FIDAGENBETA 0.1% + 0.1% Cream

Зміст інструкції

1. FIDAGENBETA 0.1% + 0.1% cream
   1. What FIDAGENBETA is and what it is used for
   2. What you need to know before using FIDAGENBETA
   3. How to use FIDAGENBETA
   4. Possible side effects
   5. How to store FIDAGENBETA
   6. Contents of the pack and other information

FIDAGENBETA 0.1% + 0.1% cream

Generic medicine
Read this leaflet carefully before using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FIDAGENBETA is and what it is used for

FIDAGENBETA is a cream for topical application that contains two active ingredients: gentamicin and
betamethasone. Gentamicin belongs to the group of aminoglycoside antibiotics, used against
bacterial infections. Betamethasone belongs to the group of corticosteroids, used to relieve
inflammation and allergies.
FIDAGENBETA is indicated for the treatment of skin irritations of an allergic or inflammatory
nature such as:

• eczema of various types (atopic, infantile, nummular), an inflammatory reaction of the skin with itching;
• anal and genital itching (anogenital) and itching that occurs in the elderly (senile);
• inflammatory skin reactions of an immune nature such as contact dermatitis and seborrheic dermatitis (which affects areas rich in sebaceous glands such as scalp, face, chest);
• irritation that manifests with dry skin and itching (neurodermatitis);
• irritation caused by continuous friction of two parts of the body (intertrigo);
• irritation caused by exposure to sunlight (sunburn);
• other forms of skin irritations such as exfoliative dermatitis, radiation dermatitis, stasis dermatitis;
• psoriasis, a chronic inflammatory disease of the skin 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 skin infection caused by a virus such as herpes simplex or other viral skin infections;

Warnings and precautions
Talk to your doctor or pharmacist before using FIDAGENBETA.
This medicine should 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 experience irritation or an allergic reaction
(sensitization) following the use of this medicine in case microorganisms
resistant to the drug develop, including some types of fungi, which may occur after prolonged use of
gentamicin as well as other antibiotics. In this case, or if irritation,
sensitization or superinfection develops, treatment with gentamicin should be discontinued and specific
therapy should be started.

• Use the medicine with caution and inform your doctor if you need to start treatment on large areas or for long periods, because corticosteroids (betamethasone) can pass through the skin. This is even more likely to happen if the cream is applied under an occlusive (non-breathable) bandage or if you are a child.

Children
In children, the medicine should only be used in cases of real need and under the direct control of the
doctor, because it may increase the risk of side effects due to increased absorption of
corticosteroids (see section Additional side effects in children).

Other medicines and FIDAGENBETA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only if absolutely necessary and under the direct
control of your doctor.
If you are breastfeeding, use this medicine with caution and under the direct control of your doctor, who may
need to interrupt breastfeeding or stop therapy.

Driving and using machines
This medicine does not affect the ability to drive vehicles or use machines.

FIDAGENBETA contains chlorocresol andcetostearyl alcohol
This medicine contains chlorocresol, which can cause allergic reactions, and cetostearyl alcohol, which can
cause localized skin reactions (e.g. contact dermatitis).

3. How to use FIDAGENBETA

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts,
ask your doctor or pharmacist.
FIDAGENBETA should not be applied to the eyes.
Apply a small amount of cream to the affected area 2-3 times a day.
For the treatment of psoriasis or infected deep dermatosis lesions, occlusive bandaging may be used
to obtain a better response to therapy.
Apply the occlusive bandage as follows:

• 1) apply a thick layer of cream to the entire surface of the lesion under a light gauze and cover with transparent, waterproof and flexible plastic material, beyond the edges of the treated area;
• 2) seal the edges to healthy skin with adhesive tape or other means;
• 3) leave the dressing at the application site for 1-3 days and repeat the procedure 3-4 times as needed.

With this method, a noticeable 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 medicine can cause undesirable effects due to corticosteroids
such as: adrenal gland dysfunction, increased levels of steroids in the body
(hypercorticism), Cushing's syndrome, a condition in which the body produces too much cortisol,
formation of lesions caused by bacteria and fungi.
These symptoms may disappear after discontinuation of treatment, which should be gradual.
In case of ingestion/accidental intake of FIDAGENBETA, contact your doctor or go
immediately to the Emergency Room of the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Treatment with gentamicina may cause transient skin irritation such as rash,
redness or itching. These effects do not require discontinuation of therapy.
The use of occlusive bandages may cause an increase in side effects such as the formation of skin lesions
(skin maceration), secondary infection, thinning of the skin (skin atrophy),
stretch marks (striae) and skin inflammation known as miliaria.

Additional side effects in children
Children are more sensitive than adults to side effects caused by corticosteroids, and may
experience:

• suppression of the hypothalamus-pituitary-adrenal axis and a decrease in the amount of cortisol in the blood;
• increased production of cortisol (Cushing's syndrome);
• growth retardation;
• increased pressure in the brain (intracranial hypertension) which manifests with tension of the fontanelles, headache and swelling of the nerves behind the eye (bilateral papilledema).

The following effects may occur with uncommon frequency:

• blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through 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 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 “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FIDAGENBETA contains

• The active ingredients are gentamicin sulfate and betamethasone valerate. 100 g of cream contains 0.1 g of gentamicin sulfate and 0.1 g of betamethasone valerate.
• The other ingredients are: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white soft paraffin, liquid paraffin, disodium phosphate dihydrate, disodium phosphate dodecahydrate, purified water.

Description of the appearance of FIDAGENBETA and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 3503,1 Abano Terme (PD)

Manufacturer and final control
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016, Cortemaggiore (PC)