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Tablet: There have been very few reports of severe skin lesions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants such as ambroxol hydrochloride. Mostly these could be explained by the severity of the patient's underlying disease and/or concomitant medication. In addition during the early phase of a Stevens-Johnson Syndrome or TEN, a patient may first experience non-specific influenza-like prodromes e.g. fever, aching body, rhinitis, cough and sore throat. Misled by these non-specific influenza-like prodromes, it is possible that a symptomatic treatment is started with a cough and cold medication.
Therefore if new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with ambroxol hydrochloride discontinued as a precaution.
In the presence of impaired renal function, Ambroxol hydrochloride (AMBROXYL) may be used only after consulting a physician.
Syrup: Severe skin lesion such as Stevens-Johnson syndrome and Lyell's syndrome have been reported rarely with the administration of mucolytics such as Ambroxol. These may be due to the severity of the underlying disease or concomitant medication. If new skin or mucosal lesions occur, patient should discontinue Ambroxol and consult a physician immediately.
When should a patient consult a doctor: Tablet: A doctor should be consulted if the cough persists for more than 14 days and if symptoms do not improve or if new symptoms appear.
If the patient has any further questions on the use of this product, he/she should consult a doctor.
Syrup: If symptoms do not improve or new symptoms appear.
If undesirable effect develops.
