Diprosalic

Package Leaflet: Information for the Patient

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

Betamethasone Dipropionate + 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 any not listed in this leaflet, please inform your doctor or pharmacist. 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;
used topically, it has anti-inflammatory, anti-pruritic, and vasoconstrictive effects.
Salicylic acid, used topically, softens keratin and thickened skin and exfoliates the skin, facilitating the penetration of betamethasone dipropionate into the skin.

Indications

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

Warnings and precautions

Before starting treatment with Diprosalic, discuss it with your doctor or pharmacist.
It is recommended to avoid using the medicine on a large surface of the body, especially in children.
If during the use of Diprosalic, symptoms of irritation, allergy, or excessive skin dryness appear, you should stop using the medicine immediately and contact your doctor.
If bacterial infections occur, the doctor will use appropriate antibacterial treatment.
During the use of the medicine, side effects similar to those that occur with the use of systemic corticosteroids may occur, including adrenal insufficiency. Therefore, it is recommended to avoid using the medicine on a large surface of the skin, wounds, damaged skin, using the medicine in large doses, and long-term use.
In case of need to use the medicine in such cases, special precautions should be taken.
The medicine should be used with particular caution in psoriasis. The use of 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 the corticosteroid.
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 inhibition of the hypothalamic-pituitary-adrenal axis and the occurrence of side effects characteristic of corticosteroids.
In children treated with topical corticosteroids, inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth inhibition, decreased body weight gain, and increased intracranial pressure have been reported.
If the patient experiences blurred vision or other vision disturbances, they should contact their 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 the medicines you are taking, have recently taken, or might take.

Pregnancy and breastfeeding

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.
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 potential risk to the fetus.
It is not known whether topical corticosteroids are excreted in human milk. A decision should be made to either discontinue breastfeeding or discontinue Diprosalic therapy, taking into account the importance of breastfeeding to the child and the importance of the therapy to the mother.

Driving and using machines

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

3. How to use Diprosalic

Always use this medicine exactly as your doctor has told you.
In case of doubt, 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. The treatment should not last longer than 14 days. In case of relapse of the disease, the doctor will consider whether the treatment can be repeated.
Do not use 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 inhibition 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 salicylate poisoning.
In case of overdose, the doctor will use appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, the doctor will correct the electrolyte balance, and in case of chronic poisoning, will recommend gradual, step-by-step withdrawal of the medicine.
In case of salicylate 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 the use of Diprosalic, the following side effects may occur: burning, itching, irritation, skin dryness, 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, during prolonged use, skin irritation may occur.
As a result of the absorption of active substances into the blood, general side effects of betamethasone (characteristic of corticosteroids) and salicylic acid may also occur.
General side effects occur mainly in the case of prolonged use of the medicine, use on a large surface of the skin, and use in children.
During the use of corticosteroids, blurred vision (frequency not known - cannot be estimated from the available data) has been observed.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. 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, Tel.: +48 22 49 21 301, Fax: +48 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 Diprosalic

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and aluminum tube after "EXP". 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. These measures 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.
Pack sizes:
Aluminum tube in a cardboard box containing 15 g or 30 g of ointment.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Organon Polska Sp. z o.o.
Marszałkowska 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Date of last revision of the leaflet: 11/2022