2               QUALITATIVE AND QUANTITATIVE COMPOSITION

            Fucidin^® Ointment contains Sodium Fusidate Ph.Eur.2% .

Excipient: cetyl alcohol

Excipient: lanolin

For full list of excipients, see section 6.1

4.3              Contraindications

Known hypersensitivity to fusidic acid/sodium fusidate or to any of the excipients.

            Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa.

            Fucidin ointment is contra-indicated in patients with hypersensitivity to fusidic acid and its salts.

4.4                 Special warnings and precautions for use

The sodium salt of fusidic acid has been shown to cause conjunctival irritation.  The ointment should not be used in or near the eye.  Bacterial resistance has been reported to occur with the use of fusidic acid applied topically.  As with all topical antibiotics, extended or recurrent use application may increase the risk of developing contact sensitisation and the development of antibiotic resistance.

Extended or recurrent use may increase the risk of developing contact sensitisation.

Fucidin^® Ointment contains cetyl alcohol and lanolin, which may cause allergic reactions (possibly delayed).

4.5                 Interaction with other medicinal products and other forms of interaction

                Not applicable.

            None known.

4.7                 Effects on ability to drive and use machines

            Not applicable.

            Fucidin^® administered topically has no or negligible influence on the ability to drive and to use machines.

4.8                 Undesirable effects

            Hypersensitivity reactions to the active ingredient in the form of skin rashes, mild stinging and irritation on application have been reported rarely.

            Based on combined clinical data for Fucidin^® cream and Fucidin^® ointment, less than 5% of patients can be expected to experience an undesirable effect.

            The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions.

            Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

            Very common ≥1/10

            Common ≥1/100 and <1/10

            Uncommon ≥1/1,000 and <1/100

            Rare ≥1/10,000 and <1/1,000

            Very rare <1/10,000

            Not known (cannot be estimated from the available data)

                      Immune system disorders

                      Rare

            Hypersensitivity

                      Eye disorders

                      Rare

            Conjunctivitis

            Skin and subcutaneous tissue disorders

            Uncommon

                      Pruritus

                      Rash including erythematous, maculo-papular and pustular reactions

                      Contact Dermatitis

                      Irritation at site of application (including pain, stinging, burning and erythema)

                      Not known

                      Urticaria

                      Angioedema

                      Eczema

                      Periorbital oedema

4.9                 Overdose

            Not applicable.

            Overdose is unlikely to occur.

            Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Fucidin^® ointment is unlikely to cause any harm. The total quantity of fusidic acid (30g Fucidin^® ointment contains 576mg fusidic acid) will usually not exceed the approved total daily oral dose of fusidic acid containing products except in children aged less than 1 year and weighing ≤ 10kg. Although in this instance a child of this particular age group is unlikely to ingest a whole tube of Fucidin^® ointment. The concentration of the excipients is too low to constitute a safety risk.

10             DATE OF REVISION OF THE TEXT

May 1998   5 August 2010