Gebetil

Package Leaflet: Information for the User

Gebetil, (0.64 mg + 1 mg)/g, Cream

Betamethasone dipropionate+ Gentamicin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Gebetil and what is it used for
• 2. Important information before using Gebetil
• 3. How to use Gebetil
• 4. Possible side effects
• 5. How to store Gebetil
• 6. Contents of the pack and other information

1. What is Gebetil and what is it used for

Gebetil is a combination medicine for external use. Gebetil contains two active substances:

• betamethasone (as betamethasone dipropionate) - a synthetic corticosteroid (glucocorticosteroid)
• gentamicin (as gentamicin sulfate) - an antibiotic from the aminoglycoside group.

Gebetil is used for local skin diseases covering a small area, when:

• they require treatment with potent glucocorticosteroids and
• there is also a concurrent bacterial infection (superinfection) and
• the bacteria can be effectively combated by the active substance - gentamicin.

Generally, the active substance betamethasone has anti-inflammatory effects, and thus can relieve itching, redness, swelling, and pain. The active substance gentamicin combats bacterial infections. Gebetil cream is particularly suitable for use on oily skin or in the treatment of weeping skin diseases.

2. Important information before using Gebetil

When not to use Gebetil

• if you are allergic to betamethasone or gentamicin, other glucocorticosteroids or aminoglycoside antibiotics, methyl parahydroxybenzoate, propyl parahydroxybenzoate, or any of the other ingredients of this medicine (listed in section 6),
• in the case of viral infections, including post-vaccination reactions and chickenpox,
• in the case of skin changes caused by tuberculosis or syphilis,
• in the case of viral skin infections (e.g., herpes simplex, shingles),
• in the case of a skin rash around the mouth,
• in the case of rosacea (redness of the face) and skin inflammation similar to rosacea,
• in the case of swelling around the mouth (perioral dermatitis),
• if you have a fungal skin infection,
• in the case of eye diseases,
• if you are also taking oral aminoglycoside antibiotics, due to the risk of toxic blood levels of the antibiotic,
• if you have advanced kidney function disorders,
• during the first three months of pregnancy,
• in newborns and infants in the first year of life.

Warnings and precautions

Before starting treatment with Gebetil, discuss it with your doctor. Do not use Gebetil in the ear canal, eyes, or on mucous membranes. In case of accidental contact with the eyes, rinse them with plenty of water and, if necessary, consult an ophthalmologist. Be particularly careful when applying Gebetil to the face. Do not use Gebetil under airtight dressings (e.g., bandages, diapers). Side effects reported with systemic glucocorticosteroids may also occur with topical glucocorticosteroids. This is especially true for infants and children. The risk of local skin infections may be increased with the use of topical glucocorticosteroids. The effect of glucocorticosteroids on the body after application to the skin usually increases with their potency, duration of treatment, size of the treated skin area, and in the case of use in skin folds. Due to the possibility of absorption of the active substances into the body, prolonged treatment and (or) use on large skin areas should be avoided. Consult your doctor if you are unsure whether you have a widespread skin disease. If you experience blurred vision or other vision disturbances, contact your doctor. The use of Gebetil should be carefully selected for each individual treatment. It should only be used when the response to antiseptic measures is slow or if the response to antiseptic measures is insufficient or cannot be used. The external use of the active substance gentamicin contained in Gebetil for skin infections is associated with a risk of allergic reactions. This risk increases with the frequency of use and duration of treatment. If you are allergic to other aminoglycoside antibiotics, such as neomycin and kanamycin, you will also experience an allergic reaction to the active substance gentamicin contained in Gebetil. If an allergy to gentamicin has developed due to external use, you can no longer use or take gentamicin or any other aminoglycoside antibiotics in the future. Sometimes, prolonged use or use on large skin areas of antibiotics can lead to colonization with insensitive pathogens, including fungi. In such a case or if skin irritation, allergic reactions, or additional infections occur, discontinue the use of Gebetil and start appropriate treatment. When using gentamicin externally, the absorption of the active substance into the body may increase in the case of treatment of large skin areas. This is especially true for prolonged use or in the case of skin damage. Particular caution is recommended in children, as the risk of side effects is higher in them. Be cautious if you have a certain type of muscle weakness (myasthenia), Parkinson's disease, or other conditions with muscle weakness. Aminoglycoside antibiotics can inhibit nerve and muscle function. Caution is also advised when using other medicines with a nerve-muscle blocking effect. Do not use Gebetil on wounds or ulcers on the lower limbs. Due to the excipients (other ingredients), white petrolatum and liquid paraffin, the use of Gebetil in the genital or anal area may cause condoms to rupture more easily, reducing their effectiveness.

Gebetil and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. Do not apply Gebetil to the skin at the same time as other medicines, as they may interact with Gebetil. Do not use Gebetil if you are being treated with other medicines containing the following active substances:

• amphotericin B used in severe fungal infections,
• heparin used to thin the blood
• the following antibiotics:
• sulfadiazine,
• 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 plan to have a child, ask your doctor or pharmacist for advice before using this medicine. Women who are pregnant should not use Gebetil during the first three months of pregnancy. You should immediately contact your doctor for advice on stopping or changing treatment. After the first three months of pregnancy, your doctor will decide whether to use Gebetil.

