Belosalic

Package Leaflet: Information for the User

BELOSALIC,(0.5 mg + 20 mg)/g, liquid for the skin
Betamethasone + Salicylic Acid

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

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically 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 package leaflet, inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package contents and other information

1. What is Belosalic and what is it used for

Belosalic in the form of a liquid for the skin contains the active substances: betamethasone (as betamethasone dipropionate) and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid for topical use in dermatology, which has a strong anti-inflammatory, antipruritic and vasoconstrictive effect.
Salicylic acid, due to its keratolytic effect, has a peeling and facilitating effect on the penetration of the corticosteroid into the skin.
Indications
Belosalic in the form of a liquid for the skin is indicated for the local treatment of skin diseases characterized by excessive keratinization, dryness and inflammation, responding to local 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 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 rash,
• in fungal or bacterial skin infections, unless appropriate causal treatment has been initiated.

Warnings and precautions

Before starting to use Belosalic, discuss it with your doctor or pharmacist.
If a skin allergic reaction occurs after using Belosalic (itching, burning or redness of the skin), inform your doctor. The doctor will decide whether to discontinue the medicine immediately.
Occlusive dressings should not be used, as they may enhance the absorption of the medicine through the skin.
Avoid contact with the eyes and mucous membranes. Do not use the medicine in the eyes or around the eyes.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
The use of the medicine on the skin of the face is not recommended due to the risk of skin inflammation (similar to acne-like changes), perioral dermatitis, skin atrophy and rosacea.
In the case of a 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, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and salicylic acid. Therefore, the use of the medicine on a large surface area of the body, damaged skin, in large doses, for a long period, and in patients with liver function disorders and in children should be avoided.
On the skin of the armpits and groin, Belosalic should be used only in cases where it is absolutely necessary, due to increased absorption.
Belosalic should be used with particular caution in patients with psoriasis, as local use of corticosteroids in psoriasis can be dangerous, including the risk of disease recurrence caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin function disorders.

Children

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

Belosalic and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other locally used medicines are known.
Concomitant use of local cosmetic or dermatological products used to treat 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of Belosalic 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 of the body.
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 discontinue Belosalic, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
The medicine should not be used on the breast skin before breastfeeding.
It is not known whether topically used 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 does not affect the ability to drive and use machines.

3. How to use Belosalic

This medicine should always be used as directed by your doctor. In case of doubts, consult your doctor or pharmacist.
Belosalic is intended for 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 a day. In milder cases, less frequent use may be sufficient.
Do not use for more than 14 days.

Use in children

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

Using more than the recommended dose of Belosalic

During prolonged use (more than 2 weeks), use on large areas of the skin, or on damaged skin, and in cases where occlusive dressings are used, as well as in children, due to increased absorption of the active substances into the bloodstream, overdose and systemic side effects of corticosteroids and salicylic acid may occur.
Overdose symptoms characteristic of corticosteroids include suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, mild intracranial hypertension, growth and development retardation in children, increased blood sugar levels (hyperglycemia), and glycosuria.
Overdose symptoms of salicylic acid include pallor, fatigue, drowsiness, hyperventilation with rapid breathing, nausea, vomiting, hearing disturbances, and disorientation.
In case of using a higher dose than recommended, consult your doctor immediately. The 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 a systemic corticosteroid.

Missing a dose of Belosalic

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

Stopping the use of Belosalic

In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Belosalic can cause side effects, although not everybody gets them.
Local use of betamethasone dipropionate may cause atrophic changes in the skin, irreversible striae, dryness of the 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.
Local 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 out of 10,000), mainly in cases of prolonged use of the medicine, use on a large surface area of the skin, 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 package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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.
Reporting side effects will help to gather 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 bottle: 12 months when stored at a temperature 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Belosalic contains

• The active substances of the medicine are (in 1 g of liquid for the skin): 0.5 mg of betamethasone (as betamethasone dipropionate) and 20 mg of salicylic acid.
• The other ingredients are: disodium edetate, hypromellose 4000, sodium hydroxide, isopropyl alcohol, purified water.

What Belosalic looks like and contents of the pack

Belosalic is a liquid for the skin.
The medicine is available in:
a polyethylene bottle with a dropper containing 50 ml or 100 ml of liquid for the skin, 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 package leaflet: