Beta 21

Package leaflet: Information for the user

BETA 21

0.5 mg/g cream
0.5 mg/g ointment
0.5 mg/ml cutaneous emulsion
Betamethasone-17-valerate-21-acetate
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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

1. What BETA 21 is and what it is used for
BETA 21 contains the active substance betamethasone-17-valerate-21-acetate and belongs to a class of medicines called topical corticosteroids.
BETA 21 is used to treat chronic dermatitis, dermatitis caused by external agents, physical agents, occupational causes, cosmetics, allergic eczema (skin inflammation), dyshidrosis (appearance of small blisters on the skin of hands and feet), localized and widespread pruritus, atopic eczema (chronic itchy inflammation), scaly dermatoses, psoriasis (chronic inflammatory skin disease), lichen simplex (a skin condition characterized by intense itching and excoriations due to scratching), and erythematosus lesions (chronic skin lesion, also known as systemic lupus erythematosus).
Consult your doctor if you do not feel better or if you feel worse.

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 have tuberculosis of the skin (cutaneous TB), Herpes simplex, or other viral skin infections.

Warnings and precautions
Talk to your doctor or pharmacist before using BETA 21.
Excessive use of this medicine, such as treatment over large areas of the body or for prolonged periods, may cause unwanted side effects due to absorption through the skin and passage into the bloodstream (systemic absorption). This is especially likely in elderly patients, children, skin folds, and when using diapers (non-breathable occlusive dressing). Therefore, when treating chronic conditions requiring long-term therapy, once improvement has been achieved, your doctor should reduce the dosage and frequency of application to the minimum necessary to control symptoms and prevent recurrence, discontinuing the medicine as soon as possible.
Prolonged use of the medicine may lead to adverse effects such as hypertension, asthenia (generalized fatigue), electrolyte imbalances, sensitization reactions, cutaneous atrophy (loss of skin consistency and elasticity, especially on the face), and eyelid problems. In such cases, stop treatment and consult your doctor for appropriate therapy.
If you have dermatological infections, contact your doctor, who will prescribe suitable antibacterial or antifungal treatment.
This medicine must not be applied to the eyes.
Contact your doctor if you experience blurred vision or other visual disturbances.
Caution for athletes: the product contains substances prohibited for doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is prohibited.

Children
In infants, diapers may act as an occlusive (non-breathable) dressing.
Use this medicine in very early infancy only when strictly necessary and under direct medical supervision.
Children may absorb proportionally higher doses of corticosteroids than adults and are therefore more sensitive to adverse effects. In such cases, discontinue treatment and consult your doctor.

Other medicines and BETA 21
Inform 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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use this medicine during pregnancy and breastfeeding only if clearly necessary and under direct medical supervision.

Driving and using machines
No effects on the ability to drive or operate machinery have been reported.

BETA 21 cream contains:
propylene glycol: May cause skin irritation. Do not use this medicine in children under 4 weeks of age with open wounds or extensive areas of damaged skin (e.g. burns) without first consulting your doctor or pharmacist;
cetostearyl alcohol ethoxylate and cetostearyl alcohol: May cause localized skin reactions (e.g. contact dermatitis);
propyl p-hydroxybenzoate: May cause allergic reactions (including delayed reactions).

BETA 21 ointment contains:
hydrogenated lanolin: May cause localized skin reactions (e.g. contact dermatitis);
cetostearyl alcohol ethoxylate: May cause localized skin reactions (e.g. contact dermatitis);
propyl p-hydroxybenzoate: May cause allergic reactions (including delayed reactions).

BETA 21 cutaneous emulsion contains:
lanolin alcohols: May cause localized skin reactions (e.g. contact dermatitis);
cetostearyl alcohol ethoxylate and stearyl alcohol: May cause localized skin reactions (e.g. contact dermatitis);
propyl p-hydroxybenzoate: May cause allergic reactions (including delayed reactions).

3. How to use BETA 21

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
BETA 21 is for topical use only.
Apply a small amount of cream or cutaneous emulsion with gentle massage to promote absorption, 2-3 times daily to the affected area. Once significant improvement has been achieved, applications may be gradually reduced and eventually discontinued.
The use of the OINTMENT is preferred in scaly, crusted dermatoses and chronic conditions, where its emollient action more effectively enhances drug penetration, especially after gentle removal of superficial crusts. When using the ointment, massage should be applied more vigorously.
The use of the CREAM is preferred in irritative, exudative (moist) dermatoses. If necessary, the treated area may be covered with dry dressings. Alternatively, an occlusive technique may be used, which should be maintained for 24–48 hours.
The use of the CUTANEOUS EMULSION is indicated in cases of extensive lesions or lesions in hard-to-reach areas, such as the scalp and other hairy regions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Prolonged corticosteroid treatments may cause the following side effects: hypopigmentation (reduction of normal skin colour), hypertrichosis (excessive hair growth), acneiform eruptions (appearance of pustular pimples), folliculitis (inflammation of the hair follicle).
When occlusive dressings are applied for prolonged periods, the following may occur: cutaneous atrophy, maceration, striae (stretch marks, especially with red base), secondary infections. If these effects occur, discontinue treatment and initiate appropriate therapies.
Blurred vision may occur with unknown frequency (frequency cannot be determined from available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at https://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 BETA 21

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 BETA 21 contains
BETA 21 cream

• The active substance is betamethasone-17-valerate-21-acetate. 1 g of cream contains 0.5 mg of betamethasone-17-valerate-21-acetate.
• The other components are: stearic acid, decyl oleate, propylene glycol, ethoxylated cetyl stearyl alcohol, white wax, cetyl stearyl alcohol, propyl p-hydroxybenzoate, distilled water.

BETA 21 ointment

• The active substance is betamethasone-17-valerate-21-acetate. 1 g of ointment contains 0.5 mg of betamethasone-17-valerate-21-acetate.
• The other components are: mineral oil, hydrogenated lanolin, ethoxylated cetyl stearyl alcohol, propyl p-hydroxybenzoate, white soft paraffin.

BETA 21 cutaneous emulsion

• The active substance is betamethasone-17-valerate-21-acetate. 1 ml of cutaneous emulsion contains 0.5 mg of betamethasone-17-valerate-21-acetate.
• The other components are: glycerin, ethanol 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 one 30 g tube of cream
Pack containing one 30 g tube of ointment
Pack containing one 30 ml bottle of cutaneous emulsion.

Marketing Authorization Holder and Manufacturer
IDI FARMACEUTICI S.r.l. - Via dei Castelli Romani 83/85 – 00071 Pomezia (RM)
March 2026
By means of the QR Code or at the address http://www.leafletidi.it/beta21 it is possible to read or listen to this
package leaflet.