Descrizione Clinica
AZIMIL
active ingredients
15 mg/2 ml nebulizing and oral solution A monodose container contains: Active ingredient: Ambroxol Hydrochloride 15 mg. AZIMIL 15 mg/5 ml syrup in monodose container A single-dose container contains: Active ingredient: Ambroxol Hydrochloride 15 mg. AZIMIL 15 mg/5 ml multidose syrup 200 ml 5 ml syrup contain: Active ingredient: Ambroxol Hydrochloride 15 mg For full list of excipients see paragraph 6.1.Excellent
Nebulizing and oral solution: Sodium chloride, Water for injectable preparations Syrup in single-dose container: Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Water for injectable preparations Multidose bottle syrup: Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Metil p–hydroxybenzoate, Propil p–hydroxybenzoate, Water for injectable preparations.Therapeutic indications
Azimil is indicated in the 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/or kidney alterations. Intake of the drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see paragraph 4.4). Pediatric population The medicinal product is contraindicated in children under 2 years of age (for oral use)Population
A. Nebulizing and oral solution Each single-dose container contains 2 ml and carries a notch to the volume of 1 ml (half dose) Nebulizing solution Adults and children over five years: 2 ml (one container) 2 times a day. Children under five years: 1–2 ml (half container - one container) 1–2 times a day. The solution can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in ratio 1:1. Oral Solution Adults: 2–4 ml (1–2 containers) 3 times a day. Children over five years: 1–2 ml (half container - one container), 2–3 times a day. Children between two and five years: 1 ml (half container) 2–3 times a day. Dilute the solution in little water, tea, milk or juice. The medicine should be taken at meals. B. Syrup Multidose bottle syrup Adults: at the beginning of treatment 10 ml 3 times a day, then 5 ml 3 times a day. Children over five years: 5 ml 3 times a day. Children between two and five years: 2.5 ml 2–3 times a day. The dosing cup attached to the bottle pack contains notches to the volumes of 2,5 ml, 5 ml and 10 ml. The medicine should be taken at meals. Syrup in single-dose container Each single-dose syrup container contains 5 ml and has a cap at the volume of 2.5 ml (half dose). Adults: at the beginning of treatment 10 ml (two containers) 3 times a day, then 5 ml (one container) 3 times a day. Children over five years: 5 ml (one container) 3 times a day. Children between two and five years: 2.5 ml (half container) 2–3 times a day. The medicine should be taken at meals.Conservation
This medicine does not require any special condition for conservation. After the opening of the aluminium envelope containing monodose containers, the medicinal product must be used within three months; after that period, the unused medicinal product must be eliminated. When using half a dose of the single-dose container, the closed container must be kept at 2°– 8°C (in the refrigerator) at most for 12 hours; after this period the remaining medicine must be eliminated. After opening the syrup bottle, the medicinal product must be used within a month; the remaining medicinal product must be eliminated.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 (for oral use, see paragraph 4.3). Azimil should be administered with caution in patients carrying peptic ulcer. Serious skin reactions such as multiform erythema, Stevens– Johnsons 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), treatment with Ambroxolo must be stopped immediately and a doctor must be consulted. 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 Steven – Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially accuse simil prodromas–specific influenzas such as fever, muscle pain, rhinitis, cough and throat pain. Due to these misleading simil prodromas–specific influenzas, a symptomatic treatment with cough and cold medicines can be established. Therefore, if new lesions of the skin or mucous membranes occur, you must immediately consult your doctor and precautionally stop the treatment with ambroxol hydrochloride. In the presence of mild or moderate renal failure or severe hepatopathy, Azimil must be used only after consulting the doctor. As with any medication with liver metabolism followed by renal elimination, in case of severe kidney failure, an accumulation of ambroxol metabolites generated in the liver may occur. During the administration of the solution to be nebulized, since in the too deep intake of aerosols it may arise coughs from irritation, it should be sought during inhalation to inhale and exhale normally. Particularly sensitive patients can recommend a preheating of inhalation at body temperature. For patients with bronchial asthma it is appropriate to resort to a bronchial spasmolytic before inhalation. Warnings related to some excipients of Azimil syrup Azimil syrup in monodose container and in multidose bottle contains maltitol: patients suffering from rare hereditary problems of fructose intolerance, should not take this medicine. Azimil syrup in multidose bottle contains para-hydroxybenzoates that can cause allergic reactions (also delayed type).Interactions
Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. Clinical interactions with other medicines have not been observed.Effects
The medicinal product is normally well tolerated at recommended doses. During therapy with ambroxol hydrochloride the undesirable effects reported below, with the frequencies: Very common ≥1/10 Municipality ≥1/100, Rare immune system disorders: hypersensitivity reactions Not known: anaphylactic reactions, including anaphylactic shock, angioedema and itching Nervous system pathologies: Municipality: disgeusia (e.g. alteration of taste) Rara: Cefalea Respiratory pathologies, thoracic and mediastinic Common: oral cavity and pharynxia Notable: bronchial obstruction Gastrointestinal pathologies: Municipality: nausea Not common: vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth. Notable: dry throat Pathologies of skin and subcutaneous tissue Rare: rash, hives Notable: severe skin adverse reactions (including multiform erythema, Stevens syndrome - Johnson/toxic epidermal necrolysis and generalized acute acute exantematic pustolosis). 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 http.//www.agenziafarmaco.gov.it/it/responsabili.Overdose
You do not know cases of overdose with Azimil. Symptoms observed in cases of accidental overdose and/or in cases of errors in the administration of the medicinal product are consistent with the expected adverse effects of Ambroxol Hydrochloride at recommended doses and may require symptomatic treatment. It is advisable to induce vomiting and/or use gastric lavender Keep in mind that the patient has not ingested other medicines at the same time.Ambroxol Hydrochloride crosses the placental barrier. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or post-birth 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 Azimil is not recommended. Ambroxol Hydrochloride is excreted in breast milk. Although there are no side effects on infants, use of Azimil is not recommended in nursing mothers.
Source: Farmadati
