Broncovir oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Broncovir oral suspension

Trimethoprim, Sulfamethoxazole, potassium sulfoguaiacolate

Read this 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, consult 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 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 Broncovir is and what it is used for
2. What you need to know before taking Broncovir
3. How to take Broncovir
4. Possible adverse effects
5. How to store Broncovir
6. Contents of the pack and other information

1. What Broncovir is and what it is used for

Broncovir belongs to a group of medicines called antibiotics that eliminate bacteria causing infections, combined with a type of medicine known as a mucolytic, which acts by reducing the viscosity of mucus secretions, liquefying them and facilitating their elimination. It contains three different active substances: trimethoprim, sulfamethoxazole (antibiotics), and potassium guaiacolsulfonate (mucolytic).

Broncovir is indicated in adults, adolescents, and children (2–11 years of age) for the treatment of the following infections:

• Acute exacerbation of pulmonary infections in patients with chronic bronchitis
• Treatment of Pneumocystis jirovecii (P. carinii) pneumonia.

Broncovir may also be useful for other infections: acute bacterial otitis media and acute bacterial sinusitis.

2. What you need to know before taking Broncovir oral suspension

Do not take Broncovir:

• If you are allergic to sulfonamides, trimethoprim, cotrimoxazole, or any of the other ingredients of this medicine (listed in section 6).
• If you have or think you have acute porphyria (a blood disorder in which hemoglobin is not properly produced).
• Do not administer to children under 2 years of age.
• If you are pregnant.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking trimethoprim.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Broncovir oral suspension.

• In elderly patients, as they may be more likely to experience serious side effects.
• If you have kidney problems (known renal insufficiency). Your doctor will need to take special precautions. To ensure adequate renal elimination, it is important that the patient receives an adequate fluid intake and that urinary pH is maintained within normal limits, avoiding urine acidification.
• If you have liver problems.
• If you have severe blood disorders, except when under close medical supervision.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).
• If you take Broncovir for a long time, or if you have folate deficiency, or if you 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 will consider the need for monitoring blood potassium and sodium levels.
• If you have phenylketonuria (a metabolic disorder affecting the enzyme phenylalanine), as trimethoprim administration alters phenylalanine metabolism. This is not a problem in patients on an appropriate restricted diet.
• Broncovir may interfere with the results of certain laboratory tests.
• If you experience unexpected worsening of cough or shortness of breath, inform your doctor immediately.

Rare cases of death due to severe reactions, including fulminant hepatic necrosis (severe liver damage), agranulocytosis (reduction in the number of certain white blood cells), aplastic anemia (bone marrow failure to produce various types of blood cells), other blood disorders, and respiratory hypersensitivity have been reported.

Severe, potentially life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of Broncovir. These initially appear as red spots or circular patches, often with a central blister.

Additional signs that may occur include mouth sores, throat, nose, genital ulcers, and conjunctivitis (swollen, red eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

The period of highest risk for severe skin reactions is during the first weeks of treatment.

If you have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis with Broncovir, you must never use Broncovir again.

If you develop skin rashes or these symptoms, stop taking Broncovir immediately, seek medical attention, and inform your doctor that you are taking this medicine.

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 trimethoprim and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Hemophagocytic lymphohistiocytosis

Very rare cases of excessive immune reactions due to unregulated activation of white blood cells causing inflammation (hemophagocytic lymphohistiocytosis) have been reported. These reactions can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen lymph nodes, weakness, dizziness, shortness of breath, bruising, or concurrent or slightly delayed skin rash, contact your doctor immediately.

Taking Broncovir oral suspension with food and drink:

Broncovir may be taken with or without food.

To ensure adequate renal elimination, it is important that the patient receives adequate fluid intake and that urinary pH is maintained within normal limits, avoiding urine acidification.

