RIABROXOL SYRUP : patient information leaflet

RIABROXOL has been shown to increase respiratory tract secretion. It enhances pulmonary surfactant production and stimulates ciliary activity. Improvement of mucociliary clearance has been shown in clinical pharmacological studies. Enhancement of fluid secretion and mucociliary clearance facilitates expectoration and eases cough.

INDICATIONS

RIABROXOL is indicated as mucolytic.

DOSAGE

  • Adults and children over 12 years: 10 ml 3 times daily. For the therapy of acute respiratory tract disorders and for the initial treatment of chronic condition up to 14 days, the dose may be increased to 20 ml 2 times daily.
  • Children 6 to 12 years: 5 ml 2 to 3 times daily.
  • Children 2 to 6 years: 2.5 ml 3 times daily.
  • Children under 2 years: 2.5 ml 2 times daily.

CONTRAINDICATIONS

Ambroxol Hydrochloride should not be used in patients known to be hypersensitive to Ambroxol or other components of the formulation.

DRUG INTERACTIONS

Administration of Ambroxol together with antibiotics (amoxycillin, cefuroxime, erythromycin and doxycycline) may lead to a higher antibiotic concentration in the lung tissue. No clinically relevant unfavourable interaction with other medications has been reported.

PRECAUTIONS

Ambroxol Hydrochloride should be taken at meal times.

ADVERSE REACTIONS

Allergic reactions and mild gastro-intestinal side effects have been rarely reported.

USE DURING PREGNANCY AND LACTATION

  • The usual precautions regarding the use of drugs during pregnancy, especially during the first trimester, should be observed.
  • The drug is excreted in breast milk, but is not likely to affect the infant when therapeutic doses are used. In both cases, consult the doctor before use.

OVERDOSAGE

  • In case of overdose, patients may suffer from increased salivation, retching, vomiting and drop in blood pressure.
  • In case of accidental or intentional extreme overdosage, the cardiovascular system should be monitored and if necessary, symptomatic measures should be taken.

COMPOSITION

  • Each 5 ml contains: Ambroxol Hydrochloride (BP) 15 mg.
  • Other ingredients: benzoic acid, Sorbitol solution 70% non-cryst., glycerol, citric acid, orange cream flavour (11022-36) and purified water.

STORAGE

  • Store at temperature (15 to 25) °C.
  • Do not use the drug after the expiry date printed on the package.

PRESENTATIONS

Syrup: 100 ml bottles.

This is a medicament

  • A medicament is a product, which affects your health, and its consumption contrary to instructions is dangerous for you.
  • Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
  • The doctor and the pharmacist are experts in medicine, its benefits and risks.
  • Do not by yourself interrupt the period of treatment prescribed for you.
  • Do not repeat the same prescription without consulting your doctor.
  • Keep medicaments out of the reach of children.

For Arabic information: ريابروكسول شراب(أمبروكسول هيدروكلوريد) المقشع والمذيب للبلغم

riabroxol syrup: patient information leaflet