GENTALYN 0.1% + 0.1% Cream

Зміст інструкції

1. Gentalyn Beta 0,1% + 0,1% cream
   1. What Gentalyn Beta is and what it is used for
   2. What you need to know before using Gentalyn Beta
   3. How to use Gentalyn Beta
   4. Possible side effects
   5. How to store Gentalyn Beta
   6. Contents of the pack and other information
2. Gentalyn Beta 0,1% + 0,05% cream
   1. What Gentalyn Beta is and what it is used for
   2. What you need to know before using Gentalyn Beta
   3. How to use Gentalyn Beta
   4. Possible side effects
   5. How to store Gentalyn Beta
   6. Contents of the pack and other information

Gentalyn Beta 0,1% + 0,1% cream

gentamicina solfato/betametasone valerato

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gentalyn Beta is and what it is used for

Gentalyn Beta 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.

Gentalyn Beta 0.1% + 0.1% is indicated in the local treatment of skin diseases (dermatoses)
due to allergies or inflammation that have become infected or when there is a
threat of infection.
Gentalyn Beta 0.1% + 0.1% 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 round or oval pruritic lesions;
• anal and genital itching;
• pruritus in the elderly;
• contact dermatitis, characterized by redness, scaling, small blisters, bullae, superficial small wounds and crusts that occur when coming into contact with certain substances;
• seborrheic dermatitis, characterized by a skin rash affecting areas rich in sebaceous glands such as the 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, 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, characterized by red patches, thickening, silvery-white scaling and sometimes itching.

2. What you need to know before using Gentalyn Beta

Do not use Gentalyn Beta

• if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you have skin tuberculosis, Herpes simplex or other viral skin diseases.

Warnings and precautions
Talk to your doctor or pharmacist before using Gentalyn Beta.
If Gentalyn Beta causes irritation or sensitization, your doctor will stop the treatment
and prescribe appropriate therapy.
Any undesirable effect reported with the use of systemic corticosteroids (taken orally or
by injection), including hypoadrenalism (reduced function of the adrenal glands), can
also occur with topical corticosteroids (used locally), especially in children.
If you apply Gentalyn Beta to a large area of skin, especially in the presence of skin damage,
under an 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, the undesirable effects that occur when
gentamicin is taken systemically can occur. The doctor will take special 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, sometimes the proliferation of
organisms that are not susceptible may occur, including fungi. In this case, or if irritation,
sensitization or further infections develop, your doctor will stop the treatment with gentamicin and
prescribe specific therapy.
Do not use Gentalyn Beta on the eyes.
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).

Other medicines and Gentalyn Beta
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Use Gentalyn Beta 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 stop therapy, taking into account
the importance of taking the medicine in your case.

Driving and using machines
Gentalyn Beta does not impair the ability to drive vehicles and operate machinery.

Gentalyn Beta contains chlorocresol.It may cause allergic reactions.

Gentalyn Beta contains cetostearyl alcohol.It may cause localized skin reactions (e.g.
contact dermatitis).

3. How to use Gentalyn Beta

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask 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 Gentalyn Beta 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 a bandage or other means.
• 3. Keep the dressing on the affected part for a period of 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 may develop on the skin under the dressing, which requires removal of the occlusive dressing.

If you use more Gentalyn Beta than you should
In case of ingestion/accidental intake of an excessive dose of Gentalyn Beta, immediately inform your doctor or go to the nearest hospital.
Excessive or prolonged use of Gentalyn Beta may 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.

If you forget to use Gentalyn Beta
Do not use a double dose to make up for a missed dose.

If you stop using Gentalyn Beta
If you have any doubts about the use of this medicine, ask 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
• dry skin
• inflammation of the 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)
• maceration of the skin
• further skin infection (secondary infection)
• thinning of the skin (skin atrophy)
• skin striae
• acute inflammation of the skin 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, please 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 Gentalyn Beta

This medicine does not require any particular storage conditions.
After first opening, the medicine is valid for 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package 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 Gentalyn Beta contains

• The active ingredients are gentamicin sulfate and betamethasone valerate. 100 g of cream contains 0.166 g of gentamicin sulfate (corresponding to 0.1 g of gentamicin) and 0.122 g of betamethasone valerate (corresponding to 0.1 g of betamethasone).
• The other ingredients are chlorocresol, polyethylene glycol monocetyl ether (cetomacrogol 1000), cetostearyl alcohol, white petrolatum, liquid paraffin, sodium phosphate, phosphoric acid, purified water.

Description of the appearance of Gentalyn Beta and contents of the pack
Gentalyn Beta 0.1% + 0.1% cream - tube of 30 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Organon Italia S.r.l., Piazza Carlo Magno, 21 - 00162 Roma

Manufacturer
Schering-Plough Labo N.V., Industriepark 30, 2220 Heist-Op-Den-Berg, Belgium.

