BETA 0.05 MG/G Cream

Зміст інструкції

1. BETA 21
   1. What is BETA 21 and what is it used for
   2. What you need to know before using BETA 21
   3. How to use BETA 21
   4. Possible side effects
   5. How to store BETA 21
   6. Contents of the pack and other information

BETA 21

0.5 mg/g cream
0.5 mg/g ointment
0.5 mg/ml cutaneous emulsion
Betametasone-17-valerate-21-acetate

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 could 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 BETA 21 is and what it is used for
• 2. What you need to know before you use BETA 21
• 3. How to use BETA 21
• 4. Possible side effects
• 5. How to store BETA 21
• 6. Contents of the pack and other information

1. What is BETA 21 and what is it used for

BETA 21 contains the active ingredient betamethasone-17-valerate-21-acetate and belongs to the class
of medicines called topical corticosteroids.
BETA 21 is used for the treatment of chronic dermatitis, dermatitis caused by external factors, by physical agents, by
occupational causes, by cosmetics, allergic eczema (skin inflammation), dyshidrosis (appearance of small
blisters on the skin of the hands and feet), localized and widespread itching, atopic eczema (chronic pruritic inflammation), scaling dermatoses, psoriasis (chronic inflammatory skin disease), lichen
simplex (skin disease characterized by intense itching with excoriation lesions), lupus erythematosus
(chronic skin lesion, also called systemic lupus erythematosus).
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before using BETA 21

Do not use BETA 21

• if you are allergic to betamethasone 17-valerate-21-acetate or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from cutaneous tuberculosis Tbc cutanea Herpes simplex as well as viral diseases with skin localization.

Warnings and precautions
Consult your doctor or pharmacist before using BETA 21.
Excessive use of this medicine, as in the case of treating large areas of the body or for prolonged periods, may cause undesirable effects due to absorption through the skin and passage into the bloodstream (systemic absorption). This is especially likely to occur in the elderly and in children in skin folds and with the use of diapers (non-breathable occlusive dressing). Therefore, in the treatment of chronic diseases requiring prolonged therapies, once improvement is achieved, your doctor should reduce the dosage and frequency of applications to the minimum necessary to control symptoms and avoid recurrence of the disease, suspending the use of the medicine as soon as possible.
Prolonged use of the medicine can lead to undesirable effects such as hypertension, asthenia (general fatigue), electrolyte imbalances, and sensitization phenomena, skin atrophy (loss of consistency and elasticity of the skin, especially of the face) and problems with the eyelids. In this case, stop treatment and consult your doctor to adopt appropriate therapy.
If you have dermatological infections, contact your doctor who will prescribe appropriate antibacterial or antifungal therapy.
This medicine should not be applied to the eyes.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
In newborns, the diaper can act as an occlusive (non-breathable) dressing.
Use this medicine in early infancy only when absolutely necessary and under the direct supervision of a doctor.
Children may absorb proportionally higher doses of corticosteroids than adults, and are therefore more sensitive to adverse effects. In this case, stop treatment and consult your doctor.

Other medicines and BETA 21
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, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use this medicine during pregnancy and breastfeeding only when absolutely necessary and under the direct supervision of a doctor

Driving and operating machinery
No effects on the ability to drive and operate machinery have been reported.

BETA 21 creamcontains : propylene glycol: May cause skin irritation. Do not use this medicine in children under 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without talking to your doctor or pharmacist; cetylstearyl alcohol ethoxylated and cetylstearyl alcohol: May cause localized skin reactions (e.g. contact dermatitis); propyl p-hydroxybenzoate: May cause allergic reactions (even delayed).

BETA 21 ointmentcontains : hydrogenated lanolinMay cause localized skin reactions (e.g. contact dermatitis); cetylstearyl alcohol ethoxylated:May cause localized skin reactions (e.g. contact dermatitis); propyl p-hydroxybenzoate: May cause allergic reactions (even delayed).

BETA 21 cutaneous emulsioncontains : lanolin alcohols:May cause localized skin reactions (e.g. contact dermatitis); cetylstearyl alcohol ethoxylated and stearyl alcohol:May cause localized skin reactions (e.g. contact dermatitis); propyl p-hydroxybenzoate: May cause allergic reactions (even delayed).

3. How to use BETA 21

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts,
consult your doctor or pharmacist.
BETA 21 is only for external use.
Apply a small amount of cream or cutaneous emulsion with a light massage to facilitate
absorption 2-3 times a day on the affected area. After obtaining a significant
improvement, applications may be spaced out until they are discontinued.
The application of the OINTMENT is more indicated in scaly and crusty dermatoses and in chronic forms,
where the emollient action contributes more effectively to the penetration of the medicine, especially after gentle
removal of superficial crusts. When using the ointment, the massage should be performed with greater
insistence.
The application of the CREAM is preferred in irritative, exudative (wet) dermatoses. The medicated area, if
necessary, can be bandaged with dry bandages. In addition, an occlusive technique can be used, which should
be maintained for 24-48 hours.
The application of the CUTANEOUS EMULSION is indicated in cases of extensive and difficult-to-reach
lesions such as the scalp and other hairy areas.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Prolonged corticosteroid treatments may cause the following side effects: hypopigmentation
(decrease in normal skin color), hypertrichosis (increased hair growth), acneiform eruptions (appearance of
pustules), folliculitis (inflammation of the hair follicle).
With occlusive bandages applied for a long time, the following may occur: skin atrophy,
maceration, striae (stretch marks, especially with a reddish background of the skin), secondary infections. If such
effects occur, discontinue treatment and institute appropriate therapies.
Blurred vision may occur with an unknown frequency (the frequency cannot be defined based on
available data).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store BETA 21

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.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the drain or in 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 BETA 21 contains
BETA 21 cream

• The active ingredient is betamethasone-17-valerate-21-acetate. 1g of cream contains 0.5 mg of betamethasone-17-valerate 21-acetate.
• The other ingredients are: stearic acid, decyl oleate, propylene glycol, ethoxylated cetylstearyl alcohol, white wax, cetylstearyl alcohol, propyl p-hydroxybenzoate, distilled water. BETA 21 ointment
• The active ingredient is betamethasone-17-valerate-21-acetate. 1g of ointment contains 0.5 mg of betamethasone-17-valerate-21-acetate.
• The other ingredients are: petrolatum, hydrogenated lanolin, ethoxylated propyl p-hydroxybenzoate cetylstearyl alcohol, flowing white petrolatum.

BETA 21 cutaneous emulsion

• The active ingredient is betamethasone-17-valerate-21-acetate. 1 ml of cutaneous emulsion contains 0.5 mg of betamethasone-17-valerate-21-acetate.
• The other ingredients are: glycerin, ethyl alcohol F.U., lanolin alcohols, ethoxylated cetyl stearyl alcohol, decyl oleate, ethoxylated stearyl alcohol, stearyl alcohol, propyl p-hydroxybenzoate, distilled water.

Description of the appearance of BETA 21 and contents of the pack
Pack containing a tube of 30 g of cream
Pack containing a tube of 30 g of ointment
Pack containing a bottle of 30 ml of cutaneous emulsion.

Marketing Authorisation Holder and Manufacturer
IDI FARMACEUTICI S.r.l. - Via dei Castelli Romani 83/85 – 00071 Pomezia (RM)