GENTAMICINA 0.1% + 0.1% Cream

Зміст інструкції

1. Gentamicina e Betametasone Hexal 0,1%+0,1% cream
   1. What is Gentamicina and Betametasone Hexal and what is it used for
   2. What you need to know before using Gentamicina e Betametasone Hexal
   3. How to use Gentamicina and Betametasone Hexal
   4. Possible side effects
   5. How to store Gentamicina e Betametasone Hexal
   6. Contents of the pack and other information

Gentamicina e Betametasone Hexal 0,1%+0,1% cream

Generic medicine

Read this leaflet carefully before you use 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 pass it on to others, even if their symptoms are the same as yours, as it could 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 Gentamicina e Betametasone Hexal is and what it is used for
• 2. What you need to know before you use Gentamicina e Betametasone Hexal
• 3. How to use Gentamicina e Betametasone Hexal
• 4. Possible side effects
• 5. How to store Gentamicina e Betametasone Hexal
• 6. Contents of the pack and other information

1. What is Gentamicina and Betametasone Hexal and what is it used for

Gentamicina and Betametasone Hexal 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.
Gentamicina and Betametasone Hexal is indicated for the treatment of skin irritations of an 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);
• skin irritation caused by continuous exposure to sunlight (sunburn);
• other forms of skin irritations such as exfoliative dermatitis, radiation dermatitis, stasis dermatitis, neurodermatitis;
• psoriasis, a chronic inflammatory disease of the skin involving the immune system.

2. What you need to know before using Gentamicina e Betametasone Hexal

Do not use Gentamicina e Betametasone Hexal

• 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 skin infections caused by viruses such as herpes simplex.

Warnings and precautions
Consult your doctor or pharmacist before using Gentamicina e Betametasone Hexal.
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 the drug develop, including some types of fungi, which may occur
after 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 betamethasone and gentamicin may pass through the skin. This is even more likely to occur if the cream is applied in the presence of skin damage, under an occlusive (non-breathable) bandage, or if you are an infant or a child;
• if you are allergic to other antibiotics of 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 control 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 e Betametasone Hexal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interaction studies with other medicines have been performed.

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, who will assess the risk/benefit ratio for the fetus and for the mother.
If you are breastfeeding, use this medicine with caution and under the direct control of your doctor who will determine
if it is necessary to stop breastfeeding or discontinue therapy.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

Gentamicina e Betametasone Hexal 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 Hexal

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Gentamicina and Betametasone Hexal 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 onto 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 Hexal than you should
Excessive or prolonged use of this medicine can cause undesirable effects due to corticosteroids
such as: malfunction of the adrenal glands, 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 resistant bacteria and fungi.
In case of ingestion/accidental intake of Gentamicina and Betametasone Hexal, contact your doctor or
go to 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.
Very rare side effects may occur:

• allergic reactions (hypersensitivity);
• skin irritation (rash);
• alteration of skin color (discoloration).

During the use of corticosteroids on the skin, especially after using occlusive bandages,
some of the following side effects may occur:

• burning;
• itching;
• irritation;
• dry skin;
• hair follicle infection (folliculitis);
• increased hair growth (hypertrichosis);
• irritation with pimples (acneiform eruptions), dermatitis affecting the areas around the mouth (perioral dermatitis), allergic contact dermatitis;
• reduced skin pigmentation (hypopigmentation);
• formation of skin lesions (skin maceration), secondary infections, thinning of the skin (skin atrophy), stretch marks (striae) and skin inflammation known as miliaria.

Treatment with gentamicina may cause transient skin irritation such as erythema or itching. These
effects do not require discontinuation of therapy.

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 decreased 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, tell your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at 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 Gentamicina e Betametasone Hexal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions
Do not dispose of any medicine in waste water 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 Hexal contains

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

Description of the appearance of Gentamicina and Betametasone Hexal and pack contents
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder
SANDOZ S.p.A., Largo U. Boccioni 1, 21040, Origgio (VA)

Manufacturer
Doppel Farmaceutici S.r.l., Via dei Martiri delle Foibe 1, 29016, Cortemaggiore (PC)
Mipharm S.p.A., Via B. Quaranta 12, 20141, Milano