Gentalyn Beta 0,1% + 0,05% cream

gentamicina solfato/betametasone valerato

Read this leaflet carefully before you start 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 Gentalyn Beta is and what it is used for
• 2. What you need to know before you use Gentalyn Beta
• 3. How to use Gentalyn Beta
• 4. Possible side effects
• 5. How to store Gentalyn Beta
• 6. Contents of the pack and other information

1. What Gentalyn Beta is and what it is used for

Gentalyn Beta 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.

Gentalyn Beta 0.1% + 0.05% is indicated in the local treatment of skin diseases (dermatoses)
due to allergies or inflammation that have become infected or when there is a
threat of infection.
Gentalyn Beta 0.1% + 0.05% 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 round or oval pruritic lesions;
• anal and genital itching;
• itching in the elderly;
• contact dermatitis, characterized by redness, scaling, small blisters, bubbles, superficial small wounds and crusts that occur when coming into contact with certain substances;
• seborrheic dermatitis, characterized by a skin eruption that affects areas rich in sebaceous glands such as the 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, crusts and scales generally itchy;
• radiation dermatitis, characterized by itchy 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, characterized by red patches, thickening, silvery-white scaling and sometimes itching.

Gentalyn Beta 0.1% + 0.05% is also indicated:

• in the maintenance therapy of severe or resistant dermatoses, once adequate improvement has been obtained with Gentalyn Beta 0.1% + 0.1%;
• for the treatment of less severe or less resistant dermatoses, particularly those affecting extensive areas of the body or chronic ones that require prolonged therapy.

2. What you need to know before using Gentalyn Beta

Do not use Gentalyn Beta

• if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you have skin tuberculosis, Herpes simplex or other viral skin diseases.

Warnings and precautions
Talk to your doctor or pharmacist before using Gentalyn Beta.
If Gentalyn Beta causes irritation or sensitization, your doctor will stop the treatment
and prescribe appropriate therapy.
Any undesirable effect reported with the use of systemic corticosteroids (taken orally or
by injection), including hypoadrenalism (reduced function of the adrenal glands), can
also occur with topical corticosteroids (used locally), especially in children.
If you apply Gentalyn Beta to a large area of skin, especially in the presence of skin damage,
under an 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, the undesirable effects that occur when
gentamicin is taken systemically may occur. The doctor will take special 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
organisms that are not susceptible, including fungi, may sometimes occur. In this case, or if irritation,
sensitization or further infections should develop, your doctor will stop treatment with gentamicin and
prescribe specific therapy.
Do not use Gentalyn Beta on the eyes.
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).

Other medicines and Gentalyn Beta
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, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Use Gentalyn Beta 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 taking the medicine in your case.

Driving and using machines
Gentalyn Beta does not impair the ability to drive vehicles and operate machinery.

Gentalyn Beta contains chlorocresol.It may cause allergic reactions.

Gentalyn Beta contains cetostearyl alcohol.It may cause localized skin reactions (e.g.
contact dermatitis).

3. How to use Gentalyn Beta

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any
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 Gentalyn Beta 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 to healthy skin with a bandage 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 may develop on the skin under the dressing, which requires removal of the occlusive dressing.

If you use more Gentalyn Beta than you should
In case of ingestion/accidental intake of an excessive dose of Gentalyn Beta, immediately inform
your doctor or go to the nearest hospital.
Excessive or prolonged use of Gentalyn Beta may alter some hormones
of 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.

If you forget to use Gentalyn Beta
Do not use a double dose to make up for a missed dose.

If you stop using Gentalyn Beta
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
• dry skin
• inflammation of the 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)
• maceration of the skin
• further skin infection (secondary infection)
• thinning of the skin (skin atrophy)
• stretch marks
• acute inflammation of the skin with itching and retention of sweat in the layers under the skin (miliaria).

Treatment with the antibiotic gentamicina may cause temporary irritation (erythema and pruritus) 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, please 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 Gentalyn Beta

Do not store at a temperature above 25°C.
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 pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Gentalyn Beta contains

• The active ingredients are gentamicin sulfate and betamethasone valerate. 100 g of cream contain 0.166 g of gentamicin sulfate (corresponding to 0.1 g of gentamicin) and 0.061 g of betamethasone valerate (corresponding to 0.05 g of betamethasone).
• The other ingredients are chlorocresol, polyethylene glycol monocetyl ether (cetomacrogol 1000), cetostearyl alcohol, white petrolatum, liquid paraffin, sodium phosphate, phosphoric acid, purified water.

Description of the appearance of Gentalyn Beta and contents of the pack
Gentalyn Beta 0.1% + 0.05% cream – tube of 20 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Organon Italia S.r.l., Piazza Carlo Magno, 21 - 00162 Roma

Manufacturer
Schering-Plough Labo N.V., Industriepark 30, 2220 Heist-Op-Den-Berg, Belgium.