GENTAMICINA 0.1% + 0.1% Cream

Зміст інструкції

1. GENTAMICINA E BETAMETASONE ABC 1 mg/g + 1 mg/g cream
   1. What is GENTAMICINA E BETAMETASONE ABC and what is it used for
   2. What you need to know before using GENTAMICINA E BETAMETASONE ABC
   3. How to use GENTAMICINA E BETAMETASONE ABC
   4. Possible side effects
   5. How to store GENTAMICINA E BETAMETASONE ABC
   6. Contents of the pack and other information

GENTAMICINA E BETAMETASONE ABC 1 mg/g + 1 mg/g cream

gentamicina solfato/betametasone valerato

Equivalent medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

GENTAMICINA E BETAMETASONE ABC is a cream for topical application that contains two active ingredients: gentamicin and betamethasone. Gentamicin sulfate belongs to the group of aminoglycoside antibiotics, used against infections caused by numerous bacteria. Betamethasone valerate belongs to the group of corticosteroids, hormones that perform numerous activities used to relieve inflammation and allergies.
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 diseases:

• eczema of various types, atopic, infantile, characterized by itching, redness, scaling and skin elevations);
• - nummular eczema, a reaction characterized by round or oval pruritic lesions,
• anal and genital itching and
• itching in the elderly;
• contact dermatitis, an immune-mediated inflammatory skin reaction characterized by redness, scaling, small blisters, bullae, superficial small wounds and crusts that occur when coming into contact with certain substances
• - seborrheic dermatitis, an inflammation of the skin characterized by a rash affecting areas rich in sebaceous glands such as the scalp, face and chest and ears;
• neurodermatitis, characterized by itching and scaling;
• intertrigo, characterized by redness, scaling, skin irritation and itching caused by the rubbing of two adjacent parts of the body;
• solar erythema, skin irritation caused by exposure to sunlight characterized by itching, pain, burning sensation and the presence of blisters;
• other forms of skin irritation such as exfoliative dermatitis, characterized by small blisters, redness, swelling, crusts and scales generally pruritic;
• radiation dermatitis, characterized by pruritic redness, skin patches with a more intense color, hair loss, blisters and pain;
• stasis dermatitis, characterized by darker areas, with red spots, thin, sometimes thickened, with the presence of 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 need to know before using GENTAMICINA E BETAMETASONE ABC

Do not use GENTAMICINA E BETAMETASONE ABC

• if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a skin disease called cutaneous tuberculosis;
• if you suffer from a disease caused by the Herpes Simplex virus or other viral skin diseases.

Warnings and precautions
Consult 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 undesirable effect reported with the use of systemic corticosteroids (taken orally or by
injection) including adrenal insufficiency (reduced function of the adrenal glands) may also occur with
topical corticosteroids (used locally), especially in children.
If you apply the medicine to large areas of the skin, especially in the presence of skin damage, under a
occlusive dressing, or for long periods of time, the absorption of
betamethasone and gentamicin into the body increases (see “Occlusive dressing technique”, in section 3).
In these cases, undesirable effects that occur when gentamicin is taken
systemically can occur.
The doctor will take special precautions in these situations, particularly in infants and children
(see “Children and adolescents”).
Gentamicin sulfate can cause allergic reactions with other antibiotics of the same family (cross-allergenicity
between aminoglycosides).
If you use topical antibiotics for a prolonged period, sometimes, proliferation of
organisms not susceptible to the treatment, including fungi, may occur. In this case, or if irritation, sensitization
or further infections should 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 on the eyes.

Children and adolescents
In children, the medicine should only be used in cases of actual need and under the direct control of
the doctor. Children may be more sensitive than adults to the activity of the active ingredient
betamethasone on hormones (depression of the hypothalamus-pituitary-adrenal axis, Cushing's syndrome, delayed
growth in height and weight, increased pressure in the head (intracranial hypertension) due to
greater absorption of corticosteroids.

Other medicines and GENTAMICINA E BETAMETASONE ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Use this medicine only if your doctor believes that the expected benefit justifies the potential risk
to the fetus. During pregnancy, do not use this medicine in high doses or for long periods of
time.
Breastfeeding
The doctor will decide whether to discontinue breastfeeding or suspend therapy, taking into account
the importance of taking this medicine in your case.

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

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

3. How to use GENTAMICINA E BETAMETASONE ABC

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have doubts,
consult your doctor or pharmacist.
Apply a small amount of cream to the affected area 2-3 times a day.
Psoriatic lesions that do not respond to treatment and deep dermatoses that have become
infected 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 to the entire surface of the lesion and cover with a light gauze and with transparent, waterproof and flexible plastic material, beyond the edges of the treated area;
• 2) Seal the edges onto healthy skin with adhesive tape or other means;
• 3) Keep the dressing on the affected part for a period of time from 1 to 3 days and repeat the procedure 3-4 times as needed. With this method you will observe a noticeable improvement in a few days. Rarely, inflammation of the skin under the dressing may develop; in this case, remove the occlusive dressing.

If you use more GENTAMICINA E BETAMETASONE ABC than you should
In case of ingestion/accidental intake of an excessive dose of GENTAMICINA E
BETAMETASONE ABC, contact your doctor or go immediately to the Emergency Room of the nearest
hospital.
Excessive or prolonged use of this medicine can alter some hormones in the body (it may
depress pituitary-adrenal function causing secondary adrenal insufficiency and manifestations of
hypercortisolism, including Cushing's syndrome.)
A single episode of overdose of the antibiotic gentamicin should not produce any symptoms.
Excessive and prolonged use of gentamicin on the skin can lead to the formation of lesions due to
fungi and bacteria that are not sensitive.
These symptoms may disappear after discontinuation of treatment, which should occur gradually.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rarely, the following side effects have been reported:

• hypersensitivity
• skin rash
• skin discoloration. The following side effects have been reported due to the use of corticosteroids on the skin, especially after the use of occlusive dressings:
• burning sensation;
• itching;
• irritation;
• dry skin;
• inflammation of the hair follicles, areas of skin where hair grows (folliculitis);
• excessive hair growth (hypertrichosis);
• acne (acneiform eruptions);
• alteration of skin color (hypopigmentation);
• inflammation of the skin with red rashes around the mouth (perioral dermatitis);
• inflammation of the skin due to contact with allergenic substances (allergic contact dermatitis);
• formation of skin lesions (skin maceration);
• further skin infection (secondary infection);
• thinning of the skin (skin atrophy);
• stretch marks (striae);
• acute skin inflammation with itching and sweat retention in the layers under the skin (miliaria).

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

• Blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Scad.” The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GENTAMICINA E BETAMETASONE ABC contains

• The active ingredients 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, cetostearyl alcohol, white petrolatum, liquid paraffin, sodium phosphate monobasic, phosphoric acid, purified water.

Description of the appearance of GENTAMICINA E BETAMETASONE ABC and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation 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 distributor:
ABC Farmaceutici S.p.A. Corso Vittorio Emanuele II n. 72 –10121 Torino