MIBETIN 0.5 mg/g + 1 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Mibetin 0.5 mg/g + 1 mg/g Cream

Betamethasone / Gentamicin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Mibetin and what is it used for
2. What you need to know before you use Mibetin
3. How to use Mibetin
4. Possible side effects
5. Storage of Mibetin
6. Contents of the pack and other information

1. What is Mibetin and what is it used for

Mibetin cream is a combined preparation for external use. Mibetin contains two active substances:

• Betamethasone (as betamethasone dipropionate), a synthetic corticosteroid (glucocorticoid).
• Gentamicin (as gentamicin sulfate), an antibiotic from the aminoglycoside group.

Mibetin cream is used for localized skin conditions in small areas, when:

• they require treatment with a potent glucocorticoid and
• there is an additional infection (superinfection) with bacteria present at the same time and
• these bacteria can be effectively treated with the active substance gentamicin.

In general, the active substance betamethasone has an anti-inflammatory effect and can thus alleviate itching, redness, swelling, and pain.

The active substance gentamicin combats bacterial infections.

In particular, Mibetin cream is intended for use on greasy skin or to treat suppurating skin conditions.

2. What you need to know before you use Mibetin

Do not use Mibetin cream:

• if you are allergic to betamethasone, gentamicin, or other medicines from the group of glucocorticoids or aminoglycoside antibiotics, or to methylparahydroxybenzoate, propylparahydroxybenzoate, or any of the other ingredients of this medicine (listed in section 6),
• for viral infections, including vaccination reactions and chickenpox,
• for tuberculosis or syphilis affecting the skin,
• for viral skin infections (e.g., herpes simplex, shingles),
• skin rash around the mouth,
• for rosacea (facial redness) and skin inflammation similar to rosacea,
• swelling around the mouth (perioral dermatitis),
• if you have a fungal infection on any part of 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 disease,
• during the first 3 months of pregnancy,
• in infants and breastfed babies under 1 year.

Warnings and precautions

Talk to your doctor before using Mibetin cream.

Do not use Mibetin cream in the ear canal, eyes, or mucous membranes. In case of accidental contact with the eyes, rinse with plenty of water and consult an ophthalmologist if necessary.

Be particularly careful when applying Mibetin cream to your face.

Do not use Mibetin with occlusive dressings (e.g., under bandages, diapers).

The side effects reported with systemically absorbed glucocorticoids may also occur with glucocorticoids used on the skin. This applies particularly to babies and children.

The risk of local skin infections may increase with the topical use of glucocorticoids.

The effect of glucocorticoids on the body when applied to the skin generally increases with their potency, duration of use, extent of body surface area treated, and when used on skin folds.

Due to the possible absorption of the active substances into the body, prolonged treatment and/or use on large areas of skin should be avoided. Ask your doctor if you are unsure whether you have a generalized skin condition.

If you experience blurred vision or other vision problems, contact your doctor.

Mibetin cream should be carefully selected for each individual treatment. It should only be used if the response to other measures is slow to appear or if these measures are insufficient or cannot be used.

The external use of the active substance gentamicin in Mibetin cream for skin infections carries the risk of allergic reactions. This risk increases with the frequency of use and the duration of treatment.

If you are allergic to other medicines from the group of aminoglycoside antibiotics, 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 not use or take gentamicin or any other aminoglycoside antibiotic at any time in the future.

Occasionally, prolonged or extensive external use of antibiotics leads to colonization with non-susceptible pathogens, including fungi. In this case, or if skin irritation, allergic reactions, or additional infections occur, treatment with Mibetin cream should be discontinued and appropriate treatment initiated.

With the external use of gentamicin, the absorption of the active substance into the body may increase when large areas of skin are treated. This applies particularly when used during prolonged periods or in the presence of damaged skin areas. Special caution is recommended in children, as the risk of side effects increases.

Cautious use is recommended if you suffer from a certain type of muscle weakness (myasthenia gravis), Parkinson's disease, or other conditions with muscle weakness. Aminoglycoside antibiotics may inhibit (block) nerve and muscle function. Cautious use is also recommended if you are using other medicines with an inhibitory effect on muscles and nerves.

Do not apply Mibetin cream to wounds or ulcers on the legs.

Due to the excipients (other ingredients), white petrolatum and liquid petrolatum, treatment with Mibetin cream in the genital or anal region may cause condoms to break more easily, compromising the safety of such condoms.

Other medicines and Mibetin

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or might take/use any other medicines, including those obtained without a 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 if you are being treated with other medicines that contain the following active substances:

• the active substance amphotericin B for severe fungal infections
• the active substance heparin used to thin the blood
• the following antibiotics:

• the active substance sulfadiazine
• active substances from the group of beta-lactam antibiotics (e.g., cephalosporins).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 during the first 3 months of pregnancy. Contact your doctor immediately for advice on how to stop or change therapy.

After the first 3 months of pregnancy, your doctor will decide whether you should use Mibetin.

Breastfeeding

Mibetin cream must not be used during breastfeeding, as the active substances may pass into breast milk.

At all times, you must avoid your baby coming into contact with the treated skin areas.

Driving and using machines

Mibetin cream has a negligible influence on the ability to drive and use machines.

Mibetin contains methylparahydroxybenzoate, propylparahydroxybenzoate (E218 and E216), and cetearyl alcohol

It may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate and propylparahydroxybenzoate.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol.

3. How to use Mibetin

Follow exactly the administration instructions of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is

• For adults:

Mibetin cream is applied in a thin layer one or two times a day to the affected skin areas and gently rubbed in.

