MEDOFED Oral solution Ref.[28365] Active ingredients: Pseudoephedrine

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

Product name and form

Medofed 30mg/1.25mg per 5ml oral solution.

Pharmaceutical Form

Oral solution.

Clear, yellow, flavoured solution for oral administration.

Qualitative and quantitative composition

Each 5ml of solution contains 30mg pseudoephedrine hydrochloride and 1.25 mg triprolidine hydrochloride.

Excipients with known effect: sucrose, methyl para-hydroxybenzoate, tartrazine yellow lake.

Each 5ml of oral solution contain 3500mg sucrose, 5mg methyl para-hydroxybenzoate and 0.08mg tartrazine yellow lake.

For the full list of excipients, see section 6.1.

Active Ingredient Description
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

Sucrose
Glycerol
Methyl para-Hydroxybenzoate (Ε218)
Sodium Benzoate (E211)
Tartrazine Yellow Lake (E102)
Strawberry flavour
Purified Water

Pack sizes and marketing

Amber glass bottles having metal roll on closures or plastic screw caps. Each cap type pilar proof lined with atoxic polyvinyl chloride liner.

Bottles containing either 100 ml or 150 ml or 200 ml of Medofed are available. Measuring spoon is provided inside the carton box.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

19978

Date of first authorisation: 20/12/2005
Date of renewal authorisation: 30/07/2013

Drugs

Drug Countries
MEDOFED Cyprus, Malta

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