Ambrosan 60 mg tablets

Basic information

Composition

Ambroxol hydrochloride 60 mg in 1 tablet

Pharmacotherapeutic group

Expectorant and mucolytic agent (ATC code: R05CB06)

Therapeutic indications

Mucolytic treatment of acute and chronic bronchopulmonary diseases accompanied by abnormal production of mucus and its transport disorder (inflammations and infectious diseases of the upper and lower air passages), inflammatory rhino-pharyngeal diseases. 

Pharmacological properties

Ambroxol, a potent bromhexine metabolite, has secretolytic effects and at the same time by secretomotorically direct stimulation of cilia activity, it increases the creation of pulmonary surfactant, inactivates free oxygen radicals, improves penetration of some ATBs in the pulmonary tissue and decreases bronchial hyperactivity.

Pharmaceutical form

Tablets

More information

Posology and method of administration

  • Adults and children over 12 years of age: 1 tablet twice daily.This dosing pattern is appropriate for the therapy of acute respiratory diseases and initial treatment of chronic conditions for a period of 14 days.
  • Children 5–12 years of age: ¼ tablet 2–3 times daily.

Tablets should be taken after meals and sufficiently washed down. The mucolytic effect of ambroxol is enhanced by intake of fluid.The duration of treatment by Ambrosan 60 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, 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, especially in the first trimester the administration of ambroxol-containing medications is not recommended. Ambroxol gets into the breast milk and therefore the administration of this medicinal product during lactation is not recommended. 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

20, 30, 60, 100 and 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

9 March 2018

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