Diprosalic

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Diprosalic, (0.64 mg + 20 mg)/g, skin solution

Betamethasone dipropionate + Salicylic acid

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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. Package contents and other information

1. What is Diprosalic and what is it used for

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

Indications

Diprosalic is indicated for local treatment of scalp psoriasis, more severe forms of seborrheic dermatitis, lichen planus, severe forms of allergic dermatitis, contact dermatitis on the scalp, and discoid lupus erythematosus.

2. Important information before using Diprosalic

When not to use Diprosalic:

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

Warnings and precautions

Before starting to use Diprosalic, you should discuss it with your doctor or pharmacist.
It is necessary to avoid using the medicine on a large area of the body, especially in children.
If, during the use of Diprosalic, symptoms of irritation, allergy, or excessive skin dryness appear, you should immediately stop using the medicine and contact your doctor.
If bacterial infections occur, the doctor will prescribe appropriate antibacterial treatment.
During the use of the medicine, side effects similar to those that occur when using systemic corticosteroids may occur, including adrenal insufficiency. Therefore, it is necessary to avoid using the medicine on a large area of skin, wounds, damaged skin, using the medicine in large doses, and long-term use.
In case of necessity 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 can 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 barrier disruption.
The medicine should not be used under occlusive dressings, as it may increase percutaneous absorption of the corticosteroid.
Do not use in the eyes.
It is necessary to 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 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.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should 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, in the doctor's opinion, the potential benefit to the mother outweighs the possible risk to the fetus.
It is not known whether topical corticosteroids pass into breast milk. A decision should be made to either discontinue breastfeeding or discontinue Diprosalic, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

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

3. How to use Diprosalic

This medicine should always be used as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist.
This medicine is intended for use on the skin.

Adults and children over 12 years of age:

Usually, a small amount of the medicine (about 0.5 ml of solution per 10 cm of skin surface) is applied to the affected areas on the skin twice a day (in the 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. If the disease relapses, the doctor will consider whether the treatment can be repeated.
The medicine should not be used in children under 12 years of age.
If you feel that the effect of Diprosalic is too strong or too weak, you should consult your doctor.

Using a higher dose of Diprosalic than recommended

Long-term use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis and, consequently, to secondary adrenal insufficiency, as well as to hypercorticism, including Cushing's syndrome.
Additionally, long-term or high-dose 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 the electrolyte balance, and in the 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

You should 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, skin inflammation may occur during long-term use.
As a result of the absorption of the 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 long-term use of the medicine, use on a large area of skin, and use in children.
During the use of corticosteroids, blurred vision (frequency not known - cannot be determined based on available data) has been observed.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform 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
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Diprosalic

Store in a temperature below 25°C, in the original packaging.
Shelf life after opening: 6 weeks.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should 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 Diprosalic contains

• The active substances of the medicine are betamethasone dipropionate and salicylic acid. Each gram of solution contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) and 20 mg of salicylic acid.
• The other ingredients are: disodium edetate, hypromellose, sodium hydroxide, isopropyl alcohol, purified water.

What Diprosalic looks like and what the package contains

Diprosalic is a solution for the skin.
Available packages:
Bottle in a cardboard box.
1 LDPE bottle contains 30 ml of solution.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer:

Marketing authorization holder in Romania, the country of export:

Organon Biosciences S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania

Manufacturer:

Organon Heist bv, Industriepark 30, 2220 Heist-op-den Berg, Belgium
Cenexi HSC, 2, rue Louis Pasteur, 14200, Herouville-Saint-Clair, France

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
Romanian export authorization number: 10102/2017/01

Parallel import authorization number: 349/18

Date of leaflet approval: 28.11.2023

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