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 Mupirocin 2% w/w Ointment (simply called Mupirocin Ointment throughout the rest of this leaflet) is an antibiotic. It is used to kill bacteria in skin infections such as impetigo (which may appear as a small scratch or itchy patch of eczema), folliculitis (swelling of the skin around the hair roots) and boils. Mupirocin Ointment is for external use on your skin only.
e Mupirocin Ointment Do not use Mupirocin Ointment: if you are allergic to Mupirocin or any of the other ingredients of this medicine (listed in section 6) to treat infections in your nose to treat infections in your eyes around intravenous cannula ("drip") sites. Symptoms of an allergic reaction may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away (see section 4).
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Mupirocin Ointment if you have problems with your kidneys if you have open wounds or damaged skin. If you use Mupirocin Ointment for a long period of time, you may develop thrush (a yeast infection). If this occurs, tell your doctor or pharmacist. Other medicines and Mupirocin Ointment There are no known interactions with other medicines. Tell your doctor, pharmacist or nurse 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 taking this medicine if your doctor has given you Mupirocin Ointment to treat a cracked nipple, the ointment must be thoroughly washed off prior to breast-feeding. Driving and using machines It is unlikely that Mupirocin Ointment will affect your ability to drive or operate machinery.
Mupirocin Ointment Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For use on the skin only do not mix Mupirocin Ointment with other creams or ointments on the infected area of your skin, as this may reduce the effectiveness of Mupirocin Ointment if you are using Mupirocin Ointment on your face, you should be careful not to get it in your eyes or in your nose. If you accidentally get Mupirocin Ointment in your eyes, wash them thoroughly with water and contact your doctor or nearest hospital Accident and Emergency Department immediately wash and dry your hands before, and after, you use Mupirocin Ointment. Adults, the elderly and children use on the infected area of skin up to three times a day you can cover the infected area with a plaster (s) or suitable dressing (s), unless your doctor has told you to leave it uncovered replace the cap on the tube and wash your hands use Mupirocin Ointment for as long as your doctor has told you. The bacteria are normally cleared from your skin within 10 days of starting treatment. Do not use for more than 10 days. If your symptoms persist, talk to your doctor or pharmacist throw away any ointment that is left over.
If you use more Mupirocin Ointment than you should
if you use more Mupirocin Ointment than your doctor prescribed, tell your doctor, pharmacist or nurse
if you or a child accidentally swallows Mupirocin Ointment, you should contact your doctor or the nearest hospital Accident and Emergency Department immediately.
If you forget to use Mupirocin Ointment
do not worry, use the ointment when you remember and then carry on as normal. If your next dose is due within an hour, skip the missed dose. Do not apply double the amount to make up for the amount missed.
If you stop using Mupirocin Ointment If you stop using Mupirocin Ointment too early, not all of the bacteria, causing your skin infection, may have been killed, and your infection may come back. Ask your doctor, pharmacist or nurse when to stop using the ointment. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Very rare (may affect up to 1 in 10,000 people) If you have any of the following very rare side effects while using your medicine, rinse the product off of your skin and tell your doctor immediately or go to hospital straight away:
severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away. inflammation of the colon (larger intestine), causing diarrhoea, usually with blood and mucus, stomach pain, fever (pseudomembranous colitis)
Common (may affect up to 1 in 10 people) burning sensation where you have applied the ointment. Uncommon (may affect up to 1 in 100 people) itching, redness, stinging and dryness where you have applied the ointment allergic rash, redness or soreness of the skin on the face, hands or body. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Mupirocin Ointment Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after Exp: . The expiry date refers to the last day of that month. Do not store above 25oC. Once opened, use within 6 months. Do not use this medicine if you notice any visible signs of damage or deterioration to the tube or product. Return it to your pharmacist. 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 Mupirocin Ointment contains the active substance is mupirocin. Each gram of ointment contains 20 mg mupirocin the other ingredients are macrogol 400 and macrogol 3350. What Mupirocin Ointment looks like and contents of the pack Mupirocin Ointment is a smooth, translucent, white ointment. Each tube of Mupirocin Ointment contains 15g of ointment.
Marketing Authorisation Holder Focus Pharmaceuticals Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer Kleva Pharmaceuticals S.A., 189 Parnithos Avenue, 136 75 Acharnai, Greece This leaflet was last revised in December 2023
Mupirocin 2% w/w Ointment comes as ointment. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Mupirocin 2% w/w Ointment is mupirocin.
Medicines with the same active substance, strength and form include: Bactroban Nasal Ointment 2%, Bactroban Ointment 2%, Mupirocin Ointment 2%. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Mupirocin 2% w/w Ointment, 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.
Mupirocin is indicated in adults and children.
Mupirocin 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. Mupirocin Ointment is used for skin infections, e.g. impetigo, folliculitis, furunculosis.
Posology:
Adults (including elderly) and Paediatric population:
Mupirocin Ointment should be applied to the affected area up to three times a day for up to 10 days.
The area may be covered with a dressing or occluded if desired.
Method of administration:
Topical.
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.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
This Mupirocin Ointment formulation is not suitable for ophthalmic or intranasal use.
Should a possible sensitisation reaction or severe local irritation occur with the use of Mupirocin 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.
Mupirocin Ointment is not suitable for:
- ophthalmic use;
- intranasal use (in neonates or infants);
- use in conjunction with cannulae;
- 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.
No interaction studies have been performed
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 Ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Breast-feeding:
It is unknown whether mupirocin is 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).
Mupirocin 2% w/w Ointment has no or negligible influence on the ability to drive and use machines.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), 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.
System organ class
Frequency
Undesirable effects
Immune system disorders
Very rare
Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with Mupirocin Ointment.
Skin and subcutaneous tissue disorders
Common
Uncommon
Burning localised to the area of application
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 authorisations 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 Website:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
There is currently limited experience with overdosage of mupirocin.
Management
The toxicity of mupirocin is very low. In the event of accidental ingestion of the ointment, symptomatic treatment should be given.
In case of erroneous oral intake of large quantities of the ointment, renal function should be closely monitored in patients with renal insufficiency because of the possible side effects of polyethylene glycol.
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 anything about Mupirocin 2% w/w Ointment. 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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