Breastfeeding

Gebetil should not be used during breastfeeding, as the active substances may pass into breast milk. Always protect your baby from contact with the treated skin areas.

Driving and using machines

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

Gebetil contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), and cetearyl alcohol

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late-type reactions). Cetearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

3. How to use Gebetil

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist. The recommended dose is:

• Adults: A thin layer of Gebetil should be applied once or twice a day to the affected areas of the skin and gently rubbed in. The treated skin area should not exceed 10% of the body surface. The treatment duration with Gebetil should not exceed 7 to 10 days. Do not prolong or repeat the treatment without consulting your doctor.
• Children: Generally, in children, particular caution is recommended when using medicines containing glucocorticosteroids, as there may be increased absorption of the active substance through the child's skin compared to adults. A thin layer of Gebetil should be applied once a day to the affected areas of the skin and gently rubbed in. Gebetil should only be used in children on small skin areas. The treatment duration with Gebetil should not exceed 7 days. Do not prolong or repeat the treatment without consulting your doctor. Gebetil should not be used in newborns and infants in the first year of life.

For further treatment, consult your doctor. Your doctor may recommend changing the medicine to one containing only one active substance, depending on the progress of the disease. Do not use Gebetil under airtight dressings, due to the risk of possible absorption of the active substance betamethasone into the body. Gebetil cream is particularly suitable for use on oily skin or in the treatment of weeping skin diseases. Gebetil ointment is available for use on dry skin, as it contains more fats than the cream.

Using more than the recommended dose of Gebetil

If Gebetil has been accidentally ingested or if it has been used in excessive amounts or for too long, immediately inform your doctor, as this may lead to certain disorders (e.g., Cushing's syndrome, wound colonization by fungi or insensitive pathogens), which require treatment.

Missing a dose of Gebetil

Apply the missed dose as soon as possible and continue using Gebetil as directed by your doctor.

4. Possible side effects

Like all medicines, Gebetil can cause side effects, although not everybody gets them. Gebetil is usually very well tolerated. The following side effects have been reported: Frequency not known(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, delayed growth, more body hair). Skin and subcutaneous tissue disorders (frequency not known): Burning, itching (pruritus), skin irritation, dryness, folliculitis, hypertrichosis, post-rosacea acne (acne-like rash), skin pigmentation changes, rosacea-like symptoms, perioral dermatitis, allergic contact dermatitis, skin maceration (skin edema), skin atrophy (skin thinning), striae, and petechiae (blisters), erythema, hypersensitivity, skin discoloration. Musculoskeletal and connective tissue disorders (frequency not known): Growth retardation in children. Vascular disorders (frequency not known): Increased intracranial pressure in children (bulging fontanelle, headache, bilateral papilledema). Metabolic and nutritional disorders (frequency not known): Reduced weight gain in children. Eye disorders (frequency not known): Blurred vision. During prolonged use (more than 4 weeks) and (or) use on large skin areas (about 10% of the body surface or more), especially under airtight dressings, the following side effects may occur: skin thinning or thickening, telangiectasias, striae, post-rosacea acne (acne-like rash), petechiae (blisters), folliculitis, hypertrichosis, skin pigmentation changes, and perioral dermatitis. Transient irritation (erythema, pruritus) caused by gentamicin usually does not require discontinuation of treatment. If severe irritation, allergy, or superinfection occurs, discontinue treatment and contact your doctor. Local use of gentamicin may impair wound healing. Additionally, ototoxic, nephrotoxic, and vestibular toxic effects (hearing disturbances, balance disturbances, and kidney function disturbances) may occur, even after external use of gentamicin, especially with repeated use on extensive wounds. Gentamicin treatment has caused transient irritation (erythema and pruritus).

Additional side effects in children and adolescents

Due to lower endogenous cortisol production, there is a decrease in cortisol levels in the blood. Increased intracranial pressure is manifested by a bulging fontanelle, headache, and bilateral papilledema. Children are particularly susceptible to side effects during glucocorticosteroid treatment. Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late-type reactions).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gebetil

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of the month.

Shelf life after first opening

The shelf life of Gebetil after first opening the tube is 6 months. This medicine does not require any special storage conditions. Short-term storage in the refrigerator does not affect the medicine. Do not store in the refrigerator for more than 8 weeks. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gebetil contains

The active substances are betamethasone and gentamicin. One gram of cream contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) and 1 mg of gentamicin (as 1.67 mg of gentamicin sulfate). The other ingredients are: white petrolatum (contains all-rac-α-tocopherol), liquid paraffin, cetearyl alcohol, macrogol cetostearyl ether 20, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium dihydrogen phosphate dihydrate, phosphoric acid, sodium hydroxide, purified water.

What Gebetil looks like and contents of the pack

Gebetil is a white cream, available in an aluminum tube of 30 g, in a carton box.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki, tel. +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel, Münchener Straße 15, 06796 Brehna, Germany, SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki, Date of last revision of the leaflet:03.2023