GENTAMICINA 0.1% + 0.1% Крем

Содержание инструкции

1. GENTAMICINA e BETAMETASONE PENSA 0.1g/100 g + 0.1g/100 g cream
   1. What is GENTAMICINA and BETAMETASONE PENSA and what is it used for
   2. What you need to know before using GENTAMICINA and BETAMETASONE PENSA
   3. How to use GENTAMICINA and BETAMETASONE PENSA
   4. Possible side effects
   5. How to store GENTAMICINA and BETAMETASONE PENSA
   6. Contents of the pack and other information

GENTAMICINA e BETAMETASONE PENSA 0.1g/100 g + 0.1g/100 g cream

Gentamicin sulfate and betamethasone valerate

Equivalent medicinal product
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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

GENTAMICINA and BETAMETASONE PENSA is a cream for topical application that contains two
active ingredients: gentamicina and betamethasone. Gentamicina belongs to the group of aminoglycoside
antibiotics, used against bacterial infections. Betamethasone belongs to the group of
corticosteroids, used to relieve inflammation and allergies.
GENTAMICINA and BETAMETASONE PENSA is indicated for the treatment of skin irritations of
allergic or inflammatory type 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);
• skin 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 skin disease involving the immune system.

2. What you need to know before using GENTAMICINA and BETAMETASONE PENSA

Do not use GENTAMICINA 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 skin infection caused by a virus such as herpes simplex;
• if you have viral diseases located on the skin.

Warnings and precautions
Consult your doctor or pharmacist before using GENTAMICINA and BETAMETASONE PENSA.
This medicine should 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 for prolonged periods or in the event
that microorganisms resistant to it develop, including some types of fungi, which may occur
following prolonged use of gentamicin as well as other antibiotics.
Use the medicine with caution and inform your doctor in the following cases:

• 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;
• if you are allergic to other antibiotics in the aminoglycoside group, because an allergic reaction (cross-hypersensitivity) may occur.

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

Other medicines and GENTAMICINA and BETAMETASONE PENSA
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 may be pregnant or are planning to become pregnant, 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
supervision of your doctor.
If you are breastfeeding, use this medicine with caution and under the direct supervision of your doctor, who may
decide to stop breastfeeding or suspend therapy.

Driving and operating machinery
No data are available to establish the effect of the medicine on the ability to drive and operate
machinery.

GENTAMICINA and BETAMETASONE PENSA contains chlorocresol andcetostearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetostearyl alcohol, which may
cause localized skin reactions (e.g. contact dermatitis).

3. How to use GENTAMICINA and BETAMETASONE PENSA

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts,
ask your doctor or pharmacist.
GENTAMICINA and BETAMETASONE PENSA 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 can 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 GENTAMICINA and BETAMETASONE PENSA than you should
Excessive or prolonged use of this medicine can cause undesirable effects due to corticosteroids
such as: malfunctioning of the adrenal glands, increased levels of steroids in the body
(hypercortisolism), 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 GENTAMICINA and BETAMETASONE PENSA, 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.
During the use of corticosteroids on the skin, especially if used intensely and for long periods of time,
some of the following side effects may occur:

• skin irritation and dryness;
• burning, itching;
• hair follicle infection (folliculitis);
• increased hair growth (hypertrichosis);
• irritation with pimples, dermatitis affecting the areas around the mouth, allergic contact dermatitis;
• reduced skin pigmentation (hypopigmentation).

The use of occlusive dressings may cause an increase in side effects such as skin lesions (skin maceration), secondary infection, skin thinning (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 bulging fontanelles, headache and swelling of the nerves behind the eye (bilateral papilledema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 GENTAMICINA and BETAMETASONE PENSA

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 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 GENTAMICINA and BETAMETASONE PENSA 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 petrolatum, liquid paraffin, sodium phosphate monobasic, phosphoric acid, purified water.

Description of the appearance of GENTAMICINA and BETAMETASONE PENSA and pack contents
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milano
Italy

Manufacturer
IDI Farmaceutici S.r.l. – Via dei Castelli Romani 83/85 – 00040 Pomezia (RM)