BALSOPRIM 26.6mg/mL + 5.4mg/mL + 0.5mg/mL ORAL SUSPENSION

Introduction

Leaflet: information for the patient

BALSOPRIM 26.6MG/ML+5.4MG/ML+0.5MG/ML ORAL SUSPENSION

Sulfamethoxazole / trimethoprim / bromhexine hydrochloride

Read all of this 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.
• 1. If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Balsoprim and what is it used for
2. What you need to know before you take Balsoprim
3. How to take Balsoprim
4. Possible side effects

5 Conservation of Balsoprim

1. Contents of the pack and additional information

1. What is Balsoprim and what is it used for

Balsoprim is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs called trimethoprim and sulfamethoxazole (a sulfonamide). It also contains bromhexine, a drug with mucolytic action.

Balsoprim is indicated in adults, adolescents, and children (2-11 years) for the treatment of the following infections that also require the combined action of a mucolytic:

• Acute exacerbation of chronic bronchitis in patients without risk factors.

It is also indicated when the use of normally recommended antibacterial agents is considered inappropriate for the initial treatment of this infection:

• Acute otitis media
• Acute bacterial sinusitis

2. What you need to know before you take Balsoprim.

Do not take Balsoprim

• if you are allergic to sulfamethoxazole, trimethoprim, bromhexine, or any of the other components of this medicine listed in section 6.
• In the case of children under 2 years of age.
• If you have acute porphyria (a blood disease in which hemoglobin is not produced properly).
• In combination with dofetilide (a drug used to control irregular or rapid heartbeats).
• If you are pregnant or think you may be pregnant, or if you are breastfeeding

Warnings and precautions

Consult your doctor or pharmacist before starting to take Balsoprim.

• In elderly patients, as they may be more likely to experience serious side effects.
• If you take Balsoprim 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.
• Balsoprim may interfere with the results of some laboratory tests.
• If you have phenylketonuria (a metabolic disease that affects the enzyme phenylalanine), as the administration of trimethoprim alters the metabolism of phenylalanine. This is not a problem in patients with an adequate restrictive diet.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).
• 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.
• Balsoprim should not be used to treat streptococcal pharyngitis.
• Due to the mucolytic properties of bromhexine and its ability to disrupt the digestive mucosa barrier, it should be administered with caution in patients with a history of peptic ulcer, due to the risk of bleeding.
• As a consequence of colonization with Clostridium difficile, the use of Balsoprim may lead to the development of pseudomembranous colitis, which manifests through diarrhea.
• 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 urinary pH should be maintained within normal limits, avoiding acidification of the urine.
• If you have liver problems (severe liver parenchyma damage).
• Cotrimoxazole has been administered to patients undergoing treatment with cytotoxics with little or no additional effect on the bone marrow or peripheral blood.
• At the start of treatment, the fluidification and mobilization of secretions may partially obstruct the bronchi, which will be alleviated throughout the treatment.
• If you experience an unexpected worsening of cough and shortness of breath, inform your doctor immediately.
• If you have severe blood disorders, except in cases where there is close medical supervision.

Rare cases of death have occurred due to severe reactions, including fulminant hepatic necrosis, agranulocytosis, aplastic anemia, other blood disorders, and respiratory hypersensitivity.

Severe skin rashes have been described associated with the administration of cotrimoxazole that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and acute febrile neutrophilic dermatosis or Sweet syndrome) with the initial use of Balsoprim, which appear as red, circular spots, 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 the formation of generalized blisters or skin peeling.

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

If you have developed rashes or Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute febrile neutrophilic dermatosis with the use of Balsoprim, you should not use Balsoprim again at any time. Contact a doctor and inform them about this.

If you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (acute generalized exanthematous pustulosis), go to a doctor immediately and inform them that you are taking this medicine.

Severe skin reactions have been reported associated with the administration of bromhexine. If a skin rash appears (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using Balsoprim and consult your doctor immediately.

Rare cases of hypersensitivity reactions with eosinophilia and associated systemic symptoms have been reported with the use of Balsoprim.

