Label: information for the user

Broncovir oral suspension

Trimetoprim, Sulfametoxazol, potassium sulfoguaiacolate

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, 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 label. See section 4.

Broncovir belongs to a group of medications called antibiotics that eliminate the bacteria that cause infections associated with a medication called mucolytics that act by reducing the viscosity of mucous secretions, liquefying them and facilitating their elimination. It contains three different drugs called trimetoprima, sulfametoxazol (antibiotics) and sulfoguayacolato potásico (mucolytic).

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

• Recurrent Pulmonary Infections in patients with chronic bronchitis
• Treatment of Pneumocystis jiroveci (P.carinii) pneumonia.

Broncovir may also be useful for other infections: middle ear infections and acute bacterial sinusitis.

Do not take Broncovir:

• If you are allergic to sulfonamides, trimethoprim, co-trimoxazole, or any of the other components of this medication (listed in section 6).
• If you have or think you have acute porphyria (a blood disorder in which hemoglobin is not produced properly).
• Do not administer to children under 2 years old.
• If you are pregnant.

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 severe side effects.
• If you have kidney problems (known renal insufficiency). Your doctor will need to take special measures. To ensure adequate renal elimination, ensure the patient receives adequate fluid intake and that the urine pH is maintained within normal limits, avoiding urine acidification.
• If you have liver problems.
• 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 Broncovir for a long time or have a folate deficiency or are an elderly patient, your doctor may request that you undergo blood tests to perform blood counts.
• If you have a risk of hyperkalemia (high potassium levels) or 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 disorder that affects the enzyme phenylalanine), as the administration of trimethoprim alters the metabolism of phenylalanine. This does not pose a problem in patients with an adequate restrictive diet.
• Broncovir may interfere with the results of some laboratory tests.
• If you experience an unexpected worsening of cough and shortness of breath, inform your doctor immediately.

Rare cases of death have been reported due to severe reactions, including fulminant hepatic necrosis (severe liver damage), agranulocytosis (decrease in a certain type of white blood cells), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), other blood disorders, and hypersensitivity of the respiratory system.

Severe skin eruptions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of Broncovir, initially appearing as red circular spots or patches, often with a central blister.

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

These life-threatening skin eruptions often accompany flu-like symptoms. The rash may progress to generalized blistering or skin peeling.

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

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Broncovir, do not use Broncovir again at any time.

If you develop rashes or these skin symptoms, stop taking Broncovir, immediately see a doctor, and inform them that you are taking this medication.

Lymphohistiocytosis hemophagocytosis:

Rare 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. If you experience multiple symptoms such as fever, swelling of lymph nodes, feeling weak, dizziness, shortness of breath, bruises, or skin rash with or without a slight delay, contact your doctor immediately.

Taking Broncovir oral suspension with food and drinks:

Broncovir can be taken with or without food.

To ensure adequate renal elimination, ensure the patient receives adequate fluid intake and that the urine 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 medication.

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

When Broncovir is administered to the mother before birth, there may be 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 children at higher risk of hyperbilirubinemia, such as premature infants or those with glucose-6-phosphate dehydrogenase deficiency.

Administration of trimethoprim/sulfamethoxazole should be avoided in the final stages of pregnancy and in lactating mothers, when mothers or infants have, or are at particular risk of developing hyperbilirubinemia, are premature, or have glucose-6-phosphate dehydrogenase deficiency (G-6-PD).

The medication is excreted in breast milk.

Driving and operating machines:

The influence of Broncovir on the ability to drive and operate machines is negligible or insignificant.

However, if you experience any symptoms, do not drive or operate machines until you know how you tolerate the medication.

Broncovir oral suspension contains saccharose:

This medication contains 3g of saccharose per 7.5ml, which should be taken into account in patients with hereditary intolerance to fructose, problems with glucose/galactose absorption, saccharose-isomaltose deficiency, and diabetic patients.

This medication may produce severe allergic reactions and bronchospasm (sudden feeling of choking) due to the presence of ammonium sulfite.

Use of other medications:

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Broncovir may potentiate the effect and/or toxicity of some medications. It is essential to inform your doctor if you are taking or have recently taken any of the following medications:

• Diuretics (especially thiazides) used to increase urine elimination: The concomitant administration of diuretics with trimethoprim/sulfamethoxazole in elderly patients may have a higher risk of thrombocytopenia (decrease in platelet count) and hyponatremia (low sodium levels).
• Antifolic 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 is administered and phenytoin is administered, the effect of phenytoin should be considered. If Broncovir is administered with methotrexate, consider administering folate supplementation.
• Medications to treat diabetes or to make blood thinner (anticoagulants). If you notice a variation in response to usual doses of anticoagulant or antidiabetic, your doctor will adjust the dose during the period of concomitant administration with Broncovir.

