MUCODYNE Syrup Ref.[27671] Active ingredients: Carbocisteine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Mucodyne 250 mg/5 ml Syrup.

Mucodyne 250 mg/5 ml Paediatric Syrup.

Pharmaceutical Form

Syrup.

A clear amber-coloured syrupy liquid.

Qualitative and quantitative composition

Each 5 ml of oral solution contains 250 mg of Carbocisteine.

Excipient(s) with known effect:

Also contains 2 g of sucrose, 67.2 mg of ethanol (1.6% v/v), 7.5 mg of methyl parahydroxybenzoate (E218) and 32.52 mg of sodium (1.4 mmol).

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

Methyl parahydroxybenzoate (E218)
Sucrose
Caramel powder (E150)
Aromatic Elixir (containing ethanol and aromatic flavourings)
Cinnamon oil
Sodium hydroxide
Purified water

Pack sizes and marketing

*125 ml, 200 ml, 250 ml or 300 ml clear glass bottle (Type III glass) and a polypropylene childproof, tamper-evident screw cap with polyethylene liner together with a graduated polypropylene beaker for oral dose delivery to adults.

125 ml clear glass bottle (Type III glass) and a polypropylene childproof, tamper-evident cap with a polyethylene liner together with a 5 ml CE marked graduated syringe for oral dose delivery in children.

* The 125 ml pack size only will be provided with a syringe composed of a polyethylene barrel and a polystyrene piston with graduation markings each of 0.25 ml on the outside of the barrel.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as:

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0204

Date of first authorisation: 03 November 1972
Date of latest renewal: 12 February 2003

Drugs

Drug Countries
MUCODYNE Japan, Netherlands, United Kingdom, South Africa

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