Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Belosalic
(0.5 mg + 20 mg)/g, solution for skin
Betamethasone + Salicylic acid
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Belosalic is and what it is used for
Important information before using Belosalic
How to use Belosalic
Possible side effects
How to store Belosalic
Contents of the pack and other information

1. What Belosalic is and what it is used for

Belosalic medicine in the form of a solution for skin contains the active substances: betamethasone (in the form of betamethasone dipropionate) and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid for topical use in dermatology, which exerts a potent anti-inflammatory, antipruritic, and vasoconstrictive effect.
Salicylic acid exerts a keratolytic action, causing desquamation and facilitating the penetration of corticosteroid into the skin.
Indications
Belosalic in the form of a solution for skin is indicated for the topical treatment of skin diseases characterized by excessive keratinization, dryness, and inflammation, which respond to topical corticosteroid therapy.

2. Important information before using Belosalic medicine

When not to use Belosalic:

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

Warnings and precautions
Before starting treatment with Belosalic, discuss it with your doctor or pharmacist.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after applying Belosalic solution, inform your doctor. The doctor will decide whether the medicine should be discontinued immediately.
Do not use occlusive dressings or bandages, as they may enhance absorption of the medicine through the skin.
Avoid contact of the medicine with eyes and mucous membranes. Do not apply the medicine to the eyes or around the eyes.
If the patient experiences blurred vision or other visual disturbances, consult a doctor.
Use on the facial skin is not recommended due to the risk of dermatitis (resembling acneiform lesions), perioral dermatitis, skin atrophy, and acne.
In case of skin infection, the doctor will initiate appropriate antibacterial or antifungal treatment.
Since corticosteroids and salicylic acid are absorbed through the skin, there is a risk of systemic adverse effects of corticosteroids (including suppression of adrenal cortex function) and of salicylic acid during treatment with Belosalic solution. Therefore, avoid using the medicine over large body surface areas, on damaged skin, in high doses, for prolonged periods, and in patients with liver function disorders or in children.
Belosalic solution should be used under the arms and in the groin area only when absolutely necessary, due to increased absorption.
Particular caution is required when using Belosalic solution in patients with psoriasis, as topical use of corticosteroids in psoriasis may be hazardous, including the risk of disease rebound due to development of tolerance, risk of generalized pustular psoriasis, and systemic toxic effects caused by impaired skin function.

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

Belosalic and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No interactions with other topically applied medicines are known.
Concurrent topical use of cosmetic or dermatological products used in acne treatment, products containing exfoliating agents or ethanol, and drying soaps may intensify skin irritation.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Use of Belosalic solution in pregnant women is permitted only if the doctor considers that the benefit to the pregnant woman outweighs the risk to the fetus. However, treatment should be short-term and limited to a small body surface area.
There are no data or only limited data available on the use of betamethasone dipropionate and salicylic acid in pregnant women. However, it is known that these substances may be absorbed through the skin.

Breastfeeding
The doctor will consider whether to discontinue breastfeeding or to discontinue treatment with Belosalic solution, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Do not apply the medicine to the skin of the breasts before breastfeeding.
It is not known whether topically applied corticosteroids, including betamethasone dipropionate, are absorbed through the skin to such an extent that they can pass into breast milk. Systemically acting corticosteroids are known to pass into milk.
Salicylic acid may be absorbed into the body after topical application.

Driving and operating machinery
Belosalic solution has no effect on the ability to drive vehicles or operate machinery.

3. How to use Belosalic

This medicine should always be used as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Belosalic lotion is for topical use 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 daily. In milder cases, less frequent application may be sufficient.
Do not use for longer than 14 days.
Use in children
Use of this medicine is not recommended in children under 12 years of age.
Use of more than the recommended dose of Belosalic
Prolonged use (beyond 2 weeks), application over large skin areas or on damaged skin, use under occlusive dressings, and use in children may lead to increased systemic absorption of the active substances into the bloodstream, resulting in overdose and general adverse effects of corticosteroids and salicylic acid.
Symptoms of corticosteroid overdose include, among others: suppression of the hypothalamic–pituitary–adrenal (HPA) axis, Cushing's syndrome, benign intracranial hypertension, growth and developmental retardation in children, increased blood glucose levels (hyperglycemia), and glucosuria.
Symptoms of salicylic acid overdose include, among others: pallor, fatigue, drowsiness, hyperventilation with rapid breathing, nausea, vomiting, hearing disturbances, and disorientation.
In case of using more than the recommended dose, seek immediate medical advice.
The physician will decide whether treatment with the medicine should be discontinued.
If symptoms such as fever, muscle pain, joint pain, and general weakness occur, the physician may consider administering a systemic corticosteroid.
Missed dose of Belosalic
Do not use a double dose to make up for a missed dose.
Discontinuation of Belosalic
In case of any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Local application of betamethasone dipropionate may cause skin atrophy, irreversible striae, dry skin, capillary dilation, folliculitis, hypertrichosis, acneiform eruptions, allergic contact dermatitis (burning, swelling, and inflammatory blisters on the skin), perioral dermatitis, itching, skin discoloration, suppression of sweat gland function (miliaria), and secondary infections.
Local application of salicylic acid may cause skin inflammation.
As a result of systemic absorption of the active substances into the bloodstream, general adverse effects of betamethasone and salicylic acid may also occur (see above – Use of a higher than recommended dose of Belosalic).
General adverse effects are rare (in 1 to 10 patients per 10,000), occurring primarily with prolonged use, application over large skin areas, use under occlusive dressings, and use in children; these effects usually resolve after discontinuation of the medicine.
Frequency unknown (cannot be estimated from available data): blurred vision.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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,
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Belosalic medicine

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Usable period after first opening – 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Belosalic contains

The active substances in the medicine are (in 1 g of cutaneous solution): 0.5 mg betamethasone (as betamethasone dipropionate 0.64 mg) and 20 mg salicylic acid.
The other ingredients are: disodium edetate, hypromellose, sodium hydroxide, isopropyl alcohol, purified water.

What Belosalic looks like and contents of the pack
Belosalic is a cutaneous solution.
The available pack is a HDPE bottle with a dropper containing 50 ml of cutaneous solution,
placed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in the Slovak Republic, country of export:
Belupo, s.r.o.
Cukrová 14
811 08 Bratislava
Slovak Republic
Manufacturer:
Belupo Pharmaceuticals and Cosmetics, Inc.
Ulica Danica 5
48 000 Koprivnica
Republic of Croatia
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in the Slovak Republic, country of export: 46/0467/94-S
Parallel Import Licence Number: 68/15