Gebetil

Package Leaflet: Information for the User

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

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 only. 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 any not listed in this leaflet, please 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 affecting a small area, when:

• they require treatment with potent glucocorticosteroids and
• there is also a 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 ointment is specifically intended for use on dry skin.

2. Important information before using Gebetil

When not to use Gebetil

• during the first three months of pregnancy,

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 a large amount of water and, if necessary, consult an ophthalmologist. Be particularly careful when applying Gebetil to the face. Do not use Gebetil under occlusive dressings (e.g., under bandages, diapers). Adverse reactions reported with systemic glucocorticosteroids may also occur with topical glucocorticosteroids, especially in infants and children. The risk of local skin infections may be increased with topical glucocorticosteroids. The effect of glucocorticosteroids on the body after topical application generally increases with their potency, duration of treatment, size of the treated skin surface, and in the case of application in skin folds. Due to the possibility of absorption of the active substances into the body, prolonged treatment and/or application to large skin surfaces 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. Topical application of the active substance gentamicin 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 the patient is allergic to other aminoglycoside antibiotics, such as neomycin and kanamycin, the patient will also experience an allergic reaction to the active substance gentamicin in Gebetil. If an allergy to gentamicin has developed due to external use, the patient can no longer use or take gentamicin or any other aminoglycoside antibiotics in the future. Sometimes, prolonged use or application to large skin surfaces of antibiotics can lead to colonization by insensitive pathogens, including fungi. In such cases or if skin irritation, allergic reactions, or additional infections occur, the use of Gebetil should be discontinued and appropriate treatment started. When using gentamicin topically, absorption of the active substance into the body may increase in the case of treatment of large skin surfaces. This is especially true for prolonged use or in the case of skin damage. Particular caution is recommended in children, as the risk of adverse reactions is higher in them. Caution is also recommended if the patient has a certain type of muscle weakness (myasthenia), Parkinson's disease, or other conditions with muscle weakness. Aminoglycoside antibiotics may inhibit nerve and muscle function. Caution is also recommended when using other medicines with a neuromuscular blocking effect. Do not use Gebetil on wounds or ulcers of 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 break more easily, reducing their effectiveness.

Gebetil and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained 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,
• active substances from the beta-lactam antibiotic group (e.g., cephalosporins).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, 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 contact your doctor immediately 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. You should protect your baby from contact with the treated skin areas at all times.

Driving and using machines

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

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 surface should not exceed 10% of the body surface. The duration of treatment with Gebetil should not exceed 7 to 10 days. Do not prolong or restart treatment without consulting your doctor.
• Children: Generally, caution is recommended when using glucocorticosteroid-containing medicines in children, 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 surfaces. The duration of treatment with Gebetil should not exceed 7 days. Do not prolong or restart 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 occlusive dressings, due to the risk of possible absorption of the active substance betamethasone into the body. Gebetil ointment is specifically intended for use on dry skin. Gebetil cream is available for use on oily skin or in the treatment of weeping skin diseases, as the cream contains less fat than the ointment.

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, you should immediately inform your doctor, as this may lead to certain disorders (e.g., Cushing's syndrome, wound colonization by fungi or insensitive pathogens) that 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): Inhibition of the hypothalamic-pituitary-adrenal axis (reduced cortisol production by the body) and Cushing's syndrome in children (moon face, delayed growth, excessive hair on the body). Skin and subcutaneous tissue disorders (frequency not known): Burning, itching (pruritus), skin irritation, dryness of the skin, folliculitis, hypertrichosis, acneiform rash (post-steroid acne), 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): Intracranial hypertension in children (bulging fontanelle, headache, bilateral papilledema). Metabolic and nutritional disorders (frequency not known): Decreased weight gain in children. Eye disorders (frequency not known): Blurred vision. During prolonged use (more than 4 weeks) and/or application to large skin surfaces (about 10% of the body surface or more), especially under occlusive dressings, the following side effects may occur: skin edema or thinning, telangiectasia, striae, acneiform rash (post-steroid acne), blisters (petechiae), 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, treatment should be discontinued and a doctor consulted. Topical use of gentamicin may impair wound healing. Additionally, ototoxic, nephrotoxic, and vestibulotoxic effects (hearing disturbances, balance disturbances, and kidney function disturbances) may occur, even after topical 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. Intracranial hypertension is characterized by a bulging fontanelle, headache, and bilateral papilledema. Children are particularly susceptible to side effects during glucocorticosteroid treatment.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 stated.

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 ointment 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) and liquid paraffin.

What Gebetil looks like and contents of the pack

Gebetil is a shiny ointment with a white to light yellow color, available in a 30 g aluminum tube, 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