Respiratory toxicity

During treatment with cotrimoxazole, very rare and severe cases of respiratory toxicity have been reported, which sometimes evolve into acute respiratory distress syndrome (ARDS). The appearance of pulmonary signs such as cough, fever, and dyspnea (difficulty breathing) associated with radiological signs of pulmonary infiltrates and deterioration of pulmonary function may be preliminary signs of ARDS. In such circumstances, the administration of cotrimoxazole should be discontinued and appropriate treatment should be administered.

Lymphohistiocytosis

Very rare cases of excessive immune reactions due to unregulated activation of white blood cells that cause inflammation (lymphohistiocytosis) have been reported, which can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swelling of the lymph nodes, weakness, dizziness, shortness of breath, bruising, or skin rash, either concurrently or with a slight delay, contact your doctor immediately.

Children

-In children from 2 to 6 years old, the benefit-risk ratio should be evaluated.

Other medicines and Balsoprim

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

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

• Medicines used to control heart rhythm (class III antiarrhythmics), such as dofetilide. Elevated plasma levels of dofetilide have been reported after concomitant administration with trimethoprim. (See section 2 Do not take Balsoprim).
• Medicines used to increase urine elimination: diuretics (especially thiazides). The concomitant administration of diuretics with trimethoprim/sulfamethoxazole in elderly patients may have a greater risk of thrombocytopenia and hyponatremia.
• Oral anticoagulant medicines such as warfarin. Trimethoprim/sulfamethoxazole potentiates the anticoagulant activity of warfarin. Careful monitoring of anticoagulant treatment is advised during the use of Balsoprim.
• Certain medicines used to control blood sugar levels: oral hypoglycemics or antidiabetics (sulfonylurea).
• Medicines used to treat heart problems (digoxin). The concomitant use of trimethoprim and digoxin has shown an increase in digoxin levels in some elderly patients.
• Medicines used to treat infections caused by some parasites (pyrimethamine). The concomitant administration of trimethoprim/sulfamethoxazole with doses of pyrimethamine greater than 25 mg per week may lead to the development of megaloblastic anemia.
• Certain medicines used to treat the human immunodeficiency virus (HIV): antiretrovirals (lamivudine, zidovudine). The concomitant treatment of Balsoprim with zidovudine may increase the risk of hematological adverse reactions to trimethoprim/sulfamethoxazole; consideration should be given to monitoring blood parameters.
• Medicines that are antagonists of 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 trimethoprim/sulfamethoxazole is administered with phenytoin, the excessive effect of phenytoin should be taken into account. If Balsoprim is administered with methotrexate, consideration should be given to the administration of a folate supplement.
• Medicines used in transplants: immunosuppressants (cyclosporin). In patients treated with trimethoprim/sulfamethoxazole and cyclosporin, a reversible deterioration in renal function has been observed after kidney transplantation.
• Medicines that produce hyperkalemia (increased potassium in the blood).
• Antibiotics: The concomitant administration of bromhexine and antibiotics (such as amoxicillin, oxytetracycline, and erythromycin) increases the concentration of these antibiotics in lung tissue. However, the clinical relevance of this interaction has not been demonstrated.
• Medicines used as cough suppressants: The simultaneous administration of a cough suppressant (anticholinergics, antihistamines, etc.) causes the inhibition of the cough reflex and may cause stasis of the mucus fluidized by bromhexine.

When trimethoprim is administered with drugs such as procainamide and amantadine, there is a possibility of increased plasma concentration of one or both drugs.

Other interactions

-Antiarrhythmics and other medicines with an effect on the QT interval

-Rifampicin and Dapsone

-Phenylalanine

-Tricyclic antidepressants and other inhibitors of bronchial secretion

Taking Balsoprim with food, drinks, and alcohol

• Alcohol consumption should be avoided during treatment with Balsoprim
• Precautions should be taken in patients with diets rich in potassium.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 is greater than the potential risk to the fetus, and consideration should be given to supplementation with high doses of folate (up to 4 or 5 mg/day) if trimethoprim/sulfamethoxazole is used during pregnancy.

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

The administration of trimethoprim/sulfamethoxazole should be avoided in the final stages of pregnancy and in breastfeeding mothers, when the mothers or children have or are at particular risk of developing hyperbilirubinemia

Bromhexine crosses the placental barrier. There are insufficient preclinical studies on teratogenesis. In clinical practice, the follow-up of pregnant women exposed to bromhexine treatment is insufficient to exclude the risk entirely.

