BACTROBAN 2% Cream Ref.[9582] Active ingredients: Mupirocin

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. These inactive ingredients may cause local skin reactions (e.g. contact dermatitis).

No drug interactions have been identified.

Fertility

There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility (see section 5.3).

Pregnancy

Reproduction studies on mupirocin in animals have revealed no evidence of harm to the foetus (see section 5.3). As there is no clinical experience on its use during pregnancy, mupirocin should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

Breast-feeding

There is no information on the excretion of mupirocin in milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.

No adverse effects on the ability to drive or operate machinery have been identified.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk.yellowcard.

None known.