Belosalic
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Belosalic, (0.5 mg + 30 mg)/g, ointment
Betamethasone + Salicylic acid
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
- Keep this leaflet, so you can read it again if necessary.
- If you have any doubts, 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 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
- 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 following active substances: betamethasone (as betamethasone dipropionate) and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid intended for topical use in dermatology, which exerts a potent anti-inflammatory, antipruritic, and vasoconstrictive effect.
Salicylic acid exerts a keratolytic action, promoting desquamation and facilitating the penetration of corticosteroid into the skin.
Indications
Belosalic ointment is indicated for the local treatment of skin diseases 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 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, or 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.
Do not use Belosalic ointment on hairy scalp skin.
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 (similar to 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 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 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 topical corticosteroids in psoriasis may be hazardous, including the risk of disease rebound due to development of tolerance, generalized pustular psoriasis, and systemic toxic effects resulting from 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 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 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 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 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 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 breast milk.
Salicylic acid may be absorbed into the body after topical application.
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 exactly as directed by the physician. In case of doubt, consult
your 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 skin areas 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 include, among others: suppression of the hypothalamic–
pituitary–adrenal axis, Cushing's syndrome, benign intracranial hypertension, growth and
development 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 application of a higher than 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 apply a double dose to make up for a missed dose.
Stopping treatment with Belosalic
In case of any further doubts regarding 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 everyone 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, swelling, and inflammatory blisters on the skin), perioral dermatitis, itching, skin depigmentation, suppression of sweat gland function (hypohidrosis), 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 higher than recommended dose of Belosalic).
General 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 upon discontinuation of the medicine.
Frequency unknown (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 or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 effects helps to provide more information on the safety of the medicine.
5. How to store Belosalic
Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Use within 12 months after first opening the tube.
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 practices help protect the environment.
6. Contents of the packaging and other information
What Belosalic contains
- The active substances in the medicine are (in 1 g of ointment): 0.5 mg betamethasone (as 0.64 mg 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.
The medicine is available in a tube containing 30 g of ointment, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Slovakia, country of export:
Belupo, s.r.o.
Cukrová 14
811 08 Bratislava
Slovakia
Manufacturer:
Belupo Pharmaceuticals and Cosmetics, Inc.
Ulica Danica 5
48 000 Koprivnica
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 Slovakia, country of export: 46/0023/82-S
Parallel import authorisation number: 78/20