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 and sulfamethoxazole cross the placenta, and their safety in pregnant women has not been established. Trimethoprim/sulfamethoxazole should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. Folate supplementation may be considered if trimethoprim/sulfamethoxazole is used during pregnancy.

When Broncovir is administered to the mother before delivery, there may be a theoretical risk of kernicterus (a serious neurological complication due to elevated blood bilirubin) in the newborn. This theoretical risk is particularly important in infants at higher risk of hyperbilirubinemia, such as premature infants or those with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

The administration of trimethoprim/sulfamethoxazole should be avoided in the late stages of pregnancy and in breastfeeding mothers when either the mother or infant has, or is at particular risk of developing, hyperbilirubinemia, is premature, or has glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

This medicine is excreted in breast milk.

Driving and using machines:

The effect of Broncovir on the ability to drive and use machines is negligible or none.

However, if you experience any symptoms, do not drive or operate machinery until you know how you react to the medicine.

Broncovir oral suspension contains sucrose

This medicine contains 3 g of sucrose per 7.5 ml, which should be considered in patients with hereditary fructose intolerance, glucose/galactose malabsorption, saccharase-isomaltase deficiency, or diabetes.

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains ammonium sulfite.

Use of other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Broncovir may enhance the effect and/or toxicity of certain medicines. It is important to inform your doctor if you are taking or have recently taken any of the following medicines:

• Medicines used to increase urine output: diuretics (especially thiazides). The concomitant use of diuretics with trimethoprim/sulfamethoxazole in elderly patients may carry a higher risk of thrombocytopenia (low platelet count) and hyponatremia (low sodium levels).
• Folic acid antagonists such as phenytoin (used in the treatment of epilepsy) and methotrexate (used to treat various types of cancer and also rheumatoid arthritis). When trimethoprim/sulfamethoxazole is administered with phenytoin, the excessive effect of phenytoin should be considered. If Broncovir is administered with methotrexate, folate supplementation should be considered.
• Medicines for treating diabetes or for thinning the blood (anticoagulants). If changes in response to usual doses of anticoagulants or antidiabetic medicines are observed, your doctor will adjust the dose during concomitant treatment with Broncovir.

3. How to take Broncovir

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

Remember to take your medicine.

Your doctor will determine the duration of your treatment with Broncovir. Do not stop the treatment early.

Pneumocystis jiroveci (P. carinii) pneumonia

Adults, adolescents and children:

20 mg of trimethoprim and 100 mg of sulfamethoxazole/kg/day in two or more divided doses over two weeks.

The daily dose administered per treatment day is approximately 150 mg of trimethoprim/day and 750 mg of sulfamethoxazole/day. The total daily dose must not exceed 320 mg of trimethoprim and 1600 mg of sulfamethoxazole (30 ml).

Acute exacerbations of chronic bronchitis in patients without risk factors, acute otitis media, and acute bacterial sinusitis:

• Adults and adolescents (12 to 18 years):

15 ml of Broncovir oral suspension every 12 hours (160 mg trimethoprim / 800 mg sulfamethoxazole / 12 hours)

• Children (2–11 years):

3.75 ml of Broncovir oral suspension every 12 hours (40 mg trimethoprim / 200 mg sulfamethoxazole / 12 hours)

Special populations

Elderly patients:

Available data do not indicate that dose adjustment is required in this population; therefore, the standard dose should be used.

Patients with renal impairment:

Adults and adolescents (12 to 18 years)

Plasma sulfamethoxazole concentrations should be measured every 2 to 3 days using samples obtained 12 hours after administration of Broncovir. If total sulfamethoxazole concentration exceeds 150 micrograms/ml, treatment should be discontinued until levels fall below 120 micrograms/ml.

There is no information available for children under 12 years of age.

If you take more Broncovir than you should:

Symptoms of overdose include vomiting, visual and mental disturbances, yellow discoloration of the skin (jaundice), and skin lesions (purpura and petechiae).

