GEBEXONE 0.1% + 0.1% Krem

Treść ulotki

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

GENTAMICINA E BETAMETASONE ESAPHARMA 1 mg/g + 1 mg/g cream
Gentamicin sulfate and betamethasone valerate

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

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

GENTAMICINA E BETAMETASONE ESAPHARMA contains two active ingredients:

• gentamicin sulfate, an antibiotic active against numerous bacteria;
• betamethasone valerate which belongs to a class of medicines called corticosteroids, hormones that perform numerous activities, with an important function in controlling inflammation.

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

• atopic eczema, infantile, characterized by itching, redness, scaling and skin relief;
• nummular eczema, characterized by redness, scaling and skin relief;
• anal and genital itching (anogenital);
• itching in the elderly;
• contact dermatitis, characterized by redness, scaling, small blisters, bubbles, superficial small wounds and scabs that occur when coming into contact with determining substances;
• seborrheic dermatitis, characterized by a skin eruption that affects areas rich in sebaceous glands such as scalp, face, chest and ears;
• neurodermatitis, characterized by itching and scaling;
• intertrigo, characterized by redness, scaling, irritation and itching due to rubbing of two close parts of the body;
• solar erythema, characterized by itching, pain, burning sensation and the presence of blisters;
• exfoliative dermatitis, characterized by small blisters, redness, swelling, scabs and itchy scales;
• radiation dermatitis, characterized by itchy redness, skin patches with more intense choler, 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, characterized by red patches, thickening, silvery-white scaling and
• sometimes itching.

2. What you need to know before using GENTAMICINA E BETAMETASONE ESAPHARMA

Do not use GENTAMICINA E BETAMETASONE ESAPHARMA

• 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 cutaneous tuberculosis caused by Herpes simplex or other viral skin diseases.

Warnings and precautions
Consult your doctor or pharmacist before using GENTAMICINA E BETAMETASONE ESAPHARMA.
This medicine should not be applied to the eyes.
If GENTAMICINA E BETAMETASONE ESAPHARMA causes irritation or sensitization, your
doctor will discontinue treatment and 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 GENTAMICINA E BETAMETASONE ESAPHARMA to a large area of skin,
especially in the presence of skin damage, under an occlusive dressing or for prolonged 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 may occur
that are evident when gentamicin is taken systemically. The doctor will take
particular precautions, especially 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, proliferation of
non-sensitive organisms, including fungi, may sometimes 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.

Children and adolescents
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, growth and weight retardation and intracranial hypertension) (see section Additional undesirable effects in children).

Other medicines and GENTAMICINA E BETAMETASONE ESAPHARMA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions with other medicines are known.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you are 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 GENTAMICINA E BETAMETASONE ESAPHARMA only if your doctor believes that the expected
benefit justifies the potential risk to the fetus. If you are pregnant, do not use
this medicine at 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 using the medicine in your case.

Driving and using machines
This medicine does not impair the ability to drive vehicles or use machines.

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

3. How to use GENTAMICINA E BETAMETASONE ESAPHARMA

Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
GENTAMICINA E BETAMETASONE ESAPHARMA should not be applied to the eyes.
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 ESAPHARMA when this medicine is used with the occlusive dressing
technique described below.
occlusive dressing technique:

• 1) Apply a thick layer of cream to the entire surface of the lesion, 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 area for a period of 1-3 days and repeat the procedure 3-4 times as needed.

With this method, a noticeable improvement is often observed within a few days. Rarely may
develop
skin inflammations under the dressing, which require removal of the
occlusive dressing.

If you use more GENTAMICINA E BETAMETASONE ESAPHARMA than you should
In case of ingestion/accidental intake of an excessive dose of GENTAMICINA E
BETAMETASONE ESAPHARMA, immediately
inform your doctor or go to the nearest hospital.
Excessive or prolonged use of this medicine can cause undesirable effects due to
corticosteroids such as: adrenal gland dysfunction, increased levels of steroids
in the body (hypercortisolism), Cushing's syndrome, a condition in which the body
produces too much cortisol, formation of lesions caused by bacteria and fungi.
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.
In case of ingestion/accidental intake of GENTAMICINA E BETAMETASONE ESAPHARMA
contact your doctor or go immediately to the Emergency Room of the nearest hospital.

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

If you stop using GENTAMICINA E BETAMETASONE ESAPHARMA
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 described, due to the use of corticosteroids used on the skin,
especially after the use of occlusive dressings:

• burning
• itching
• irritation
• skin dryness
• inflammation of the skin where hair grows (folliculitis)
• increased hair growth (hypertrichosis)
• acne (acneiform eruptions)
• inflammation of the skin with red rashes around the mouth (perioral dermatitis)
• skin inflammation due to contact with allergenic substances (allergic contact dermatitis)
• skin maceration
• further skin infection (secondary infection)
• thinning of the skin (skin atrophy)
• skin striae
• acute skin inflammation with itching and sweat retention in the layers under the skin (miliaria).

Treatment with gentamicina may produce temporary irritation (erythema and itching) which
usually does not require discontinuation of treatment.
The following side 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 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 ESAPHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging 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
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GENTAMICINA E BETAMETASONE ESAPHARMA contains

• The active ingredients are gentamicina sulfate and betamethasone valerate. 100 g of cream contains 0.166 g of gentamicina sulfate, equivalent to 0.1 g of gentamicina and 0.122 g of betamethasone valerate, equivalent to 0.1 g of betamethasone.
• The other ingredients 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 ESAPHARMA and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder
ESAPHARMA S.P.A. VIA GIUSEPPE MAZZINI, 18 20066 – MELZO(MI)

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) – Italy.