BETAMESOL 0.05% Cream

Зміст інструкції

1. BETAMESOL 0.05% cream
   1. What is BETAMESOL and what is it used for?
   2. What you need to know before using BETAMESOL
   3. How to use BETAMESOL
   4. Possible side effects
   5. How to store BETAMESOL
   6. Contents of the pack and other information

BETAMESOL 0.05% cream

betametasone dipropionate

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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is BETAMESOL and what is it used for?

BETAMESOL contains the active ingredient betamethasone dipropionate which belongs to a class of
medicines called corticosteroids.
Corticosteroids are hormones that perform numerous activities, with an important function in
controlling inflammation.
BETAMESOL is indicated in the treatment of the following skin diseases (dermatoses):

• Contact eczema, characterized by redness, scaling, small blisters, vesicles, small superficial wounds and caused by contact with certain substances such as detergents, cosmetics or substances used for work;
• Constitutional eczema, characterized by redness and vesicles, often accompanied by severe itching;
• Seborrheic eczema of adults and infants (cradle cap), characterized by yellowish and greasy scales, redness, small crusts and sometimes itching affecting the scalp, face, ears and chest;
• Stasis eczema, characterized by darker areas of the skin, with red, thin, sometimes thickened spots, with the presence of itching and pain;
• Dyshidrosis, characterized by small, often itchy vesicles, containing a transparent liquid;
• Generalized and anogenital itching;
• Intertrigo, characterized by redness, scaling, irritation and itching due to the rubbing of two close parts of the body;
• Solar erythema, characterized by itching, pain, burning sensation and the presence of blisters;
• Irritative forms caused by plants, chemicals, insect bites;
• Psoriasis, characterized by red patches, thickening, silvery-white scaling and sometimes itching;
• Other inflammatory skin diseases such as Vidal-Brocq simple lichen characterized by severe itching and thickening of the skin and lichen ruber planus characterized by itchy skin elevations of a dark red, rounded or polygonal shape;
• Dermatoses in which bacteria are also present. In this case, you must associate BETAMESOL with a specific antibiotic.

2. What you need to know before using BETAMESOL

Do not use BETAMESOL

• if you are allergic to the active ingredient, to other corticosteroids or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from cutaneous tuberculosis, a form of tuberculosis that affects the skin;
• if you have viral diseases localized on the skin (herpes simplex, smallpox, chickenpox). If you have atopic dermatitis, characterized by itching, redness, scaling and skin reliefs, do not use an occlusive (non-breathable, e.g. polyethylene) bandage with BETAMESOL.

Warnings and precautions
Consult your doctor or pharmacist before using BETAMESOL.
Do not put BETAMESOL in contact with your eyes.
It is recommended not to apply this medicine under a non-breathable (occlusive) bandage.
The doctor will pay particular attention in cases where BETAMESOL is used for long periods, on
a large area of skin and especially if it is applied under an occlusive (non-breathable, e.g.
in polyethylene) bandage. This is because the medicine in these cases can pass into the blood and can affect some
hormones, blood sugar and urine values and the decrease in the elimination with urine of
some hormones (17-KS and 17-OHCS).
If, following the application of the medicine, you develop irritation, stop treatment and immediately inform
your doctor who will prescribe appropriate therapy.
If you develop a skin infection during the use of BETAMESOL, consult your doctor who will advise you on
suitable treatment. If the treatment is not effective, the doctor will suspend therapy with
BETAMESOL, until the infection is resolved.
The use, especially if prolonged, of medicines applied to the skin can cause allergic reactions. In this
case the doctor will suspend the treatment and prescribe suitable therapy.
As with all topical corticosteroid preparations with high activity, the doctor will interrupt the treatment
with BETAMESOL as soon as the disease is under control.
Any maintenance therapy will be carried out with BETAMESOL.
Given the characteristics of BETAMESOL, application with an occlusive bandage is not recommended.
All adverse effects that are reported after systemic use of corticosteroids (administered
for example by mouth) can also occur with corticosteroids applied locally to the
skin (topical use), especially in infants and children.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In early infancy, the medicine should be administered only when absolutely necessary.
All adverse effects, including the influence on some hormones, can occur especially in
infants and children, including delayed growth with repercussions on both height and body weight.
In newborns, the diaper can act as an occlusive bandage.

Other medicines and BETAMESOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The effectiveness of BETAMESOL is reduced by:

• barbiturates (medicines used mainly for the treatment of anxiety and to induce sleep);
• antihistamines (medicines used for the treatment of allergies);
• diphenylhydantoin (medicines used for the treatment of epilepsy).

The effectiveness of BETAMESOL is increased by:

• salicylates and phenylbutazone (medicines used for the treatment of inflammation).

BETAMESOL reduces the effectiveness of:

• oral hypoglycemic agents and insulin (medicines used for the treatment of diabetes).

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.

Pregnancy:
If you are pregnant or breastfeeding, use this medicine only if absolutely necessary
and under the direct supervision of your doctor.

Breastfeeding:
It is not known whether the medicine passes into breast milk. The doctor will decide whether to interrupt BETAMESOL,
taking into account how important the treatment is for you.

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

BETAMESOL contains:

• cetostearyl alcoholwhich can cause skin reactions (e.g. contact dermatitis);
• chlorocresolwhich can cause allergic reactions.

3. How to use BETAMESOL

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts,
ask your doctor or pharmacist.
Apply the cream 1 or 2 times a day. Spread a sufficient amount to cover the entire affected area and
gently massage until completely absorbed.
Do not exceed the recommended doses.

If you use more BETAMESOL than you should
In case of ingestion/accidental application of an excessive dose of BETAMESOL, immediately notify
your doctor or go to the nearest hospital.
Avoid excessive and prolonged use of BETAMESOL, as it may cause malfunction of the
adrenal glands, generally reversible. In this case, your doctor will advise you to discontinue the
treatment, reduce the frequency of applications, or replace BETAMESOL with another medicine.

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

If you stop using BETAMESOL
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.
During cortisone therapy on the skin, especially for intensive and prolonged treatments, the following side effects may occur:

Uncommon frequency(may affect up to 1 in 100 people)

• Blurred vision

Frequency not known(the frequency cannot be estimated from the available data)

• burning sensation;
• itching;
• irritation;
• skin dryness;
• thinning of the skin (skin atrophy);
• acne
• change in skin color (hypopigmentation);
• inflammation with red rashes around the mouth (perioral dermatitis);
• skin reaction due to contact (contact dermatitis);
• skin maceration;
• fungal, bacterial and viral infections;
• atrophy, itchy rash with sweat retention (miliaria) and streaks localized to areas of friction treated for long periods of time with occlusive dressing.

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.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 BETAMESOL

This medicine does not require any particular storage conditions. Keep this medicine
out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
The indicated expiry date refers to the product in intact packaging, correctly
stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BETAMESOL contains

• The active ingredient is betamethasone dipropionate. 100 g of cream contains 0.064 g of betamethasone dipropionate (equivalent to 0.05 g of betamethasone alcohol).
• The other ingredients are: chlorocresol, sodium phosphate monobasic, phosphoric acid, white petrolatum, liquid paraffin, polyethylene glycol monocetyl ether (cetomacrogol 1000), cetostearyl alcohol, deionized water.

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

Marketing Authorisation Holder
PROGE FARM S.r.l. – Largo Donegani, 4/A – 28100 Novara – Italy

Manufacturers
Beltapharm S.r.l. – Via Stelvio, 66 – 20095 Cusano Milanino (MI) – Italy