As a precautionary measure, it is preferable not to use Balsoprim during pregnancy unless the potential benefit to the mother is greater than the potential risk to the fetus, and consideration should be given to supplementation with high doses of folate (up to 4 or 5 mg/day) if cotrimoxazole is used during pregnancy.

Breastfeeding

Trimethoprim and sulfamethoxazole are excreted in breast milk.

You should not take Balsoprim during breastfeeding.

Fertility

No studies have been conducted on the effects of Balsoprim on human fertility.

Based on the available preclinical experience, at normal doses, there are no indications of possible effects on fertility due to the use of bromhexine.

Driving and using machines

During treatment with Balsoprim, dizziness may occur due to the effect of bromhexine, which should be taken into account when driving or operating hazardous machinery.

Balsoprim contains propyl hydroxybenzoate and methyl hydroxybenzoate

May cause allergic reactions (possibly delayed)

Balsoprim contains sorbitol

This medicine contains 191.10 mg of sorbitol (E-420) per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine. Sorbitol may cause gastrointestinal upset and a mild laxative effect.

Balsoprim contains sodium

This medicine contains 68.6 mg of sodium (the main component of table salt/cooking salt) per 20 ml dose (3.43 mg of sodium per ml). This is equivalent to 3.43% of the maximum recommended daily intake of sodium for an adult.

Balsoprim contains propylene glycol

This medicine contains 2.02 mg of propylene glycol per ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

3. How to take Balsoprim.

Follow the administration instructions of this medication exactly as indicated by your doctor. 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 Balsoprim. Do not suspend treatment before.

Balsoprim should be administered preferably after food intake. It is recommended to shake well before use.

If clinical improvement is not evident after 7 days of treatment, consult your doctor.

Adults

The standard dose for adults is 20 ml three times a day, which corresponds to 324 mg of trimethoprim / 1596 mg of sulfamethoxazole / 30 mg of bromhexine / 24 hours

Use in children and adolescents

Pediatric population

• Children over 12 years and adolescents: The recommended dosage for children over 12 years is 20 ml three times a day, which corresponds to 324 mg of trimethoprim / 1596 mg of sulfamethoxazole / 30 mg of bromhexine / 24 hours.
• Children from 6 to 12 years: The recommended dosage for children between 6 and 12 years is 10 ml three times a day, which corresponds to 162 mg of trimethoprim / 798 mg of sulfamethoxazole / 15 mg of bromhexine / 24 hours

• Children from 2 to 6 years: The recommended dosage for children between 2 and 6 years is 5 ml three times a day, which corresponds to 81 mg of trimethoprim / 399 mg of sulfamethoxazole / 7.5 mg of bromhexine / 24 hours.

Elderly patients

Balsoprim should be used with caution in elderly patients. If no other dosage is indicated, the standard dose will be used.

Patient with renal insufficiency

Adults and children over 12 years (no information is available for children under 12 years):

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

Patient with hepatic function disorders

Balsoprim should be used with caution in patients with hepatic function disorders.

If you take more Balsoprim than you should

The most frequent symptoms of overdose are vomiting, nausea, dizziness, and confusion.

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

If vomiting does not appear, it should be induced. Gastric lavage should be performed. Depending on the state of renal function, administration of fluids is recommended if urinary elimination is low. Both trimethoprim and sulfamethoxazole are dialyzable by hemodialysis. Peritoneal dialysis is not effective

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

If you forget to take Balsoprim

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

The adverse effects described for Balsoprim are classified by order of frequency and are as follows:

Very frequent (may affect more than 1 in 10 people)

• Hyperkalemia (high potassium level in the blood).

Frequent (may affect up to 1 in 10 people)

• Candidiasis (overgrowth of the Candida fungus)
• Headache, nausea, diarrhea
• Skin rashes

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Pain in the upper abdomen

Rare (may affect up to 1 in 1,000 people)

• Hypersensitivity reactions
• Exanthema (pinkish skin rash), urticaria
• Hypersensitivity reactions with eosinophilia (increase in a certain type of white blood cells) and systemic symptoms
• Bronchospasm (narrowing of the bronchi)

