Patient leaflet - Mibetin 1 mg/g + 0.5 mg/g cream
1. What Mibetin cream is and what it is used for
Mibetin cream is a combination preparation for external use. Mibetin cream contains two active substances:
Betamethasone (as betamethasone dipropionate), a potent synthetic corticosteroid
(glucocorticoid)
- Gentamicin (as gentamicin sulfate), an antibiotic from the aminoglycoside group.
Mibetin cream is used in localised inflammatory skin conditions, when:
- these require treatment with a potent glucocorticoid and
- an infection with bacteria is present at the same time and
- these bacteria can be effectively treated with the active substance gentamicin.
Ask your doctor if you are not sure whether you have a small-area skin condition.
In general, the active substance betamethasone has an anti-inflammatory effect and can thus relieve itching, redness, swelling and pain.
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.
The active substance gentamicin combats infections caused by bacteria.
In particular, Mibetin cream is intended for use on greasy skin or to treat weeping skin conditions.
2. What you need to know before you use Mibetin cream
Do not use Mibetin cream
- during pregnancy,
- if you are allergic to betamethasone or gentamicin, methyl parahydroxybenzoate, propyl parahydroxybenzoate or any of the other ingredients of this medicine (listed in section 6),
- if you are hypersensitive to other medicines from the group of glucocorticoids or aminoglycoside antibiotics,
- for viral infections, including vaccination reactions and chickenpox,
- for tuberculosis or syphilis involving the skin,
- for viral infections of the skin (e.g. herpes simplex, shingles),
- skin rash around the mouth,
- for rosacea (facial redness) and rosacea-like skin inflammation,
- if you have a fungal disease anywhere on your skin,
- for eye conditions,
- if you are also taking oral antibiotics from the aminoglycoside group, due to the risk of harmful amounts of antibiotic in the blood,
- if you have advanced kidney dysfunction,
- in babies and infants under one year of age.
Do not use Mibetin cream in the ear canal, eyes or on mucous membranes.
Do not use with Mibetin cream airtight occlusive dressings.
Warnings and precautions
Talk to your doctor before using Mibetin cream.
Take special care when applying Mibetin cream on your face.
The side effects reported for glucocorticoids absorbed into the body may also occur with glucocorticoids used on the skin. This particularly applies to infants and children.
The risk of local skin infections may be increased with topical glucocorticoid use.
The effect of glucocorticoids in the body when applied to the skin generally increases with their strength (potency), duration of use, the extent of treated body surface areas and when used in skin folds.
Due to possible absorption of the active substances into the body, long-term treatment and/or use over large skin areas should be avoided. Ask your doctor if you are not sure whether you have a widespread skin condition.
If blurred vision or other eyesight problems occur, contact your doctor.
Mibetin cream should be carefully selected for each individual treatment. Mibetin cream should only be used if there is no prompt response to other treatments, if other treatments are not sufficient or if other treatments are contraindicated.
External use of the active substance gentamicin in Mibetin cream for skin infections carries the risk of allergic reactions. This risk increases with frequency of use and duration of treatment.
If you are allergic to other medicines from the aminoglycoside antibiotic group, such as neomycin and kanamycin, you will also react to the active substance gentamicin in Mibetin cream.
If you have developed an allergy to gentamicin through external use, you must no longer use or take gentamicin - or any other aminoglycoside antibiotics - at any time in the future.
Occasionally, prolonged or extensive external use of antibiotics leads to colonisation with non-sensitive pathogens, including fungi. In this case, or if skin irritation, allergic reactions or additional infections occur, treatment with Mibetin cream should be stopped and appropriate treatment started.
With external use of gentamicin, absorption of the active substance into the body may be increased when treating large areas of skin. This particularly applies when used over prolonged periods or in the presence of broken skin sites. Particular caution is advised in children, as the risk of side effects is increased.
In some cases gentamicin may cause irreversible partial or total deafness when given systemically (orally or injected) or when applied on the skin to open wounds or large areas of damaged skin. This effect is dose-related and is enhanced by renal and/or hepatic impairment and is more likely in the elderly.
Caution is advised if you are suffering from a certain type of muscle weakness (myasthenia gravis), Parkinson’s disease or other conditions with muscular weakness. Medicines from the group of aminoglycoside antibiotics may inhibit (block) nerve and muscle function. Caution is advised if you are also using other medicines with an inhibitory effect on muscles and nerves.
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 do 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.
Do not apply Mibetin cream on wounds or leg ulcers.
Due to the excipients (other ingredients) white paraffin and liquid paraffin, treatment with Mibetin cream in the genital or anal region may make condoms tear more easily, thereby impairing the safety of such condoms.
Other medicines and Mibetin cream
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including medicines obtained without prescription.
Do not apply Mibetin cream to the skin at the same time as other medicines, as they may interact with each other.
Do not use Mibetin cream if you are being treated with other medicines containing the following active substances:
- amphotericin B for severe fungal infections
- heparin used for thinning the blood
the following antibiotics:
- sulfadiazine
- active substances from the group of beta-lactam antibiotics (e.g. cephalosporins).
Pregnancy and breast-feeding
If you are 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, you must not use Mibetin cream. Please contact your doctor immediately for advice about stopping or switching therapy.
Breast-feeding
Mibetin cream should not be used during breast-feeding, as the active substances may pass into breast milk.
At all times, you must prevent the infant from coming into contact with your treated skin areas.
Driving and using machines
Mibetin cream has no or negligible influence on the ability to drive and use machines.
