Prospecto:information for the patient

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

Sulfamethoxazole / trimethoprim / bromhexine hydrochloride

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

• Keep this prospectus, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor,pharmacistor nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult yourdoctor,pharmacistor nurse, even if they are not listed in this prospectus. See section 4

1.What is Balsoprim and for what it is used

2.What you need to knowbeforestarting totake Balsoprim

3.How to take Balsoprim

4.Possible adverse effects

5Storage of Balsoprim

6.Contents of the package and additional information

Balsoprim is an antibiotic that eliminates bacteria that cause infections. It contains two different medications called trimetoprima and sulfametoxazol (a sulfonamide). Additionally, it contains bromhexina, a medication with mucolytic action.

Balsoprim is indicated for 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 inflammation of the ear (acute otitis media)
• Acute bacterial sinusitis

Do not take Balsoprim

• if you are allergic to sulfamethoxazole, trimethoprim, bromhexine, or any of the other components of this medication listed in section 6.
• in children under 2 years old.
• if you have or think you have acute porphyria (a blood disorder in which hemoglobin is not produced properly).
• in combination with dofetilide (a medication 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 severe side effects.
• if you take Balsoprim for a long time or have a folate deficiency or are elderly, 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 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.
• if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).
• if you have a risk of hyperkalemia (high potassium levels) and hyponatremia (low sodium levels), your doctor will consider the need to perform a blood test for potassium and sodium.
• Balsoprim should not be used to treat streptococcal pharyngitis (Group A beta-hemolytic streptococcus, S. pyogenes).
• Due to the mucolytic properties of bromhexine and the ability to disrupt the digestive mucosa barrier, it should be administered with caution in patients with a history of peptic ulcers, due to the risk of bleeding.
• As a result of colonization with Clostridium difficile, the use of Balsoprim may lead to very rare cases of pseudomembranous colitis, which manifests through diarrhea.
• if you have kidney problems (you have known renal insufficiency). Your doctor should take special measures. To ensure adequate renal elimination, the patient should receive adequate fluid intake and the urine pH should be maintained within normal limits, avoiding acidification of the urine.
• if you have liver problems (severe damage to the hepatic parenchyma).
• Cotrimoxazole has been administered to patients undergoing chemotherapy with little or no additional effect on the bone marrow or peripheral blood.
• At the beginning of treatment, fluidification and mobilization of secretions may partially obstruct the bronchi, which will be attenuated over time.
• 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 close medical supervision is present.

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 apparatus.

Severe skin eruptions associated with the administration of cotrimoxazole have been described, which can threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis, generalized acute pustular exanthema, and acute febrile neutrophilic dermatosis or Sweet syndrome) with the initial use of Balsoprim 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 skin eruptions that can threaten the patient's life often accompany flu-like symptoms. The eruption may progress to the formation of generalized blisters or skin peeling.

The period of highest risk of appearance of severe skin eruptions is during the first weeks of treatment.

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

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

Severe skin eruptions associated with the administration of bromhexine have been reported. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals), stop using Balsoprim and consult your doctor immediately.

Rare cases of hypersensitivity reactions with eosinophilia (increase in a certain type of white blood cells) and systemic symptoms associated with the use of Balsoprim have been reported.

Respiratory toxicity

During treatment with cotrimoxazole, 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, cotrimoxazole administration should be interrupted and appropriate treatment should be administered.

Lymphohistiocytic hemophagocytosis

Rare cases of excessive immune reactions due to unregulated activation of white blood cells that cause inflammation (lymphohistiocytic hemophagocytosis) have been reported, which can be potentially fatal if not diagnosed and treated promptly. If you experience multiple symptoms such as fever, swelling of lymph nodes, feeling of weakness, dizziness, shortness of breath, bruises, or skin rash with or without a slight delay, contact your doctor immediately.

Children

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

Other medications and Balsoprim

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

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

• Medications used to control heart rhythm (class III antiarrhythmics), such as dofetilide. Elevated plasma levels of dofetilide have been reported after concurrent administration with trimethoprim. (See section 2 Do not take Balsoprim).
• Medications used to increase urine elimination: diuretics (especially thiazides). Concurrent 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).
• Oral anticoagulants such as warfarin. Trimethoprim/sulfamethoxazole potentiates the anticoagulant activity of warfarin. It is recommended to carefully control anticoagulant treatment during the use of Balsoprim.
• Some medications used to control blood sugar or glucose in the blood: hypoglycemics or oral antidiabetics (sulfonilurea).
• Medications used to treat heart problems (digoxin). Concurrent use of trimethoprim and digoxin has shown an increase in digoxin levels in some elderly patients.
• Medications used to treat infections caused by some parasites (pirimetamine). Concurrent administration of trimethoprim/sulfamethoxazole with pirimetamine doses greater than 25 mg per week may lead to the development of megaloblastic anemia (decrease in red blood cell count and increase in size).
• Certain medications used to treat HIV: antiretrovirals (lamivudine, zidovudine). Concurrent treatment of Balsoprim with zidovudine may increase the risk of adverse hematological reactions to trimethoprim/sulfamethoxazole, and consideration should be given to monitoring blood parameters.
• Medications used as antifolate 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 considered. If Balsoprim is administered with methotrexate, consideration should be given to administering a folate supplement.
• Medications used in transplants: immunosuppressants (ciclosporin). In patients treated with trimethoprim/sulfamethoxazole and ciclosporin, reversible deterioration in renal function has been observed after renal transplantation.
• Medications that cause hyperkalemia (elevated potassium levels).
• Antibiotics:The concurrent administration of bromhexine and antibiotics (such as amoxicillin, oxytetracycline, and erythromycin) increases the concentration of these in the pulmonary tissue. However, no clinical relevance has been demonstrated for this interaction.
• Medications used as antitussives:The concurrent administration of an antitussive (anticholinergics, antihistamines, etc.) inhibits the cough reflex and may cause stasis of the fluidified mucus by bromhexine.

