Broxol syrup 150ml 0.3%

BROXOL * SCIR 150ML 0.3%

Therapeutic indications

Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.

Dosage and method of use

Dosage Adults 10 ml 3 times a day. Pediatric population Children from 2 to 5 years2.5 ml 3 times a day.Children over 5 years old3 ml 4 times a day. Broxol can be taken with or without meals.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Severe hepatic and renal disorders. Taking the drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see section 4.4). The drug is contraindicated in children under 2 years of age.

Side effects

Adverse reactions are listed below by system organ class and frequency, according to the following categories:Very common≥ 1/10Common≥ 1/100, Uncommon ≥ 1 / 1,000, Rare ≥ 1 / 10,000, Very rare Not knownfrequency cannot be estimated from the available data. Disorders of the immune system Rare: hypersensitivity reactions. Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Skin and subcutaneous tissue disorders Rare: rash, urticaria. Not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis). Nervous system disorders Common: dysgeusia. Gastrointestinal disorders Common: nausea, oral hypoesthesia. Uncommon: vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth. Not known: dry throat. Heartburn has also been reported. Respiratory, thoracic and mediastinal disorders Common: pharyngeal hypoesthesia. Not known: bronchial obstruction. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Special warnings

Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children less than 2 years of age (see section 4.3). Ambroxol hydrochloride should be administered with caution to patients with peptic ulcer. There have been reports of severe skin reactions such as erythema multiforme, Stevens Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of ambroxol. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol should be discontinued immediately and a physician consulted. Most of these could be explained by the severity of underlying disease or other concomitant medications. Also in the early stage of Stevens Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific flu-like symptoms, such as fever, chills, rhinitis, cold and sore throat. Due to these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. In case of impaired kidney function, Broxol can only be used after consulting your doctor.Broxol 15mg / 5ml syrup contains methyl hydroxybenzoate, propyl hydroxybenzoate and sucroseBroxol contains methylhydroxybenzoate and propylhydroxybenzoate which can cause allergic reactions (including delayed). Broxol contains 3.5 g of sucrose in 10 ml: to be taken into consideration when administering to people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

Pregnancy and breastfeeding

PregnancyAmbroxol hydrochloride crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonic / fetal development, parturition or postnatal development. Although preclinical studies and extensive clinical experience have not shown any harmful effects on the fetus after 28^toweek of gestation, it is advisable to take normal precautions about taking medications during pregnancy. Especially during the first trimester it is not recommended to take Broxol.Feeding timeAmbroxol hydrochloride is excreted in breast milk. Although no adverse effects are expected in breastfed infants, the use of Broxol is not recommended during breastfeeding.

Expiration and retention

No special instructions.

Interactions with other drugs

Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No interactions with other medicinal products have been reported.

Overdose

No specific symptoms of overdose in humans have been reported to date. Symptoms observed in cases of accidental overdose and / or medication errors are consistent with the expected side effects of Broxol at recommended doses and may require symptomatic treatment.

Active principles

100 ml of syrup contain:active principle: ambroxol hydrochloride 300 mg Excipients with known effects: sucrose, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216). For the full list of excipients, see section 6.1.

Excipients

Sucrose, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cherry flavor, purified water.