Amobronc * 0.3%

Syrup

Composition:

15 mg / 2 ml - Nebuliser solution One ampoule contains: Active ingredient: ambroxol hydrochloride 15 mg 15 mg / 5 ml - Syrup for oral use 100 ml of syrup contain: Active ingredient: ambroxol hydrochloride 0.300 g For the complete list of excipients , see section 6.1.

Excipients

Amobronc “15 mg / 2 ml - Solution for nebulisation” One ampoule contains: Excipients: Monobasic sodium phosphate, dibasic sodium phosphate, Water for injections. Amobronc “15 mg / 5 ml - Syrup for oral use” 100 ml of syrup contain: Excipients: Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Glycerol, Sorbitol solution 70%, Fruit flavor, Purified water.

Therapeutic indications

Treatment of disorders of the secretion of the respiratory system.

Contraindications

• The drug is contraindicated in children under 2 years of age (for oral and rectal use). • Hypersensitivity to the drug or its components. • Severe hepatic and / or renal disorders.

Dosage

Inhaled administration 15 mg ampoules. The contents of a vial are diluted with the same amount of water (2 ml) in the dispensing device. Adults: 2-3 ampoules per day. Children over 5 years: 2-3 ampoules per day. Children up to 5 years: 1-2 ampoules once a day. For maintenance therapy, to be established 8/10 days from the start of treatment, use the lowest recommended dosages. Oral administration Syrup. Each ml of syrup is equivalent to 3 mg of ambroxol hydrochloride. A measuring cup with notches corresponding to 2.5 - 5 - 10 ml is attached to the syrup package. Adults: 10 ml 2-3 times a day. Children over 5 years: 5 ml 2-3 times a day. The drug should preferably be taken during or after meals.

Warnings and Precautions

Mucolytics can induce bronchial obstruction in children less than 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 should therefore not be used in children less than 2 years of age (see section 4.3). In patients with peptic ulcer the drug should be administered with caution. In cases of bronchial asthma, resort to a spasmolytic before inhalation.

Interactions

Ambroxol does not interfere with other drugs such as cardioglycosides, corticosteroids, bronchodilators, antibiotics, drugs that have frequent concomitant use in lung diseases. It is not incompatible with anticoagulants or antidiabetics.

Side effects

At the recommended doses the drug is normally well tolerated. Rarely observed nausea, headache, gastrointestinal disturbances Frequency not known: bronchial obstruction.

Pregnancy and breastfeeding

Teratogenic and fetal toxicity studies on animals did not reveal any harmful effects of Amobronc, even at high doses. However, it is not advisable, as with all recently created drugs, to use it during the first three months of pregnancy; in the further period it will be administered only in case of real need and under the direct supervision of the doctor.