Gentamicin and betamethasone Hexal

Package leaflet: Information for the patient

Gentamicin and Betamethasone Hexal 0.1%+0.1% cream

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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gentamicina e Betametasone Hexal is and what it is used for

Gentamicina e Betametasone Hexal is a topical cream containing two active substances: gentamicin and betamethasone. Gentamicin belongs to the aminoglycoside antibiotics group, used to treat bacterial infections. Betamethasone belongs to the corticosteroid group, used to reduce inflammation and allergic reactions.

Gentamicina e Betametasone Hexal is indicated for the treatment of allergic or inflammatory skin irritations such as:

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

2. What you need to know before using Gentamicina e Betametasone Hexal

Do not use Gentamicina e Betametasone Hexal

• if you are allergic to betamethasone, gentamicin sulfate, or to 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 skin infections caused by viruses such as herpes simplex.

Warnings and precautions
Talk to your doctor or pharmacist before using Gentamicina e Betametasone Hexal.
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 after prolonged use, or if resistant microorganisms develop, including certain types of fungi, which may occur following prolonged use of gentamicin, as with other antibiotics.
Use this medicine with caution and inform your doctor in the following cases:

• if you are treating large areas of skin or for long periods, because betamethasone and gentamicin may pass through the skin. This is even more likely if the cream is applied to damaged skin, under occlusive (non-breathable) dressings, or if you are an infant or child;
• if you are allergic to other antibiotics of the aminoglycoside group, because you may experience an allergic reaction (cross-sensitivity).

Children
In children, this medicine should be used only when strictly necessary and under direct medical supervision, because 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 Hexal
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interaction studies with other medicines have been conducted.
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.
If you are pregnant, use this medicine only when strictly necessary and under direct medical supervision; your doctor will evaluate the risk/benefit ratio for both fetus and mother.
If you are breastfeeding, use this medicine with caution and under direct medical supervision; your doctor will decide whether it is necessary to discontinue breastfeeding or stop the treatment.
Driving and operating machinery
This medicine does not affect the ability to drive vehicles or operate machinery.
Gentamicina e Betametasone Hexal contains chlorocresol and cetostearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Gentamicina e Betametasone Hexal

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Gentamicina e Betametasone Hexal must not be applied to the eyes.
Apply a small amount of cream to the affected area 2–3 times daily.
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 lesion surface under a light gauze and cover with 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. 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 you notice
   skin irritation, remove the plastic covering.
   If you use more Gentamicina e Betametasone Hexal than you should
   Excessive or prolonged use of this medicine may cause corticosteroid-related side effects such as:
   adrenal gland dysfunction, increased steroid levels in the body (hypercorticism), Cushing's syndrome
   (a condition in which the body produces too much cortisol), and development of infections caused by
   resistant bacteria or fungi.
   In case of accidental ingestion/ingestion of Gentamicina e Betametasone Hexal, contact your doctor or go
   to the nearest hospital immediately.
   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 everyone experiences them.
The following side effects may very rarely occur:

• allergic reactions (hypersensitivity);
• skin irritation (rash);
• change in skin colour (discoloration).

When corticosteroids are used on the skin, especially following the use of occlusive dressings, some of the following side effects may occur:

• burning;
• itching;
• irritation;
• dryness of the skin;
• infection of hair follicles (folliculitis);
• increased hair growth (hypertrichosis);
• acne-like eruptions, dermatitis affecting areas around the mouth (perioral dermatitis), allergic contact dermatitis;
• reduced skin pigmentation (hypopigmentation);
• skin lesions (skin maceration), secondary infections, thinning of the skin (cutaneous atrophy), stretch marks (striae), and a skin inflammation known as miliaria.

Treatment with gentamicin may cause transient skin irritation such as erythema or itching. These effects do not require discontinuation of treatment.

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 axis and reduced blood cortisol levels;
• increased cortisol production (Cushing's syndrome);
• growth retardation;
• increased pressure in the brain (intracranial hypertension), manifested by bulging fontanelles, headache, and swelling of the optic nerves at the back of the eyes (bilateral papilledema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gentamicina e Betametasone Hexal

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.
This medicine does not require any special storage conditions.
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 Hexal contains

• The active substances are: gentamicin sulfate and betamethasone valerate. 100 g of cream contain 0.1 g of gentamicin (as gentamicin sulfate) and 0.1 g of betamethasone (as betamethasone valerate).
• The other components are: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white soft paraffin, liquid paraffin, disodium phosphate dihydrate, sodium phosphate dodecahydrate, purified water.

Description of the appearance of Gentamicina e Betametasone Hexal and package contents
Pack containing one tube of 30 g of cream.
Marketing Authorization Holder
SANDOZ S.p.A., Largo U. Boccioni 1, 21040, Origgio (VA)
Manufacturer
Doppel Farmaceutici S.r.l., Via dei Martiri delle Foibe 1, 29016, Cortemaggiore (PC)
Mipharm S.p.A., Via B. Quaranta 12, 20141, Milan