Ambroxol hydrochloride 30 mg

OTC

Indications

• Secretolytic therapy in acute and chronic diseases of the respiratory tract accompanied by abnormal bronchial secretions, particularly in exacerbation of chronic bronchitis, asthmatic bronchitis.

Dosage

• Adults and children > 10 years: 30 – 60 mg, 2 times daily.
• Children 5 – 10 years: 15 – 30 mg, 2 times daily.

Administration

• Administered orally with liquid, after meals.

• Hypersensitivity to ambroxol or to any ingredient in the formulation.
• Active peptic ulcer.

Possible adverse reactions:

• Nausea.

• Patients with peptic ulcers and those with hemoptysis because ambroxol can lyse fibrin coagulates and therefore new bleeding. Only treat ambroxol for a short time, a doctor should be consulted if there is no improvement during treatment.
• There have been reports of severe cutaneous adverse reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthemous pustulosis (AGEP) associated with the use of ambroxol hydrochloride. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.
• In the event of renal insufficiency or severe hepatopathy, ambroxol hydrochcloride may only be used after consultation with a doctor.
• Ambroxol hydrochloride 30 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Ambroxol hydrochloride is not recommended during the first trimester and lactation.
• Patients should be aware of how they react to drug before driving or operating machinery.