Gentamicin and betamethasone ABC

Package leaflet: Information for the user

GENTAMICIN AND BETAMETHASONE ABC 1 mg/g + 1 mg/g cream

sulfate gentamicin/betamethasone valerate
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What GENTAMICINA E BETAMETASONE ABC is and what it is used for

GENTAMICINA E BETAMETASONE ABC is a topical cream containing two active substances: gentamicin and betamethasone. Gentamicin sulfate belongs to the group of aminoglycoside antibiotics, used to treat infections caused by various bacteria. Betamethasone valerate belongs to the group of corticosteroids, hormones that have numerous actions and are used to relieve inflammation and allergic reactions.

GENTAMICINA E BETAMETASONE ABC is indicated for the local treatment of skin diseases (dermatoses) due to allergies or inflammation that have become infected or when there is a risk of infection.

GENTAMICINA E BETAMETASONE ABC is indicated for the treatment of the following skin conditions:

• various types of eczema (atopic, infantile), characterized by itching, redness, desquamation, and skin elevations;
• nummular eczema, a reaction characterized by itchy, round or oval lesions;
• anal and genital itching;
• senile pruritus;
• contact dermatitis, an immune-mediated inflammatory skin reaction characterized by redness, desquamation, small blisters, vesicles, minor superficial wounds, and crusts, occurring upon contact with certain substances;
• seborrheic dermatitis, an inflammatory skin condition characterized by skin eruptions affecting areas rich in sebaceous glands such as the scalp, face, chest, and ears;
• neurodermatitis, characterized by itching and desquamation;
• intertrigo, characterized by redness, desquamation, skin irritation, and itching caused by friction between adjacent body parts;
• sunburn, skin irritation caused by exposure to sunlight, characterized by itching, pain, burning sensation, and blistering;
• other forms of skin irritation such as exfoliative dermatitis, characterized by small blisters, redness, swelling, crusts, and scales, generally accompanied by itching;
• radiation dermatitis, characterized by itchy redness, areas of darker skin pigmentation, hair loss, blisters, and pain;
• stasis dermatitis, characterized by darkened areas, red spots, thin or sometimes thickened skin, accompanied by itching and pain;
• psoriasis, a chronic inflammatory skin disease involving the immune system, characterized by red patches, thickening, silvery-white scaling, and sometimes itching.

2. What you should know before using GENTAMICINA E BETAMETASONE ABC

Do not use GENTAMICINA E BETAMETASONE ABC

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have a skin disease called cutaneous tuberculosis;
• if you have a herpes simplex virus infection or other viral skin diseases.

Warnings and precautions
Talk to your doctor or pharmacist before using GENTAMICINA E BETAMETASONE ABC.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization); your doctor will prescribe appropriate therapy.
Any adverse effects reported with systemic corticosteroids (taken orally or by injection), including adrenal suppression, may also occur with topical corticosteroids (used locally), especially in children.
If you apply the medicine over large areas of skin, particularly if the skin is damaged, under occlusive dressing, or for prolonged periods, absorption into the body of betamethasone and gentamicin increases (see "Occlusive dressing technique" in section 3).
In such cases, adverse effects associated with systemic use of gentamicin may occur.
Your doctor will take special precautions in these situations, particularly in infants and children (see "Children and adolescents").
Gentamicin sulfate may cause allergic reactions to other antibiotics of the same family (cross-allergenicity among aminoglycosides).
Prolonged use of topical antibiotics may sometimes lead to overgrowth of non-susceptible organisms, including fungi. In such cases, or if irritation, sensitization, or further infections develop, your doctor will discontinue treatment with gentamicin and prescribe specific therapy.
Contact your doctor if you experience blurred vision or other visual disturbances.
Do not use GENTAMICINA E BETAMETASONE ABC in the eyes.

Children and adolescents
In children, this medicine should be used only when strictly necessary and under direct medical supervision. Children may be more sensitive than adults to the hormonal effects of the active substance betamethasone (hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, growth retardation in height and weight, increased intracranial pressure) due to higher corticosteroid absorption.

Other medicines and GENTAMICINA E BETAMETASONE ABC
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Use this medicine only if your doctor considers that the expected benefit justifies the potential risk to the fetus. Do not use this medicine at high doses or for prolonged periods during pregnancy.

Breastfeeding
Your doctor will decide whether you should discontinue breastfeeding or stop the treatment, taking into account the importance of this medicine for your condition.

Driving and using machines
GENTAMICINA E BETAMETASONE ABC does not affect the ability to drive or operate machinery.

GENTAMICINA E BETAMETASONE ABC contains chlorocresol and cetyl stearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetyl stearyl alcohol, which may cause localized skin reactions (e.g., contact dermatitis).

3. How to use GENTAMICINA E BETAMETASONE ABC

Use this medicine exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Apply a small amount of cream to the affected area 2-3 times daily.
Psoriatic lesions unresponsive to treatment and deep dermatoses complicated by infection may respond better to therapy with GENTAMICINA E BETAMETASONE ABC when this medicine is used with the occlusive dressing technique as described below.

Occlusive dressing technique

1. Apply a thick layer of cream over the entire surface of the lesion and cover it with a light gauze and a transparent, waterproof, flexible plastic material extending beyond the edges of the treated area;
2. Seal the edges onto healthy skin with adhesive tape or other means;
3. Keep the dressing in place on the affected area for 1 to 3 days and repeat the procedure 3-4 times as needed.

With this method, you will observe significant improvement within a few days. Rarely, skin inflammation under the dressing may develop; in such a case, remove the occlusive dressing.

If you use more GENTAMICINA E BETAMETASONE ABC than you should
In case of accidental ingestion/overdose of GENTAMICINA E BETAMETASONE ABC, contact your doctor or go immediately to the nearest hospital Emergency Department.

Excessive or prolonged use of this medicine may alter certain hormones in the body (it may suppress pituitary-adrenal function, causing secondary adrenal insufficiency, and symptoms of hypercorticism, including Cushing's syndrome).
A single episode of overdose with the antibiotic gentamicin is unlikely to produce symptoms.
Prolonged and excessive use of gentamicin on the skin may lead to the development of lesions caused by fungi and bacteria that are not sensitive to it.

These symptoms may resolve after discontinuation of treatment, which should be done gradually.

If you forget to use GENTAMICINA E BETAMETASONE ABC
Do not use a double dose to make up for the forgotten dose.

If you stop using GENTAMICINA E BETAMETASONE ABC
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported very rarely:

• hypersensitivity
• rash
• skin discoloration.

The following side effects have been reported due to the use of corticosteroids on the skin, especially following the use of occlusive bandaging:

• burning;
• itching;
• irritation;
• dryness of the skin;
• inflammation of hair follicles, the areas of skin where hairs grow (folliculitis);
• excessive hair growth (hypertrichosis);
• acne (acneiform eruptions);
• change in skin color (hypopigmentation);
• skin inflammation with red rashes around the mouth (perioral dermatitis);
• skin inflammation due to contact with substances causing allergy (allergic contact dermatitis);
• development of skin lesions (skin maceration);
• additional skin infection (secondary infection);
• thinning of the skin (cutaneous atrophy);
• skin streaks (striae);
• acute skin inflammation with itching and sweat retention beneath the skin layers (miliaria).

Treatment with the antibiotic gentamicin may cause temporary irritation (erythema and itching), which usually does not require discontinuation of treatment.
The following side effects may occur with frequency not known:

• Blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GENTAMICINA E BETAMETASONE ABC

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GENTAMICINA E BETAMETASONE ABC contains

• The active substances are gentamicin sulfate and betamethasone valerate. 100 g of cream contain 0.1 g of gentamicin and 0.1 g of betamethasone.
• The other components are: chlorocresol, macrogol cetostearyl ether, cetyl stearyl alcohol, white vaseline, liquid paraffin, monobasic sodium phosphate, phosphoric acid, purified water.

Description of the appearance of GENTAMICINA E BETAMETASONE ABC and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio Farmacologico Milanese S.r.l. - Via Monterosso 273 - 21042 Caronno Pertusella (VA)
Manufacturer
Vamfarma S.r.l. – Via Kennedy, 5 – 26833 Comazzo (LO)
Sales Licensee:
ABC Farmaceutici S.p.A. Corso Vittorio Emanuele II n. 72 –10121 Torino