SODERM 0.5 MG/G AND 20 MG/G Topical solution

Зміст інструкції

1. SODERM 0.5 mg/g and 20 mg/g cutaneous solution
   1. What is SODERM and what is it used for
   2. What you need to know before using SODERM
   3. How to use SODERM
   4. Possible side effects
   5. How to store SODERM
   6. Contents of the pack and other information

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

betamethasone dipropionate and salicylic acid
equivalent medicine

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

Contents of this leaflet

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

1. What is SODERM and what is it used for

SODERM is an association for topical use. It contains betamethasone dipropionate (a
corticosteroid) and salicylic acid (a keratolytic agent). Betamethasone dipropionate reduces
skin inflammation and allergic reactions, as well as reactions associated with excessive
cell proliferation in the skin, and salicylic acid softens the outer horny layer of the skin and
facilitates the 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 viral-related diseases (e.g. chickenpox, herpes)
• if you suffer from bacterial diseases (such as skin tuberculosis, erysipelas or syphilitic skin manifestations)
• if you suffer from bacterial or fungal skin infections (unless they are being treated)
• on areas of skin that show a reaction to the vaccine
• on areas of skin affected by acne, rosacea (inflammation of the skin that is red/pink in color), perioral dermatitis (inflammation of the skin in the area of the upper lip and chin)
• on the eye, mucous membranes, in the genital area and on deep open wounds.
• in case of repeated use: if you suffer from gastric or intestinal ulcers or in case of a certain form of blood coagulation disorder (hypocoagulation)

SODERM should not be used in newborns and young children.
SODERM should not be used under occlusive conditions (bandages/patches, etc.).

Warnings and precautions
Consult your doctor or pharmacist before using SODERM.
Treatment should be discontinued if irritation or skin sensitization develops during use
of SODERM.
Anti-inflammatory drugs (corticosteroids) such as the active ingredient betamethasone dipropionate in
SODERM have strong effects on the body. It is not recommended to use SODERM on large areas of the
body or for prolonged periods of time as this will significantly increase the risk of side
effects.
To reduce the risk of side effects:
 use the least amount possible, especially in children;
 use it only for the time absolutely necessary to relieve the skin condition; The
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. the
anal and genital area);
 do not use SODERM on large areas of the body; in children, the maximum treated area
must be less than 10% of the body surface area
 do not use SODERM under waterproof or airtight products including bandages, poorly breathable dressings, clothing or diapers;
If you use SODERM for conditions other than those prescribed, it is possible that symptoms may be
masked, hindering correct diagnosis and therapy.
SODERM should be used with caution in the facial area and should not be used for any
reason in the eye area.
Contact your doctor if you experience blurred vision or other visual disturbances.
In order to avoid intoxication symptoms, a maximum daily dose of 2 g
of salicylic acid must not be exceeded in adults.

Children
In general, greater 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 acid
salicylic acid must not exceed 0.2 g. In children, the maximum treated area must be less than 10% of the body
surface area.

Other medicines and SODERM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
While using SODERM, medicated shampoos for hair should not be used, as
to date there is no practical experience to exclude their interaction.
Currently, no influence on laboratory tests is known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
To avoid any risk to the baby, you should not use SODERM if you are pregnant unless your
doctor tells you otherwise. If you are prescribed SODERM, use it as little as possible and only
for the strictly necessary time.
Breastfeeding:
If your doctor recommends using SODERM during breastfeeding, do not apply the medicine
to the breast. Do not allow the baby to come into contact with the treated areas. Ask your doctor or
pharmacist for advice before taking/using any medicine.

Driving and operating machinery
No special precautions are required.

3. How to use SODERM

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist. Always follow the instructions for use, otherwise SODERM
may not work correctly.
Recommended dose:
Apply SODERM one or two times a day to the affected areas of the skin.
For some medical conditions, applying it once a day is sufficient. The frequency of
application may be reduced as the medical condition improves.
The affected areas of skin should be covered with a thin layer of solution.
Duration of use:
The duration of use should not exceed 3 weeks.
Children should not be treated with SODERM for more than 1 week.
SODERM should 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
There is no risk from a single overdose (excessive amount, too large an area of skin
or too frequent use).
Repeated overdoses or misuse can cause side effects.
Excessive use of locally applied corticosteroids (repeated overdoses or misuse) can
lead to so-called hypercorticism with serious symptoms, which will be treated appropriately by
the doctor. The acute symptoms of hypercorticism (e.g. “moon face”) are largely reversible.
Disturbances in electrolyte balance should be treated if necessary.
Excessive use of locally applied preparations containing salicylic acid can cause symptoms of
salicylate poisoning (ringing in the ears with hearing loss, nosebleeds,
nausea, vomiting, irritability and dryness of the mucous membranes). The doctor may initiate treatment
appropriate for such symptoms.

If you forget to use SODERM
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 frequencies:
Not known (frequency cannot be estimated from available data):
skin irritation, skin thinning (atrophy), stretch marks, blisters, steroid acne,
development of light spots 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 in the area of the upper lip and chin), allergic skin
reaction (contact dermatitis), skin maceration, delayed wound healing, scaling, 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 (diapers, plasters): skin maceration, additional infections caused
by pathogens (secondary infections), skin thinning, stretch marks and blisters.
Side effects can occur not only at the site of treatment, but also in completely different areas
of the body (e.g. systemic side effects). This happens if the
active ingredient (corticosteroid) is absorbed into the body through the skin. This can 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 children are more susceptible.

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 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 which is stated on the bottle and the packaging after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C

Shelf life after first opening
After opening the bottle for the first time, SODERM has a shelf life of 3 months.
Do not dispose of any medicine in wastewater or 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 SODERM contains
The active ingredients 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 ingredients are:
sodium edetate, hypromellose, isopropyl alcohol, sodium hydroxide and hydrochloric acid (to correct the
pH), purified water

Description of the appearance of SODERM and contents of the pack
SODERM is a colorless, slightly viscous solution and is available in polyethylene bottles with
polyethylene droppers and polyethylene caps 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

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

This medicinal product is authorised in the Member States of the European Economic Area under
the following denominations:
Austria Betamethason/Salicylsäure Dermapharm 0.5 mg/g + 20 mg/g solution for cutaneous
application
Italy Soderm 0.5 mg/g and 20 mg/g cutaneous solution
Spain Salbetan 0.5 mg/g + 20 mg/g cutaneous solution