Belosalic

Package Leaflet: Information for the User

BELOSALIC, (0.5 mg + 30 mg)/g, Ointment

Betamethasone + Salicylic Acid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Belosalic and what is it used for
• 2. Important information before using Belosalic
• 3. How to use Belosalic
• 4. Possible side effects
• 5. How to store Belosalic
• 6. Contents of the pack and other information

1. What is Belosalic and what is it used for

Belosalic ointment for topical use contains the active substances: betamethasone (as betamethasone dipropionate) and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated topical corticosteroid used in dermatology, which has strong anti-inflammatory, antipruritic, and vasoconstrictive effects.
Salicylic acid, due to its keratolytic effect, has a peeling and facilitating effect on the penetration of corticosteroids into the skin.
Indications
Belosalic ointment 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

When not to use Belosalic:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• in skin tuberculosis,
• in viral skin infections (e.g., herpes simplex, chickenpox, shingles),
• in acne, perioral dermatitis, rosacea,
• in the anal and genital areas,
• in diaper dermatitis,
• in fungal or bacterial skin infections, unless appropriate causal treatment has been instituted.

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 of the skin) occurs after using Belosalic ointment, inform your doctor. The doctor will decide whether to discontinue the medicine.
Do not use occlusive dressings, as they may enhance the absorption of the medicine through the skin.
Avoid contact with the eyes and mucous membranes. Do not apply the medicine to the eyes or around the eyes.
If you experience blurred vision or other visual disturbances, contact your doctor.
It is not recommended to use the medicine on the skin of the face, due to the risk of skin inflammation (similar to acne-like changes), perioral dermatitis, skin atrophy, and acne.
In the case of skin infection, the doctor will use appropriate antibacterial or antifungal treatment.
Due to the fact that corticosteroids and salicylic acid are absorbed through the skin, during the use of Belosalic ointment, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and salicylic acid. Therefore, it is recommended to avoid using the medicine on a large surface area, damaged skin, in large doses, for prolonged treatment, and in patients with liver function disorders and in children.
On the skin of the armpits and groin, use Belosalic ointment only in cases where it is absolutely necessary, due to increased absorption.
Particular caution is advised when using Belosalic ointment in patients with psoriasis, as topical corticosteroid therapy in psoriasis can be hazardous, including the risk of disease recurrence due to the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin function disorders.

Children

It is not recommended to use the medicine in children under 12 years of age due to the risk of adrenal suppression, Cushing's syndrome, and increased intracranial pressure after topical use of potent corticosteroids.

Belosalic and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
No interactions with other topical medicines are known.
Concomitant use of topical cosmetic or dermatological products used in the treatment of acne, products containing peeling agents or ethanol, and drying soaps may enhance skin irritation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of Belosalic ointment in pregnant women is allowed only in cases where the doctor considers that the benefit to the pregnant woman outweighs the risk to the fetus. However, it should be short-term and limited to a small 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 stop breastfeeding or stop using Belosalic ointment, taking into account the benefit of breastfeeding to the baby and the benefit of treatment to 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 may pass into breast milk. Systemic corticosteroids pass into breast milk.
Salicylic acid may be absorbed into the body after topical application.

Driving and using machines

Belosalic ointment has no influence on the ability to drive and use machines.

3. How to use Belosalic

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Belosalic ointment is for use on the skin only.

Adults and children over 12 years

A thin layer of the medicine should be gently rubbed into the affected areas of the skin, usually twice a day.
In milder cases, less frequent application may be sufficient.
Do not use for more than 14 days.

Use in children

It is not recommended to use the medicine in children under 12 years of age.

Using more than the recommended dose of Belosalic

During prolonged use (more than 2 weeks), use on large skin surfaces, or on damaged skin, and in cases where occlusive dressings are used, and in children, due to increased absorption of the active substances into the bloodstream, there may be an increased risk of their overdose and the occurrence of systemic side effects of corticosteroids and salicylic acid.
Symptoms of overdose characteristic of corticosteroids include adrenal suppression, Cushing's syndrome, mild intracranial hypertension, growth and development retardation in children, increased blood sugar levels (hyperglycemia), and glycosuria.
Symptoms of salicylic acid overdose include pallor, fatigue, drowsiness, hyperventilation with rapid breathing, nausea, vomiting, hearing disturbances, and disorientation.
If you use more than the recommended dose of the medicine, seek medical attention immediately.
Your doctor will decide whether to discontinue the medicine.
If symptoms such as fever, muscle pain, joint pain, and general weakness occur, the doctor will consider the use of systemic corticosteroids.

Missing a dose of Belosalic

Do not use a double dose to make up for a forgotten dose.

Stopping treatment with Belosalic

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Topical use of betamethasone dipropionate may cause atrophic skin changes, irreversible striae, dry skin, dilation of small blood vessels, 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 (hypohidrosis), and secondary infections.
Topical use of salicylic acid may cause skin inflammation.
Due to the absorption of the active substances into the bloodstream, systemic side effects of betamethasone and salicylic acid may also occur (see above – Using more than the recommended dose of Belosalic).
Systemic side effects occur rarely (in 1 to 10 patients per 10,000), mainly in cases of prolonged use of the medicine, use on large skin surfaces, under occlusive dressings, and in children, and usually disappear after discontinuation of the medicine.
Unknown frequency (cannot be estimated from the available data): blurred vision.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: (22) 49 21 301
Fax: (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Belosalic

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life 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 month.
Medicines should 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 are (in 1 g of ointment): 0.5 mg of betamethasone (as betamethasone dipropionate) and 30 mg of salicylic acid.
• The other ingredients are: liquid paraffin and white petrolatum.

What Belosalic looks like and contents of the pack

Belosalic is an ointment.
The medicine is available in tubes containing 30 g or 40 g of ointment, placed in a cardboard box.

Marketing authorization holder

Belupo s.r.o.
Cukrová 14,
81108 Bratislava, Slovakia
Phone: +421 2 5932 4330
Fax: +421 2 5932 4331

Manufacturer

BELUPO Pharmaceuticals & Cosmetics
Danica Street 5
48 000 Koprivnica
Croatia

Date of last revision of the leaflet: