Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Diprosalic
(0.64 mg + 30 mg)/g, ointment
Betamethasone dipropionate + Salicylic acid
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those 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 vasoconstriction.
Salicylic acid, when applied topically, softens keratin and thickened epidermis, and exfoliates the skin, thereby facilitating the 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, syphilis), 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, consult 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 occur, the doctor will initiate appropriate antibacterial treatment.
Adverse effects similar to those associated with systemic corticosteroids, including suppression of adrenal cortex function, may occur during treatment. Therefore, avoid applying the medicine over large skin areas, open wounds, damaged skin, using high doses or prolonged treatment.
If use under such conditions is necessary, special precautions should be taken.
Particular caution is required when using the medicine in psoriasis. Treatment of psoriasis with Diprosalic may lead to rebound of the disease 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 eyes and mucous membranes.
Use with caution in children. In children, suppression of the hypothalamic-pituitary-adrenal (HPA) axis and corticosteroid-related adverse effects may occur more easily 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 currently or recently used, as well as any medicines the patient intends to use.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning 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 should be used only if, in the opinion of the physician, the potential benefit to the mother outweighs the possible risk to the fetus.
It is unknown whether topically applied corticosteroids pass into human milk. A decision should be made whether to discontinue breastfeeding or to discontinue treatment with Diprosalic, 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 influence on the ability to drive or operate machinery.

3. How to use Diprosalic

This medicine should always be used as directed by the physician. 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
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 the skin and gently massaged 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 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.
Furthermore, prolonged use or use in high doses may cause salicylic acid poisoning.
In case of overdose, the physician will administer appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, the physician will correct electrolyte imbalances, and in cases of chronic toxicity, will recommend gradual, stepwise discontinuation of the medicine.
In case of salicylic acid poisoning, the physician 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 will experience them.
The following adverse reactions may occur during the use of Diprosalic: burning,
itching, irritation, dryness of the skin, folliculitis, hypertrichosis, acneiform changes,
depigmentation of the skin, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, skin striae, and miliaria.
Due to the presence of salicylic acid, prolonged use of the product may lead to dermatitis.
Systemic adverse reactions of betamethasone (typical of corticosteroids) and salicylic acid may also occur as a result of absorption of the active substances into the bloodstream.
Systemic adverse effects occur primarily with prolonged use, application over large areas of skin, 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 for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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

Do not store above 25°C.
Keep the medicine in a place invisible and out of 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.
Medicines must not be disposed of via the sewage system or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. 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 ingredients: white vaseline and liquid paraffin.

What Diprosalic looks like and contents of the pack
Diprosalic is an ointment.
Available pack sizes: Aluminium tube with a screw cap made of HDPE containing 15 g of ointment, in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Manufacturer:
Schering-Plough Labo N.V.
Heist-op-den Berg
Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in the Czech Republic, country of export: 46/061/92-S/C
Parallel import authorisation number: 224/22