Package leaflet: Information for the user

SODERM 0.5 mg/g and 20 mg/g cutaneous solution

betamethasone dipropionate and salicylic acid
equivalent medicine
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, 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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What SODERM is and what it is used for

SODERM is a topical combination preparation. It contains betamethasone dipropionate (a corticosteroid) and salicylic acid (a keratolytic agent). Betamethasone dipropionate reduces inflammation and allergic reactions of the skin, as well as reactions associated with excessive cellular proliferation in the skin, while salicylic acid loosens the outer horny layer of the skin and facilitates penetration of the corticosteroid.
SODERM is used to treat psoriasis (psoriasis vulgaris).

2. What you need to know before using SODERM

Do not use SODERM

if you are allergic to betamethasone dipropionate, salicylic acid, or any of the other ingredients of this medicine (listed in section 6).
if you suffer from certain virus-related diseases (e.g. chickenpox, herpes)
if you suffer from bacterial diseases (such as cutaneous tuberculosis, erysipelas, or syphilitic skin manifestations)
if you have bacterial or fungal skin infections (unless they are being treated)
on skin areas showing a reaction to vaccination
on skin areas affected by acne, rosacea (red/pink skin inflammation), or perioral dermatitis (inflammation of the skin around the upper lip and chin)
on the eyes, mucous membranes, genital area, or on deep open wounds.
in case of repeated use: if you have gastric or intestinal ulcers or a certain type of blood coagulation disorder (hypocoagulation)

SODERM must not be used in neonates and young children.
SODERM must not be used under occlusive conditions (patches, dressings, etc.).

Warnings and precautions
Talk to your doctor or pharmacist before using SODERM.
Treatment must be discontinued if irritation or skin sensitization develops during use of SODERM.
Anti-inflammatory drugs (corticosteroids) such as the active substance betamethasone dipropionate in SODERM have strong effects on the body. It is not recommended to use SODERM over large areas of the body or for prolonged periods, as this will significantly increase the risk of side effects.
To reduce the risk of side effects:
 use the smallest amount possible, especially in children;
 use it only for the minimum time necessary to relieve the skin condition; duration of use should not exceed 3 weeks in adults; children should not be treated with SODERM for more than 1 week;
 do not use SODERM in the eyes or mouth, on open wounds, or on mucous membranes (e.g. anal and genital areas);
 do not use SODERM over extensive body surfaces; in children, the maximum treated area should be less than 10% of the body surface area;
 do not use SODERM under waterproof or airtight coverings, including bandages, non-breathable dressings, clothing, or diapers;
If SODERM is used for conditions other than those prescribed, symptoms may be masked, potentially interfering with correct diagnosis and treatment.
SODERM should be used cautiously on the face and must not be used for any reason around the eyes.
Contact your doctor if you experience blurred vision or other visual disturbances.
To avoid symptoms of intoxication, the maximum daily dose of 2 g of salicylic acid must not be exceeded in adults.

Children
In general, extra caution should be exercised when treating children with SODERM, as increased absorption of the corticosteroid and salicylic acid through the child's skin may occur.
When using SODERM in children, the daily dose of salicylic acid must not exceed 0.2 g. In children, the maximum treated area should be less than 10% of the body surface area.

Other medicines and SODERM
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
During use of SODERM, medicated shampoos for the hair should not be used, as there is currently no practical experience to rule out potential interactions.
Currently, no influence on laboratory tests is known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
To avoid any risk to the unborn child, do not use SODERM during pregnancy unless specifically instructed by your doctor. If SODERM is prescribed, use it as little as possible and only for the shortest time necessary.

Breastfeeding:
If your doctor advises you to use SODERM during breastfeeding, do not apply the medicine on the breast. Avoid contact between the treated areas and the infant. Consult your doctor or pharmacist before taking/using any medicine.

Driving and using machines
No special precautions are required.