Very rare (may 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 cells)
• Thrombocytopenia (decrease in the number of platelets)
• Agranulocytosis (decrease in the number of a certain type of white blood cells)
• Megaloblastic anemia (decrease in the number of red blood cells and increase in their size), aplastic anemia (insufficiency of the bone marrow to produce 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 amount of a certain type of white blood cells)
• Purpura (red spots on the skin), hemolysis (breakdown of red blood cells) in certain susceptible patients deficient in G-6-PD
• Serum sickness (hypersensitivity reaction similar to an allergy)
• Allergic myocarditis (allergic reaction that affects the heart)
• Fever
• Vasculitis similar to Henoch-Schönlein purpura (inflammation that mainly affects small veins)
• Periarteritis nodosa (vascular disease)
• Systemic lupus erythematosus (immune system disease)
• Hypoglycemia (decrease in blood glucose)
• Decreased appetite
• Hyponatremia (decrease in sodium in the blood)
• Depression
• Hallucinations
• Aseptic meningitis
• Seizures
• Peripheral neuritis (lesion and deterioration of peripheral nerves leading to loss of sensitivity in the hands or loss of muscle strength), ataxia (loss of coordination)
• Dizziness, tinnitus (ringing in the ears)
• Uveitis (inflammation of the eye)
• 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) such as increased levels of transaminases (liver enzymes), elevated bilirubin in the blood, cholestatic jaundice (yellowing of the skin, mucous membranes, or the white part of the eyes) or liver necrosis.
• Photosensitivity (skin reaction produced by interaction with light)
• Exfoliative dermatitis (severe inflammation of the entire skin surface)
• Fixed drug eruption (allergic reaction)
• Arthralgia (joint pain), myalgia (muscle pain)
• Renal function disorder
• Tubulointerstitial nephritis (inflammation of a area of the kidney)

Rare adverse effects related to the treatment of Pneumocystis jiroveci (P. carinii) pneumonia:

• Severe hypersensitivity reactions
• Rashes
• Fever
• Neutropenia (decrease in the number of a certain type of white blood cells)
• Thrombocytopenia (decrease in the number of platelets)
• Increased liver enzymes
• Hyperkalemia (high potassium level in the blood)
• Hyponatremia (decrease in sodium in the blood)
• Rhabdomyolysis (destruction or inflammation of muscle that occurs with severe muscle pain and weakness)

Frequency not known (cannot be estimated from available data)

• Anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus
• Dizziness
• Heartburn
• Skin rashes that can be life-threatening, such as erythema multiforme (allergic reaction that affects the skin), Stevens-Johnson syndrome / toxic epidermal necrolysis (appearance of vesicles and blisters on the skin), acute generalized exanthematous pustulosis (red and scaly rash with bumps under the skin and blisters)
• Purple, elevated, and painful sores on the extremities and sometimes on the face and neck, with fever (Sweet's syndrome)

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.

Contact a doctor as soon as possible if you experience a severe skin reaction (see section 2: warnings and precautions).

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

Reporting of 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. Conservation of Balsoprim

It does not require special storage conditions.

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.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

6. Package contents and additional information

Composition of Balsoprim

• The active ingredients are sulfamethoxazole, trimethoprim, bromhexine hydrochloride
• The other excipients are

• Sodium carboxymethyl cellulose (E466)
• Microcrystalline cellulose (E460)
• Sodium hydroxide (E524)
• Methyl parahydroxybenzoate (E218)
• Propyl parahydroxybenzoate (E216)
• Citric acid monohydrate (E330)
• Polysorbate 80 (E433)
• Dimethicone (E900)
• Sorbitol 70% (E420)
• Sodium saccharin (E954)
• Banana flavor (85509H) (contains propylene glycol)
• Turmeric (E100)
• Purified water.

Appearance of the product and package contents

Balsoprim 26.6mg / mL + 5.4mg / mL + 0.5mg / mL oral suspension is presented in 150 ml glass bottles and a dosing cup.

Marketing authorization holder and manufacturer

Marketing authorization holder

DESMA Laboratory Pharmaceutical SL

Paseo de la Castellana 121, Escalera Izquierda 3ºB

28046 Madrid

Phone: +34 91 3238792

Fax: +34 91 323 21 05

Manufacturer

Pharmaceutical Laboratory SIT S.r.l.

Via Provinciale per Lecco, 78 - 22038 Tavernerio (CO) – Italy

Date of the last revision of this prospectus: July 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/-