BISOLVON Oral solution Ref.[9892] Active ingredients: Bromhexine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Bisolvon 4mg/5ml Oral Solution.

Pharmaceutical Form

Oral solution.

A clear to almost clear, colourless to almost colourless solution with a fruity aromatic odour.

Qualitative and quantitative composition

Each 5 ml contains bromhexine hydrochloride 4 mg.

Excipients: contains maltitol liquid.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Bromhexine

Bromhexine is an expectorant used in the treatment of respiratory disorders associated with viscid or excessive mucus. Bromhexine is a synthetic derivative of the herbal active ingredient vasicine. It has been shown to increase the proportion of serous bronchial secretion, making it more easily expectorated. It is indicated as “secretolytic therapy in bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport”.

List of Excipients

Maltitol liquid (E965)
Sucralose (E955)
Benzoic acid (E210)
Cherry aroma 96323-33
Chocolate aroma 96534-33
Levomenthol
Water, purified

Pack sizes and marketing

Bisolvon Oral Solution is available in amber type III glass bottles with tamper-evident polyethylene caps with low density polyethylene liners. The registered pack sizes are 100 ml, 200 ml, and 250 ml.

Not all pack sizes may be marketed.

A polypropylene measuring dish is provided.

Marketing authorization holder

Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0540/180/001

Date of first authorisation: 14 November 1984
Date of last renewal: 01 April 2008

Drugs

Drug Countries
BISOLVON Austria, Brazil, Germany, Ecuador, Finland, France, Croatia, Ireland, Japan, Malta, Mexico, Netherlands, New Zealand, United Kingdom, South Africa

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