Package leaflet: Information for the user

Warning!
Keep this leaflet. The information on the immediate packaging is in a foreign language.
Belosalic
(0.5 mg + 30 mg)/g, ointment
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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

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 ointment for topical application 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, through its keratolytic action, exerts a desquamating effect and facilitates penetration of the corticosteroid into the skin.
Indications
Belosalic ointment is indicated for local treatment of skin diseases characterized by excessive keratosis, 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 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 perianal and genital areas,
in diaper dermatitis,

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

Warnings and precautions
Before starting treatment with Belosalic, discuss this with your doctor or pharmacist.
Do not use Belosalic ointment on hairy skin of the scalp.
If a skin allergic reaction (itching, burning, or redness) occurs after applying Belosalic ointment, 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.
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 salicylic acid during treatment with Belosalic ointment. Therefore, avoid use over large body surface areas, on damaged skin, in high doses, during prolonged treatment, and in patients with impaired liver function or in children.
Apply Belosalic ointment to the axillae and groin areas only when absolutely necessary due to increased absorption.
Particular caution is required when using Belosalic ointment in patients with psoriasis, as local use of corticosteroids in psoriasis may be hazardous, 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
Use of this medicine is not recommended in children under 12 years of age due to the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and increased intracranial pressure associated with topical application of potent corticosteroids.

Belosalic and other medicines
Tell 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 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
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If the patient is pregnant or 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
Use of Belosalic ointment in pregnant women is permitted only when the doctor considers that the benefit to the pregnant woman outweighs the risk to the fetus. However, such use should be short-term and limited to small body surface areas.
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 ointment, 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 breast skin before breastfeeding.
It is not known whether topically applied corticosteroids, including betamethasone dipropionate, are absorbed through the skin to an extent that allows passage into breast milk. Systemically acting corticosteroids are known to pass into milk.
Salicylic acid may be absorbed into the body after application to the skin.

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

3. How to use Belosalic

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Belosalic ointment is intended 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 a higher than recommended dose of Belosalic
Prolonged use (beyond 2 weeks), application over large skin surface areas or damaged skin, use under occlusive dressings, and use in children may lead to increased absorption of the active substances into the systemic circulation, resulting in overdose and the occurrence of systemic adverse effects associated with corticosteroids and salicylic acid.
Symptoms of corticosteroid overdose include, among others: suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, benign intracranial hypertension, growth and developmental retardation in children, increased blood glucose levels (hyperglycaemia), and glycosuria.
Symptoms of salicylic acid overdose include, among others: pallor, fatigue, drowsiness, hyperventilation with rapid breathing, nausea, vomiting, hearing disturbances, and disorientation.
If a higher than recommended dose has been used, seek medical advice immediately.
The physician will decide whether treatment with this medicine should be discontinued.
If symptoms such as fever, muscle pain, joint pain, and general weakness occur, the physician may consider administering a systemic-acting corticosteroid.
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Missed dose of Belosalic
Do not use a double dose to make up for a missed dose.
Discontinuation of Belosalic
If you have any further questions 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 everyone will experience them.
Local application of betamethasone dipropionate may cause skin atrophy, irreversible striae, dry skin, telangiectasia (dilation of small blood vessels), folliculitis, hypertrichosis, acneiform eruptions, allergic contact dermatitis (burning, swelling, and inflammatory blisters on the skin), perioral dermatitis, pruritus, skin discoloration, suppression of sweat gland function (miliaria), and secondary infections.
Local application of salicylic acid may cause skin irritation.
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 dose higher than recommended for Belosalic).
General adverse effects are rare (occurring in 1 to 10 people per 10,000), primarily occurring after prolonged use, application over a large skin surface area, use under occlusive dressing, and use in children; these effects usually resolve after discontinuation of the medicine.
Frequency not known (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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Belosalic medicine

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Keep for 12 months after first opening.
Do not use this medicine after the expiry date stated on the container. 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 in use. 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 betamethasone (as betamethasone dipropionate 0.64 mg) and 30 mg salicylic acid.
Other ingredients: liquid paraffin and white soft paraffin.

What Belosalic looks like and contents of the pack
Belosalic is an ointment.
The available pack is a tube containing 30 g of ointment, placed in a cardboard carton.
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
Slovak Republic

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
Poland

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

Marketing Authorisation Number in the Czech Republic, country of export: 46/023/82-S/C
Parallel Import Licence Number: 205/15
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