Amxolstad 30 mg/10 ml

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

• Children up to 2 years: Take 2.5 ml twice a day (equivalent to 15 mg ambroxol hydrochloride per day).
• Children from 2 to 5 years: Take 2.5 ml three times daily (equivalent to 22.5 mg ambroxol hydrochloride per day).
• Children from 6 to 12 years: Take 5 ml two to three times daily (equivalent to 30 – 45 mg ambroxol hydrochloride per day).
• Adults and adolescents from 12 years: Take 10 ml three times daily (equivalent to 90 mg ambroxol hydrochloride per day) for the first 2 – 3 days and 10 ml twice a day (equivalent to 60 mg ambroxol hydrochloride per day) thereafter.
  For adults and adolescents from 12 years of age, the therapeutic effect may be enhanced by increasing the dosage to 20 ml twice a day (equivalent to 120 mg ambroxol hydrochloride per day).
• Amxolstad 30 mg/10 ml should not be taken for longer 4 – 5 days without the advice of a doctor.

Usage

• Administered orally, with or without food. Using the measuring cup inside the box to measure the volume.

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

Common

• Nausea and oral hypoaesthesia;
• Dysgeusia (e.g. change taste);
• Pharyngeal hypoaesthesia.

• 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.
• Because of a possible build-up of secretion, Amxolstad 30 mg/10 ml should be used with caution in disturbed bronchomotor function and large quantities of secretion (e.g. in the rare primary ciliary dyskinesia).
• In the event of renal insufficiency or severe hepatopathy, ambroxol hydrochcloride may only be used after consultation with a doctor.
• Amxolstad 30 mg/10 ml contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
• Amxolstad 30 mg/10 ml contains sodium benzoate which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
• Amxolstad 30 mg/10 ml is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
• 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.