Gebetil

Patient Information Leaflet

Gebetil, (0.64 mg + 1 mg)/g, ointment
Betamethasone dipropionate + Gentamicin
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Gebetil is and what it is 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 Gebetil is and what it is used for

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

• betamethasone (in the form of betamethasone dipropionate) – a synthetically produced corticosteroid (glucocorticosteroid)
• gentamicin (in the form of gentamicin sulfate) – an antibiotic belonging to the aminoglycoside group.

Gebetil is used in local skin disorders affecting a small surface area when:

• treatment with potent glucocorticosteroids is required, and
• there is a concurrent bacterial infection (superinfection), and
• these bacteria are susceptible to the active substance gentamicin.

Generally, the active substance betamethasone has an anti-inflammatory effect and thus may relieve itching, redness, swelling, and pain.
The active substance gentamicin acts against bacterial infections.
Gebetil ointment is particularly intended for use on dry skin.

2. Important information before using Gebetil

When not to use Gebetil

• if the patient is allergic to betamethasone or gentamicin, other medicines from the glucocorticosteroid group or aminoglycoside antibiotics, or any of the other ingredients of this medicine (listed in section 6),
• in viral infections, including post-vaccination reactions and chickenpox,
• in tuberculosis or syphilis-related skin lesions,
• in viral skin infections (e.g. herpes simplex, shingles),
• in perioral rash (rash around the mouth),
• in rosacea (facial redness) and rosacea-like dermatitis,
• in perioral dermatitis (inflammation around the mouth),
• if the patient has fungal skin infections,
• in eye diseases,
• if the patient is also taking oral aminoglycoside antibiotics, due to the risk of developing toxic antibiotic blood levels,
• if the patient has severely impaired kidney function,
• during the first three months of pregnancy,
• in newborns and infants under 1 year of age.

Warnings and precautions
Before starting treatment with Gebetil, consult a doctor.
Do not use Gebetil in the ear canal, eyes, or on mucous membranes. In case of accidental contact with the eyes, rinse thoroughly with plenty of water and consult an ophthalmologist if necessary.
Exercise particular caution when applying Gebetil to the face.
Do not use Gebetil under occlusive dressings that do not allow air passage (e.g. under bandages, diapers).
Adverse effects reported with systemic absorption of glucocorticosteroids may also occur with topical glucocorticosteroids, especially in infants and children.
The risk of local skin infections may be increased with local use of glucocorticosteroids.
The systemic effect of glucocorticosteroids after topical application generally increases with their potency, duration of treatment, size of treated body surface area, and when used in skin folds.
Due to the potential absorption of active substances into the body, prolonged treatment and (or) application over large skin areas should be avoided. Consult a doctor if the patient is unsure whether they have extensive skin disease.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
The use of Gebetil should be carefully considered for each individual case. It should only be used when the response to antiseptics is slow, inadequate, or when antiseptics cannot be used.
Topical application of the active ingredient gentamicin contained in Gebetil for skin infections carries 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 or kanamycin, they may also have an allergic reaction to the active ingredient gentamicin in Gebetil.
If the patient develops an allergy to gentamicin after topical use, they must not use or take gentamicin or any other aminoglycoside antibiotics in the future.
Prolonged or extensive use of antibiotics may sometimes lead to colonization by resistant pathogens, including fungi. In such cases, or if skin irritation, allergic reactions, or additional infections occur, discontinue use of Gebetil and start appropriate treatment.
When gentamicin is applied topically, absorption of the active ingredient into the body may increase when treating large skin areas, especially with prolonged use or in the presence of skin damage. Particular caution is advised in children, as they are at higher risk of adverse effects.
Exercise caution if the patient has a certain type of muscle weakness (myasthenia), Parkinson's disease, or other conditions involving muscle weakness. Aminoglycoside antibiotics may inhibit (block) nerve-muscle transmission.
Caution is also recommended when using other drugs that impair neuromuscular conduction simultaneously.
Do not apply Gebetil to wounds or leg ulcers.
Due to excipients (other ingredients): white soft paraffin and liquid paraffin, use of Gebetil in the genital or anal area may cause condoms to break more easily, thereby reducing their effectiveness.

Gebetil and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines they plan to use, including over-the-counter medicines.
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 the patient is 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Women must not use Gebetil during the first three months of pregnancy. Immediately contact a doctor for advice on discontinuing or changing treatment.
After the first three months of pregnancy, the doctor will decide whether Gebetil should be used.

Breastfeeding
Gebetil should not be used during breastfeeding, as active substances may pass into breast milk.
The infant should be protected from contact with treated skin areas at all times.

