MEDOFED COMPOUND Oral solution Ref.[28366] Active ingredients: Demorphan Guaifenesin Pseudoephedrine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medofed Compound Oral Solution.

Pharmaceutical Form

Oral Solution.

Red, clear, flavored solution.

Qualitative and quantitative composition

Each 5 ml of Medofed Compound oral solution contains 100 mg Guaifenesin, 15 mg Dextromethorphan hydrobromide, 20 mg Pseudoephedrine hydrochloride and 1.25 mg Triprolidine hydrochloride.

Excipients with known effect: propylene glycol, sucrose, sorbitol.

Each 5 ml of Medofed Compound contain 250 mg propylene glycol, 1150 mg sucrose and 2960 mg sorbitol 70%.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Demorphan

Dextromethorphan is a non-opioid antitussive drug. The major metabolite of dextromethorphan, dextrorphan, binds with high affinity to σ-receptors to produce its antitussive activity without exhibiting the classic opiate effects that occur from binding into μ- and δ-receptors. In larger than therapeutic doses, dextrorphan is also an antagonist of N-methyl-D-aspartate (NMDA) receptors.

Guaifenesin

Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions. Guaifenesin is over-the-counter drug for the treatment of cough and common cold.

Pseudoephedrine

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.

List of Excipients

Propylene glycol
Glycerol
Sorbitol 70%
Sodium benzoate
Sucrose
Sodium saccharin
Citric acid
Ponceau red E124
Acacia gum
Ethanol absolute
Peppermint oil
Cherry Morella
Purified water

Pack sizes and marketing

Amber glass bottles having metal roll-on closures or plastic screw caps. Each cap type is pilfar proof lined with atoxic polyvinyl chloride liner. Bottles containing either 100 ml, 150 ml or 200 ml of Medofed Compound are available. Measuring spoon is provided inside the carton box.

Not all pack sizes may be available.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

19889

Date of first authorisation: 28/12/2005
Date of Renewal Authorisation: 29/01/2015

Drugs

Drug Countries
MEDOFED COMPOUND Cyprus

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