Mucosolvan Syrup Special Precautions

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 like 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 (Mucosolvan) may be used only after consulting a physician.
Syrup 30 mg/5 mL: 5 mL syrup or infant drops contain 1.2 g sorbitol resulting in 4.9 g sorbitol per maximum recommended daily dose (20 mL). Patients with rare hereditary condition of fructose intolerance should not take this medicine.
Syrup 15 mg/5 mL: 5 mL syrup contains 1.2 g sorbitol resulting in 7.4 g sorbitol per maximum recommended daily dose (30 mL). Patients with rare hereditary condition of fructose intolerance should not take this medicine. It may also have a mild laxative effect.
Effects on ability to drive and use machines: There is no evidence from postmarketing data for an effect on ability to drive and use machines. Studies on the effects on the ability to drive and use machines have not been performed.