SALBETAN (0.64 mg + 20 mg)/g Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Salbetan, (0.64 mg + 20 mg)/g, Skin Solution
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
3. What is Salbetan and what is it used for
4. Important information before using Salbetan
   1. When not to use Salbetan
   2. Warnings and precautions
   3. Children
   4. Salbetan and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to use Salbetan
   1. Using more Salbetan than you should
   2. Forgetting to use Salbetan
6. Possible side effects
   1. Reporting side effects
7. How to store Salbetan
8. Contents of the pack and other information
   1. What Salbetan contains
   2. What Salbetan looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Salbetan, (0.64 mg + 20 mg)/g, Skin Solution

Betamethasone Dipropionate + Salicylic Acid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Salbetan and what is it used for

Salbetan is a combination medicine for use on the skin, containing betamethasone dipropionate (a corticosteroid) and salicylic acid (a peeling agent). Betamethasone dipropionate reduces inflammation and allergic reactions in the skin, as well as reactions related to excessive cell division in the skin. Salicylic acid causes loosening of the outer (horny) layer of the skin and facilitates the absorption of the corticosteroid.

Salbetan is used to treat psoriasis (psoriasis vulgaris).

2. Important information before using Salbetan

When not to use Salbetan

• on skin surfaces with post-vaccination skin reactions;
• on skin surfaces with acne, rosacea (inflammation of the skin with redness), or inflammation of the skin around the mouth (perioral area);
• in the eyes, on mucous membranes, in the genital area and deep, open wounds;
• in case of repeated use: if you have stomach or intestinal ulcers or certain blood clotting disorders (decreased blood clotting).

Salbetan should not be used in newborns and small children.

Salbetan should not be used under occlusive dressings (e.g. patches, plaster casts).

Warnings and precautions

Before starting to use Salbetan, discuss it with your doctor or pharmacist.

Stop using the medicine if you experience skin irritation or allergic reactions during treatment with Salbetan.

Corticosteroids, such as betamethasone dipropionate, the active substance of Salbetan, have a strong effect on the body. It is not recommended to use Salbetan on large areas of skin or for a long time, as this may increase the risk of side effects.

To minimize the risk of side effects:

• use the smallest possible amount of medicine, especially in children;
• use the medicine only for as long as necessary to achieve improvement; the treatment duration in adults should not be longer than 3 weeks; in children, the medicine should not be used for longer than 1 week;
• do not use Salbetan orally or in the eyes, on open wounds or mucous membranes (e.g. around the anus or genital area);
• do not use Salbetan on large areas of the body; in children, the maximum skin surface area to be treated with the medicine must be less than 10% of the child's body surface area;
• do not use Salbetan under airtight and watertight materials, including bandages, dressings, and clothing that does not allow air to pass through or diapers.

If you are using Salbetan to treat a condition other than the one for which it was prescribed, the symptoms of the condition may be masked, making it difficult to diagnose and treat the condition properly.

Use Salbetan with caution on the face and absolutely avoid using it in the eyes.

If you experience blurred vision or other vision disturbances, contact your doctor.

To avoid symptoms of salicylate poisoning, do not exceed the maximum daily dose of salicylic acid of 2 g in adults.

Children

Particular caution should be exercised when using Salbetan in children, due to increased absorption of corticosteroids and salicylic acid through the child's skin.

When using Salbetan in children, do not exceed the daily dose of salicylic acid of 0.2 g. In children, the maximum skin surface area to be treated with Salbetan must be less than 10% of the child's body surface area.

Salbetan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

When using Salbetan, do not use medicated shampoos, as there is currently no sufficient practical experience to rule out the possibility of interactions.

The effect of this medicine on laboratory test results is not currently known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:

Unless your doctor has told you otherwise, do not use Salbetan during pregnancy to avoid exposing the fetus to the medicine. If your doctor has prescribed Salbetan during pregnancy, use the smallest possible amount of medicine for the shortest possible time.

Breastfeeding:

If your doctor has prescribed Salbetan during breastfeeding, do not apply the medicine to the breast area. Avoid contact between the child and the skin surface treated with the medicine.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

No special warnings.

3. How to use Salbetan

Always use this medicine exactly as your doctor or pharmacist has told you.

If you are not sure, ask your doctor or pharmacist.

Follow the instructions for use carefully, as otherwise Salbetan may not work properly.

Recommended dose:

Apply Salbetan once or twice a day to the affected skin area.

In some conditions, it may be sufficient to use the medicine once a day. If improvement occurs, the frequency of application can be reduced.

A thin layer of the solution should be applied to the affected skin area.

Duration of treatment:

The treatment duration should not be longer than 3 weeks.

In children, Salbetan should not be used for longer than 1 week.

Salbetan should not be used in newborns and small children.

If you feel that the effect of Salbetan is too strong or too weak, talk to your doctor or pharmacist.

Using more Salbetan than you should

You should not expect any danger due to a single overdose (using too much medicine or applying it to too large a skin area or too frequently).

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 treated by your doctor. Acute symptoms of hypercorticism (e.g. moon face) are largely reversible. If necessary, treatment of electrolyte imbalance should be carried out.

Excessive use of topical medicines containing salicylic acid may cause symptoms of salicylate poisoning (ringing in the ears with hearing loss, nosebleeds, nausea, vomiting, irritation, and dryness of mucous membranes). Your doctor may initiate appropriate treatment for these symptoms.

Forgetting to use Salbetan

Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Salbetan can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using Salbetan and contact your doctor immediately.

Side effects are classified based on the following frequency:

unknown (frequency cannot be estimated from the available data):

skin irritation, skin thinning (atrophy), stretch marks, blisters, steroid acne, formation of light spots on the skin (skin hypopigmentation), spider veins, skin burning, skin itching, skin dryness, folliculitis, changes in hair growth, allergic reactions, perioral dermatitis, skin maceration, delayed wound healing, desquamation, secondary infections (additional infections caused by microorganisms), blurred vision.

The following side effects may occur more frequently when using Salbetan under occlusive dressings (diapers, plaster casts): skin maceration, secondary infections (additional infections caused by microorganisms), skin thinning, stretch marks, and blisters.

Side effects may occur not only at the site of application but also in a completely different area 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 lead to, for example, Cushing's syndrome, and in children, growth retardation, decreased weight gain, and increased intracranial pressure. This is particularly important in children, who are more susceptible to the side effects of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salbetan

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 carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Shelf life after first opening the bottle: 3 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Salbetan contains

• The active substances are betamethasone dipropionate and salicylic acid. 1 g of Salbetan contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) and 20 mg of salicylic acid.
• The other ingredients are disodium edetate, hypromellose type 2910, isopropyl alcohol, sodium hydroxide, hydrochloric acid, and purified water.

What Salbetan looks like and contents of the pack

Salbetan is a colorless, slightly sticky solution.

Salbetan is available in a polyethylene bottle with a polyethylene dropper and polyethylene cap, containing 50 ml (47.0 g) or 100 ml (94.0 g) of solution, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.

Dolna 21

05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

Date of last revision of the leaflet: