Gentamicin and betamethasone Tecnigen

PACKAGE LEAFLET: INFORMATION FOR THE USER

GENTAMICIN AND BETAMETASONE TECNIGEN

0.1% + 0.1% cream
Generic medicine
Please read all of this leaflet carefully before you start 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What GENTAMICIN AND BETAMETASONE TECNIGEN is and what it is used for

2. What you need to know before using GENTAMICIN AND BETAMETASONE TECNIGEN

3. How to use GENTAMICIN AND BETAMETASONE TECNIGEN

4. Possible side effects

5. How to store GENTAMICIN AND BETAMETASONE TECNIGEN

6. Contents of the pack and other information

7. What GENTAMICIN AND BETAMETASONE TECNIGEN is and what it is used for
   GENTAMICIN AND BETAMETASONE TECNIGEN 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.

GENTAMICIN AND BETAMETASONE TECNIGEN is indicated for the treatment of allergic or inflammatory skin irritations such as:

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

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

Do not use GENTAMICINA E BETAMETASONE TECNIGEN

• 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 TECNIGEN.
If GENTAMICINA E BETAMETASONE TECNIGEN causes irritation or sensitization, your doctor will stop treatment and prescribe appropriate therapy.
Any adverse effects reported with systemic corticosteroids (taken orally or by injection), including adrenal suppression (reduced adrenal gland function), may also occur with topical corticosteroids (used locally), especially in children.
Stop treatment and inform your doctor if you develop irritation or an allergic reaction (sensitization) after using this medicine, particularly after prolonged use, or if resistant microorganisms, including certain types of fungi, develop—this 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 starting treatment over large areas of skin or for long periods, because corticosteroids (betamethasone) may pass through the skin. This is even more likely if the cream is applied under occlusive dressings (non-breathable) or if it is used in children;
• if you are allergic to other antibiotics of the aminoglycoside group, because you may experience an allergic reaction (cross-sensitivity). Do not use GENTAMICINA E BETAMETASONE TECNIGEN in 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 hormonal effects of the active ingredient betamethasone (hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, delayed linear and weight growth, and intracranial hypertension).

Other medicines and GENTAMICINA E BETAMETASONE TECNIGEN
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.
Pregnancy
If you are pregnant, use this medicine only if clearly needed and under direct medical supervision. Do not use this medicine at high doses or for prolonged periods during pregnancy.
Breastfeeding
If you are breastfeeding, your doctor will decide whether it is better to discontinue breastfeeding or to stop the treatment, based on your individual condition.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

GENTAMICINA E BETAMETASONE TECNIGEN 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).

BETAMETHASONE
Caution for athletes: This product contains substances prohibited in doping.
It is forbidden to use this medicine in a manner different from the therapeutic indications, dosage regimen, or route of administration stated.

3. How to use GENTAMICINA E BETAMETASONE TECNIGEN

Use this medicine exactly as directed by your doctor or pharmacist. If in doubt,
ask your doctor or pharmacist.
GENTAMICINA E BETAMETASONE TECNIGEN 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.

Occlusive dressing technique

1. Apply a thick layer of cream over the entire lesion surface under a light gauze and cover with
   a 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.

Marked improvement is often observed within a few days using this method. Rarely, skin inflammation may develop under the dressing, requiring removal of the occlusive dressing.

If you use more GENTAMICINA E BETAMETASONE TECNIGEN than you should
Excessive or prolonged use of this medicine may cause corticosteroid-related adverse effects such as:
adrenal gland dysfunction, increased steroid levels in the body (hypercorticism), including Cushing's syndrome—a condition in which the body produces too much cortisol— and development of lesions caused by bacteria and fungi.
These symptoms may resolve after discontinuation of treatment, which should be gradual.
In case of accidental ingestion/ingestion of GENTAMICINA E BETAMETASONE TECNIGEN, contact your
doctor or go immediately to the Emergency Room of the nearest hospital.
A single episode of overdose with the antibiotic gentamicin is unlikely to produce any symptoms. Excessive and prolonged use of gentamicin on the skin may lead to the development of lesions caused by non-sensitive bacteria and fungi.

If you forget to use GENTAMICINA E BETAMETASONE TECNIGEN
Do not use a double dose to make up for the forgotten dose.

If you stop using GENTAMICINA E BETAMETASONE TECNIGEN
If you have any doubts about using 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.
The following side effects have been reported very rarely:

• hypersensitivity
• skin rash
• skin discolouration

The following side effects have been described due to the use of corticosteroids applied to the skin, especially after using occlusive dressings:

• irritation
• itching
• burning sensation
• dry skin
• inflammation of the hair-bearing skin (folliculitis)
• excessive hair growth (hypertrichosis)
• acne (acneiform eruptions)
• skin inflammation with red rashes around the mouth (perioral dermatitis)
• skin inflammation due to contact with substances causing allergy (allergic contact dermatitis)
• changes in skin colour (hypopigmentation)
• skin maceration
• secondary skin infection
• thinning of the skin (cutaneous atrophy)
• stretch marks
• acute skin inflammation with itching and sweat retention in the layers beneath the skin (miliaria).

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

• blurred vision.

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), presenting as bulging fontanelles, headache and swelling of the nerves behind the eyes (bilateral papilledema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 TECNIGEN

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 “Expiry”. 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 no longer required. This will help protect the environment.

6. Package contents and other information

What GENTAMICINA E BETAMETASONE TECNIGEN contains

• The active substances are gentamicin and betametasone. 100 g of cream contain 0.1 g of gentamicin (corresponding to gentamicin sulfate) and 0.1 g of betametasone (corresponding to betamethasone valerate).
• The other components are: chlorocresol, macrogol cetylstearyl ether, cetylstearyl alcohol, white soft paraffin, liquid paraffin, monobasic sodium phosphate, phosphoric acid, purified water.

Description of the appearance of GENTAMICINA E BETAMETASONE TECNIGEN and contents of the
pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan
Italy
Manufacturer
Special Product’s Line S.p.A. – Strada Paduni, 240 – 03012 Anagni (FR) - Italy
Lachifarma S.p.A. – Laboratorio Chimico Farmaceutico Salentino – S.S. 16 Adriatica – Zona Industriale 73010
Zollino (LE) - Italy