Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Mupirocin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Bactroban 2% Cream (called 'Bactroban' in this leaflet) contains a medicine called mupirocin calcium. Bactroban is an antibiotic cream. It is used:
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e Bactroban
Do not use Bactroban:
Other medicines and Bactroban Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If a cracked nipple is being treated, the cream must be thoroughly washed off prior to breast-feeding. Bactroban contains cetyl alcohol, stearyl alcohol and benzyl alcohol. Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis) where you apply the cream. Benzyl alcohol may cause mild local irritation. See also section 4.
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Bactroban
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Using this medicine Do not mix Bactroban with any other external cream or ointment medicines on the infected area of your skin as this may reduce the effectiveness of Bactroban. You usually apply Bactroban on your skin up to 3 times a day. 1. Wash and dry your hands. 2. Place a small amount of Bactroban on a clean cotton wool pad or gauze swab. 3. Apply the cream to the infected area of your skin. 4. You can cover the treated area with a plaster or other suitable dressing, unless your doctor has told you to leave it uncovered. 5. Replace the cap on the tube and wash your hands. How long should you use Bactroban for? Use Bactroban for as long as your doctor has told you. If you are not sure, ask your doctor, pharmacist or nurse. The bacteria are normally cleared from your skin within 10 days of starting treatment. Do not use for more than 10 days. Throw away any cream that is left over. If your skin condition does not improve within 3 to 5 days, see your doctor. If you swallow any or use more Bactroban than you should
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Like all medicines, this medicine can cause side effects, although not everybody gets them. Conditions to look out for Severe skin reactions or allergies These are very rare in people using Bactroban. Signs include:
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Bactroban Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not freeze. Do not use this medicine after the expiry date which is stated on the tube. The expiry date refers to the last day of that month. Do not use this medicine if it looks different to normal. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Bactroban contains
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Bactroban is available in a 15 g tube. Each tube comes in a carton.
Marketing authorisation holder and manufacturer Marketing Authorisation Holder Beecham Group plc 79 New Oxford Street London WC1A 1DG United Kingdom
Manufacturer Glaxo Wellcome Operations Harmire Road Barnard Castle Co Durham DL12 8DT GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin 24 Ireland
Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only) Please be ready to give the following information: Product name
Bactroban 2% Cream
Reference number
00038/0372
This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in November 2024 Trade marks are owned by or licensed to the GSK group of companies © 2024 GSK group of companies or its licensor
Bactroban 2% Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Bactroban 2% Cream is mupirocin.
This leaflet reproduces the patient information leaflet approved for Bactroban 2% Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Bactroban Cream is indicated for the topical treatment of secondarily infected traumatic lesions such as small lacerations, sutured wounds or abrasions (up to 10cm in length or 100cm2 in area), due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.
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.
Hypersensitivity to mupirocin or to any of the excipients listed in section 6.1.
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).
Bactroban Cream also contains 153 mg benzyl alcohol in each 15 g tube. This inactive ingredient may cause mild local irritation.
No interaction studies have been performed.
Pregnancy
Animal studies do not indicate reproductive toxicity (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
It is unknown whether mupirocin /metabolites are excreted in human milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.
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).
Bactroban Cream has no or negligible influence on the ability to drive and use machines.
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
Symptoms
There is currently limited experience with overdosage of Bactroban Cream.
Management
There is no specific treatment for an overdose of Bactroban Cream. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Bactroban 2% Cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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