BETACREAM 0.1% + 0.1% Cream

Зміст інструкції

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

BETACREAM 0,1% + 0,1% cream

Gentamicina solfato and betametasone valerate

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

1. What is BETACREAM and what is it used for

BETACREAM is a cream for topical application that contains two active ingredients: gentamicin sulfate and
betamethasone valerate. 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.
BETACREAM is indicated for the local treatment of skin diseases (dermatoses) of an allergic or
inflammatory type, which have become infected or when there is a threat of infection, such as:

• eczema of various types (atopic, infantile, nummular), an inflammatory reaction of the skin with itching;
• anal and genital itching (anogenital);
• itching that manifests in the elderly (senile);
• immune-related skin inflammatory reactions such as contact dermatitis and seborrheic dermatitis (which affects areas rich in sebaceous glands such as the scalp, face, chest);
• neurodermatitis, also called atopic eczema or atopic dermatitis;
• skin irritation caused by continuous friction of two parts of the body (intertrigo);
• irritation caused by exposure to sunlight (sunburn);
• 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 BETACREAM

Do not use BETACREAM

• if you are allergic to betamethasone, gentamicin 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.

Warnings and precautions
Talk to your doctor or pharmacist before using BETACREAM.
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 use of this medicine, especially for prolonged periods or in the event
that resistant microorganisms develop, including some types of fungi, which may occur after
prolonged use of gentamicin as well as other antibiotics.
In these cases, your doctor will discontinue treatment and prescribe appropriate therapy.
Any adverse effect reported with the use of systemic corticosteroids (taken orally or by
injection) including hypoadrenalism (reduced adrenal gland function) may also occur with
locally used corticosteroids, especially in children.
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 applied to a child.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In pediatric patients, the medicine should only be used when absolutely necessary and under the direct
supervision of a doctor, because it may increase the risk of adverse effects due to increased
absorption of corticosteroids (see section Additional adverse effects in children).

Other medicines and BETACREAM
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 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 a doctor. The use of BETACREAM should be limited to cases where the doctor considers that the
expected benefit justifies the potential risk to the fetus. If you are pregnant, this medicine should not
be used at high doses or for long periods of time.
If you are breastfeeding, use this medicine with caution and under the direct supervision of your doctor who will decide
whether to discontinue breastfeeding or stop the therapy, taking into account the importance of
the use of the medicine in your case.

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

BETACREAM 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 BETACREAM

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts,
consult your doctor or pharmacist.
BETACREAM 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 lesions that do not respond to treatment or of infected deep dermatoses
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 onto 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.

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 BETACREAM than you should
Excessive or prolonged use of this medicine may 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 bacteria and fungi.
A single episode of overdose of the antibiotic gentamicin should not produce any symptoms.
In case of accidental ingestion/intake of BETACREAM, contact your doctor or go
immediately to the Emergency Room of the nearest hospital.

If you forget to use BETACREAM
Do not use a double dose to make up for a missed dose.

If you stop using BETACREAM
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• burning, itching, irritation and dryness of the 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 color (hypopigmentation).

The use of occlusive dressings may cause an increase in side effects such as skin lesions (skin maceration), secondary infection, thinning of the skin (skin atrophy), stretch marks (striae) and inflammation of the skin known as miliaria.
Treatment with gentamicina may produce temporary irritation (erythema and pruritus) which usually does not require discontinuation of treatment.
The following effects may occur with unknown frequency (frequency cannot be estimated based on available data):

• blurred vision.

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 if not listed in this leaflet, please tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at 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 BETACREAM

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 “Expiry”.
The expiry date refers to the last day of that month.
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 BETACREAM 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, dodecahydrate sodium phosphate, purified water.

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

Marketing Authorisation Holder
Laboratorio Chimico Deca Dr. Capuani S.r.l. - Via Giotto 1, - 30172 Venezia (VE) – Italy

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) – Italy.