BACTROBAN Nasal ointment Ref.[7727] Active ingredients: Mupirocin

Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Nasal Ointment, treatment should be discontinued, the product should be wiped away 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.

This mupirocin nasal ointment formulation is not suitable for ophthalmic use.

Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.

No drug interactions have been identified.

Pregnancy

Reproduction studies on Bactroban 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, Bactroban 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 Bactroban in milk.

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).

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

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), including isolated reports.

Uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 422 treated patients encompassing 12 clinical studies. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.

Immune system disorders

Very rare: Cutaneous hypersensitivity reactions. Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema.

Respiratory, thoracic and mediastinal disorders

Uncommon: Nasal mucosa reactions.

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.