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.
Bactroban Ointment 2%
⚠ 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.
What it is and what it is used for
for
Bactroban 2% Ointment (called 'Bactroban' in this leaflet) contains the active substance called mupirocin. Bactroban is an antibiotic ointment. It is used: •
• •
2
to treat skin infections on the skin such as
- infected hair follicles which form pimples containing pus ("folliculitis"),
- an infectious skin infection with blistering and crusting known as "impetigo" or
- recurring boils ("furunculosis") to kill various bacteria which cause other skin infections including Staphylococci, Streptococci and E. coli. This group includes MRSA (Methicillin Resistant Staphylococcus aureus). This ointment is for external use on your skin only.
What you need to know before you take it
e Bactroban
Do not use Bactroban:
- if you are allergic (hypersensitive) to mupirocin or any of the other ingredients of this medicine (listed in section 6). Do not use if the above applies to you. If you are not sure do not use this medicine. Talk to your doctor, nurse or pharmacist before using Bactroban. Warnings and precautions
- Bactroban can cause severe skin reactions or allergies. See 'Conditions to look out for' in Section 4
- Bactroban is not suitable for use in your eyes, nose or around intravenous cannula ('drip') sites. Thrush (a yeast yeast infection ) may develop if Bactroban is used for a long time. If this occurs, tell your doctor, pharmacist or nurse. Keep the ointment away from your eyes.
- If the ointment gets into your eyes accidentally, wash them thoroughly with water. Other medicines and Bactroban
- Only marketed pack size(s) will be shown. 1
Reason for Update: Type IA(IN) Variation to Update MAH Address (Project Emerald – GSK House Move) Market: UK Agency Approval Date: 06/11/2024 Text Date: 24/06/2024 Text Issue and Draft No.: Issue 6, Draft 1
Tell your doctor, nurse 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 ointment must be thoroughly washed off prior to breastfeeding. Driving and using machines It is unlikely that Bactroban will affect your ability to drive or operate machinery. Bactroban Ointment contains polyethylene glycol Talk to your doctor before using this medicine if you:
- have kidney problems
- have large areas of open wounds or damaged skin to be treated
3
How to take it
Bactroban
Always use this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist 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 two to three times a day. 1. Wash and dry your hands. 2. Apply ointment to the infected area of your skin. 3. You can cover the treated area with a plaster(s) or suitable dressing(s), unless your doctor has told you to leave it uncovered. 4. 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, nurse or pharmacist. 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 ointment that is left over. If you swallow any Bactroban If you swallow any of the ointment, speak to your doctor, nurse or pharmacist for advice. 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, nurse or pharmacist when to stop using the ointment. If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
4
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reason for Update: Type IA(IN) Variation to Update MAH Address (Project Emerald – GSK House Move) Market: UK Agency Approval Date: 06/11/2024 Text Date: 24/06/2024 Text Issue and Draft No.: Issue 6, Draft 1
Conditions to look out for Severe skin reactions or allergies: These are very rare in people using Bactroban Ointment. 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:
- wash off the ointment
- 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 1 in 10 people)
- Burning where the ointment is applied. Uncommon (may affect up to 1 in 100 people)
- Itching, redness, stinging and dryness on your skin in the place where Bactroban is applied.
- Allergic rash, itching, redness or soreness of the skin can also occur on other parts of your body. Very rare (may affect up to 1 in 10,000 people)
- Swollen face and/or difficulty breathing. This may be a sign of a serious allergic reaction that could require emergency treatment. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This include any possible side effects not listed in this leaflet. You can also report side effects direclty 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 • • • • •
How to store it
Bactroban Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use Bactroban after the expiry date which is stated on the tube or carton after (EXP). The expiry date refers to the last day of that month. Bactroban is an off-white, translucent ointment. Do not use it if it looks different to normal. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Reason for Update: Type IA(IN) Variation to Update MAH Address (Project Emerald – GSK House Move) Market: UK Agency Approval Date: 06/11/2024 Text Date: 24/06/2024 Text Issue and Draft No.: Issue 6, Draft 1
6
Contents of the pack and other information
What Bactroban contains
- The active substance is mupirocin. Each gram of ointment contains 20 mg mupirocin.
- The other ingredients are polyethylene glycol 400 and polyethylene glycol 3350. What Bactroban looks like and contents of the pack
- Bactroban is an off-white, translucent ointment.
- 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 This leaflet was last revised in November 2024. 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 Reference number
Bactroban 2% Ointment 00038/0319
This is a service provided by the Royal National Institute of Blind People. Bactroban is a registered trade mark of the GSK group of companies. © 2024 GSK group of companies. All rights reserved
Frequently asked questions about Bactroban Ointment 2%
How do I take Bactroban Ointment 2%?
Bactroban Ointment 2% comes as ointment. 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 Ointment 2%?
The active substance in Bactroban Ointment 2% is mupirocin.
Are there equivalent medicines to Bactroban Ointment 2%?
Medicines with the same active substance, strength and form include: Bactroban Nasal Ointment 2%, Mupirocin 2% w/w Ointment, Mupirocin Ointment 2%. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Bactroban Ointment 2%, 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 Ointment 2% 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: mupirocin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Bactroban is a topical antibacterial agent, active against those organisms responsible for the majority of skin infections, e.g. Staphylococcus aureus, including methicillin-resistant strains, other staphylococci, streptococci. It is also active against Gram-negative organisms such as Escherichia coli and Haemophilus influenzae. Bactroban Ointment is used for skin infections, e.g. impetigo, folliculitis, furunculosis.
4.2. Posology and method of administration
Posology
Adults (including elderly/hepatically impaired) and children
Two to three times a day for up to ten days, depending on the response.
Renally impaired
See section 4.4
Method of administration
For topical administration.
A small quantity of Bactroban ointment should be applied to cover the affected area. The treated area may be covered by a dressing.
Any product remaining at the end of treatment should be discarded.
Do not mix with other preparations as there is a risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the mupirocin in the ointment.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
This Bactroban Ointment formulation is not suitable for ophthalmic or intranasal use.
4.4. Special warnings and precautions for use
Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Ointment, 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.
Renal impairment
Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol based ointments, mupirocin ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.
Bactroban ointment is not suitable for:
- ophthalmic use
- intranasal use
- use in conjunction with cannulae and
- at the site of central venous cannulation.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
4.5. Interaction with other medicinal products and other forms of interaction
No drug interactions have been identified.
4.6. Fertility, pregnancy and lactation
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. 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
No adverse effects on the ability to drive or operate machinery have been identified.
4.8. Undesirable effects
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.
Common and uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 1573 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:
Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with Bactroban Ointment.
Skin and subcutaneous tissue disorders:
Common:
Burning localised to the area of application.
Uncommon:
Itching, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to mupirocin or the ointment base.
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 andy suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9. Overdose
Symptoms and signs
There is currently limited experience with overdosage of mupirocin.
Treatment
There is no specific treatment for an overdose of mupirocin. 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.
💬 Ask about this leaflet
Ask anything about Bactroban Ointment 2%. 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.