Package leaflet: Information for the user

BETACREAM 0.1% + 0.1% cream

Gentamicin sulfate and betamethasone valerate
Generic medicine
Please read all of this leaflet carefully before you start 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, ask 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BETACREAM is and what it is used for

BETACREAM is a topical cream containing two active substances: gentamicin sulfate and betamethasone valerate. Gentamicin belongs to the aminoglycoside antibiotic group, used to treat bacterial infections. Betamethasone belongs to the corticosteroid group, used to relieve inflammation and allergic reactions.

BETACREAM is indicated for the local treatment of allergic or inflammatory skin diseases (dermatoses) that have become infected or are at risk of infection, such as:

various types of eczema (atopic, infantile, nummular), an inflammatory skin reaction with itching;
anal and genital itching (anogenital);
itching occurring in the elderly (senile pruritus);
immune-mediated inflammatory skin reactions such as contact dermatitis and seborrheic dermatitis (affecting areas rich in sebaceous glands such as scalp, face, chest);
neurodermatitis, also called atopic eczema or atopic dermatitis;
skin irritation caused by continuous friction between body folds (intertrigo);
skin 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 viral skin infection such as herpes simplex.

Warnings and precautions
Talk to your doctor or pharmacist before using BETACREAM.
This medicine must not be applied to the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) after using this medicine, especially after prolonged use, or if resistant microorganisms develop, including certain types of fungi, which may occur following prolonged use of gentamicin, as with other antibiotics.
In such cases, your doctor will discontinue your treatment and prescribe appropriate therapy.
Any adverse effects reported with systemic corticosteroids (taken orally or by injection), including adrenal suppression (reduced function of the adrenal glands), may also occur with locally applied corticosteroids, especially in children.
Use this medicine with caution and inform your doctor if you are to be treated over large areas of skin or for long 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 used in children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In pediatric patients, this medicine should be used only when clearly necessary and under direct medical supervision, as it may increase the risk of adverse effects due to greater absorption of corticosteroids (see section "Additional adverse effects in children").

Other medicines and BETACREAM
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, planning to become pregnant, or 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. The use of BETACREAM should be limited to cases where the doctor considers that the expected benefit outweighs the potential risk to the fetus. If you are pregnant, this medicine should not be used at high doses or for prolonged periods.
If you are breastfeeding, use this medicine with caution and under direct medical supervision. Your doctor will decide whether to discontinue breastfeeding or stop the treatment, taking into account the importance of the medicine for your condition.

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

BETACREAM 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 BETACREAM

Use this medicine exactly as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
BETACREAM 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 unresponsive to therapy or infected deep dermatoses,
occlusive dressings 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 using 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 skin
irritation occurs, remove the plastic covering.
If you use more BETACREAM than you should
Excessive or prolonged use of this medicine 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 bacterial or fungal infections.
A single episode of overdose with the antibiotic gentamicin is unlikely to cause symptoms.
In case of accidental ingestion/ingestion of BETACREAM, contact your doctor or go immediately
to the Emergency Department of the nearest hospital.
If you forget to use BETACREAM
Do not apply a double dose to make up for the missed dose.
If you stop using BETACREAM
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 pimple-like eruptions (acneiform eruptions), dermatitis affecting areas around the mouth (perioral dermatitis), allergic contact dermatitis;
reduced skin pigmentation (hypopigmentation).

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

blurred vision.

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

suppression of the hypothalamic-pituitary-adrenal axis and reduced blood cortisol levels;
increased cortisol production (Cushing's syndrome);
growth retardation;
increased pressure in the brain (intracranial hypertension), presenting as bulging of the fontanelles, headache, and swelling of the nerves behind the eyes (bilateral papilledema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
You may 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 further information on the safety of this medicine.

5. How to store BETACREAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 BETACREAM 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 soft paraffin, liquid paraffin, disodium phosphate dihydrate, sodium phosphate dodecahydrate, purified water.

Description of the appearance of BETACREAM and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
Laboratorio Chimico Deca Dr. Capuani S.r.l. - Via Giotto 1, - 30172 Venice (VE) – Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) – Italy.