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Broncovir. Do not discontinue treatment before.

Pneumonia caused by Pneumocystis jiroveci (P. carinii)

Adults, adolescents, and children:

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

The daily dose administered on a treatment day approximates 150 mg of trimethoprim/day and 750 mg of sulfamethoxazole/day. The total daily dose should 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 of trimethoprim/800 mg of sulfamethoxazole/12 hours)

• Children (2-11 years):

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

Special populations

Older patients:

The available data do not indicate that the dose should be adjusted in this population, therefore the standard dose will be used.

Patients with renal insufficiency:

Adults and adolescents (12 to 18 years)

It is recommended to perform plasma sulfamethoxazole concentration measurements at intervals of 2-3 days in samples obtained 12 hours after administration of Broncovir. If the total sulfamethoxazole concentration exceeds 150 micrograms/ml, treatment should be interrupted until the value is below 120 micrograms/ml.

No information is available for children under 12 years.

If you take more Broncovir than you should:

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

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

In case of vomiting does not appear, it should be induced. Gastric lavage should be performed. Depending on renal function, the administration of fluids is recommended if urine elimination is low.

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

If you forgot to take Broncovir:

Do not take a double dose to compensate for the missed doses, wait for the next dose and continue taking Broncovir as usual.

Like all medicines, Broncovir can cause side effects, although not everyone will experience them.

The side effects described for Broncovir oral suspension are classified by order of frequency and include gastrointestinal disorders (nausea, vomiting, anorexia) and dermatological disorders (rash or urticaria). Very rarely, with a risk to life, are the reactions associated with cotrimoxazole (association of sulfamethoxazole and trimethoprim), including severe dermatological reactions, discrasia, and hepatotoxic reactions.

The side effects described for Broncovir oral suspension are classified by order of frequency and are as follows:

• Very common (can affect more than 1 in 10 people): hyperkalemia (elevated potassium level).

• Common (can affect up to 1 in 10 people): candidiasis (overgrowth of a fungus called Candida), headache, nausea, diarrhea, and skin rash.

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

• Very rare (can affect up to 1 in 10,000 people): leukopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of a certain type of white blood cell), thrombocytopenia (decrease in the number of platelets), agranulocytosis (decrease in the number of a certain type of white blood cell), megaloblastic anemia (decrease in the number of red blood cells and increase in their size), aplastic anemia (insufficiency of the bone marrow to produce the different types of cells), hemolytic anemia (characterized by an insufficient number of red blood cells), methemoglobinemia (inability of hemoglobin to transport oxygen), eosinophilia (abnormally high number of a certain type of white blood cell), purpura (red spots on the skin), hemolysis (rupture of red blood cells) in certain susceptible patients deficient in G-6-PD.

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 similar to Schoenlein-Henoch purpura (inflammation affecting mainly small veins), periarteritis nodosa (inflammation of blood vessels), systemic lupus erythematosus (immune system disease).

Hypoglycemia (decrease in blood glucose), hyponatremia (decrease in sodium in the blood), anorexia (loss of appetite). Depression, hallucinations, aseptic meningitis, convulsions, peripheral neuritis (nerve damage and deterioration), ataxia (loss of coordination), vertigo, tinnitus (buzzing in the ear), dizziness, inflammation of a part of the eye (uveitis), 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 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 alteration, uveitis (inflammation of the eye). Skin eruptions that can threaten the patient's life may appear (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

• Very rare side effects (can affect up to 1 in 10,000 people) related to the treatment of Pneumocystis jiroveci pneumonia (P.carinii): severe hypersensitivity reactions, rashes, fever, neutropenia (decrease in the number of a certain type of white blood cell), thrombocytopenia (decrease in the number of platelets), increased liver enzymes, hyperkalemia (elevated potassium level), hyponatremia (decrease in sodium in the blood), and rhabdomyolysis (muscle destruction or inflammation that is accompanied by severe muscle pain and weakness).

• Unknown frequency: purple-colored, elevated, and painful lesions on the extremities and sometimes on the face and neck, with fever (Sweet syndrome)

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the box, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Composition of Broncovir

The active principles are sulfamethoxazole, trimethoprim, and potassium sulfoguaiacolate. Each spoonful contains 5 ml of the mixture.

Each 5 ml contains:

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

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

Appearance of the product and contents of the packaging:

Broncovir is presented in a white-yellowish oral suspension with a raspberry odor and taste.

Each package contains 150 ml.

Holder of the marketing authorization and responsible for manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

Date of the last review of this leaflet: July 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es