AMBROXOL Pharmaceutical form Tablets. Composition active

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AMBROXOL
Pharmaceutical form
Tablets.
Composition
active substance: аmbroxol;
1 tablet contains 30 mg of ambroxol hydrochloride, equivalent of 100% substance;
Excipients: potato starch, lactose monohydrate, calcium stearate.
Indications
Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with impaired
bronchial secretion and sputum expectoration.
Contraindications
Hypersensitivity to ambroxol hydrochloride and/or other components of the product; gastric and
duodenal ulcer, hereditary galactose intolerance; I trimester of pregnancy; lactation; children
under 12 years of age.
Dosage and administration
Tablets should be taken after meals with water.
In children over 12 years of age and adults the following regimen should be prescribed: during
the first 2-3 days: 1 tablet (30 mg) three times daily, then 1 tablet twice daily.
Duration of the treatment course – 4-14 days.
If the cough is getting worse the patient should consult a physician.
Side effects
Ambroxol is usually well tolerated. The following adverse reactions may occur:
- gastrointestinal disorders: nausea, vomiting, diarrhea, gastralgia, discomfort in the epigastric
area, mild heartburn;
- allergic reactions: skin rash, pruritus, urticaria, in isolated cases – contact dermatitis,
Quincke’s edema, anaphylactic shock; very rarely skin eruptions have been reported (StevensJohnson’s syndrome, Lyell’s syndrome);
- others: asthenia, headache, dysuria, rhinorrhea.
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