BROMEXINE PE * SCIR 250ML4MG / 5ML

BROMEXINE PE * SCIR 250ML4MG / 5ML

Therapeutic indications

BROMEXINA PENSA is indicated in the treatment of secretion disorders in acute and chronic respiratory diseases.

Dosage and method of use

The following dosages are recommended unless otherwise prescribed: Adults: 5-10 ml 3 times a day In adults, at the start of treatment, it may be necessary to increase the total daily dose up to 48 mg divided in three times. Children over 2 years of age: 2.5 - 5 ml 3 times a day The syrup can be administered to diabetics and children over 2 years , it does not contain fructose or sucrose, but it contains sorbitol which can induce hyperglycemia and as such should be considered when correcting the insulin units to be administered.Do not exceed the recommended dose.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. In case of hereditary conditions which may be incompatible with any of the excipients (see section 4.4). There are no absolute contraindications, but in patients with gastroduodenal ulcer, its use is recommended after consulting your doctor. Contraindicated during lactation (see section 4.6). The medicine is contraindicated in children under 2 years of age.

Side effects

Undesirable effects are reported according to system organ class and frequency according to the following categories: Very common ≥ 1/10; Common ≥ 1/100, Immune system disorders Rare: hypersensitivity reactions Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritusSkin and subcutaneous tissue disordersRare: rash, urticaria Not known: severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis). Cases of diarrhea, nausea, vomiting and cases of other mild gastrointestinal disturbances have been reported. Cases of bronchospasm and bronchial obstruction have also been reported.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Treatment with BROMEXINA PENSA involves an increase in bronchial secretion (this favors expectoration). 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 administration of bromhexine. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with bromhexine should be discontinued immediately and a physician consulted. Most of these could be explained by the severity of underlying diseases or other medications taken at the same time. Do not use for prolonged treatments. After a short period of treatment without appreciable results, conduct further investigations. 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). Excipients with known effect: This medicinal product contains 571.4 mg ofsorbitolper ml. The additive effect of co-administration of sorbitol (or fructose) containing medicinal products and the daily dietary intake of sorbitol (or fructose) must be considered. The content of sorbitol in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. Patients with hereditary fructose intolerance should not be given this medicine. It can cause gastrointestinal problems and have a mild laxative effect. This medicine contains 30 mg ofethanolper ml, which is equivalent to 3.7 vol% ethanol. A 10 ml serving can contain up to 0.3 g of ethanol per serving equivalent to 7.4 ml of beer and 3 ml of wine per serving. The small amount of alcohol in this medicine will not have any noticeable effects. A 5 ml dose of this medicine given to a child weighing 10 kg or less would result in exposure to 15 mg / kg of ethanol which can cause an increase in blood alcohol concentration (BAC) of approximately 2.5. mg / 100 ml. Co-administration with medicinal products containing e.g. Propylene glycol or ethanol can lead to the accumulation of ethanol and induce adverse effects, particularly in young children with low or immature metabolic activity. This medicine contains 2 mg ofbenzoic acidper ml This medicinal product contains 0.46 mg ofsodiumper ml, less than 1 mmol (23 mg) sodium per 10 ml dose, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

Pregnancy Use the product in cases of real need under direct medical supervision. The results of preclinical studies and the clinical use of BROMEXINE PENSA have shown no adverse effects in pregnancy. However, it is necessary to observe the usual precautions regarding the administration of drugs during pregnancy, especially in the first trimester. Breastfeeding As the drug passes into breast milk avoid administration if breastfeeding.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

No clinically relevant interactions with other medicinal products have been reported.

Overdose

No symptoms of overdose have ever been reported. In the event of an overdose, symptomatic treatment is advised.

Active principles

5 ml of syrup contain: Active ingredient: 4 mg bromhexine hydrochloride (equivalent to 3.65 mg bromhexine). Excipients with known effects: sorbitol, ethanol (alcohol), benzoic acid and sodium. For the full list of excipients, see section 6.1.

Excipients

Tartaric acid, benzoic acid, sodium caramellose, glycerol, liquid sorbitol, ethanol (96%), all fruit flavor, sodium hydroxide, purified water.