Gentamicin and betamethasone PensA

Package leaflet: Information for the user

GENTAMICIN and BETAMETHASONE PENSA 0.1 g/100 g + 0.1 g/100 g cream

Gentamicin sulfate and betamethasone valerate
Generic medicine
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 they have the same symptoms as you, because it could be dangerous.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What GENTAMICINA and BETAMETASONE PENSA is and what it is used for

GENTAMICINA and BETAMETASONE PENSA 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 and BETAMETASONE PENSA 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) itching, and itching occurring in the elderly (senile pruritus);
• 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 continuous friction between body parts (intertrigo);
• irritation caused by exposure to sunlight (solar erythema);
• 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 GENTAMICIN and BETAMETASONE PENSA

Do not use GENTAMICIN and BETAMETASONE PENSA

• 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;
• if you have viral diseases localized on the skin.

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

• if treatment involves large skin areas or prolonged periods, because corticosteroids (betamethasone) may pass through the skin. This is even more likely if the cream is applied under an occlusive dressing (non-breathable) or if the patient is a 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, as there may be an increased risk of adverse effects due to higher absorption of corticosteroids (see section “Additional adverse effects in children”).
Other medicines and GENTAMICIN and BETAMETASONE PENSA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
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 necessary and under direct medical supervision.
If you are breastfeeding, use this medicine with caution and under direct medical supervision; your doctor may decide to discontinue breastfeeding or stop the treatment.
Driving and using machines
There are no available data to determine the effect of this medicine on the ability to drive and use machinery.
GENTAMICIN and BETAMETASONE PENSA contains chlorocresol and cetyl stearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetyl stearyl alcohol, which may cause localized skin reactions (e.g. contact dermatitis).

3. How to use GENTAMICINA and BETAMETASONE PENSA

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
ask your doctor or pharmacist.
GENTAMICINA and BETAMETASONE PENSA 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 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.
   This method often results in significant improvement within a few days. However, if skin irritation occurs,
   remove the plastic covering.
   If you use more GENTAMICINA and BETAMETASONE PENSA 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—bacterial and fungal infections.
   These symptoms may resolve after gradually discontinuing treatment.
   In case of accidental ingestion/intake of GENTAMICINA and BETAMETASONE PENSA, contact your
   doctor or go immediately to the Emergency Room 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 will experience them.

When corticosteroids are used on the skin, especially intensively and for long periods of time, some of the following side effects may occur:

• skin irritation and dryness;
• burning, itching;
• infection of the 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.

Additional side effects in children
Children, who are more sensitive than adults to the side effects of 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 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 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 GENTAMICIN and BETAMETHASONE DRESSING

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. Package contents and other information

What GENTAMICINA e BETAMETASONE PENSA 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, phosphoric acid, purified water.

Description of the appearance of GENTAMICINA e BETAMETASONE PENSA and contents of the
pack
Pack containing one tube of 30 g of cream.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy
Manufacturer
IDI Farmaceutici S.r.l. – Via dei Castelli Romani 83/85 – 00040 Pomezia (RM)