Descrizione Clinica
Cool Mucoaricodil scir 600mg 200ml
OTHER MEDICINAL PRODUCTS
active ingredients
MUCOARIODIL 30 mg tablets One tablet contains Active ingredient: ambroxol Hydrochloride 30 mg Excipients with known effects: lactose MUCOARICODIL 30 mg/10ml syrup 100 ml of syrup contain Active ingredient: ambroxol hydrochloride 300 mg Excipients with known effects: sorbitol, glycerol For the full list of excipients, see paragraph 6.1.Excellent
Tablets Lactose monohydrate, corn starch, cellulose powder, sodium croscarmellose, povidone (K30), magnesium stearate. Syrup Benzoic acid, glycerol 85%, sorbitol 70% solution, hydroxyetylcellulose, raspberry aroma, purified water.Therapeutic indications
MUCOARICODIL is indicated in the treatment of secretion turbs in acute and chronic bronchopolmonary affections.Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Subjects with severe liver and/or kidney alterations. Children under 2 years of age. Intake of the medicinal product is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see paragraph 4.4).Population
Population Adult tablets: 1 tablet 3 times a day for the first 8–10 days; posology can be reduced to 1 tablet 2 times a day. Adult syrup: at the beginning 10 ml 3 times a day, then 5 ml 3 times a day. Children: – from two to five years: 2.5 ml 3 times a day; – over five years: 5 ml 3 times a day. Each ml of syrup is equivalent to 3 mg of ambroxol hydrochloride. Method of administration It is recommended to take the tablets after meals with a little liquid. A 5-ml dosing spoon with pockets corresponding to 1⁄2 and 1⁄4 is attached to the syrup packaging. It is advisable to take syrup during or after the main meals.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 two years of age (see paragraph 4.3). MUCOARICODIL should be administered with caution in patients carrying peptic ulcer. Serious skin reactions such as multiform erythema, Stevens–Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute acute edema (AGEP) have been reported. 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. Most of these skin reactions could be explained by the severity of underlying diseases or other concomitant drugs. 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 therapy and cold is possible. If new skin or mucosa lesions occur, consult your doctor immediately and precautionally stop treatment with ambroxol hydrochloride. In case of compromised kidney function or severe hepatopathy, MUCOARICODIL can only be used after consulting the doctor. As with all drugs characterized by liver metabolism followed by kidney elimination, in case of severe kidney failure, an accumulation of ambroxol metabolites generated in the liver may occur. Important information about some excipients MUCOARICODIL tablets contain lactose: patients suffering from rare hereditary problems of galactose intolerance, lactase deficiency or glucose–galactose mal absorption, should not take this medicine. MUCOARICODIL syrup contains sorbitol: patients suffering from rare hereditary problems of fructose intolerance, should not take this medicine. Sorbitol can cause gastric problems and diarrhea. MUCOARICODIL syrup also contains glycerol which is dangerous at high doses: it can cause migraine, gastric problems and diarrhea.Interactions
MUCOARICODIL does not seem to interact with other drugs, especially with cardioactive glycosides, corticosteroids, bronchodilators and diuretics commonly used in the treatment of broncopneumopathies. Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. No interactions with other medicines have been reported.Effects
Adverse reactions are classified according to the following definition: 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) Gastrointestinal diseases Municipality: nausea Not common: vomiting, diarrhea, dyspepsia, abdominal pain, mouth dry Rare: pirosis Not known: dry throat Respiratory, chest and mediastinic pathologies Common: oral hypoesthesia and pharyngeal Notable: bronchial obstruction Diseases of the nervous system Common: disgeusia (e.g. alteration of the sense of taste) Rare: cephalea. 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 the address www.aifa.gov.it/content/segnalazioni–reactions–adverse.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 undesirable expected effects of MUCOARICODIL at recommended doses and may require symptomatic treatment. In case this happens, it is recommended to induce vomiting and/or use gastric lavender. Make sure the patient didn't ingest other drugs at the same time.Pregnancy Ambroxol Hydrochloride crosses the placental barrier. Preclinical studies conducted on animals have not evidenced directly or indirectly harmful effects for pregnancy, embryo/fetal development, childbirth or postnatal development. The 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 MUCOARICODIL is not recommended. Food Ambroxol Hydrochloride is excreted in breast milk. Although there are no side effects in breast-feededed children, during breastfeeding the use of MUCOARICODIL is not recommended. Therefore it is necessary to decide whether to stop breastfeeding or treatment with the medicinal product, taking into account the importance of the drug for the mother.
Source: Farmadati
