Gentamicin and betamethasone Doc Generici

Package leaflet: Information for the user

GENTAMICIN and BETAMETHASONE DOC Generics 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 they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What GENTAMICINA e BETAMETASONE DOC Generici is and what it is used for

GENTAMICINA e BETAMETASONE DOC Generici is a topical cream containing two active substances: gentamicin and betamethasone. Gentamicin belongs to the aminoglycoside group of antibiotics, used to treat bacterial infections. Betamethasone belongs to the corticosteroid group, used to relieve inflammation and allergic reactions.

GENTAMICINA e BETAMETASONE DOC Generici is indicated for the treatment of allergic or inflammatory skin conditions such as:

• various types of eczema (atopic, infantile, nummular), an inflammatory skin reaction associated with itching;
• anal and genital itching (anogenital pruritus), and age-related itching (senile pruritus);
• 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);
• skin irritation caused by constant friction between body parts (intertrigo);
• irritation caused by exposure to sunlight (sunburn);
• other types of skin irritations 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 GENTAMICIN and BETAMETASONE DOC Generics

Do not use GENTAMICIN and BETAMETASONE DOC Generics

• 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 a viral skin infection such as herpes simplex.

Warnings and precautions
Talk to your doctor or pharmacist before using GENTAMICIN and BETAMETASONE DOC Generics.
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, 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 corticosteroids (betamethasone) may pass through the skin. This is even more likely if the cream is applied under occlusive (non-breathable) dressings or if it is used in children;
• if you are allergic to other antibiotics of the aminoglycoside group, as you may experience an allergic reaction (cross-sensitivity).

Children
In children, this medicine should only be used when strictly necessary and under direct medical supervision, because there may be an increased risk of unwanted effects due to greater absorption of corticosteroids (see section on Additional undesirable effects in children).
Other medicines and GENTAMICIN and BETAMETASONE DOC Generics
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only if clearly needed and under direct medical supervision. Do not use high doses for prolonged periods during pregnancy.
If you are breastfeeding, your doctor will decide whether it is better to discontinue breastfeeding or to stop the treatment, depending on your condition.
Driving and using machines
This medicine does not affect the ability to drive or use machinery.
GENTAMICIN and BETAMETASONE DOC Generics 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 and BETAMETASONE DOC Generici

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts,
ask your doctor or pharmacist.
GENTAMICINA and BETAMETASONE DOC Generici 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 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 to the surrounding healthy skin using 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 and BETAMETASONE DOC Generici 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 bacterial or fungal infections.
   These symptoms may resolve after gradually discontinuing treatment.
   In case of accidental ingestion/ingestion of GENTAMICINA and BETAMETASONE DOC Generici,
   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 everyone experiences them.
During the use of corticosteroids on the skin, especially when used intensively and for prolonged periods, some of the following side effects may occur:

• temporary skin irritation such as rash, erythema or pruritus;
• burning, dryness of the skin;
• infection of hair follicles (folliculitis);
• increased hair growth (hypertrichosis);
• irritation with acne-like eruptions, dermatitis affecting areas around the mouth, allergic contact dermatitis;
• reduced skin pigmentation (hypopigmentation).
  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. Treatment with gentamicin may cause temporary irritation (erythema and pruritus), which usually does 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 cortisol levels in the blood;
• increased cortisol production (Cushing's syndrome);
• growth retardation;
• increased pressure in the brain (intracranial hypertension), manifesting as bulging fontanelles, headache, and swelling of the optic nerves behind the eyes (bilateral papilledema).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult 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/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GENTAMICIN and BETAMETHASONE DOC Generics

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 you no longer use. This will help protect the environment.

6. Package contents and other information

What GENTAMICINA e BETAMETASONE DOC Generici contains

• The active substances are gentamicin and betamethasone. 100 g of cream contain 0.1 g of gentamicin (equivalent to 0.166 g of gentamicin sulfate) and 0.1 g of betamethasone (equivalent to 0.122 g of betamethasone valerate).
• The other components are: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white soft paraffin, liquid paraffin, monobasic sodium phosphate, phosphoric acid, purified water.

Description of the appearance of GENTAMICINA e BETAMETASONE DOC Generici and the contents of the
pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
DOC Generici Srl
Via Turati, 40
20121 Milan
Manufacturer
DOPPEL Farmaceutici Srl, Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)