The treated skin area must not exceed 10% of the body surface. The treatment duration with Mibetin cream must not exceed 7-10 days. Do not prolong or renew treatment without consulting your doctor.

• For children:

In general, additional caution is recommended when treating children with glucocorticoid preparations, as there may be greater absorption of the active substance through the child's skin compared to adults.

Mibetin cream is applied once a day in a thin layer to the affected skin areas and gently rubbed in.

Mibetin cream should only be used on small areas in children.

The treatment duration with Mibetin cream must not exceed 7 days. Do not prolong or renew treatment without consulting your doctor.

Mibetin must not be used in infants and breastfed babies under 1 year.

Consult your doctor about continuing treatment. He/she may recommend that you switch to a medicine that contains only one active substance, depending on how your illness progresses.

Do not use Mibetin under 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 suppurating skin conditions. Mibetin ointment is available for use on dry skin, as an ointment is more greasy than a cream.

If you use more Mibetin than you should

If you have accidentally ingested Mibetin cream, used too much, or used it for excessively long periods, you should consult a doctor immediately, as this may cause certain disorders (e.g., Cushing's syndrome, wound colonization by fungi or non-susceptible pathogens) that need to be treated.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Mibetin

Make up for the forgotten dose as soon as possible and continue applying Mibetin cream as your doctor indicated.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Mibetin is generally well tolerated.

The following side effects have been reported:

Frequency not known(frequency cannot be estimated from the available data)

Endocrine disorders (Frequency not known):

Suppression of the hypothalamic-pituitary-adrenal axis (decreased production of cortisone by the body) and Cushing's syndrome in children (moon face, growth retardation, increased body hair).

Skin and subcutaneous tissue disorders (Frequency not known):

Burning, pruritus (itching), skin irritation, dry skin, folliculitis (inflammation of the hair follicles), hypertrichosis (increased hair growth), steroid acne (eruption similar to acne), changes in skin pigmentation, dermatitis (perioral) similar to rosacea (inflammation around the mouth), allergic contact dermatitis, maceration of the skin (skin swelling), skin atrophy (thinner skin), striae (stretch marks), and miliaria (blisters), erythema, hypersensitivity, skin discoloration.

Musculoskeletal, connective tissue, and bone disorders (Frequency not known):

Growth retardation in height in children.

Vascular disorders (Frequency not known):

Intracranial hypertension in children (bulging fontanelles, headache, bilateral papilledema).

Metabolic and nutritional disorders (Frequency not known):

Decreased weight gain in children.

Eye disorders (Frequency not known):

Blurred vision.

With prolonged use (more than 4 weeks) and/or on large areas (approximately 10% of the body surface or more) and especially under occlusion, the following may occur: skin thinning or thickening, spider veins, stretch marks, acne-like eruptions (steroid acne), blisters (miliaria), folliculitis (inflammation of the hair follicles), increased hair growth (hypertrichosis), changes in pigmentation, and inflammation around the mouth.

The transient irritation (erythema, pruritus) caused by gentamicin generally does not require discontinuation of treatment.

If severe irritation, sensitization, or superinfection occurs, you must discontinue treatment and consult your doctor.

The topical use of the active substance gentamicin may lead to impaired wound healing.

Additionally, otovestibular and nephrotoxic effects (hearing disorders, disorders of the vestibular system [which controls balance], and kidney disorders) may occasionally occur, even after external use of gentamicin, particularly with repeated use of gentamicin on extensive wounds. Treatment with gentamicin caused transient irritation (erythema and pruritus).

Other side effects in children and adolescents

Due to the lower production of endogenous cortisol, reduced cortisol levels in the blood occur. Intracranial hypertension manifests as bulging fontanelles, headache, and bilateral papilledema.

Children are at particular risk of developing side effects during treatment with glucocorticoids.

Methylparahydroxybenzoate and propylparahydroxybenzoate may cause allergic reactions (possibly delayed).

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mibetin

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 carton after EXP. The expiry date refers to the last day of the month stated.

Shelf life after first opening.

Mibetin has a shelf life of 6 months after the tube is first opened.

This medicine does not require any special storage conditions. The product is not affected by short-term refrigerated storage. Prolonged refrigerated storage of the product for more than 8 weeks is not anticipated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mibetin

The active substances are:

Betamethasone and gentamicin

1 gram of cream contains 0.5 mg of betamethasone (as 0.64 mg of betamethasone dipropionate) and 1 mg of gentamicin (as 1.67 mg of gentamicin sulfate).

The other ingredients are:

White soft paraffin; all-rac-α-tocopherol; liquid paraffin; cetearyl alcohol; macrogol 20 cetearyl ether; methylparahydroxybenzoate (E 218); propylparahydroxybenzoate (E216); sodium dihydrogen phosphate dihydrate (for pH adjustment); phosphoric acid diluted (for pH adjustment); sodium hydroxide solution (for pH adjustment); purified water.

Appearance of Mibetin and contents of the pack

Mibetin is a white cream and is available in aluminum tubes of 15 g, 20 g, 25 g, 30 g, 50 g, and 60 g.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Mibe Pharma España S.L.U.

C/ Amaltea 9, 4ª planta, letra B

28045 Madrid

Spain

Manufacturer:

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 – Brehna

Germany

Or

Sun-Farm Sp. z o.o.

Ul. Dolna 21, Lomianki

Mazowieckie 05-092

Poland

Date of last revision of this leaflet: March 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).