Patient Information Leaflet

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Belosalic is and what it is used for
What you need to know 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 solution for skin contains the active substances: betamethasone (as betamethasone dipropionate) and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid for topical use in dermatology, with strong anti-inflammatory, antipruritic, and vasoconstrictive effects.
Salicylic acid exerts a keratolytic action, resulting in desquamation, and facilitates penetration of the corticosteroid into the skin.
Indications
Belosalic solution for skin is indicated for the topical treatment of skin disorders characterized by excessive scaling, dryness, and inflammation, which respond to topical 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 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.

Warnings and precautions
Before starting treatment with Belosalic, discuss this with your doctor or pharmacist.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after applying Belosalic lotion, 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, contact a doctor.
The use of this medicine on facial skin is not recommended due to the risk of skin inflammation (similar to 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 from corticosteroids (including suppression of adrenal cortex function) and from salicylic acid during treatment with Belosalic lotion. Therefore, avoid using the medicine over large areas of the body, on damaged skin, in high doses, for prolonged periods, and in patients with impaired liver function or in children.
Belosalic lotion should be used in the axillary and groin areas only when absolutely necessary due to increased absorption.
Particular caution is required when using Belosalic lotion in patients with psoriasis, as topical use of corticosteroids in psoriasis may be dangerous, including the risk of disease rebound due to development of tolerance, generalized pustular psoriasis, and systemic toxic effects caused by impaired skin barrier function.

Children
The use of this medicine is not recommended 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 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 the patient plans to take.
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 increase skin irritation.

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

Pregnancy
The use of Belosalic lotion in pregnant women is allowed only when 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 area of the body.
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 lotion, 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 unknown 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 breast milk.
Salicylic acid may be absorbed into the body after application to the skin.

Driving and operating machinery
Belosalic lotion has no influence on the ability to drive or operate machinery.

3. How to use Belosalic medicine

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Belosalic lotion is intended for external 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 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 a higher than recommended dose of Belosalic
Prolonged use (beyond 2 weeks), application over large areas of skin 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 associated with corticosteroids and salicylic acid.
Symptoms of corticosteroid overdose may include suppression of the hypothalamic–pituitary–adrenal (HPA) axis, Cushing's syndrome, benign intracranial hypertension, growth and development suppression in children, increased blood glucose (hyperglycemia), and glycosuria.
Symptoms of salicylic acid overdose may include pallor, fatigue, drowsiness, hyperventilation with rapid breathing, nausea, vomiting, hearing disturbances, and disorientation.
If a higher than recommended dose of the medicine is used, 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, or 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.
Stopping Belosalic treatment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Local application of betamethasone dipropionate may cause skin atrophy, irreversible striae, dry skin, telangiectasia, folliculitis, hypertrichosis, acneiform eruptions, allergic contact dermatitis (burning sensation, swelling, and inflammatory blisters on the skin), perioral dermatitis, pruritus, skin depigmentation, inhibition of sweat gland function (miliaria), and secondary infections.
Local application of salicylic acid may cause dermatitis.
Systemic adverse effects of betamethasone and salicylic acid may also occur due to absorption of the active substances into the bloodstream (see above – Use of a higher than recommended dose of Belosalic).
Systemic adverse effects are rare (occurring in 1 to 10 patients per 10,000), primarily occurring after prolonged use, application over a large surface area of skin, use under occlusive dressing, or use in children, and usually resolve after discontinuation of the medicine.
Frequency not known (cannot be estimated from available data): blurred vision.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: (22) 49 21 301
Fax: (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Belosalic medicine

Keep this medicine out of sight and reach of children.
Store below 25°C.
Shelf life after first opening the bottle: 12 months when stored 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Belosalic contains

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

What Belosalic looks like and contents of the pack

Belosalic is a topical solution.
Pack sizes available: bottle made of plastic with dropper, containing 50 ml of topical solution, placed in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 46/383/95-C
Parallel Import Licence Number: 269/25