3. How to use SODERM

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Always follow the instructions for use, otherwise SODERM
may not work properly.
Recommended dose:
Apply SODERM once or twice daily to the affected areas of skin.
For certain medical conditions, once-daily application is sufficient. The frequency of
application may be reduced as the medical condition improves.
The affected skin areas should be covered with a thin layer of the solution.
Duration of use:
The duration of use should not exceed 3 weeks.
Children must not be treated with SODERM for longer than 1 week.
SODERM must not be used in newborns and young children.
If you feel that the effect of SODERM is too strong or too weak, inform your doctor or
pharmacist.
If you use more SODERM than you should
No risk is expected from a single overdose (excessive amount, too large an area of skin, or too frequent use).
Repeated overdoses or misuse may cause side effects.
Excessive use of topical corticosteroids (repeated overdoses or misuse) may
lead to so-called hypercorticism with severe symptoms, which will be appropriately treated
by the doctor. Acute symptoms of hypercorticism (e.g., "moon face") are largely reversible.
Electrolyte imbalances should be treated if necessary.
Excessive use of topical preparations containing salicylic acid may cause symptoms of
salicylate poisoning (tinnitus with hearing loss, nosebleeds, nausea, vomiting, irritability and dryness of mucous membranes). The doctor may initiate appropriate treatment
for such symptoms.
If you forget to use SODERM
Do not use a double dose to make up for the missed dose.
If you have further questions 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 everyone experiences them.
If you experience any of the following side effects, stop using SODERM and contact your doctor as soon as possible.
The assessment of side effects is based on the following frequency categories:
Not known (frequency cannot be estimated from the available data):
skin irritation, thinning of the skin (atrophy), stretch marks, blisters, steroid acne, development of light-coloured patches on the skin (hypopigmentation), varicose veins, skin burning, itching, dry skin, inflammation of hair follicles (folliculitis) and altered hair growth, sensitization, perioral dermatitis (inflammation of the skin around the upper lip and chin), allergic skin reaction (contact dermatitis), maceration of the skin, delayed wound healing, desquamation, secondary infections (additional infections caused by pathogens), blurred vision.
The following side effects may occur more frequently when the product is applied under occlusive dressings (e.g. diapers, plasters): maceration of the skin, additional infections caused by pathogens (secondary infections), thinning of the skin, stretch marks and blisters.
Side effects may occur not only at the site of application but also in completely different areas of the body (e.g. systemic side effects). This may happen if the active substance (corticosteroid) is absorbed into the body through the skin. This may also lead to the so-called Cushing's syndrome; in children, growth retardation, reduced weight gain and increased intracranial pressure have been observed. This is particularly important in children, as they are more susceptible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can 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 SODERM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and packaging after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Duration after first opening
After first opening the bottle, SODERM is stable for 3 months.
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 SODERM contains
The active substances are:
betamethasone dipropionate and salicylic acid
1 g of SODERM contains 0,64 mg of betamethasone dipropionate (equivalent to 0,5 mg of
betamethasone) and 20 mg of salicylic acid.
The other components are:
edetate disodium, hypromellose, isopropyl alcohol, sodium hydroxide and hydrochloric acid (for pH adjustment), purified water

Description of the appearance of SODERM and contents of the pack
SODERM is a colourless, slightly viscous solution and is available in polyethylene bottles with a polyethylene dropper and polyethylene cap containing 15 ml (14.1 g), 20 ml (18.8 g), 30 ml (28.2 g), 50 ml (47.0 g), 60 ml (56.4 g) and 100 ml (94.0 g).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
mibe pharma Italia S.r.l.
via Leonardo da Vinci, 20/B
39100 Bolzano
Italy

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15, 06796 Brehna,
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Betamethason/Salicylsäure Dermapharm 0,5 mg/g + 20 mg/g Lösung zur Anwendung auf der Haut
Italy Soderm 0,5 mg/g e 20 mg/g soluzione cutanea
Spain Salbetan 0,5 mg/g + 20 mg/g solución cutánea