Ambroxolo Hexal 7.5mg/ml Solution To Nebulize 100ml

NAME
AMBROXOL HEXAL

PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with antitussives.

ACTIVE PRINCIPLES
Ambroxol hydrochloride.

EXCIPIENTS
Solution to be sprayed: methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium metabisulfite; citricomonohydrate acid; sodium hydroxide; purified water. Syrup: benzoic acid; sodium metabisulfite; citric acid monohydrate; sodium hydroxide; povidone; sorbitol, 70% solution; glycerol 85%; sodium cyclamate; raspberry flavoring; 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.

DOSAGE
>> Solution to be sprayed. Adults and children older than 5 years: 2-3 ml of solution 1-2 times a day. Children younger than 5 years: 2 ml of solution 1-2 times a day. Since coughing may occur in deep breathing of aerosols, one should try to breathe normally during inhalation. It is recommended to warm the solution to body temperature before inhalation. In patients with bronchial asthma it is recommended to administer the usual bronchospasmolytic before inhalation. >> Syrup. Adults: 10 ml (30 mg) 3 times a day. Children up to 2 years: 2.5 ml (7.5 mg) 2 times a day. Children 2 to 5 years: 2.5 ml (7.5 mg) 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 treatments.

STORAGE
Solution to be sprayed: store at a temperature not exceeding 25 degrees C. Syrup: no special precautions for storage.

WARNINGS
The solution to be sprayed and the syrup contain sodium metabisulfite; in sensitive individuals, especially those with a history of asthma or allergy, it can cause allergic-type reactions including symptoms of anaphylaxis and bronchospasm. The syrup medicinal product also contains sorbitol: unsuitable for hereditary fructose intolerance. It can cause stomach upset and diarrhea. Glycerol: dangerous in high doses. It can cause migraines, stomach upset and diarrhea. Acidobenzoic: mild irritant to skin, eyes and mucous membranes. It may increase the risk of jaundice in infants. The solution to be sprayed also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: they can cause allergic reactions (even delayed) and, exceptionally, bronchospasm. Ambroxol should be administered with caution to patients with peptic ulcer.

INTERACTIONS
The medicine generally does not interfere with other medications.

SIDE EFFECTS
The following side effects have been observed after taking the product. General symptoms. Uncommon (> = 0.1% - <1%): hypersensitivity reactions (exanthema, dyspnoea, pruritus), angioedema (rapid onset swelling that can affect the face and throat in particular), fever. Very rare (<0.01%): anaphylactic reactions, including anaphylactic shock. Gastrointestinal tract. Common (> = 1% - <10%): diarrhea; uncommon (> = 0.1% - <1%): nausea, abdominal pain, vomiting. Skin. Very rare (<0.01%). severe skin reactions, such as epidermal necrolysis and Steven Johnson syndrome; infrequently: tiredness, dry mouth, rhinorrhea, dysuria, headache, gastrointestinal disturbances (heartburn, dyspepsia, constipation, nausea and vomiting), contact dermatitis or other allergic reactions (especially skin rashes).

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. Although preclinical studies and extensive clinical experience have not shown any harmful effects 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.