Azimil * 15 mg / 2 ml

Solution To Nebulize

Composition :

AZIMIL 15 mg / 2 ml solution for nebulisation and oral One single-dose container contains: Active ingredient: Ambroxol hydrochloride 15 mg. AZIMIL 15 mg / 5 ml syrup in single-dose container One single-dose container contains: Active ingredient: Ambroxol hydrochloride 15 mg. AZIMIL 15 mg / 5 ml multidose syrup 200 ml 5 ml of syrup contain: Active ingredient: Ambroxol hydrochloride 15 mg For the complete list of excipients see. par. 6.1

Excipients

Nebulizer and oral solution: Sodium chloride, Water for injections Syrup in single-dose container: Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Water for injections Syrup in multidose bottle: Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Water for injections.

Therapeutic indications

Treatment of secretion disorders in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to ambroxol hydrochloride or to any of the excipients. Severe hepatic and renal disorders. The use of the drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see section 4.4).

Dosage

Nebulizer and oral solution Each single-dose container contains 2 ml and has a mark at the volume of 1 ml (half dose) Nebuliser solution Adults and children over five years of age: 2 ml (one container) 2 times a day. Children under the age of five: 1-2 ml (half a 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 the ratio 1: 1. Oral solution Adults: 2-4 ml (1-2 containers) 3 times a day. Children over five years old: 1-2 ml (half a container - one container), 2-3 times a day. Children under 5 years of age: 1 ml (half 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 Syrup Syrup in multidose bottle Adults: at the start 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 under the age of five: 2.5 ml 2-3 times a day. The measuring cup enclosed in the bottle package has notches at volumes of 2.5 ml, 5 ml and 10 ml. The medicine should be taken with meals. Syrup in single-dose container Each single-dose container of syrup contains 5 ml and has a mark at the volume of 2.5 ml (half dose) Adults: at the start of treatment 10 ml (two containers) 3 times a day, then 5 ml (one container) 3 times a day. Children over five years of age: 5 ml (one container) 3 times a day. Children under the age of five: 2.5ml (half container) 2-3 times a day. The medicine should be taken with meals.

Warnings and Precautions

Ambroxol should be administered with caution to patients with peptic ulcer. Very rarely, severe skin lesions such as Steven Johnson syndrome and Lyell syndrome have been observed at the same time as the administration of mucolytic substances such as ambroxol. Most of these could be explained by the severity of underlying disease or other concomitant medications. If new lesions of the skin or mucous membranes occur, consult your doctor immediately and discontinue treatment with ambroxol as a precaution. During the administration of the solution to be nebulized, since coughing from irritation may arise in the too deep inhalation of the aerosols, one should try to inhale and exhale normally. In particularly sensitive patients, a preheating of the inhaled to body temperature may be recommended. For patients suffering from bronchial asthma it is advisable to resort to a bronchial spasmolytic before inhalation. The syrup in single-dose container and in multi-dose bottle contains maltitol: use with caution in patients with rare hereditary problems of fructose intolerance. The syrup in a multi-dose bottle contains para-hydroxybenzoates which can cause allergic reactions (including delayed ones).

Interactions

Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No interactions with other medicinal products have been reported.

Side effects

Episodes of diarrhea have been commonly observed. Nausea, vomiting, other mild gastrointestinal disturbances, allergic reactions have been reported uncommonly. In rare cases heartburn, dyspepsia, rash, urticaria, angioedema have been found. Extremely rare cases of anaphylactic reactions (including anaphylactic shock) have been reported

Pregnancy and breastfeeding

Ambroxol crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal development. Although preclinical studies and extensive clinical experience have not shown any harmful effects on the fetus after the 28th week of gestation, it is recommended that normal precautions be taken when taking medications during pregnancy. Especially during the first trimester it is not recommended to take ambroxol. The drug is excreted in breast milk, therefore the use of ambroxol is not recommended during breastfeeding. However, no adverse effects on the suckling child are conceivable. During pregnancy and breastfeeding, the drug should be administered only in case of real need and under the direct supervision of the doctor.