Syrup that helps to thin the thick and viscous mucus present in the respiratory tract, facilitating its elimination.
Indications
Azimil is indicated in the treatment of secretion disorders in acute and chronic bronchopulmonary diseases.
Composition
Active ingredients
5 ml of syrup contain:
Active ingredient: Ambroxol hydrochloride 15 mg
Excipients
Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Water for injections.
Directions for use and Dosage
Adults: at the beginning of treatment 10 ml 3 times a day, then 5 ml 3 times a day. Children over five years of age: 5 ml 3 times a day.
Children aged between two and five years: 2.5 ml 2-3 times a day.
The measuring cup included in the bottle packaging has volume marks of 2.5 ml, 5 ml and 10 ml. The medicine should be taken with meals.
Warnings
Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the capacity to drain bronchial mucus is limited in this age group, due to the physiological characteristics of the airways. They should therefore not be used in children under 2 years of age.
Azimil should be administered with caution to patients with peptic ulcers.
Cases of serious skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported with the administration of ambroxol. If symptoms or signs of progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, treatment with ambroxol should be discontinued immediately and a doctor should be consulted.
Most of these cases can be explained by the severity of the patient's underlying disease and/or concomitant therapy. Furthermore, during the initial phase of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), patients may initially experience nonspecific flu-like symptoms such as fever, muscle aches, rhinitis, cough, and sore throat. Due to these misleading nonspecific flu-like symptoms, symptomatic treatment with cough and cold medications may be initiated. Therefore, if new skin or mucosal lesions appear, it is necessary to consult a doctor immediately and discontinue treatment with ambroxol hydrochloride as a precaution.
In the presence of mild or moderate renal insufficiency or severe liver disease, Azimil should be used only after consulting a doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, in case of severe renal insufficiency, accumulation of ambroxol metabolites generated in the liver may occur.
During administration of the nebulizer solution, since If aerosols are inhaled too deeply, an irritating cough may occur. During inhalation, try to inhale and exhale normally. In particularly sensitive patients, prewarming the inhaled product to body temperature may be recommended. Patients with bronchial asthma should take a bronchial antispasmodic before inhaling.
Warnings regarding some of the excipients in Azimil syrup: Azimil syrup in single-dose containers and multi-dose bottles contains maltitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. Azimil syrup in multidose bottle contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed.
Severe liver and/or kidney disorders.
Taking the drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients.
The medicine is contraindicated in children under 2 years of age (for oral use).
Side effects
At the recommended doses, the medicine is usually well tolerated. The following side effects have been observed during therapy with ambroxol hydrochloride, with the following frequencies:
- Very common ≥1/10
- Common ≥1/100, <1/10
- Uncommon ≥1/1,000, <1/100
- Rare ≥1/10,000, <1/1,000
- Very rare <1/10,000
- Not known, the frequency cannot be estimated from the available data. be defined on the basis of the available data.
Immune system disorders
- Rare: hypersensitivity reactions
- Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus
Nervous system disorders
- Common: dysgeusia (e.g., taste perversion)
- Rare: headache
Respiratory, thoracic and mediastinal disorders
- Common: hypoaesthesia of the oral cavity and pharynx
- Not known: bronchial obstruction
Gastrointestinal disorders
- Common: nausea
- Uncommon: vomiting, diarrhoea, dyspepsia and abdominal pain, dry mouth
- Not known: dry throat
Skin and subcutaneous tissue disorders
- Rare: rash, urticaria
- Not known: serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Pregnancy and breastfeeding
Ambroxol hydrochloride crosses the placental barrier. Animal studies have not shown direct or indirect harmful effects on pregnancy, embryonic/fetal development, parturition or postnatal development.
Clinical studies and extensive clinical experience after the 28th week of pregnancy have shown no evidence of harmful effects on the fetus.
However, it is recommended to observe the usual precautions regarding the use of medicinal products during pregnancy.
Especially during the first trimester, the use of Azimil is not recommended. Ambroxol hydrochloride is excreted in breast milk.
Although no undesirable effects on infants are expected, the use of Azimil is not recommended in breastfeeding mothers.
Format
200 ml bottle
Product Code:FRCM220529
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