Diprosalic

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Diprosalic

(0.64 mg + 30 mg)/g, ointment
Betamethasone dipropionate + Salicylic acid

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 locally, it has anti-inflammatory and antipruritic effects, as well as vasoconstrictive effects.
Salicylic acid, 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 acute and chronic skin diseases, such as: psoriasis, more severe forms of atopic dermatitis, limited neurodermatitis (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 case of bacterial infections (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 itching in the anal and genital area;
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Diprosalic, you should discuss it with your doctor or pharmacist.
You should 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 drying of the skin 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, you should avoid using the medicine on a large area of 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.
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.
You should 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 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 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 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 therapy, taking into account the benefit of breastfeeding to the baby and the benefit of 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

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 (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. In case of relapse of the disease, 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

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 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 use appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, the doctor will correct the electrolyte levels, and in case of chronic poisoning, will recommend gradual, gradual 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, dryness of the skin, folliculitis, hypertrichosis, acne-like changes, skin depigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, skin 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 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 estimated from 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 tell your doctor or pharmacist. 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: Al. 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 provide more information on the safety of this medicine.

5. How to store Diprosalic

Store in a temperature below 25°C, in the original packaging.
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 month stated.
After first opening – 3 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 what the packaging contains

Diprosalic is an ointment.
Packaging:
An aluminum tube with an epoxy resin coating, with an HDPE cap, in a cardboard box, containing 15 g of ointment.
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. Popişteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 şi Birou 307, Etaj 3, Sectorul 1
Bucharest
Romania

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 9127/2016/01
Parallel import authorization number: 263/19

Date of approval of the leaflet: 05.07.2024

[Information about the trademark]