Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Bactroban 2% Cream

⚠ This medicine appears to have been discontinued

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.

Active substance: Mupirocin
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Bactroban 2% Cream (called 'Bactroban' in this leaflet) contains a medicine called mupirocin calcium. Bactroban is an antibiotic cream. It is used:

  • to treat infections on your skin in small cuts, lacerations, wounds or on scraped skin, by killing bacteria causing infections on your skin called 'Staphylococcus aureus' and 'Streptococcus pyogens'. Treatment should not exceed 10 days. You must talk to a doctor if you do not feel better or if you feel worse during treatment.

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What you need to know before you take it

e Bactroban

Do not use Bactroban:

  • if you are allergic (hypersensitive) to mupirocin calcium, mupirocin or any of the other ingredients of this medicine (listed in section 6)
  • if the patient is less than 1 year old. If you are not sure if this applies to you, do not use this medicine. Talk to your doctor, pharmacist or nurse before using Bactroban. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Bactroban. Bactroban can cause severe skin reactions or allergies. See 'Conditions to look out for' in section 4. Thrush (a yeast infection) may develop if Bactroban is used for a long time. On the skin this looks like bright red spots which may be very itchy. On occasion small pustules may be present in the middle. If this occurs, tell your doctor, pharmacist or nurse. Keep the cream away from your eyes.
  • If the cream gets into your eyes accidentally, wash them thoroughly with water.

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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How to take it

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

  • If you use more Bactroban than you should, speak to your doctor, pharmacist or nurse for advice.
  • If you swallow any of the cream, contact your doctor immediately and indicate what and how much you have swallowed. If you forget to use Bactroban
  • If you forget to apply Bactroban, apply it as soon as you remember.
  • If your next dose is due within an hour, skip the missed dose.
  • Do not use a double dose to make up for a forgotten dose. If you stop using Bactroban If you stop using Bactroban too early, not all the bacteria may have been killed or they may continue to grow. Ask your doctor, pharmacist or nurse when to stop using the cream. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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Possible side effects

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:

  • raised and itchy rash
  • swelling, sometimes of the face or mouth, causing difficulty in breathing
  • collapse or loss of consciousness ➔ Contact a doctor immediately if you get any of these symptoms. Stop using Bactroban ➔ If you develop a severe skin reaction or an allergy:
  • wipe off the cream
  • stop using it and
  • tell your doctor as soon as possible. On rare occasions, medicines like Bactroban can cause inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, stomach pain, fever (pseudomembranous colitis). ➔ Tell your doctor as soon as possible if you get any of these symptoms. The following side effects may happen with this medicine: Common (may affect up to one in 10 people)
  • Itching, redness, burning, rash, swelling, pain on your skin where Bactroban is applied. Dryness and redness of the skin can also occur on other parts of your body. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5 • • • • •

6

How to store it

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.

Contents of the pack and other information

What Bactroban contains

  • Each gram of cream contains 21.5 mg mupirocin calcium equivalent to 20 mg mupirocin.
  • The other ingredients are xanthan gum, liquid paraffin, cetomacrogol 1000, stearyl alcohol, cetyl alcohol, phenoxyethanol, benzyl alcohol and purified water. See also section 2. What Bactroban looks like and contents of the pack
  • Bactroban is a smooth white cream.

•

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

Frequently asked questions about Bactroban 2% Cream

How do I take Bactroban 2% Cream?

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.

What is the active substance in Bactroban 2% Cream?

The active substance in Bactroban 2% Cream is mupirocin.

Where does this information come from?

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.

Can I get Bactroban 2% Cream without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Mupirocin (6 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

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.

4.2. Posology and method of administration

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.

4.3. Contraindications

Hypersensitivity to mupirocin or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

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.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

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).

4.7. Effects on ability to drive and use machines

Bactroban Cream has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

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

4.9. Overdose

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.

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • BactrobanMupirocinum · skin / topical
  • MupiroxMupirocinum · skin / topical
  • TaconalMupirocinum · skin / topical
  • SoltopinMupirocinum · skin / topical

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 about this leaflet

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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