BACTROBAN

Posology Adults/children ≥ 1 year/elderly 3 times a day for up to 10 days, depending on the response. Patients not showing a clinical response within 3 to 5 days should be re-evaluated. The duration of treatment should not exceed 10 days.

Children < 1 year The safety and efficacy of Bactroban Cream in children aged less than one year have not yet been established. No data are available. Hepatic impairment No dosage adjustment is necessary. Renal impairment No dosage adjustment is necessary.

Method of administration A thin layer of cream should be applied to the affected area with a piece of clean cotton wool or gauze swab. The treated area may be covered by a dressing. Do not mix with other preparations, as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the cream.

Data from clinical trials was used to determine the frequency of very common to rare undesirable effects. Very rare adverse reactions were primarily determined from post- marketing experience data and therefore refer to reporting rate rather than true frequency.

The following convention has been used for the classification of frequency:- very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1000 and <1/100, rare ≥1/10,000 and <1/1000 , very rare <1/10,000.

Immune system disorders:

Very rare: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema Skin and subcutaneous tissue disorders: Common: Application site hypersensitivity reactions including urticaria, pruritus, erythema, burning sensation, contact dermatitis, rash Skin dryness and erythema have been reported in irritancy studies in volunteers.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. yellowcard

Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Cream, treatment should be discontinued, the product should be washed off and appropriate therapy instituted. As with other antibacterial products, prolonged use may result in overgrowth of non- susceptible organisms.

Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use.

Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.

Bactroban Cream formulation is not suitable for ophthalmic use and intranasal use. Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the cream residues have been removed. Bactroban Cream contains cetyl alcohol and stearyl alcohol.

g. contact dermatitis). Bactroban Cream also contains 153 mg benzyl alcohol in each 15 g tube. This inactive ingredient may cause mild local irritation.

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