Driving and operating machinery
Gebetil has no effect or negligible effect on the ability to drive vehicles or operate machinery.

3. How to use Gebetil

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose:

• Adults: Apply a thin layer of Gebetil once or twice daily to the affected areas of skin and gently rub in. The treated area of skin should not exceed 10% of the body surface. The duration of treatment with Gebetil should not exceed 7 to 10 days. Do not extend or restart treatment without consulting your doctor.

• Children: In general, particular caution should be exercised when using glucocorticosteroid-containing medicines in children, as absorption of the active substance through a child's skin may be greater than in adults. Apply a thin layer of Gebetil once daily to the affected areas of skin and gently rub in. Gebetil should only be used on small areas of skin in children. The duration of treatment with Gebetil should not exceed 7 days. Do not extend or restart treatment without consulting your doctor. Gebetil must not be used in newborns and infants during the first year of life.

For further treatment, consult your doctor. Your doctor may recommend switching to a medicine containing only one active substance, depending on the course of the disease.

Do not use Gebetil under occlusive dressings (airtight, non-breathable coverings), due to the risk of increased systemic absorption of the active substance betamethasone.

Gebetil ointment is particularly intended for use on dry skin. Gebetil cream is suitable for use on oily skin or in the treatment of weeping skin conditions, as the cream contains less fat than the ointment.

Use of a higher than recommended dose of Gebetil

If Gebetil has been accidentally swallowed or used in excessive amounts or for too long, inform your doctor immediately, as this may lead to certain adverse effects (e.g. Cushing's syndrome, fungal colonization of wounds, or colonization by resistant pathogens), which require treatment.

Missed dose of Gebetil

Apply the missed dose as soon as possible and continue using Gebetil according to your doctor's instructions.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Gebetil is generally very well tolerated.
The following adverse reactions have been reported:
Frequency unknown (cannot be estimated from available data):
Endocrine disorders (frequency unknown):
Suppression of the hypothalamic-pituitary-adrenal axis (reduced cortisol production by the body) and Cushing's syndrome in children (moon face, delayed growth, increased body hair).
Skin and subcutaneous tissue disorders (frequency unknown):
Burning, itching (pruritus), skin irritation, dry skin, folliculitis, hypertrichosis, steroid acne (acneiform rash), skin pigmentation changes, rosacea-like symptoms, perioral dermatitis, allergic contact dermatitis, skin maceration (skin swelling), skin atrophy (thinning of the skin), striae, and bullae (blisters), erythema, hypersensitivity, skin discoloration.
Musculoskeletal and connective tissue disorders (frequency unknown):
Growth delay in children.
Vascular disorders (frequency unknown):
Increased intracranial pressure in children (bulging fontanelle, headache, optic nerve edema).
Metabolism and nutrition disorders (frequency unknown):
Reduced weight gain in children.
Eye disorders (frequency unknown):
Blurred vision.

During prolonged use (more than 4 weeks) and/or application over large areas (approximately 10% or more of body surface area), especially under occlusive dressings, the following adverse reactions may occur: skin edema or thinning, spider veins, striae, acneiform rash (steroid acne), bullae (blisters), folliculitis, hypertrichosis, skin pigmentation changes, and perioral dermatitis.

Transient irritation (erythema, itching) caused by gentamicin usually does not require discontinuation of treatment.
If severe irritation, hypersensitivity, or secondary infection occurs, treatment should be discontinued and a physician should be consulted.

Local application of gentamicin may impair wound healing.
Additionally, ototoxic, nephrotoxic, and vestibular toxicity [hearing disturbances, labyrinthine disorders (which control balance), and kidney dysfunction] may occasionally occur even after topical application of gentamicin, particularly with repeated use on extensive wounds. Treatment with gentamicin has caused transient irritation (erythema and itching).

Additional adverse reactions in children and adolescents
Due to lower endogenous cortisol production, a decrease in blood cortisol concentration may occur. Increased intracranial pressure manifests as a bulging fontanelle, headache, and bilateral papilledema.
Children are particularly susceptible to adverse reactions during treatment with glucocorticosteroids.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 the cardboard
pack. The expiry date refers to the last day of the stated 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 a refrigerator does not affect the medicine. Do not store in the refrigerator for
longer than 8 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the packaging and other information

What Gebetil contains
The active substances in this medicine 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 gentamicin sulphate).
The other ingredients are:
White vaseline (containing all-rac-α-tocopherol), liquid paraffin.

What Gebetil looks like and contents of the pack
Gebetil is a shiny ointment, white to slightly yellow in colour, available in 30 g aluminium tubes in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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