Amobronc Syrup 0.3% Mucolytic Ambroxol 200ml

NAME
AMOBRONC 3 MG / ML - SYRUP

PHARMACOTHERAPEUTIC CATEGORY
Mucolytics, expectorants.

ACTIVE PRINCIPLES
100 ml of syrup contain: ambroxol hydrochloride 0.300 g.

EXCIPIENTS
100 ml of syrup contain: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, glycerol, 70% sorbitol solution, fruit flavor, purified water.

INDICATIONS
Treatment of disorders of the secretion of the respiratory system.

CONTRAINDICATIONS / SECONDARY EFFECT
The drug is contraindicated in children younger than 2 years (for oral use). Hypersensitivity 'to the active substance or to any of the excipients. Severe hepatic and / or renal disorders.

DOSAGE
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 syrup should preferably be taken during or after meals.

STORAGE
No special storage precautions.

WARNINGS
Syrup: mucolytics can induce bronchial obstruction in children younger 'less than 2 years. 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 younger 'less than 2 years. In patients with peptic ulcer the drug should be administered with caution. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with administration. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol should be stopped immediately and a physician consulted. Contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. Contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (including delayed type).

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. Not known: bronchial obstruction. Disorders of the immune system. Rare: hypersensitivity reactions; not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Skin and subcutaneous tissue disorders. Rare: rash, hives; not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis). Report any suspected adverse reactions via the national reporting system

PREGNANCY AND BREASTFEEDING
Studies of teratogenesis and fetal toxicity on animals have not shown any harmful effects of Amobronc, even at high doses. However, as with all recently created drugs, it is not advisable 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.