FROBEN FAT COUGH * SCIR 250ML

FROBEN FAT COUGH * SCIR 250ML

Therapeutic indications

Froben Cough Fat is indicated in the treatment of secretion disorders in acute and chronic respiratory diseases.

Dosage and method of use

Dosage The following dosages are recommended unless otherwise prescribed: Adults: 1-2 teaspoons (5-10 ml) 3 times a day (= 24 mg per day) In adults, at the start of treatment, it may be necessary to increase the total dose daily up to 48 mg (60 ml) divided into three times.Pediatric populationChildren over 2 years of age: ½ -1 teaspoon (2.5 - 5 ml) 3 times a day (= 12 mg per day) It is recommended to take the drug after meals. The syrup can be administered to diabetics and children over 2 years, it does not contain fructose or sucrose. Do not exceed the recommended dose.

Contraindications

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

Side effects

Frequencies are defined according to the following convention: Very common: ≥ 1/10 Common: ≥ 1/100, Reporting of suspected adverse reactions Reporting suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows for a 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Treatment with Froben Cough Fat leads to 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 the physician consulted. Do not use for prolonged treatments. After a short period of treatment with no appreciable results, conduct further investigations. Most of these reactions could be explained by the severity of underlying disease or other medications taken at the same time. Also in the early stages of Stevens Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific flu-like symptoms such as fever, chills, rhinitis, cough and sore throat. Due to these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. 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). Froben Cough Fat contains in each maximum dose (20 ml): • 40 mg of benzoic acid equivalent to 0.73 mg / kg; • less than 23 mg of sodium ie essentially “sodium-free”; • 11.43 g of sorbitol equivalent to 207.8 mg / kg. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disorder where patients cannot process fructose, talk to your doctor first. you (or the child) take this medicine. It can cause gastrointestinal problems and have a mild laxative effect; • 576 mg of alcohol (ethanol) which is equivalent to 10.47 mg / kg. The volume quantity of this medicine is equivalent to less than 15ml of beer or 6ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

Pregnancy and breastfeeding

PregnancyThere are limited data from the use of bromhexine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Froben Cough Fat during pregnancy.Feeding timeIt is not known whether bromhexine and its metabolites pass into human milk. Available pharmacodynamic and toxicology data in animals have shown excretion of bromhexine and its metabolites in breast milk. A risk to breastfed babies cannot be excluded. Froben oily cough should not be used during breastfeeding.FertilityNo studies have been conducted to investigate the effects on human fertility. Based on preclinical experience there are no indications of possible effects on fertility following the use of bromhexine.

Expiry 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

Until now, no specific symptoms of overdose have ever been reported in humans. In reported cases of accidental overdose and / or medication errors, the symptoms observed correspond to the known side effects of Froben Cough Fat at the recommended dosages; symptomatic treatment may be required.

Active principles

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

Excipients

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