Ambroxolo Almus Syrup 30mg/10ml Bottle 200ml

NAME
AMBROXOLO ALMUS

PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with antitussives.

ACTIVE PRINCIPLES
Ambroxol hydrochloride.

EXCIPIENTS
Solution to be nebulized 15 mg / 2 ml: monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate, water for injections. Syrup 30 mg / 10 ml bottle 200 ml: hydroxyethylcellulose; sorbitol 70%; glycerol; benzoic acid; black cherry aroma; propylene glycol; tartaric acid; purified water. Syrup 30 mg / 10 ml single-dose containers of 10 ml: hydroxyethylcellulose; sorbitol 70%; glycerol; benzoic acid; black cherry aroma; propylene glycol; tartaric acid; purified water.

INDICATIONS
Treatment of secretion disorders in acute and chronic bronchopulmonary affections.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; severe liver and / or kidney changes; the drug is contraindicated in children younger than 2 years (for oral forms).

DOSAGE
>> Solution to be sprayed. Adults: 2-3 ampoules per day. Children up to 5 years: 1-2 ampoules per day. Children over 5 years: 2-3 ampoules per day. As coughing can occur in deep breathing of aerosols, you should try to breathe normally during inhalation. It is advisable to warm the solution to body temperature before inhalation. In patients with bronchial asthma it is recommended to administer the usual bronchospasmolytic before inhalation. The solution to be nebulized can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in the ratio 1: 1. >> Syrup. Adults: 10 ml (30 mg) 3 times a day. Children 2 to 5 years: 2.5ml (7.5mg) 3 times a day. Children over 5 years: 5 ml (15 mg) 3 times a day. It is recommended to take the syrup after meals. Do not use ambroxol for prolonged treatment.

STORAGE
None.

WARNINGS
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 aged less than 2 years (for oral forms). The syrup contains sorbitol. It can cause gastric upset and diarrhea; glycerol; benzoic acid. It may increase the risk of jaundice in infants. Ambroxol should be administered with caution in patients with peptic ulcer.

INTERACTIONS
The product generally does not interfere with other medications.

SIDE EFFECTS
Rarely: tiredness, dry mouth, rhinorrhea, dysuria, headache, gastrointestinal disturbances (heartburn, dyspepsia, constipation, nausea and vomiting), contact dermatitis or other allergic reactions (especially skin rashes). Bronchial obstruction: frequency unknown.

PREGNANCY AND BREASTFEEDING
For ambroxol, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Caution should be exercised when prescribing the medicine to pregnant women. During pregnancy, drugs should only be prescribed if the expected benefit to the mother is considered to be greater than the risk to the fetus. All medications should be avoided, if possible, during the first trimester of pregnancy. The drug is secreted in breast milk. The use of ambroxol by the mother can 'cause undesirable effects in the infant; therefore a decision must be made whether to discontinue breastfeeding or treatment with the drug, taking into account the importance of the drug for the mother.