BETESIL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

BETESIL 2.250 mg medicated patch

Betamethasone valerate
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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

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

1. What BETESIL is and what it is used for

BETESIL is a medicated patch for application to the skin. BETESIL contains betamethasone valerate, a potent corticosteroid. When applied to the skin, it reduces redness, swelling, and itching.
BETESIL should be used to treat inflammatory skin diseases that do not respond to less potent corticosteroids, such as eczema and psoriasis, although your doctor may prescribe it for the treatment of other localized skin conditions.
BETESIL is suitable for the treatment of mild to moderate psoriasis (isolated red patches covered with whitish skin scales) located in hard-to-treat areas such as elbows and knees.
Overall, the treated area with BETESIL should not exceed 5 times the surface of your palm.

2. What you need to know before using BETESIL

Do not use BETESIL:

• If you are allergic to betamethasone valerate or to any of the other ingredients of this medicine (listed in section 6). If your skin condition is caused by a viral infection (herpes zoster, herpes simplex, vaccinia pustules), fungal or bacterial (e.g. skin lesions due to syphilis).
• If the area of skin to be treated is affected by acne, rosacea, perioral dermatitis (around the mouth), skin ulcers, burns, frostbite, or where the skin is damaged, with or without fluid leakage (serum).
• If your skin condition is located on the face.
• If you are under 18 years of age.

Warnings and precautions
Talk to your doctor before using BETESIL.

• If you need to use it for a long time and over large areas of the body, as this may lead to increased absorption of the corticosteroid into the bloodstream. The use of an occlusive dressing, especially if made of plastic material, may increase this effect, whose symptoms include: facial redness, changes in body weight (increase in fat mass localized in the trunk and face, decrease in arms and legs), reddish striae on the stomach, headache, menstrual disturbances, or increased unwanted hair growth on face and body. In such cases, contact your doctor immediately and do not stop treatment without first consulting your doctor.
• If you decide to stop treatment, you should be aware that in psoriasis, abruptly stopping treatment may worsen symptoms. Discontinuation should occur gradually and under close medical supervision.
• If your condition worsens during treatment, contact your doctor – you may be experiencing an allergic reaction, have an infection, or your condition may require a different treatment. If your condition relapses shortly after stopping treatment, within two weeks, do not restart using BETESIL without first consulting your doctor. If your condition had resolved, but during the relapse redness spreads beyond the initially treated area and you experience a burning sensation, consult your doctor before restarting treatment.
• If you have widespread psoriasis or widespread eczema, or if your lesions are located in skin folds (e.g. inner elbow or knee, armpits, groin, genital area). In these cases, long-term use of BETESIL is not recommended (except for the treatment of isolated plaques), as these conditions may lead to increased absorption of corticosteroid into the bloodstream.
• BETESIL works by reducing inflammation, but prolonged use may irritate the skin or cause sensitization reactions. Moreover, it may damage and thin the skin, impairing its natural repair process.
• If you are scheduled to undergo a test known as the nitroblue tetrazolium (NBT) test, to check for bacterial infections. The corticosteroid contained in the medicated patch may alter the results of this test.
• If your body is unable to fight infections as it should, or if you are taking medicines that reduce your ability to combat diseases (immunosuppressants). These medicines are used to prevent transplant rejection and may also be prescribed for skin conditions that could be treated with BETESIL.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children
The use of BETESIL is indicated only in adults.
Other medicines and BETESIL
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Since only a minimal amount of corticosteroid is absorbed into your body, it is unlikely that
BETESIL will interact with other medicines.
BETESIL with food and drink
Since only a minimal amount of corticosteroid is absorbed into your body, it is unlikely that
BETESIL will interact with food and drink.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor for advice before using this medicine.
Driving and using machines
BETESIL does not affect the ability to drive or operate machinery.
BETESIL contains
Methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216). These substances may cause
allergic reactions (including delayed reactions).

3. How to use BETESIL

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:
Apply BETESIL to the affected skin area once daily. Do not use more than 6 medicated patches at the same time.
A new medicated patch should be applied every 24 hours, and it is recommended to leave an interval of at least 30 minutes between one application and the next.
Do not use BETESIL for longer than 30 days.

Use in children and adolescents
Since clinical data on pediatric use of the medicinal product are not available, BETESIL must not be used if you are under 18 years of age.

