FROBEN COUGHING UP FAT 250 ML

FROBEN FATTY COUGH 4 MG/5 ML SYRUP

active ingredients

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

Excellent

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

Therapeutic indications

Froben Tosse Grassa is indicated in the treatment of the turbs of secretion in acute and chronic respiratory affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. 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 drug is contraindicated in children under 2 years of age.

Population

Population We recommend the following dosages unless otherwise prescribed: Adults: 1-2 teaspoons (5-10 ml) 3 times a day (=24 mg die) In adults, at the beginning of treatment, it may be necessary to increase the total daily dose up to 48 mg (60 ml) divided into three times. Pediatric population Children over 2 years: 1⁄2 -1 teaspoon (2.5 - 5 ml) 3 times a day (= 12 mg die) It is recommended to take the drug after meals. The syrup is administered to diabetics and children over 2 years, does not contain fructose or sucrose. Do not exceed the recommended doses.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Treatment with Froben Tosse Grassa involves an increase in bronchial secretion (this promotes expectation). Cases of severe 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 blisters or mucosa lesions), the treatment with bromexin must be stopped immediately and should be consulted by the doctor. Do not use for protracted treatments. After a short period of treatment without appreciable results conduct further investigations. Most of these reactions could be explained by the severity of underlying diseases or other medications taken simultaneously. In addition, in the initial phase of Stevens Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific symptoms similar to those of flu, such as fever, chills, rhinitis, cough and throat. Due to these misleading symptoms, symptomatic treatment with cough and cold therapy is possible. 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). Froben Fat cough contains in each maximum dose (20 ml): • 40 mg of benzoic acid equivalent to 0.73 mg/kg; • less than 23 mg of sodium i.e. essentially “without sodium”; • 11.43 g of sorbitol equivalent to 207.8 mg/kg. Sorbitol is a source of fructose. If your doctor told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary intolerance to fructose, a rare genetic disease for which patients fail to transform fructose, speak to the doctor before you (or the child) take this medicine. It can cause gastrointestinal problems and have a slight laxative effect; • 576 mg of alcohol (ethanol) which is equivalent to 10.47 mg/kg. The volume quantity of this medicine is less than 15 ml of beer or 6 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Interactions

Clinical interactions with other medicines have not been reported.

Effects

The frequencies are defined according to the following convention: Very common: ≥ 1/10 Municipality: ≥ 1/100, Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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 the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Until now, specific overdose symptoms have never been reported in man. In reported cases of accidental overdose and/or drug intake errors, observed symptoms correspond to the well-known side effects of Froben Tosse Grassa to the recommended dosages; symptomatic treatment may be necessary.

Pregnancy

There are limited data on the use of bromexin in pregnant women. Animal studies indicate no direct or indirect harmful effects on reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Froben Tosse Grassa during pregnancy.

Food

It is not known if bromexin and its metabolites pass into human milk. The pharmacodynamic and toxicology data available on animals showed the excretion of bromexin and its metabolites in breast milk. A risk for breast-feededed children cannot be excluded. Fat cough froben should not be used during breastfeeding.

Fertility

Studies have not been conducted to investigate the effects on human fertility. Based on the preclinical experience there are no indications of possible effects on fertility as a result of the use of bromexin.

Source: Farmadati