Package leaflet: Information for the user

FIDAGENBETA 0.1% + 0.1% cream

Generic 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, consult 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:

What FIDAGENBETA is and what it is used for
What you need to know before using FIDAGENBETA
How to use FIDAGENBETA
Possible side effects
How to store FIDAGENBETA
Contents of the pack and other information

1. What FIDAGENBETA is and what it is used for

FIDAGENBETA is a topical cream containing two active substances: gentamicin and betametasone. Gentamicin belongs to the group of aminoglycoside antibiotics, used to treat bacterial infections. Betametasone belongs to the corticosteroid group, used to relieve inflammation and allergic reactions.
FIDAGENBETA 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 age-related pruritus (senile pruritus);
immune-mediated inflammatory skin reactions such as contact dermatitis and seborrheic dermatitis (affecting areas rich in sebaceous glands, such as scalp, face, and chest);
skin irritation characterized by dryness and itching (neurodermatitis);
skin irritation caused by continuous friction between body parts (intertrigo);
skin irritation caused by exposure to sunlight (sunburn);
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 FIDAGENBETA

Do not use FIDAGENBETA

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 or other viral skin infections;

Warnings and precautions
Talk to your doctor or pharmacist before using FIDAGENBETA.
This medicine must not be applied to the eyes.
Contact your doctor if you experience blurred vision or other visual disturbances.
Stop treatment and inform your doctor if you develop irritation or an allergic reaction (sensitization) following the use of this medicine, especially if resistant microorganisms, including certain types of fungi, develop. This may occur with prolonged use of gentamicin, as with other antibiotics. In such cases, or if irritation, sensitization, or superinfection occurs, treatment with gentamicin should be discontinued and specific therapy should be initiated.

Use this medicine with caution and inform your doctor if treatment is to be started over large areas or for prolonged periods, as corticosteroids (betamethasone) may pass through the skin. This is even more likely if the cream is applied under occlusive (non-breathable) dressings 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 this may increase the risk of adverse effects due to higher absorption of corticosteroids (see section Additional undesirable effects in children).
Other medicines and FIDAGENBETA
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, are planning to become pregnant, or are 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 it is necessary to discontinue breastfeeding or stop the treatment.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
FIDAGENBETA 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 FIDAGENBETA

Use this medicinal product exactly as instructed by your doctor or pharmacist. If you have any doubts,
ask your doctor or pharmacist.
FIDAGENBETA 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:

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;
seal the edges onto healthy skin with adhesive tape or other means;
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 FIDAGENBETA than you should
Excessive or prolonged use of this medicinal product may cause corticosteroid-related adverse 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 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 FIDAGENBETA, contact your doctor or go immediately
to the Emergency Room of the nearest hospital.
If you have any doubts about how to use this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
When corticosteroids are used on the skin, some of the following side effects may occur:

burning,
itching,
skin irritation (rash), dryness of the skin;
infection of hair follicles (folliculitis);
increased hair growth (hypertrichosis);
irritation with pimples (acneiform eruptions), dermatitis affecting areas around the mouth (perioral dermatitis), allergic contact dermatitis;
reduced skin pigmentation (hypopigmentation).

Treatment with gentamicin may cause transient skin irritation such as rash, 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 of corticosteroids, may experience:

suppression of the hypothalamic-pituitary-adrenal (HPA) 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 nerves behind the eyes (bilateral papilledema).

The following side effects may occur with uncommon frequency:

blurred vision.

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 the following website: 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 FIDAGENBETA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 FIDAGENBETA 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 vaseline, liquid paraffin, disodium phosphate dihydrate, disodium phosphate dodecahydrate, purified water.

Description of the appearance of FIDAGENBETA and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD)
Manufacturer and final controller
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)