Descrizione Clinica
Cool Golasept Tosse Fat Scir 200 Golasept
GOLASEPT TOSSE GRASSA 3 MG/ ML SCIROP
active ingredients
100 ml of syrup contain: active ingredient: ambroxol hydrochloride 300 mg. Excipient with known effects: sorbitol, glycol propylene and benzoic acid For the full list of excipients, see paragraph 6.1
Excellent
GOLASEPT TOSSE GRASS 3 mg/ml syrup: hydroxyethylcellulose; 70% sorbitol; glycerol; benzoic acid; bitter aroma; propylene glycol; tartaric acid; purified water.
Therapeutic indications
GOLASEPT TOSSE GRASSA is indicated for the treatment of respiratory diseases characterized by dense and viscous hypersecretion.
Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Severe liver and/or kidney alterations. The medicinal product is contraindicated in children under 2 years of age.
Population
Population Adults: 10 ml (30 mg) 3 times a day. Pediatric population Children over 5 years: 5 ml (15 mg) 3 times a day. Children from 2 to 5 years: 2.5 ml (7,5 mg) 3 times a day. Method of administration It is recommended to take syrup after meals. Do not use GOLASEPT TOSSE GRASSA for extended treatments.
Conservation
Do not store at temperature above 25°C.
Warnings
Ambroxol should be given with caution in patients with peptic ulcer. 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. Most of these cases can be explained by the severity of the underlying disease of the patient and/or concomitant therapy. In addition, during the initial phase of Stevens-Johnson's or TEN's syndrome, patients may charge unspecified flu-like prodromas such as fever, muscle pain, rhinitis, cough and throat pain. Due to these misleading aspecific symil-fluid prodromas, a symptomatic treatment with cough and cold medicines can be established. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with ambroxol hydrochloride should be stopped immediately and a doctor should be consulted. In the presence of mild or moderate renal failure, GOLASEPT TOSSE GRASSA must be used only after consulting the doctor. As with any medication with liver metabolism followed by renal elimination, in case of severe renal failure, an accumulation of ambroxol metabolites generated in the liver may occur. GOLASEPT FAT COUGH contains 3.5 g sorbitol per dose equivalent to 10 ml. 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. Patients with hereditary fructose intolerance should not be given this medicine. It can cause gastrointestinal problems and have a slight laxative effect. GOLASEPT FAT COUGH contains 300 mg of glycol propylene per dose equivalent to 10 ml. GOLASEPT FAT COUGH contains 20 mg of benzoic acid per dose equivalent to 10 ml. Pediatric population 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).
Interactions
Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. No clinically relevant adverse interactions with other medicines have been observed.
Effects
The desired effects listed by frequency are reported using the following convention: Very common (≥1/10); common (≥1/100, Rare immune system disorders: hypersensitivity reactions Not known: anaphylactic reactions, including anaphylactic shock, angioedema and itching Diseases of the nervous system City: Disgeusia (e.g. alterations of the sense of taste) Rare: Cephalea Respiratory, chest and mediastinic pathologies City: Hypoesthesia of oral cavity and Rare pharynx: Rinorrea Notable: Bronchial obstruction Gastrointestinal diseases City: Nausea Not common: Vomito, diarrhea, dyspepsia and abdominal pain, mouth dry Raro: Pirosis, stips Not known: Dry gorge Pathologies of skin and subcutaneous tissue Rare: Rash, hives, contact dermatitis Not known: severe skin adverse reactions (including multiform erythema, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute urstolosis). Kidney and urinary pathologies Rare: Disuria Systemic pathologies and conditions for administration Rare: Tiredness 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 reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Overdosing
To date, no specific overdose symptoms have been reported in man. Based on cases of accidental overdose and/or therapy errors, observed symptoms are consistent with the known side effects of GOLASEPT TOSSE GRASSA at recommended doses and symptomatic treatment may be required.
Pregnancy
Ambroxol Hydrochloride crosses the placental barrier. Animal studies showed no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or postnatal development. Clinical studies and extensive clinical experience after the 28th week of pregnancy showed no evidence of harmful effects on the fetus. However, it is recommended to observe the usual precautions regarding the use of medicines during pregnancy. In particular during the first quarter, the use of GOLASEPT TOSSE GRASSA is not recommended.
Food
Ambroxol Hydrochloride is secreted in breast milk. Although there are no side effects on infants, the use of GOLASEPT TOSSE GRASSA is not recommended in nursing mothers.
Source: Farmadati
