Package leaflet: Information for the user

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
BELOSALIC
(0.5 mg + 30 mg)/g, ointment
Betamethasone + Salicylic acid
Please read carefully the entire leaflet before using this medicine, because it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 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 potent anti-inflammatory, antipruritic and vasoconstrictive effects.
Salicylic acid exerts a keratolytic action, promoting desquamation and facilitating 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, vaccinia, varicella),
in acne, perioral dermatitis, rosacea,
in the anal and genital areas,
in diaper dermatitis,
in fungal or bacterial skin infections, unless appropriate specific 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 of the skin) 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.
The use of Belosalic on facial skin is not recommended due to the risk of dermatitis (resembling acneiform eruptions), perioral dermatitis, skin atrophy, and acne.
If skin infection occurs, the doctor will initiate appropriate antibacterial or antifungal treatment.
Since corticosteroids and salicylic acid can be 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 ointment. Therefore, avoid using the medicine over large body surface areas, on damaged skin, in high doses, for prolonged periods, 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 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 Belosalic 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 keratolytic agents or ethanol, and drying soaps may increase skin irritation.

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

Pregnancy
The use of Belosalic ointment 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 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 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 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 application to the skin.

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

3. How to use Belosalic

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Belosalic ointment is intended for topical 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 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 may include suppression of the hypothalamic–pituitary–adrenal (HPA) axis, Cushing's syndrome, benign intracranial hypertension, growth and developmental retardation 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 is used, seek immediate medical advice. The physician will decide whether treatment 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 apply a double dose to make up for a missed dose.
Discontinuation of Belosalic
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, acne-like changes, allergic contact dermatitis (burning, swelling and inflammatory blisters on the skin), perioral dermatitis, itching, skin discoloration, suppression of sweat gland function (miliaria), and occurrence of 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 active substances into the bloodstream (see above – Use of a dose higher than recommended 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 skin surface area, use under occlusive dressing, and 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 Adverse Drug Reactions of 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 enables more information on the safety of the medicine to be collected.

5. How to store Belosalic medicine

Keep this medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Period of usability after first opening the tube: 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. Following this advice helps protect the environment.

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) 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.
Pack sizes: tube containing 30 g of ointment, placed in a cardboard box.
For further information, please contact the responsible party or 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
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in the Czech Republic, country of export: 46/023/82-S/C
Parallel import licence number: 70/24