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 Sodium fusidate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Fucidin ointment contains sodium fusidate. It is a type of antibiotic. Fucidin ointment works by killing germs (bacteria) that cause infections. Fucidin ointment is used to treat conditions where the skin is infected by germs (bacteria), such as:
2.
e Fucidin® ointment
Do not use Fucidin ointment
Other medicines and Fucidin ointment Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding
3.
Fucidin® 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.
How to put on Fucidin ointment
This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body. Remove the cap. Check the seal is not broken before you first use the ointment. Then push the spike in the cap through the seal on the tube. Always wash your hands before using Fucidin ointment. Rub the medicine gently on the skin. If you use it on your face be careful to avoid your eyes. Unless you are using the ointment to treat your hands, always wash your hands after using Fucidin ointment. If you accidentally get any medicine in your eye, wash it out with cold water straight away. Then bathe your eye with eyewash if possible. Your eye may sting. If you start to have any problems with your sight or your eye is sore, contact your doctor immediately. How much Fucidin ointment to use Your doctor will tell you how much Fucidin ointment to use. Usually, you should use this medicine three or four times each day. If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.
If you use more Fucidin ointment than you should If you accidentally apply too much ointment or a small quantity of the ointment is accidentally swallowed, it is unlikely to cause any harm. If a larger quantity of the ointment is accidentally swallowed or you are worried, contact your doctor, pharmacist or A&E department for advice. If you forget to use Fucidin ointment If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual time. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Important side effects to look out for: Rare (may affect up to 1 in 1,000 people) You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:
5.
Fucidin® 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 label after EXP. The expiry date refers to the last day of that month.
• •
The tube should be discarded 3 months after first opening. Write the date you first opened the tube in the space provided on the carton. This medicine does not require any special storage conditions.
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 protect the environment.
What Fucidin ointment contains
This leaflet was last revised in April 2023.
For information in large print, Braille or audio/CD, telephone +44 (0)1844 347333. Registered Trade Mark
®
Fucidin 20 mg/g Ointment comes as ointment containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Fucidin 20 mg/g Ointment is sodium fusidate.
This leaflet reproduces the patient information leaflet approved for Fucidin 20 mg/g 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.
Fucidin 20mg/g ointment is indicated either alone or in combination with systemic therapy, in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts /abrasions.
Posology
Adults and Paediatric Population
Uncovered lesions - apply gently, three or four times daily.
Covered lesions - less frequent applications may be adequate.
Method of administration
Cutaneous use.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Bacterial resistance among staphylococcus aureus has been reported to occur with the use of topical Fucidin. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Extended or recurrent use may increase the risk of developing contact sensitisation.
Fucidin ointment contains cetyl alcohol and hydrous lanolin. These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidin ointment contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
When Fucidin ointment is used on the face; care should be taken to avoid the eyes as the excipients in the ointment may cause conjunctival irritation.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Fucidin is negligible.
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to topically-applied fusidic acid/sodium fusidate is negligible. Topical Fucidin can be used during pregnancy.
Breast-feeding
No effects on the breast-fed new-born/infant are anticipated since the systemic exposure of topically-applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical Fucidin can be used during breast-feeding but it is recommended to avoid applying topical Fucidin on the breast.
Fertility
There are no clinical studies with topical Fucidin regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically-applied fusidic acid/sodium fusidate is negligible.
Fucidin administered topically has no or negligible influence on the ability to drive or to use machines.
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
Based on pooled data from clinical studies including 4724 patients who received Fucidin cream or Fucidin ointment, the frequency of undesirable effects is 2.3%.
The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients.
Hypersensitivity and angioedema have been reported.
Undesirable effects are listed by MedDRA System Organ Class (SOC) and the individual undesirable effects are listed, starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000
Immune system disorders
Rare
(≥1/10,000 and <1/1,000)
Hypersensitivity
Eye disorders
Rare
(≥1/10,000 and <1/1,000)
Conjunctivitis
Skin and subcutaneous tissue disorders
Uncommon
(≥1/1,000 and <1/100)
Dermatitis (including dermatitis contact, eczema)
Rash*
Pruritus
Erythema
*Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papular have been reported. Rash generalised has also occurred.
Rare
(≥1/10,000 and <1/1,000)
Angioedema
Urticaria
Blister
General disorders and administration site conditions
Uncommon
(≥1/1,000 and <1/100)
Application site pain (including skin burning sensation)
Application site irritation
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdose is unlikely to occur.
Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Fucidin ointment is unlikely to cause any harm. The total quantity of fusidic acid (30 g Fucidin ointment contains 576 mg fusidic acid) will usually not exceed the approved total daily oral dose of fusidic acid containing products except in children aged less than 1 year and weighing ≤ 10 kg. Although in this instance a child of this particular age group is unlikely to ingest a whole tube of Fucidin ointment. The concentration of the excipients is too low to constitute a safety risk.
Ask anything about Fucidin 20 mg/g 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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