Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging is 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.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so you can read it again if needed.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Diprosalic is and what it is used for
Important information before using Diprosalic
How to use Diprosalic
Possible side effects
How to store Diprosalic
Contents of the pack and other information

1. What Diprosalic is and what it is used for

Diprosalic ointment contains the active substances: betamethasone dipropionate and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid with potent activity; when applied topically, it exerts anti-inflammatory and antipruritic effects, as well as vasoconstrictive action.
Topically applied salicylic acid softens keratin and thickened epidermis, and promotes desquamation of the skin, thereby facilitating the penetration of betamethasone dipropionate into the skin.

Indications
Diprosalic is indicated for the topical treatment of subacute and chronic skin disorders such as: psoriasis, severe forms of atopic dermatitis, localized prurigo (neurodermitis), lichen planus, and severe forms of eczema (including nummular eczema, contact dermatitis).

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 bacterial infections (e.g. tuberculosis, syphilis), viral infections (herpes simplex, shingles, chickenpox) or fungal infections of the skin;
in acne vulgaris;
in rosacea;
in perioral dermatitis;
on the face;
in diaper dermatitis;
in anal or genital pruritus;
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Diprosalic, consult your doctor or pharmacist.
Avoid applying the medicine over a large surface area of the body, especially in children.
If irritation, allergic reactions or excessive skin dryness occur during treatment with Diprosalic, discontinue use immediately and contact your doctor.
If bacterial infections develop, the doctor will initiate appropriate antibacterial treatment.
During treatment, adverse effects similar to those associated with systemic corticosteroids may occur, including suppression of adrenal cortex function. Therefore, avoid applying the medicine over large areas of skin, open wounds, damaged skin, using high doses or prolonged treatment. If treatment under such circumstances is necessary, special precautions should be taken.
Particular caution is required when using the medicine in psoriasis. Treatment with Diprosalic in psoriasis may lead to relapse due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects related to impaired skin barrier.
Do not use under occlusive dressings, as percutaneous absorption of corticosteroids may increase.
Do not apply to the eyes.
Avoid contact of the medicine with the eyes and mucous membranes.
Use with caution in children. Suppression of the hypothalamic-pituitary-adrenal axis and adverse effects typical of corticosteroids occur more easily in children than in adults.
In children treated with topical corticosteroids, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, reduced weight gain, and increased intracranial pressure have been reported.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children
Do not use in children under 12 years of age.

Diprosalic and other medicines
No data available.
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient intends to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There are no data on the use of topical corticosteroids in pregnant women. Diprosalic may be used only if, in the opinion of the doctor, the potential benefit to the mother outweighs the possible risk to the fetus.
It is not known whether topically applied corticosteroids pass into human milk. A decision should be made whether to discontinue breastfeeding or to discontinue Diprosalic therapy, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the mother.

Driving and operating machinery
Diprosalic has no effect on the ability to drive or operate machinery.

3. How to use Diprosalic

This medicine should always be used exactly as recommended by your doctor. If in doubt, consult
your doctor or pharmacist.
This medicine is intended for topical 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) should be applied
to the affected areas of skin and gently rubbed in twice daily (morning and evening).
In some cases, your doctor may recommend less frequent application. Treatment should not last
longer than 14 days. If symptoms recur, your doctor will consider whether treatment may be repeated.
Do not use this 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.
Use of more than the recommended dose of Diprosalic
Prolonged use of this medicine may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis
and consequently to secondary adrenal insufficiency, as well as adrenal cortical hyperactivity, including
Cushing's syndrome.
Additionally, prolonged or high-dose use may cause salicylic acid poisoning.
In case of overdose, your doctor will administer appropriate symptomatic treatment. Acute symptoms of
adrenal corticosteroid overdose are usually reversible. If necessary, your doctor will correct electrolyte
levels and, in cases of chronic intoxication, will recommend gradual, slow withdrawal of the medicine.
In case of salicylic acid poisoning, your doctor will take measures aimed at rapid elimination of salicylates
from the patient's body.
Missed dose of Diprosalic
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during the use of Diprosalic: burning,
itching, irritation, dryness of the skin, folliculitis, hypertrichosis, acne-like changes, depigmentation of the skin, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria.
Due to the presence of salicylic acid, prolonged use of this medicine may lead to dermatitis.
As a result of systemic absorption of the active substances into the bloodstream, general adverse reactions associated with betamethasone (typical of corticosteroids) and salicylic acid may also occur.
Systemic adverse effects are mainly observed during long-term use, application over large areas of skin, and use in children.
Blurred vision has been observed during corticosteroid use (frequency unknown – cannot be estimated based on available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Adverse reactions may also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diprosalic

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Use within 3 months after opening.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diprosalic contains

The active substances in this medicine are betamethasone dipropionate and salicylic acid. Each gram of ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) and 30 mg salicylic acid.
Other components are: white soft paraffin and liquid paraffin.

What Diprosalic looks like and contents of the pack
Diprosalic is an ointment.
Available pack sizes:
Aluminium tube in a cardboard box containing 30 g of ointment.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Spain, country of export: 656810.1
Parallel import licence number: 363/24