Belosalic

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Belosalic

(0.5 mg + 20 mg)/g, solution for the skin
Betamethasone + Salicylic Acid

You should carefully read the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Belosalic and what is it used for

Belosalic solution for the skin contains the active substances: betamethasone (as betamethasone dipropionate) and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid for topical use in dermatology, which has strong anti-inflammatory, antipruritic, and vasoconstrictive effects.
Salicylic acid, due to its keratolytic effect, has a peeling effect and facilitates the penetration of the corticosteroid into the skin.
Indications
Belosalic solution for the skin is indicated for the local treatment of skin diseases characterized by excessive keratinization, dryness, and inflammation, which respond to local corticosteroid therapy.

2. Important information before using Belosalic

When not to use Belosalic:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• in tuberculosis of the skin,
• in viral skin infections (e.g., herpes simplex, chickenpox, shingles),
• in acne, perioral dermatitis, rosacea,
• in the anal and genital areas,
• in diaper rash,
• in fungal or bacterial skin infections, unless appropriate causal treatment has been initiated.

Warnings and precautions

Before starting to use Belosalic, you should discuss it with your doctor or pharmacist.
If a skin allergic reaction occurs after using Belosalic solution (itching, burning, or redness of the skin), you should inform your doctor. The doctor will decide whether to discontinue the medicine immediately.
You should not use occlusive dressings, as they may enhance the absorption of the medicine through the skin.
Avoid contact of the medicine with the eyes and mucous membranes. Do not use the medicine in the eyes or around the eyes.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
It is not recommended to use the medicine on the skin of the face, due to the risk of skin inflammation (similar to acne-like changes), perioral dermatitis, skin atrophy, and rosacea.
In case of skin infection, the doctor will use appropriate antibacterial or antifungal treatment.
Due to the fact that corticosteroids and salicylic acid are absorbed through the skin, during the use of Belosalic solution, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and salicylic acid. Therefore, you should avoid using the medicine on a large surface area of the body, damaged skin, using large amounts, prolonged treatment, using in patients with liver function disorders, and in children.
On the skin of the armpits and groin, use Belosalic solution only in cases where it is absolutely necessary, due to increased absorption.
Particular caution is required when using Belosalic solution in patients with psoriasis, as local use of corticosteroids in psoriasis can be hazardous, including the risk of relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin function disorders.

Children

It is not recommended to use the medicine in children under 12 years of age due to the risk of suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, and increased intracranial pressure after topical use of potent corticosteroids.

Belosalic and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other locally used medicines are known.
Concomitant local use of cosmetic or dermatological products used to treat acne, products containing peeling agents or ethanol, and drying soaps may enhance skin irritation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of Belosalic solution in pregnant women is allowed only in cases where the doctor considers that the benefit to the pregnant woman outweighs the risk to the fetus. However, it should be short-term and limited to a small surface area of the body.
There are no data or only limited data on the use of betamethasone dipropionate and salicylic acid in pregnant women. However, it is known that these substances can be absorbed through the skin.
Breastfeeding
The doctor will consider whether to stop breastfeeding or discontinue Belosalic solution, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother.
You should not use the medicine on the skin of the breast before breastfeeding.
It is not known whether topically used corticosteroids, including betamethasone dipropionate, are absorbed through the skin to an extent that may pass into breast milk.
Corticosteroids with systemic effects pass into breast milk.
Salicylic acid may be absorbed into the body after topical application.

Driving and using machines

Belosalic solution has no effect on the ability to drive and use machines.

3. How to use Belosalic

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Belosalic solution is for use on the skin only.

Adults and children over 12 years of age

A thin layer of the medicine should be gently rubbed into the affected areas of the skin, usually twice a day. In milder cases, less frequent application may be sufficient.
Do not use for more than 14 days.

Use in children

It is not recommended to use the medicine in children under 12 years of age.

Using more than the recommended dose of Belosalic

During prolonged use (more than 2 weeks), use on large areas of the skin, or on damaged skin, and in cases where occlusive dressings are used, and in children, due to increased absorption of the active substances into the bloodstream, there may be an overdose and systemic side effects of corticosteroids and salicylic acid may occur.
Overdose symptoms characteristic of corticosteroids include suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, mild intracranial hypertension, growth and development retardation in children, increased blood sugar levels (hyperglycemia), and glycosuria.
Overdose symptoms of salicylic acid include pallor, fatigue, drowsiness, hyperventilation with rapid breathing, nausea, vomiting, hearing disturbances, and disorientation.
If you have used more than the recommended dose of the medicine, you should immediately consult your doctor.
The doctor will decide whether to discontinue the medicine.
If symptoms such as fever, muscle pain, joint pain, and general weakness occur, the doctor will consider using a systemic corticosteroid.

Missing a dose of Belosalic

You should not use a double dose to make up for a missed dose.

Stopping the use of Belosalic

If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local use of betamethasone dipropionate may cause atrophic changes in the skin, irreversible striae, dryness of the skin, dilation of small blood vessels, folliculitis, hypertrichosis, acne-like changes, allergic contact dermatitis (burning, swelling, and inflammatory blisters on the skin), perioral dermatitis, itching, skin discoloration, suppression of sweat gland function (hypohidrosis), and secondary infections.
Local use of salicylic acid may cause skin inflammation.
Due to the absorption of the active substances into the bloodstream, systemic side effects of betamethasone and salicylic acid may also occur (see above – Using more than the recommended dose of Belosalic).
Systemic side effects are rare (in 1 to 10 patients out of 10,000), mainly in cases of prolonged use of the medicine, use on large areas of the skin, under occlusive dressings, and in children, and usually disappear after discontinuation of the medicine.
Frequency not known (cannot be estimated from the available data): blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Belosalic

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Belosalic contains

• The active substances of the medicine are (in 1 g of solution for the skin): 0.5 mg of betamethasone (as betamethasone dipropionate) and 20 mg of salicylic acid.
• The other ingredients are: disodium edetate, hypromellose, sodium hydroxide, isopropyl alcohol, purified water.

What Belosalic looks like and contents of the packaging

Belosalic is a solution for the skin.
The medicine is available in a white, opaque plastic bottle with a dropper and a yellow plastic cap with a security ring, containing 50 ml of solution for the skin, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Belupo s.r.o.
Cukrová 14
811 08 Bratislava
Slovakia

Manufacturer:

BELUPO lijekovi i kozmetika, d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:46/383/95-C

Parallel import authorization number: 92/24

Date of approval of the leaflet: 07.03.2024

[Information about the trademark]