Gentamicin and betamethasone Alter

Package leaflet: Information for the patient

GENTAMICIN AND BETAMETHASONE ALTER 0.1% + 0.1% cream

Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

GENTAMICINA E BETAMETASONE ALTER is a topical cream containing two active substances: gentamicin and betametasone. Gentamicin belongs to the aminoglycoside antibiotics, which are used against bacterial infections. Betametasone belongs to the corticosteroid group, used to reduce inflammation and allergic reactions.

GENTAMICINA E BETAMETASONE ALTER is indicated for the treatment of allergic or inflammatory skin conditions that are either infected or at risk of infection, such as:

• various types of eczema (atopic, infantile, nummular), an inflammatory skin reaction associated with itching;
• anal and genital (anogenital) pruritus, and age-related pruritus (senile);
• immune-mediated inflammatory skin reactions such as contact dermatitis and seborrheic dermatitis (affecting areas rich in sebaceous glands, such as the scalp, face, and chest);
• chronic itching and skin scaling (neurodermatitis);
• skin irritation caused by constant friction between adjacent body parts (intertrigo);
• sun-induced skin irritation (solar erythema);
• other forms of skin irritation such as exfoliative dermatitis, radiation dermatitis, and stasis dermatitis;
• psoriasis, a chronic inflammatory skin disease involving the immune system.

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

Do not use GENTAMICINA E BETAMETASONE ALTER
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• if you are allergic to betamethasone, gentamicin sulfate, or any of the other ingredients of this medicine (listed in section 6);
• if you have a type of skin infection called cutaneous tuberculosis;
• if you have a viral skin infection such as herpes simplex.

Warnings and precautions
Talk to your doctor or pharmacist before using GENTAMICINA E BETAMETASONE ALTER.
This medicine must not be applied to the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) after using this medicine, especially with prolonged use, or if resistant microorganisms develop, including certain types of fungi, which may occur following prolonged use of gentamicin and other antibiotics.

• Use this medicine with caution and inform your doctor if you are treating large areas of skin or using it for long periods, as corticosteroids (betamethasone) may pass through the skin. This is even more likely if the cream is applied under occlusive dressings (non-breathable) or if the patient is a child.

Children
In children, this medicine should be used only when strictly necessary and under direct medical supervision, as there may be an increased risk of undesirable effects due to higher absorption of corticosteroids (see section "Additional undesirable effects in children").
Other medicines and GENTAMICINA E BETAMETASONE ALTER
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only if clearly needed and under direct medical supervision, after careful assessment of the risk/benefit balance for both fetus and mother.
If you are breastfeeding, use this medicine with caution and under direct medical supervision; your doctor may consider it necessary to discontinue breastfeeding or stop the treatment.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
GENTAMICINA E BETAMETASONE ALTER contains chlorocresol
It may cause allergic reactions.
GENTAMICINA E BETAMETASONE ALTER contains cetyl stearyl alcohol
It may cause localized skin reactions (e.g. contact dermatitis).
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3. How to use GENTAMICINA E BETAMETASONE ALTER

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
GENTAMICINA E BETAMETASONE ALTER must not be applied to the eyes.
Apply a small amount of cream to the affected area 2–3 times a day.
For the treatment of psoriatic lesions or infected deep dermatoses, occlusive dressing may be used to achieve a better therapeutic response.

Apply the occlusive dressing as follows:

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

With this method, significant improvement is often observed within a few days. However, if skin irritation occurs, remove the plastic covering.

If you use more GENTAMICINA E BETAMETASONE ALTER than you should
Excessive or prolonged use of this medicine may cause corticosteroid-related side effects such as: impaired adrenal gland function, increased steroid levels in the body (hypercorticism), Cushing's syndrome (a condition in which the body produces too much cortisol), and bacterial or fungal infections.
These symptoms may disappear after gradually discontinuing treatment.

In case of accidental ingestion/ingestion of GENTAMICINA E BETAMETASONE ALTER, contact your doctor or go immediately to the Emergency Department of the nearest hospital.

If you have any doubts about how to use 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.
When using corticosteroids on the skin, some of the following side effects may occur:

• burning sensation
• itching
• skin irritation (rash), dryness of the skin
• infection of hair follicles (folliculitis)
• increased hair growth (hypertrichosis)
• acne-like irritation, dermatitis affecting areas around the mouth, allergic contact dermatitis
• reduced skin pigmentation (hypopigmentation).

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Treatment with gentamicin may cause transient skin irritation such as temporary irritation, redness or itching. These effects do not require discontinuation of therapy.
The use of occlusive dressings may increase the occurrence of side effects, such as skin lesions (skin maceration), secondary infection, thinning of the skin (cutaneous atrophy), stretch marks (striae), and a skin inflammation known as miliaria.

Additional side effects in children
Children, who are more sensitive than adults to the side effects caused by corticosteroids, may experience:

• suppression of the hypothalamic-pituitary-adrenal (HPA) axis and decreased levels of cortisol in the blood;
• increased cortisol production (Cushing's syndrome);
• growth retardation (height and weight);
• increased pressure in the brain (intracranial hypertension), presenting as bulging of the fontanelles, headache, and swelling of the optic nerves (bilateral papilledema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GENTAMICINA E BETAMETASONE ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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. Contents of the pack and other information

What GENTAMICINA E BETAMETASONE ALTER contains

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

Description of the appearance of GENTAMICINA E BETAMETASONE ALTER and pack contents
Pack containing one tube of 30 g cream.
Marketing Authorization Holder
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Laboratori Alter S.r.l., Via Egadi 7, 20144 Milano
Manufacturer
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A. – Via Licinio, 11 – 22036 Erba (CO)
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