CARBOCISTEINE Oral solution in sachet Ref.[6299] Active ingredients: Carbocisteine

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Intrapharm Laboratories Limited, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT, UNITED KINGDOM

Product name and form

Carbocisteine unither pharmaceuticals 750mg/10ml sugar-free oral solution in sachet.

Carbocisteine 750mg/10ml sugar-free oral solution in sachet.

Pharmaceutical Form
Oral solution in sachet. Limpid, viscous, light brown solution.

Qualitative and quantitative composition

Each 10 ml of oral solution contains 750 mg of carbocisteine

Excipients with known effect:

sodium methyl para-hydroxybenzoate (E219) 15mg per dose
sorbitol liquid (non-crystallising) 1.3g per dose
maltitol, liquid 1.3g per dose
sodium 97.5mg per dose
ethanol (trace)

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Carbocisteine	Carbocisteine (5-carboxymethyl L-cysteine) has been shown in normal and bronchitic animal models to affect the nature and amount of mucus glycoprotein that is secreted by the respiratory tract. An increase in the acid:neutral glycoprotein ratio of the mucus and a transformation of serous cells to mucus cells is known to be the initial response to irritation and will normally be followed by hypersecretion.

List of Excipients
Saccharin sodium Sodium methyl para-hydroxybenzoate (E219) Hydroxyethylcellulose Caramel/vanilla flavouring (contains ethanol) Sorbitol liquid (non-crystallising) Maltitol liquid Sodium hydroxide* Purified water * sodium hydroxide pellets or sodium hydroxide 30 % solution can be used

Pack sizes and marketing

10 ml sachet (PET/Aluminium/PE); box of 10, 12 or 15.

Not all pack sizes may be marketed.

Marketing authorization holder

Intrapharm Laboratories Limited, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT, UNITED KINGDOM

Marketing authorization dates and numbers

PL 17509/0074

26^th March 2015

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