Amxolstad 60 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 1.25 ml twice a day.
• Children from 2 to 5 years: Take 1.25 ml three times daily.
• Children from 6 to 12 years: Take 2.5 ml two to three times daily.
• Adults and adolescents from 12 years: Take 5 ml three times daily for the first 2 – 3 days and 5 ml twice a day thereafter. Therapeutic effect may be enhanced by increasing the dosage to 10 ml twice a day.
  In principle, the duration of use is not limited on medical advice. Nevertheless, Amxolstad 60 mg/10 ml should not be taken for longer 4 – 5 days without the advice of a doctor.

Usage

Amxolstad 60 mg/10 ml is administered orally, with or without food.

• 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.
• Uncommon
  Vomiting, dyspepsia, diarrhea, abdominal pain and dry mouth.

• Patients with peptic ulcers and those with hemoptysis because ambroxol can lyse fibrin coagulates and therefore new bleeding.
• 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 are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.
• Because of a possible build-up of secretion, Amxolstad 60 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. As with any medicinal product exhibiting hepatic metabolism followed by renal elimination, an accumulation of hepatic ambroxol metabolites is to be expected in severe renal impairment.
• Amxolstad 60 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 60 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 60 mg/10 ml is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
• Pregnancy: The use of ambroxol hydrochloride is not recommended in the first trimester of pregnancy.
• Ambroxol hydrochloride is not recommended for use in nursing mothers.
• The effects on the ability to drive and use machines have not been studied.Patients should be aware of how they react to drug before driving or operating machinery.