FUCIDIN Oral Suspension Ref.[6872] Active ingredients: Fusidic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Product name and form

Fucidin 250 mg/5 ml Oral Suspension.

Pharmaceutical Form

Suspension for oral administration.

Cream coloured suspension with odour of banana.

Qualitative and quantitative composition

Each 5 ml of Suspension contains 250 mg Fusidic Acid, Ph.Eur. (therapeutically equivalent to 175 mg Sodium Fusidate Ph.Eur.).

Excipients with known effect:

Glucose liquid 250 mg/1 ml suspension.

Sorbitol (E420) 100 mg/1 ml suspension.

Sodium 1.6 mg/1 ml suspension.

Orange dry flavour (containing sucrose) 400 mcg/1 ml suspension.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fusidic acid

Fusidic acid belongs to a unique group of antibiotics, the fusidanes, which act to inhibit bacterial protein synthesis by blocking the lengthening of factor G. Fusidic acid is active against staphylococcus epidermidis and methicillin resistant staphylococci.

List of Excipients

Acesulfame potassium
Banana flavour
Citric acid
Disodium phosphate dihydrate
Hydroxyethylcellulose
Glucose liquid
Methylcellulose
Orange dry flavour
Sodium benzoate (E211)
Sorbitol (E420)
Purified water

Pack sizes and marketing

Bottles of 50 ml.

Marketing authorization holder

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Marketing authorization dates and numbers

PL 00043/5014R

Date of first authorisation: 11 November 1986
Date of latest renewal: 20 June 2003

Drugs

Drug Countries
FUCIDIN Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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