Ambrosan 30 mg

Basic information

Composition

Ambroxol hydrochloride 30 mg in 1 tablet

Pharmacotherapeutic group

Expectorant and mucolytic agent (ATC code: R05CB06)

Therapeutic indications

Secretolytic treatment of acute and chronic bronchopulmonary diseases that are associated with abnormal sputum secretion and mucus transport disturbances.

Pharmacological properties

Ambroxol increases sputum secretion in the respiratory tract and normalizes mucous viscosity. It increases the formation of pulmonary surfactant and stimulates the cilia. This action leads to an improvement in mucous transport (mucociliary clearance). Increasing sputum secretion and mucociliary clearance facilitates expectoration and eases coughs. Ambroxol reduces bronchial hyperreactivity, increases IgA secretion in bronchial secretions, and has an antioxidant effect.

Pharmaceutical form

Tablets

More information

Posology and method of administration

  • Adults and adolescents over 12 years of age: 1 tablet thrice daily.

 Therapeutic effect may be enhanced by administering 2 tablets twice daily.

  •  Children 5–12 years of age: 0.5 tablet 2–3 times daily.

 Tablets should be taken after meals and should be sufficiently washed down. The mucolytic effect of ambroxol is enhanced by intake of fluid.

The duration of treatment by Ambrosan30 mg is determined individually, depending on therapeutic indications and type of disease.

Contraindications

Hypersensitivity to active substance or any of the excipients of this product, acute ulceration of the gastrointestinal tract.

Interactions

Concomitant administration with antitussive agents may result in dangerous secretion congestion. Ambroxol administered concomitantly with antibiotics (amoxicillin, cefuroxime and erythromycin) results in increased concentration of antibiotics in bronchopulmonary secretion and in sputum. This effect may be used for therapeutic purposes.

Undesirable effects

Ambrosan may cause nausea. In isolated cases, there may be vomiting, diarrhoea, dyspepsia, abdominal pain, rash or urticaria.

Special warnings and precautions for use

In patients with impaired renal function or severe hepatic damage, ambroxol may be administered only with extra caution. During pregnancy, general principles of drug administration should be followed; administration of ambroxol-containing medications is not recommended especially during the first trimester. As Ambroxol passes into the breast milk, administration of this medicinal product is not recommended during lactation. Serious skin reactions have been reported, such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP). If symptoms or signs of progressive skin rashes appear (sometimes in the form of blisters or mucosal lesions), it is necessary to immediately stop taking ambroxol-hydrochloride and seek medical assistance.

Availability

The medicinal product is sold over the counter and is not covered by health insurance.

Contents of container

10, 20, 30, 60, 100 or 500 tablets

Package available in the Czech Republic

20 tablets

SPC and PIL

Detailed information

For more detailed product information, see the Summary of Product Characteristics.

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

5 February 2019

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