders (alteration of liver function), photosensitivity (skin reaction produced by interaction with light), exfoliative dermatitis (severe inflammation of the entire skin surface), fixed drug eruption (allergic reaction), erythema multiforme (allergic reaction that affects the skin), arthralgia (joint pain), myalgia (muscle pain), alteration of renal function, uveitis (inflammation of the eye).

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

Reporting Adverse Effects

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

5. Storage of Bronquidiazina CR

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Bronquidiazina CR

• The active ingredients are trimethoprim, sulfamethoxazole, bromhexine, and fluid extract of Tolu balsam. 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 Tolu balsam.
• The other components are: glycerin, sucrose, xanthan gum, sodium saccharin, methyl parahydroxybenzoate (E-218), sodium benzoate, propyl parahydroxybenzoate (E-216), simethicone, anise essence, ethanol (derived from the fluid extract of Tolu balsam), and water.

Appearance of the Product and Package Contents

White, homogeneous oral suspension with an aniseed flavor.

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

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Bizkaia Science and Technology Park

Ibaizabal Bidea, Building 901

48160 Derio (Bizkaia)

Spain

Date of the Last Revision of this Prospectus:July 2025