Method of administration
Before using BETESIL, clean and thoroughly dry the skin area where the medicated patch will be applied.
Open the sachet and, if necessary, cut the medicated patch to fit the size of the area to be treated. Then remove the protective liner and apply the medicated adhesive side to the affected area.
Any unused portion of the patch should be returned to the sachet to preserve it for the next application (see section 5).
Once removed, the medicated patch must not be reapplied.

The medicated patch should not get wet: it is advisable to take a bath or shower between two consecutive applications. If the patch is applied to particularly mobile areas (e.g. elbow, knee) and you notice lifting at the edges, use the adhesive fixation patches for dressings supplied in the medicinal product package. Under no circumstances should the medicated patch be completely covered with plastic or an occlusive dressing.

If you use more BETESIL than you should
Always use BETESIL exactly as prescribed by your doctor. If by mistake you use more medicated patches than prescribed on any given day, do not be alarmed, but avoid repeating this error.

If you forget to use BETESIL
If you forget to apply the medicated patch on any given day, simply apply the next patch as usual on the following day.
Do not apply two patches on the same day to the same area to make up for the missed dose.

If you stop using BETESIL
If you are following your treatment correctly but do not notice any improvement, consult your doctor before deciding to stop treatment with BETESIL.

If you have any doubts about the use of BETESIL, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects that may occur with the use of BETESIL involve skin changes limited to the area where the patch is applied. These include: redness, itching, boils, skin eruptions with or without pus, thinning of the skin, appearance of small red spots of various shapes caused by dilation of superficial blood vessels, and skin erosion.
These side effects are common.

Side effects not observed with BETESIL but reported with other topical corticosteroids include: swelling, allergic reactions, skin irritation, dryness and peeling of the skin, sensation of skin tightness, stretch marks due to skin thinning, increased hair growth, redness of the skin around the mouth and hair follicles, burning, and skin discoloration.

Blurred vision may occur, frequency unknown.

Discontinuation after prolonged high-dose treatment may lead to worsening of psoriasis, including severe skin reactions with pus formation.
In such cases, contact your doctor immediately and do not stop treatment without first consulting them.

Prolonged high-dose treatment may increase absorption of the medicine, possibly increasing side effects. These effects disappear rapidly and completely once treatment is stopped.

Steroid withdrawal reaction
If BETESIL is used continuously for prolonged periods, stopping treatment may lead to steroid withdrawal reactions, with some or all of the following features: skin redness that may extend beyond the initially treated area, burning and/or stinging sensation, intense itching, skin peeling, and open sores with secretion (see section 2).
Steroid withdrawal reaction may occur with unknown frequency.

If you notice a worsening of your condition during treatment, you may be allergic to BETESIL or may require a different therapy. In this case, consult your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 BETESIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. If the expiry date is stated as month/year, the expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not use this medicine if you notice any visible signs of deterioration.
Store the medicated patch in its original pouch to maintain its integrity (note the date of opening in the designated space on the inner pouch).
After opening the pouch, the medicated patch remains suitable for use for 1 month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What BETESIL contains:
Each medicated patch 7.5 cm x 10 cm contains the active substance:
2,250 mg of betamethasone valerate (equivalent to 1,845 mg of Betamethasone).
The excipients are:
Backing: non-woven fabric (composed of polypropylene/polyethylene and rayon fibers) laminated with an
ethylene-methyl methacrylate resin.
Adhesive layer: sodium hyaluronate, 1-3 butylene glycol, glycerol, disodium edetate, tartaric acid,
aluminium glycinate, polyacrylic acid, sodium polyacrylate, hydroxypropylcellulose, sodium carmellose,
methyl para-hydroxybenzoate (E218), propyl para-hydroxybenzoate (E216), purified water.
Protective film: polyethylene terephthalate film.
Description of the appearance of BETESIL and package contents
This medicinal product is a medicated patch consisting of a colourless backing. Each medicated patch is
covered with a removable protective film.
Each medicated patch is individually packaged in a pouch within packs containing 4, 8 or 16 patches.
Each medicinal product package contains adhesive patches for securing dressings (medical device).
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
IBSA FARMACEUTICI ITALIA S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi.
Manufacturer
Altergon Italia S.r.l., Zona Industriale, 83040, Morra de Sanctis, Avellino (Italy)
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