Belosalic

Package Leaflet: Information for the User

Warning!

The leaflet must be kept. Information on the immediate packaging in a foreign language.

Belosalic

(0.5 mg + 30 mg)/g, ointment
Betamethasone + Salicylic Acid

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

• The leaflet must be kept so that it can be re-read if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 pack and other information

1. What is Belosalic and what is it used for

Belosalic ointment for topical use contains the active substances: betamethasone (as betamethasone dipropionate) and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated topical corticosteroid used in dermatology, which has strong anti-inflammatory, antipruritic, and vasoconstrictive effects.
Salicylic acid, due to its keratolytic effect, has a peeling and facilitating effect on the penetration of the corticosteroid into the skin.
Indications
Belosalic ointment 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 dermatitis,

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• in fungal or bacterial skin infections, unless appropriate causal treatment has been instituted.

Warnings and precautions

Before starting treatment with Belosalic, the patient should discuss it with their doctor or pharmacist.
Belosalic ointment should not be used on hairy scalp skin.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after using Belosalic ointment, the patient should inform their doctor. The doctor will decide whether to discontinue the medicine immediately.
Occlusive dressings and bandages should not be used, as they may enhance the absorption of the medicine through the skin.
Contact with the eyes and mucous membranes should be avoided. The medicine should not be used in the eyes or around the eyes.
If the patient experiences blurred vision or other visual disturbances, they should consult their doctor.
The medicine is not recommended for use on the face, due to the risk of skin inflammation (similar to acne-like changes), perioral dermatitis, skin atrophy, and rosacea.
In the 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 ointment, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and salicylic acid. Therefore, the medicine should be avoided on large areas of the body, damaged skin, in high doses, for prolonged treatment, and in patients with liver function disorders and children.
Belosalic ointment should only be used on the armpits and groin area in cases where it is absolutely necessary, due to increased absorption.
The medicine should be used with caution in patients with psoriasis, as local corticosteroid therapy in psoriasis can be hazardous, including the risk of relapse caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin function disorders.

Children

The use of Belosalic in children under 12 years of age is not recommended due to the risk of adrenal suppression, Cushing's syndrome, and increased intracranial pressure after topical use of potent corticosteroids.

Belosalic and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other locally used medicines are known.
Concomitant use of local 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

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If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
The use of Belosalic ointment in pregnant women is only allowed when 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 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 decide whether to stop breastfeeding or discontinue Belosalic ointment, considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.
The medicine should not be used on the breast skin 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 ointment 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 the doctor. In case of doubts, consult a doctor or pharmacist.
Belosalic ointment 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

The use of Belosalic in children under 12 years of age is not recommended.

Using more Belosalic than prescribed

During prolonged use (more than 2 weeks), use on large areas of the skin, or on damaged skin, and in the case of occlusive dressings, as well as in children, due to increased absorption of the active substances into the bloodstream, overdose and systemic side effects of corticosteroids and salicylic acid may occur.
Overdose symptoms characteristic of corticosteroids include adrenal suppression, 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.
In case of using more medicine than prescribed, consult a doctor immediately. 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.
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Missing a dose of Belosalic

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

Stopping Belosalic treatment

In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Belosalic can cause side effects, although not everybody gets them.
Topical use of betamethasone dipropionate may cause atrophic skin changes, irreversible striae, dry 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.
Topical use of salicylic acid may cause skin inflammation.
Due to the absorption of the active substances into the blood, systemic side effects of betamethasone and salicylic acid may also occur (see above – Using more Belosalic than prescribed).
Systemic side effects are rare (occurring in 1 to 10 people per 10,000), mainly in the case 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.
Unknown frequency (cannot be estimated from available data): blurred vision.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Belosalic

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Shelf life after first opening – 12 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.
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6. Contents of the pack and other information

What Belosalic contains

• The active substances are (in 1 g of ointment): 0.5 mg of betamethasone (as betamethasone dipropionate 0.64 mg) and 30 mg of salicylic acid.
• The other ingredients are: liquid paraffin and white petrolatum.

What Belosalic looks like and contents of the pack

Belosalic is an ointment.
The medicine is available in a tube containing 30 g of ointment, placed in a cardboard box.
For more detailed information, consult the marketing authorization holder or 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 46/023/82-S/C

Parallel import authorization number: 205/15

Date of leaflet approval: 07.04.2025

[Information about the trademark]
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