PACKAGE LEAFLET: 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
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 vasoconstriction.
Topically applied salicylic acid softens keratin and keratinized epidermis, and promotes desquamation of the skin, thereby facilitating penetration of betamethasone dipropionate into the skin.
Indications
Diprosalic is indicated for topical treatment of subacute and chronic skin disorders such as: psoriasis, more severe forms of atopic dermatitis, localized prurigo (neurodermitis), lichen planus, and more 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, leprosy), viral infections (herpes simplex, shingles, chickenpox) or fungal infections of the skin;
in acne vulgaris;
in rosacea;
in perioral dermatitis;
on facial skin;
in diaper dermatitis;
in anal or genital pruritus;
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Diprosalic, discuss it with your doctor or pharmacist.
Avoid applying the medicine over large areas 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.
Adverse effects similar to those associated with systemic corticosteroid therapy, including suppression of adrenal cortex function, may occur during treatment. Therefore, avoid using the medicine over large skin areas, open wounds, damaged skin, using high doses or prolonged treatment.
Special precautions should be taken if use of the medicine is necessary under such circumstances.
Extreme caution is required when using the medicine in psoriasis. Treatment in psoriasis may lead to relapse due to development of tolerance, generalized pustular psoriasis or systemic toxic effects related to impaired skin integrity.
Do not use under occlusive dressings, as this may increase percutaneous absorption of the corticosteroid.
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, consult 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 is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are no data on the use of topical corticosteroids in pregnant women. Diprosalic should 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 are excreted in 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 treatment 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 directed by a physician. If in doubt, consult a
doctor or pharmacist.
This medicine is intended for topical use on the skin.
Adults and children over 12 years of age
Typically, 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 certain cases, the physician may recommend less frequent application. Treatment should not last
longer than 14 days. If symptoms recur, the physician will consider whether treatment may be repeated.
This medicine should not be used in children under 12 years of age.
If the effect of Diprosalic appears too strong or too weak, consult a doctor.
Use of a higher than recommended dose of Diprosalic
Prolonged use of this medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis and, consequently, to secondary adrenal insufficiency, as well as adrenal cortical hyperactivity, including Cushing's syndrome.
In addition, prolonged use or use in high doses may result in salicylic acid poisoning.
In case of overdose, the physician will administer appropriate symptomatic treatment.
Acute symptoms of adrenal corticosteroid overdose are usually reversible. If necessary, the physician will correct electrolyte levels, and in cases of chronic intoxication, will recommend gradual, stepwise discontinuation of the medicine.
In case of salicylic acid poisoning, the physician will take measures aimed at rapid removal 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 will experience them.
The following adverse reactions may occur during the use of Diprosalic: burning sensation,
itching, irritation, skin dryness, folliculitis, excessive hair growth, acne-like changes, skin pigment alterations, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, and miliaria.
Since the medicine contains salicylic acid, dermatitis may also occur during prolonged use.
Due to systemic absorption of the active substances into the bloodstream, general adverse effects of betamethasone (typical of corticosteroids) and salicylic acid may also occur.
Systemic adverse effects occur primarily during prolonged use of the medicine, application over large skin areas, and use in children.
Blurred vision has been observed during corticosteroid use (frequency unknown - cannot be estimated from 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 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diprosalic

Store below 25°C in the original packaging.
Keep the medicine out of the 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 stated month. After first opening – 3 months.
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 package 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 of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) and 30 mg of salicylic acid.
Other components: white soft paraffin and liquid paraffin.

What Diprosalic looks like and contents of the pack
Diprosalic is an ointment.
Pack:
An aluminium tube internally coated with epoxy resin, fitted with a HDPE cap, placed in a cardboard box,
containing 15 g of ointment.
For further detailed information, please contact the responsible entity or parallel importer.
Marketing Authorisation 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Romania, the country of export: 9127/2016/01
Parallel import licence number: 263/19