BROMEXINA PE SCIR 250ML4MG/5ML

BROMOXINE PENSA 4 MG/5 ML OF SYRUP

active ingredients

5 ml of syrup contain: Active ingredient: bromexine hydrochloride 4 mg (equivalent to bromexin 3,65 mg). Excipients with known effects: sorbitol, ethanol (alcohol), benzoic acid and sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Tartaric acid, benzoic acid, sodium caramel, glycerol, liquid sorbitol, ethanol (96%), all fruits aroma, sodium hydroxide, purified water.

Therapeutic indications

BROMEXINA PENSA is indicated in the treatment of secretion turbs in acute and chronic respiratory affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. In case of hereditary conditions which may be incompatible with one of the excipients (see paragraph 4.4). There are no absolute contraindications, but in patients with gastroduodenal ulcer, it is recommended to use it after consulting the doctor. Contraindicated during nursing (see paragraph 4.6). The medicinal product is contraindicated in children under 2 years of age.

Population

We recommend the following dosages unless otherwise prescribed: Adults: 5-10 ml 3 times a day In adults, at the beginning of treatment, it may be necessary to increase the total daily dose up to 48 mg divided in three times. Children over 2 years: 2.5 - 5 ml 3 times a day The syrup is administered to diabetics and children over 2 years , contains no fructose or sucrose, but contains sorbitol that can induce hyperglycemias and as such should be considered to carry out the possible correction of insulin units to be administered. Do not exceed the recommended doses.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Treatment with BROMEXINA PENSA involves an increase in bronchial secretion (this promotes expectation). Serious skin reactions such as multiform erythema, Stevens - Johnson syndrome (SJS) / Toxic epidermal necrolysis (TEN) and generalized acute acute edema (AGEP) were reported. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with bromexin must be stopped immediately and a doctor must be consulted. Most of these could be explained by the severity of underlying diseases or other medications taken simultaneously. Do not use for protracted treatments. After short period of treatment without appreciable results conduct further investigations. Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They must not be used in children under 2 years of age (see paragraph 4.3). Excipients with known effects: This medicine contains 571.4 mg of sorbitol by ml. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. Patients with hereditary fructose intolerance should not be given this medicine. It can cause gastrointestinal problems and have a slight laxative effect. This medicine contains 30 mg of ethanol by ml, which is equivalent to 3.7 vol% of ethanol. A dose of 10 ml may contain up to 0.3 g ethanol per dose equivalent to 7.4 ml of beer and 3 ml of wine per dose. The small amount of alcohol in this medicine will not produce significant effects. A dose of 5 ml of this medicine administered to a child weighing equal to or less than 10 kg would result in exposure to 15 mg/kg of ethanol which can cause an increase in blood alcohol concentration (BAC) of about 2.5 mg/100 ml. Co-administration with medicines containing propylene glycol or ethanol can lead to the accumulation of ethanol and induce adverse effects, especially in small children with low metabolic activity or immature. This medicine contains 2 mg of benzoic acid for ml.Questo medicine contains 0,46 mg of sodium per ml, less than 1 mmol (23 mg) of sodium per dose of 10 ml, i.e. essentially ‘without sodium’.

Interactions

Clinical interactions with other medicines have not been reported.

Effects

The side effects are shown in accordance with the classification for systems and organs and by frequency according to the following categories: Very common ≥ 1/10; Common ≥ 1/100, Rare immune system disorders: hypersensitivity reactions Not known: anaphylactic reactions, including anaphylactic shock, angioedema and itching Pathologies of skin and subcutaneous tissue Rare: rash, hives Notable: severe skin adverse reactions (including multiform erythema, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). Cases of diarrhea, nausea, vomiting and other mild gastrointestinal disorders have been reported. There were also cases of bronchospasm and bronchial obstruction. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose symptoms have ever been reported. In case of overdose, symptomatic treatment is recommended.

Pregnancy Use the product in cases of actual need under the direct control of the doctor. The results of preclinical studies and clinical use of BROMEXINA PENSA have not shown negative effects in pregnancy. However, it is necessary to observe the usual precautions regarding the administration of pregnant drugs, particularly in the first quarter. Breasting As the drug passes into breast milk avoid administration in case of breastfeeding.

Source: Farmadati