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

Other interactions

-Antiarrhythmics and other medications affecting the QT interval

-Rifampicin and Dapsona

-Phenylalanine

-Tricyclic antidepressants and other bronchial secretory inhibitors

Taking Balsoprim with food, drinks, and alcohol

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

Pregnancy,lactation,and fertility

If you are pregnant or breastfeeding, or think you may be 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 consideration may be given to administering a folate supplement of up to 4 or 5 mg/day if trimethoprim/sulfamethoxazole is used during pregnancy.

When Balsoprim is administered to the mother before delivery, 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 premature infants or those with a deficiency of glucose-6-phosphate dehydrogenase.

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 risk of developing, hyperbilirubinemia.

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

As a precaution, it is recommended not to use Balsoprim during pregnancy, unless the potential benefit to the mother outweighs the potential risk to the fetus, and consideration may be given to administering a folate supplement of up to 4 or 5 mg/day if co-trimoxazole is used during pregnancy.

Lactation

Trimethoprim and sulfamethoxazole are excreted in breast milk.

Do not take Balsoprim during lactation.

Fertility

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

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

Driving and operating machinery

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 parahydroxybenzoate of propyl and parahydroxybenzoate of methyl

May cause allergic reactions (possibly delayed).

Balsoprim contains sorbitol

This medication contains 191.10 mg of sorbitol (E-420) in each ml. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a certain sugar intolerance, or have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Balsoprim contains sodium

This medication contains 68.6 mg of sodium (main component of table salt/for cooking) in each 20 ml dose (3.43 mg of sodium per ml). This represents 3.43% of the recommended daily maximum sodium intake for an adult.

Balsoprim contains propylene glycol

This medication contains 2.02 mg of propylene glycol in each ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

Follow exactly the administration instructions of this medication 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 the 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 from 2 to 6 years:The recommended dosage for children aged 2 to 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.

Geriatric patients

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

Patients with renal insufficiency

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

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

Patients with liver function alterations

Balsoprim should be used with caution in patients with liver function alterations.

If you take more Balsoprim than you should

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

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

In case of non-emergence of vomiting, it should be induced. Gastric lavage should be performed. Depending on renal function, 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, consult the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount taken

If you forgot to take Balsoprim

Do not take a double dose to compensate for the missed doses.

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

The side effects described for Balsoprim are classified by frequency and are as follows:

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

• Hypokalemia (high potassium level in blood).

Common (may affect up to 1 in 10 people)

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

• Reactions of hypersensitivity
• Exanthema (skin rash of pink color), urticaria
• Reactions of hypersensitivity with eosinophilia (increase of a certain type of white blood cell) and systemic symptoms
• Bronchospasm (constriction of the bronchi)

Very rare (may affect up to 1 in 10,000 people)

• Leucopenia (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)
• Allergic myocarditis (allergic reaction affecting the heart)
• Fever
• Allergic vasculitis similar to Schoenlein-Henoch purpura (inflammation affecting mainly small veins)
• Periarteritis nodosa (vascular disease)
• SLE (systemic lupus erythematosus, an autoimmune disease)
• Hypoglycemia (decrease in blood glucose)
• Decreased appetite
• Hyponatremia (decrease in sodium in blood)
• Depression
• Hallucinations
• Asptic meningitis
• Seizures
• Peripheral neuritis (lesion and deterioration of peripheral nerves leading to loss of sensation 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 blood, cholestatic jaundice (yellow discoloration of skin, mucous membranes or the white part of the eyes) or hepatic necrosis.
• Phototoxicity (skin reaction caused 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 alteration
• Tubulointerstitial nephritis (inflammation of a zone of the kidney)

Very rare side 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 cell)
• Thrombocytopenia (decrease in the number of platelets)
• Increased liver enzymes
• Hypokalemia (high potassium level in blood)
• Hyponatremia (decrease in sodium in blood)
• Rhabdomyolysis (destruction or inflammation of muscle that leads to severe muscle pain and weakness)

Unknown frequency (cannot be estimated from available data)

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

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

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

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 theSpanish 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.

No special storage conditions are required.

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Balsoprim

• The active principles are sulfamethoxazole, trimethoprim, and bromhexine hydrochloride
• The others areexcipients 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)
• Curcumin (E100)
• Purified water.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

DESMA Pharmaceutical Laboratory SL

Paseo de la Castellana 121,Left staircase 3rd floor

28046 Madrid

Telephone:+34 91 3238792

Fax:+34 91 323 21 05

Responsible for manufacturing

Pharmaceutical Laboratory SIT S.r.l.

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

Date of the last review of thisleaflet:

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