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

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Broncovir:

Do not take a double dose to make up for missed doses. Wait until the next scheduled dose and continue taking Broncovir as usual.

4. Possible adverse effects

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

The adverse effects described for Broncovir oral suspension are classified in order of frequency and include gastrointestinal disorders (nausea, vomiting, anorexia) and dermatological disorders (rash or urticaria). Very rare, life-threatening reactions are those associated with cotrimoxazole (a combination of sulfamethoxazole and trimethoprim), including severe skin reactions, blood dyscrasias, and hepatotoxic reactions.

The adverse effects described for Broncovir oral suspension, classified by frequency, are as follows:

• 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 a fungus called Candida), headache, nausea, diarrhoea, and skin rashes.

• Uncommon (may affect up to 1 in 100 people): vomiting.

• Very rare (may affect up to 1 in 10,000 people): leucopenia (reduced number of white blood cells), neutropenia (reduced number of a certain type of white blood cells), thrombocytopenia (reduced number of platelets), agranulocytosis (reduced number of a certain type of white blood cells), megaloblastic anaemia (reduced number and increased size of red blood cells), aplastic anaemia (bone marrow failure to produce various blood cells), haemolytic anaemia (characterized by insufficient number of red blood cells), methaemoglobinaemia (impaired ability of haemoglobin to carry oxygen), eosinophilia (abnormally high number of a certain type of white blood cells), purpura (reddish skin spots), haemolysis (breakdown of red blood cells) in certain susceptible patients with G-6-PD deficiency.

Serum sickness (hypersensitivity reaction similar to allergy), anaphylaxis (severe allergic reaction), allergic myocarditis (allergic reaction affecting the heart), angioedema (fluid retention in skin and mucous membranes), fever, allergic vasculitis resembling Henoch-Schönlein purpura (inflammation mainly affecting small blood vessels), polyarteritis nodosa (inflammation of blood vessels), systemic lupus erythematosus (immune-mediated disease).

Hypoglycaemia (reduced blood glucose), hyponatraemia (reduced sodium levels), anorexia (loss of appetite). Depression, hallucinations, aseptic meningitis, seizures, peripheral neuritis (nerve damage and deterioration), ataxia (loss of coordination), dizziness, tinnitus (ringing in the ears), vertigo, inflammation of part of the eye (uveitis), 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 due to 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 (inflammation of the eye). Skin eruptions may occur that could be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

• Very rare adverse effects (may affect up to 1 in 10,000 people) related to treatment of Pneumocystis jiroveci (P. carinii) pneumonia: severe hypersensitivity reactions, rashes, fever, neutropenia (reduced number of a certain type of white blood cells), thrombocytopenia (reduced number of platelets), increased liver enzymes, hyperkalaemia (elevated potassium levels), hyponatraemia (reduced sodium levels), and rhabdomyolysis (muscle breakdown or inflammation causing severe muscle pain and weakness).

• Frequency not known: painful, raised plum-coloured sores on limbs, and sometimes face and neck, accompanied by fever (Sweet’s syndrome); generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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 signs of shock.

Reporting of adverse effects

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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Broncovir

The active substances are sulfamethoxazole, trimethoprim and potassium guaiacolsulfonate. Each teaspoon contains 5 ml of the mixture.

Each 5 ml contains:

Trimethoprim, 53.2 mg; sulfamethoxazole, 266.6 mg; and potassium guaiacolsulfonate, 83.4 mg.

The other components (excipients) are: sodium saccharin, sucrose, microcrystalline cellulose, raspberry flavour (contains ammonium sulfite), sodium benzoate, water.

Appearance of the medicinal product and contents of the pack:

Broncovir is an oral suspension, white-yellowish in colour, with raspberry odour and taste.

Each container contains 150 ml.

Marketing Authorization Holder and Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70, Polígono Industrial Urtinsa II - 28923 ALCORCÓN (Madrid)

Date of the most recent revision of this leaflet: January 2026

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.es