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.
Fucibet 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 Betamethasone valerate, Fusidic acid 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 Fucibet contains 2 different types of medicine. One medicine is called fusidic acid. It is a type of antibiotic. The other medicine is called betamethasone valerate. It is a type of corticosteroid (steroid). These 2 medicines work at the same time in different ways. Fucibet works by: • The antibiotic killing germs (bacteria) that cause infections. • The corticosteroid reducing any swelling, redness or itchiness of your skin. Fucibet is used to treat: • Conditions where the skin is inflamed (eczema or dermatitis) and also infected by germs (bacteria). Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Betamethasone is classed as a strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
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What you need to know before you take it
e Fucibet® Do not use Fucibet
- If you are allergic (hypersensitive) to fusidic acid or betamethasone valerate or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.
- To treat a skin condition caused by a fungus, such as athlete's foot.
- To treat a skin condition caused by a virus, such as cold sores or chickenpox.
- To treat skin conditions caused only by bacteria, such as boils or spots.
- To treat skin conditions caused by tuberculosis (TB) or syphilis.
- To treat a skin condition called perioral dermatitis. This is a red spotty rash around your mouth or chin.
- To treat a skin condition called rosacea. This is redness and inflammation over your nose and cheeks. Ask your doctor if you are unsure. Warnings and precautions Talk to your doctor, pharmacist or nurse before and during use of Fucibet:
- Do not use the cream on yourself or a child for more than 2 weeks; this is to avoid bacteria becoming resistant to the antibiotic and to avoid the steroid causing you side effects.
- Take special care if you are going to use this medicine near your eyes or the eyes of a child. If the cream gets into the eye, this may lead to glaucoma.
- Contact your doctor if you experience blurred vision or other visual disturbances.
- If you use the cream over a long time or in large amounts it may make the chance of getting any side effects or infections higher. Also your skin may get more sensitive to this medicine.
- You must not use the medicine for a long time on your face.
- Unless your doctor has told you to, you must not use Fucibet on open wounds or sensitive areas such as the nostrils, ears, lips or genitals.
- Unless your doctor has told you to, you must not use Fucibet on thin skin, skin ulcers, broken veins or acne.
- Adrenal suppression may occur. Signs are tiredness, depression and anxiety. This can be reversed by stopping Fucibet. Do not 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. If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the cream without consulting your prescriber unless your prescriber has previously advised you to so. If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. Other medicines and Fucibet 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 you are pregnant or think you might be pregnant: Fucibet should not be used during pregnancy, unless you are told to do so by your doctor.
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•
If you are breast-feeding: Fucibet may be used by women who are breast-feeding, but the cream should not be applied to the breasts to avoid accidental ingestion by the infant.
Tell your doctor if you become pregnant while using this medicine. Driving and using machines This medicine should not have any effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines. Fucibet contains • Cetostearyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used. • Chlorocresol. This is a preservative. It may give you an allergic reaction. Please read section 4 so you can spot any signs that this may be happening to you. Please ask your doctor if you are worried about any of the ingredients in this medicine.
How to take it
Fucibet® 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 apply Fucibet
This medicine is only for use 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 cream. Then push the spike in the cap through the seal on the tube. Always wash your hands before using Fucibet. 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 cream to treat your hands, always wash your hands after using Fucibet. 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 Fucibet to use Your doctor will tell you how much Fucibet to use. The usual treatment time is up to 2 weeks. Ask your doctor before using this medicine for any longer. You should notice your skin improve after just a few days of using the cream. If there is no improvement after 7 days, you should stop using the cream and go back to your doctor.
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Usually you should use this medicine twice each day. Use it in the morning and evening. To remind you to use the medicine, it may help to use it when you do another regular action, such as brushing your teeth. 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. Adults and children: Your doctor should tell you the dose that is right for you or the child. If your doctor has told you the amount of cream to use then keep to this advice. If not, the following guide will help you to use the correct amount. You can use your first (index) finger to measure how much Fucibet to use. Squeeze the cream along your finger from the tip to the first joint as shown in the diagram. This is called a fingertip unit. The usual number of fingertip units you need to cover different parts of the body is shown in the diagrams. If you need to use a little more or a little less do not worry. If you are using the cream on a child still use an adult finger to measure out the fingertip unit.
For an adult:
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For a child under 11 years:
If you use more Fucibet than you should Tell your doctor straight away if you have used more Fucibet than you should. You may need to stop using this medicine. If you forget to use Fucibet If you forget to use the cream at the right time, use it as soon as you remember. Then use this medicine again at the usual time. Do not use a double dose to make up for a forgotten dose. If you have any further questions about using this medicine, please ask your doctor or pharmacist.
Possible side effects
Like all medicines, Fucibet can cause side effects, although not everybody gets them. Important side effects to look out for: Tell your doctor or nurse immediately if any of the following happen. You may need to stop your treatment:
- You have difficulty breathing
- Your face or throat swell
- Your skin develops a severe rash.
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The following less serious side effects have also been reported. If any of them last a long time or cause problems, you should tell your doctor or nurse as soon as possible: Any of the problems listed below are more likely if the medicine is used for a long time, in large amounts or on skin folds (such as armpits or under breasts). These problems are more likely in babies and children. They are also more likely if the skin is covered with a dressing, bandage or nappy. Uncommon (may affect up to 1 in 100 people)
- Itchy rash and skin inflammation in the area where the medicine is used
- Worsening of your eczema
- Burning feeling
- Itching
- Dry skin
- Application site pain
- Application site irritation. Rare (may affect up to 1 in 1,000 people)
- Skin redness
- Hives
- Skin rash
- Application site swelling
- Application site blisters. Frequency not known (cannot be estimated from the available data)
- Blurred vision. Some side effects are known to be caused by betamethasone valerate (steroid), one of the ingredients in Fucibet. You should tell your doctor if any of the side effects occur:
- Adrenal glands may stop working properly. Signs are tiredness, depression and anxiety
- Glaucoma
- Thinning of the skin
- Red spotty rash around the mouth or chin
- Stretch marks
- Small veins near the surface of the skin become visible
- Changes in growth of your body hair
- Excessive sweating
- Lightening of your skin colour
- Redness and pimples around the mouth
- Redness of the skin, nose or mouth
- Formation of cataracts.
- Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores. Reporting of side effects
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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 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.
How to store it
Fucibet® • • • •
Keep this medicine out of the sight and reach of children. Do not use Fucibet after the expiry date which is stated on the tube or carton after EXP. The expiry date is the last day of that month. Do not store the medicine above 30°C. Do not use the tube for more than 3 months after you first open it. Make a note of the date you first opened the tube in the space provided on the carton.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Fucibet contains
- The active substances are fusidic acid and betamethasone valerate. Fucibet contains 2% fusidic acid and 0.1% betamethasone
- The other ingredients are macrogol cetostearyl ether, cetostearyl alcohol, chlorocresol, liquid paraffin, sodium dihydrogen phosphate, white soft paraffin, all-rac-α-tocopherol, purified water and sodium hydroxide for pH adjustment. You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet. What Fucibet looks like and contents of the pack Fucibet is a white cream. Fucibet comes in tubes of 3 g, 5 g, 10 g, 15 g, 25 g, 30 g, 50 g and 60 g. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: LEO Laboratories Limited, Maidenhead, Berkshire SL6 3UD, UK Manufacturers: LEO Laboratories Limited Cashel Road Dublin 12 Ireland LEO Pharma Manufacturing Italy S.r.l Via E. Schering 21 20054 Segrate (MI) Italy This leaflet was last revised in March 2024.
For information in large print, Braille or audio/CD, telephone +44 (0)1844 347333. Page 7 of 8
Registered Trade Mark
®
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Frequently asked questions about Fucibet Cream
How do I take Fucibet Cream?
Fucibet 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 Fucibet Cream?
The active substance in Fucibet Cream is betamethasone valerate, fusidic acid.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fucibet 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 Fucibet 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: betamethasone valerate, fusidic acid
- 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
Fucibet® cream is indicated for the treatment of eczematous dermatoses including atopic eczema, infantile eczema, discoid eczema, stasis eczema, contact eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.
4.2. Posology and method of administration
Posology
A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks.
In the more resistant lesions the effect of Fucibet® cream can be enhanced by occlusion with polythene film. Overnight occlusion is usually adequate.
Method of administration
Cutaneous use
4.3. Contraindications
Hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or to any of the excipients listed in section 6.1.
Due to the content of corticosteroid, Fucibet® is contraindicated in the following conditions:
Systemic fungal infections.
Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4).
Skin manifestations in relation to tuberculosis or syphilis, either untreated or uncontrolled by appropriate therapy.
Perioral dermatitis and rosacea.
4.4. Special warnings and precautions for use
Long-term continuous topical therapy with Fucibet® should be avoided.
Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucibet®.
Due to the content of corticosteroid, Fucibet® should be used with care near the eyes. Avoid getting Fucibet® into the eyes (see section 4.8).
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Fucibet® should be used with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids-induced HPA axis suppression and Cushing's syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment (see section 4.8).
Due to the content of betamethasone valerate, prolonged topical use of Fucibet® may cause skin atrophy.
Bacterial resistance has been reported to occur with the topical use of fusidic acid. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance.
This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic-resistant bacteria.
Due to the content of corticosteroid having immunosuppressant effect, Fucibet® may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment (see section 4.3).
Fucibet® cream contains cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and chlorocresol may cause allergic reactions.
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.
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
The label will state strong steroid.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal.
4.6. Fertility, pregnancy and lactation
Pregnancy
Fusidic acid:
No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible. Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals have shown negligible systemic absorption of topical fusidic acid.
Betamethasone valerate:
There are no or limited amount of data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity/foetal abnormalities (see section 5.3).
Fucibet® should not be used during pregnancy unless clearly necessary.
Breast-feeding
No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the topically applied fusidic acid and betamethasone valerate to a limited area of skin of breast-feeding woman is negligible. Fucibet® can be used during breast-feeding but should not be applied on the breasts to avoid accidental ingestion by the infant.
Fertility
There are no clinical studies with Fucibet® regarding fertility.
4.7. Effects on ability to drive and use machines
Fucibet® has no or negligible influence on the ability to drive or to use machines.
4.8. Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reaction during treatment is pruritus.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the 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
Not known (cannot be estimated from the available data)
Immune system disorders
Uncommon:
(≥1/1,000 and <1/100)
Hypersensitivity
Eye disorder
Not known
Vision, blurred*
Skin and subcutaneous tissue disorders
Uncommon:
(≥1/1,000 and <1/100)
Dermatitis contact
Eczema (condition aggravated)
Skin burning sensation
Pruritus
Dry skin
Rare:
(≥1/10,000 and <1/1,000)
Erythema
Urticaria
Rash (including rash erythematous and rash generalised)
Not known
Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules*
General disorders and administration site conditions
Uncommon:
(≥1/1,000 and <1/100)
Application site pain
Application site irritation
Rare:
(≥1/10,000 and <1/1,000)
Application site swelling
Application site vesicles
*See also section 4.4
Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal suppression especially during prolonged topical administration (see section 4.4).
Raised intra-ocular pressure, glaucoma or cataract may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma and cataract (see section 4.4).
Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (including dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis and depigmentation. Ecchymosis may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for Fucibet® as described in the frequency table above.
Paediatric population
The observed safety profile is similar in children and adults (see section 4.4).
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.
4.9. Overdose
For topically applied fusidic acid, no information concerning potential symptoms and signs due to overdose administration is available. Cushing's syndrome and adrenocortical insufficiency may develop following topical application of corticosteroids in large amounts and for more than three weeks.
Systemic consequences of an overdose of the active substances after accidental oral intake are unlikely to occur. The amount of fusidic acid in one tube of Fucibet® does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- IMAXEMA 20 mg/g+1 mg/g prescriptionCOMBINATII (ACIDUM FUSIDICUM+BETAMETHASONUM) · skin / topical
- FUCICORT 20 mg/1mg pe gram prescriptionCOMBINATII (ACIDUM FUSIDICUM+BETAMETHASONUM) · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Fusicutan plusAcidum fusidicum + Betamethasonum
- DermisilAcidum fusidicum + Betamethasonum
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 Fucibet 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.