CORYFIN SCIR200ML EXPERT

CORYFIN 3MG/ML EXPENDITURE

active ingredients

100 ml of syrup contain: ambroxol hydrochloride 300 mg. Excipients with known effects: non crystallized liquid sorbitol (E420), methyl parahydroxybenzoate (E218), bisulphite sodium (E222), ethanol 96 percent. For the full list of excipients, see paragraph 6.1.

Excellent

Liquid sodium not crystallized (E420), glycerol, methyl paradroxybenzoate (E218), benzoic acid (E210), bisulphite sodium (E222), licorice extract, raspberry essence, ethanol 96 percent, purified water.

Therapeutic indications

Treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Severe liver and kidney changes. • In children under 2 years of age.

Population

Population Adults In the first days of treatment 10 ml, 3 times a day; 5 ml, 3 times a day. Pediatric population In children from 2 to 5 years: 2.5 ml, 3 times a day; over 5 years: 3 ml, 4 times a day.

Conservation

This medicine does not require any special condition of conservation.

Warnings

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). Ambroxol Hydrochloride should be administered with caution in patients carrying peptic ulcer. Cases of severe skin reactions such as multiform erythema, Stevens Johnson syndrome (SJS)/ Toxic epidermal necrolysis (NET) and generalized acute acute (AGEP) stemming from ambroxol were reported. Most of these could be explained by the severity of underlying diseases or other concomitant drugs. In addition, in the initial phase of Stevens Johnson's syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific symptoms similar to flu symptoms, such as fever, chills, rhinitis, cold and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold therapy is possible. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with ambroxol must be stopped immediately and a doctor must be consulted. In case of compromised kidney function, CORYFIN ESPETTORANTE can only be used after consulting the doctor. Avoid mixing CORYFIN EXPECTABLE with alkaline reaction solutions, as there may be a phenomenon of numbness and/or flocculation due to the acidity of the solution CORYFIN EXPECTABLE (pH=5,0). CORYFIN EXPENDITURE: – Sodium bisolfi: rarely can cause severe hypersensitivity and bronchospasm reactions. – Sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. It can have a slight laxative effect. The caloric value of the sorbitol is 2.6 kcal/g. – Metile parahydroxybenzoate: may cause allergic reactions (also delayed). – Ethanol: This medicine contains 3.8 vol % ethanol (alcohol), e.g. up to 300 mg per dose (10 ml), equivalent to 7.6 ml of beer, 3.1 ml of wine per dose. It can be harmful to alcoholics. To be taken into account in pregnant or nursing women, children and high-risk groups such as people with liver or epilepsy disorders. The doses indicated for children from 2 to 5 years and for children over 5 years contain small amounts of ethyl alcohol (ethanol), less than 100 mg per dose.

Interactions

Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. There are no interactions with other medicines.

Effects

Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common ≥ 1/10 Municipality ≥ 1/100, Immune system disorders : Rare: hypersensitivity reactions. Notable: anaphylactic reactions including anaphylactic shock, angioedema and itching. Pathologies of skin and subcutaneous tissue :Raro: rash, hives. Notable: severe skin adverse reactions (including multiform erythema, Stevens Johnson syndrome, toxic epidermal necrolysis and generalized acute exantematic pustolosis. Diseases of the nervous system : Municipality: disgeusia. Gastrointestinal diseases : Common: nausea, oral hypoesthesia. Not common: vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth. Notable: dry throat. Pirosis has been reported. Respiratory, chest and mediastinic pathologies : Common: pharyngeal hypoesthesia. Notable: 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.agenziafarmaco.gov.it/it/responsabili.

Overdosing

So far no specific symptoms of overdose have been reported in man. Symptoms observed in cases of accidental overdose and/or in cases of errors in the administration of medicinal products are consistent with the expected adverse effects of CORYFIN EXPECTABLE at recommended doses and may require symptomatic treatment.

Ambroxol Hydrochloride crosses the placental barrier. Animal studies have not evidenced directly or indirectly harmful effects for pregnancy, embryo/fetal development, birth or post-natal development. Despite preclinical studies and extensive clinical experience, no harmful effects after 28^aweek of gestation, it is recommended to take normal precautions on taking medications in pregnancy. Particularly during the first quarter is not recommended to take CORYFIN EXPECTAL. Ambroxol Hydrochloride is excreted in breast milk. Although there are no side effects in breast-feededed children, the use of CORYFIN ESPETTORANTE is not recommended during lactation.

Source: Farmadati