Mibetin 0.5 mg/g + 1 mg/g cream

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Mibetin is and what it is used for

Mibetin cream is a combined topical preparation. Mibetin contains two active substances:

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

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

• these require treatment with a potent glucocorticoid and
• there is an additional (superimposed) bacterial infection 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 thus can relieve itching, redness, swelling, and pain.

The active substance gentamicin fights infections caused by bacteria.

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

2. What you need to know before using Mibetin

Do not use Mibetin cream:

• if you are allergic to betamethasone, gentamicin, other medicines in the group of glucocorticoids or aminoglycoside antibiotics, methyl parahydroxybenzoate, propyl parahydroxybenzoate, or any of the other ingredients of this medicine (listed in section 6),
• for viral infections, including reactions to vaccination 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 rosacea-like skin inflammation,
• swelling around the mouth (perioral dermatitis),
• if you have a fungal disease anywhere on the skin,
• for eye conditions,
• if you are also taking oral antibiotics from the aminoglycoside group, due to the risk of harmful levels of antibiotic in the blood,
• if you have advanced renal dysfunction,
• during the first 3 months of pregnancy,
• in babies and infants under one year of age.

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 thoroughly with plenty of water and consult an ophthalmologist if necessary.

Take special care when applying Mibetin cream to your face.

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

Side effects reported with glucocorticoids absorbed into the body may also occur with glucocorticoids applied to the skin. This is particularly relevant for babies and children.

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

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

Due to the possible absorption of active substances into the body, prolonged treatment and/or use over large areas of skin should be avoided. Consult 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 delayed, or if these measures are insufficient or cannot be used.

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

If you are allergic to other medicines in the group of aminoglycoside antibiotics, such as neomycin and kanamycin, you will also react to the active ingredient gentamicin in Mibetin cream.

If you have developed an allergy to gentamicin through external use, you must never use or take gentamicin, or any other aminoglycoside antibiotic, again in the future.

Occasionally, prolonged or extensive external use of antibiotics may lead to colonization by non-sensitive pathogens, including fungi. In such cases, or if skin irritation, allergic reactions, or additional infections occur, treatment with Mibetin cream should be discontinued and appropriate treatment initiated.

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

Caution is advised if you suffer from certain types of muscle weakness (myasthenia gravis), Parkinson's disease, or other conditions involving muscle weakness. Medicines in the group of aminoglycoside antibiotics may inhibit (block) nerve and muscle function. Caution is also advised if you are also using other medicines with an inhibitory effect on muscles and nerves.

Do not apply Mibetin cream to 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 cause condoms to break more easily, which compromises the effectiveness of such condoms.

Other medicines and Mibetin

Inform 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 containing the following active ingredients:

• the active ingredient amphotericin B for serious fungal infections,

• the active ingredient heparin used to thin the blood,

• the following antibiotics:

• the active ingredient sulfadiazine,

• active ingredients 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 become pregnant, consult your doctor or pharmacist 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 discontinue 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 ingredients may pass into breast milk.

At all times, you must avoid contact between the baby and treated skin areas.

Driving and using machines

Mibetin cream has no or negligible influence on the ability to drive and use machines.

Mibetin contains methyl parahydroxybenzoate, propyl parahydroxybenzoate (E218 and E216), and cetostearyl alcohol

May cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

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

3. How to use Mibetin

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

The recommended dose is

• For adults:

Apply Mibetin cream in a thin layer once or twice daily to the affected skin areas and rub in gently.

The treated skin area should not exceed 10% of the body surface. The duration of treatment with Mibetin cream should not exceed 7–10 days. Do not prolong or renew the 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 a child's skin compared to adults.

Apply Mibetin cream once daily in a thin layer to the affected skin areas and rub in gently.

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

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

Mibetin must not be used in infants under 1 year of age.

Consult your doctor regarding continuation of treatment. He/she may recommend switching to a medicine containing only one active substance, depending on how your condition progresses.

Do not use Mibetin under occlusive, impermeable dressings, due to the risk of increased absorption of the active substance betamethasone into the body.

In particular, Mibetin cream is intended for use on oily skin or for treating suppurative skin conditions. Mibetin ointment is available for use on dry skin, as an ointment is greasier than a cream.

If you use more Mibetin than you should

If you have accidentally ingested Mibetin cream, used it excessively, or used it for excessively prolonged periods, you should consult a doctor immediately, as this may cause certain disorders (e.g., Cushing's syndrome, fungal colonization of wounds, or colonization by non-sensitive pathogens) that require treatment.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Mibetin

Take the missed dose as soon as possible and continue applying Mibetin cream as instructed by your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Mibetin is generally very 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 (reduced production of cortisol 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 hair follicles), hypertrichosis (increased hair growth), steroid acne (acne-like rash), changes in skin pigmentation, dermatitis (perioral) resembling rosacea (inflammation around the mouth), allergic contact dermatitis, maceration of the skin (skin swelling), cutaneous atrophy (thinning of the skin), striae (stretch marks), miliaria (blisters), erythema, hypersensitivity, skin discoloration.

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

Growth retardation in children.

Vascular disorders (Frequency not known):

Intracranial hypertension in children (bulging fontanelles, headache, optic nerve swelling).

Metabolism and nutrition disorders (Frequency not known):

Reduced weight gain in children.

Eye disorders (Frequency not known):

Blurred vision.

With prolonged use (more than 4 weeks) and/or over large areas (approximately 10% or more of body surface area), especially under occlusion, the following may occur: skin swelling or thinning, vascular spiders, striae, acne-like rash (steroid acne), blisters (miliaria), inflammation of 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 discontinuation of treatment.

If severe irritation, sensitization, or superinfection occurs, treatment should be discontinued and you should consult your doctor.

Topical use of the active substance gentamicin may result in poor wound healing.

Additionally, ototoxic and vestibular toxicity and nephrotoxicity (hearing disorders, vestibular system disorders [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 has caused transient irritation (erythema and itching).

Other adverse effects in children and adolescents

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

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

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 the carton after EXP. The expiry date refers to the last day of the month indicated.

Validity period after first opening.

Mibetin has a shelf life of 6 months after the tube has been opened for the first time.

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 must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. 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 sulphate).

The other components are:

Paraffin, soft white; all-rac-α-tocopherol; liquid paraffin; cetostearyl alcohol; macrogol 20 cetostearyl ether; methyl 4-hydroxybenzoate (E 218); propyl 4-hydroxybenzoate (E 216); disodium hydrogen phosphate dihydrate (to adjust pH); diluted phosphoric acid (to adjust pH); sodium hydroxide solution (to adjust pH); purified water.

Appearance of Mibetin and pack contents

Mibetin is a white cream and is available in aluminium tubes of 15 g, 20 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:

Mibe Pharma España S.L.U.

C/ Amaltea 9, 4th floor, letter 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 the most recent review of this leaflet: March 2023

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