Diprosalic

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Diprosalic (Diprosalic Ointment), (0.64 mg + 30 mg)/g, ointment

Betamethasone dipropionate + Salicylic acid
Diprosalic and Diprosalic Ointment are different trade names for the same medicine.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Diprosalic and what is it used for

Diprosalic ointment contains the active substances: betamethasone dipropionate and salicylic acid. Betamethasone dipropionate is a synthetic fluorinated corticosteroid with strong action; when used topically, it has anti-inflammatory, antipruritic, and vasoconstrictive effects.
Salicylic acid, when used topically, softens keratin and thickened skin and descales the skin, facilitating the penetration of betamethasone dipropionate into the skin.

Indications

Diprosalic is indicated for the local treatment of acute and chronic skin diseases, such as: psoriasis, more severe forms of atopic dermatitis, limited neurodermatitis, lichen planus, more severe forms of eczema (including nummular eczema, contact eczema).

2. Important information before using Diprosalic

When not to use Diprosalic:

• if you are allergic to betamethasone dipropionate and salicylic acid or any of the other ingredients of this medicine (listed in section 6);
• in case of bacterial (e.g., tuberculosis, scrofula), viral (herpes, shingles, chickenpox), or fungal skin infections;
• in common acne;
• in rosacea;
• in perioral dermatitis;
• on facial skin;
• in diaper dermatitis;
• in pruritus of the anal and genital area;
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Diprosalic, discuss it with your doctor or pharmacist.
Avoid using the medicine on a large surface area, especially in children.
If you experience symptoms of irritation, allergy, or excessive drying of the skin during treatment with Diprosalic, stop using the medicine immediately and contact your doctor.
If bacterial infections occur, the doctor will prescribe appropriate antibacterial treatment.
During treatment, side effects similar to those that occur with systemic corticosteroids may occur, including adrenal insufficiency. Therefore, avoid using the medicine on a large surface area of the skin, wounds, damaged skin, using the medicine in large doses, and prolonged use.
In case of necessity to use the medicine in such cases, special precautions should be taken.
Be particularly cautious when using the medicine in psoriasis. Using the medicine in psoriasis may cause a relapse of the disease due to the development of tolerance, the occurrence of generalized pustular psoriasis, and general toxic effects related to skin continuity disorders.
The medicine should not be used under occlusive dressings, as it may increase the percutaneous absorption of corticosteroids.
Do not use in the eyes.
Avoid contact of the medicine with the eyes and mucous membranes.
Use with caution in children. In children, it is easier than in adults to cause suppression of the hypothalamic-pituitary-adrenal axis and the occurrence of side effects characteristic of corticosteroids.
In children treated with topical corticosteroids, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, decreased body weight gain, and intracranial hypertension have been reported.
If you experience blurred vision or other vision disturbances, contact your doctor.

Children

Do not use in children under 12 years of age.

Diprosalic and other medicines

No data available.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
No data are available on the topical use of corticosteroids in pregnant women. Diprosalic can be used only when the potential benefit to the mother outweighs the possible risk to the fetus.
It is not known whether topically applied corticosteroids pass into breast milk. A decision should be made to either discontinue breastfeeding or discontinue Diprosalic, taking into account the benefit of breastfeeding to the child and the benefit of treatment to the mother.

Driving and using machines

Diprosalic has no effect on the ability to drive and use machines.

3. How to use Diprosalic

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
This medicine is for use on the skin.

Adults and children over 12 years of age

Usually, a small amount of the medicine (0.2-0.5 cm of ointment per 10 cm of skin surface) is applied to the affected areas of the skin and gently rubbed in twice a day (morning and evening).
In some cases, the doctor may recommend less frequent use of the medicine. Treatment should not last longer than 14 days. If the disease relapses, the doctor will consider whether treatment can be repeated.
Do not use the medicine in children under 12 years of age.
If you feel that the effect of Diprosalic is too strong or too weak, consult your doctor.

Using more than the recommended dose of Diprosalic

Prolonged use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis and, consequently, to secondary adrenal insufficiency, as well as to Cushing's syndrome, including hypercorticism.
Additionally, prolonged or excessive use of the medicine may cause salicylic acid poisoning.
In case of overdose, the doctor will provide appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, the doctor will correct electrolyte levels and, in case of chronic poisoning, will recommend gradual, step-by-step withdrawal of the medicine.
In case of salicylic acid poisoning, the doctor will take actions to quickly remove salicylates from the patient's body.

Missing a dose of Diprosalic

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

4. Possible side effects

Like all medicines, Diprosalic can cause side effects, although not everybody gets them.
During treatment with Diprosalic, the following side effects may occur: burning, itching, irritation, dryness of the skin, folliculitis, hypertrichosis, acne-like changes, skin depigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, and furuncles.
Due to the fact that the medicine contains salicylic acid, skin inflammation may occur during prolonged use.
As a result of the absorption of active substances into the blood, general side effects of betamethasone dipropionate (characteristic of corticosteroids) and salicylic acid may also occur.
General side effects occur mainly in case of prolonged use of the medicine, use on a large surface area of the skin, and use in children.
During the use of corticosteroids, blurred vision (frequency not known - cannot be estimated from available data) has been observed.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
phone: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diprosalic

Keep the medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Shelf life after first opening the tube: 3 months.
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. Contents of the pack and other information

What Diprosalic contains

• The active substances of the medicine are betamethasone dipropionate and salicylic acid. Each gram of ointment contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) and 30 mg of salicylic acid.
• The other ingredients are: white petrolatum and liquid paraffin.

What Diprosalic looks like and contents of the pack

Diprosalic is an ointment.
Available packs:
Aluminum tube in a cardboard box containing 30 g of ointment.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain

Manufacturer:

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish export license number: 656810.1

Parallel import license number: 133/25

Date of approval of the leaflet: 08.04.2025

[Information about the trademark]