Mibetin cream contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and cetostearyl alcohol
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
3. How to use Mibetin cream
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
For adults:
Mibetin cream is applied thinly once or twice daily to the diseased skin areas and lightly rubbed in. It should be used less often as the symptoms of disease improve. The treated skin area should be no more than 10% body surface area. The duration of treatment with Mibetin cream should not exceed 10 days. Please do not prolong or renew treatment without talking to your doctor.
For children:
In general, extra caution is advised when treating children with glucocorticoid preparations, as there may be increased absorption of the active substance through the child's skin compared to adults.
Mibetin cream is applied thinly once daily to the diseased skin areas and lightly rubbed in.
Mibetin cream should only be used over small areas in children.
The duration of treatment with Mibetin cream should not exceed 7 days. Please do not prolong or renew treatment without talking to your doctor.
Mibetin cream must not be used in babies and infants less than 1 year old.
Please consult your doctor about further treatment. He/she may recommend that you switch to a medicine containing just one active substance, depending on how your disease progresses.
Do not use Mibetin cream under airtight occlusive dressings, due to the risk of possible absorption of the active substance betamethasone into the body.
In particular, Mibetin cream is intended for use on greasy skin or to treat weeping skin conditions.
If you use more Mibetin cream than you should
If Mibetin cream has been accidentally swallowed, if too much has been used or if used over excessively long periods of time, a doctor should be consulted immediately, as this may lead to certain disorders (e.g. Cushing’s syndrome, colonisation of wounds by fungi or non-sensitive pathogens) that must be treated.
If you forget to use Mibetin cream
Make up for the forgotten dose as soon as possible and continue to apply Mibetin cream as discussed with your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Mibetin cream is usually very well tolerated.
The following side effects have been reported:
Not known (Frequency cannot be estimated from the available data)
Endocrine disorders (not known):
Suppression of the hypothalamic-pituitary-adrenal axis (decreased production of cortisone by the body) and Cushing’s syndrome in children (moon face, delayed growth, more body hair).
Skin and subcutaneous tissue disorders (not known):
Burning, pruritus (itching), skin irritation, dry skin, folliculitis (inflammation of the hair follicles), hypertrichosis (increased hair growth), steroid acne (acne-like rash), changes in skin pigmentation, skin rosacea-like (perioral) dermatitis (inflammation around the mouth), allergic contact dermatitis , maceration of the skin (swelling of the skin), skin atrophy (thinning of the skin), striae (stretch marks) and miliaria (blistering), erythema, hypersensitivity, skin discoloration.
Musculoskeletal, connective tissue and bone disorders (not known):
Growth retardation in children.
Vascular disorders (not known):
Build-up of pressure around the brain which can cause swelling of the soft spot on the skull of babies. Headaches and changes to vision can occur in children and adults.
Metabolism and nutrition disorders (not known):
Decreased weight gain in children.
Eye disorders (not known)
Blurred vision.
With use over long periods (more than 4 weeks) and/or large areas (approximately 10% of body surface area or more) and especially under occlusion, the following may occur: skin swelling or thinning, spider veins, stretch marks, acne-like rash (steroid acne), blistering (miliaria), inflammation of the hair follicles (folliculitis), increased hair growth (hypertrichosis), pigmentation changes and inflammation around the mouth.
Transient irritation (erythema, itching) caused by gentamicin usually does not require a discontinuation of treatment.
If severe irritation, sensitisation or superinfection occurs, you should stop the treatment and seek your doctor.
Topical use of the active substance gentamicin may lead to impaired wound healing. Furthermore, oto-, vestibular- and nephrotoxic effects may occasionally occur (hearing disorders, disorders of the vestibular system (which controls balance) and kidneys) even after external use of gentamicin, particularly with repeated use of gentamicin on extensive wounds. Treatment with gentamicin causes transient irritation (erythema and itching).
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.
Additional side effects in children and adolescents
Due to lower endogenous cortisol production, reduced cortisol blood levels occur. Build-up of pressure around the brain, which can cause swelling of the soft spot on the skull of babies, can occur. Headaches and changes to vision can occur in children of all age groups. Children are particularly at risk of developing side effects during treatment with glucocorticoids.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card Scheme:
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.
5. How to store Mibetin cream
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 tube and on the carton. The expiry date refers to the last day of that month.
After the tube is first opened, use within 6 months.
This medicinal product does not require any special storage conditions. The product is unaffected by refrigerated storage for short periods of time. Long-time refrigerated storage of the product is not foreseen.
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.
6. Contents of the pack and other information
What Mibetin cream contains
The active substances are:
Gentamicin and betamethasone
One gram of cream contains 1 mg gentamicin (as 1.67 mg gentamicin sulfate) and 0.5 mg betamethasone (as 0.64 mg betamethasone dipropionate).
The other ingredients are:
Paraffin, white soft (containing all-rac-α-Tocopherol), liquid paraffin, cetostearyl alcohol, macrogol cetostearyl ether 20, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium dihydrogen phosphate dihydrate, phosphoric acid solution, sodium hydroxide solution, purified water
What Mibetin cream looks like and contents of the pack
Mibetin cream is a white cream and is available in 15 g, 20 g, 25 g, 30 g, 50 g, and 60 g aluminium tubes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mibe Pharma UK Ltd
4 Coleman Street
EC2R 5AR London
United Kingdom
Regulatoryaffairs.mibeUK@dermapharm.com
Manufacturer
mibe GmbH Arzneimittel
Münchener Str. 15
06796 Brehna
Germany