AZIMIL SCIR FL200ML 15MG/5ML

AZIMIL

active ingredients

AZIMIL 15 mg/2 ml nebulizer and oral solutionA single-dose container contains: Active ingredient: Ambroxol hydrochloride 15 mg. AZIMIL 15 mg/5 ml syrup in single-dose containerA single-dose container contains: Active ingredient: Ambroxol hydrochloride 15 mg. AZIMIL 15 mg/5 ml multidose syrup 200 ml 5 ml of syrup contains: Active ingredient: Ambroxol hydrochloride 15 mg For the full list of excipients, see section 6.1.

Excellent

Nebulizer and oral solution: Sodium chloride, Water for injections. Syrup in single-dose container: Maltisorb (Maltitol 75%), Glicerol 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 disorders in acute and chronic bronchopulmonary conditions.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Severe liver and/or kidney disorders.The drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see section 4.4).Paediatric population The drug 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 of age: 1-2 ml (half a container - one container), 2-3 times a day.Children between the ages of two and five years: 1 ml (half a container) 2-3 times a day.Dilute the solution in a little water, tea, milk or fruit juice.The medicine should be taken with 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 replenished container must be kept at 2°- 8°C (in the refrigerator) at most for 12 hours; after this period the remaining medicinal product 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 group, 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's syndrome - Johnson or toxic epidermal necrolysis (NET), patients may initially charge aspecific symil-fluous prodromes such as fever, muscle pain, rhinitis, cough and throat pain. Due to these misleading non-specific symil-fluous prodromas, 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; Common ≥1/100, Immune system disorders. Rare: hypersensitivity reactions; Notable: anaphylactic reactions, including anaphylactic shock, angioedema and itching. Nervous system disorders. Common: dysgeusia (e.g. taste disturbance);Rare: Headache. Respiratory, chest and mediastinic pathologies. Common: hypoesthesia of the oral cable and pharynx; Notable: bronchial obstruction. Gastrointestinal diseases. 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.

Overdosing

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 showed no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or postnatal development. Clinical studies and extensive clinical experience after 28^a week of pregnancy did not show any 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 undesirable effects on infants, use of Azimil is not recommended in nursing mothers.

Source: Farmadati