Patient Information Leaflet

Warning! Keep this leaflet! The 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 brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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

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 following active substances: betamethasone dipropionate and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid with potent activity; when applied topically, it exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Topically applied salicylic acid softens keratin and thickened epidermis and promotes desquamation of the skin, thereby facilitating penetration of betamethasone dipropionate into the skin.
Indications
Diprosalic is indicated for the 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 pustular 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 to 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 skin infections;
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 to use Diprosalic, discuss it with your doctor or pharmacist.
Avoid applying the medicine over large areas of the body, especially in children.
If irritation, hypersensitivity or excessive skin dryness occurs 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 corticosteroid therapy may occur during treatment, including suppression of adrenal cortex function. Therefore, avoid using the medicine over large skin areas, on wounds or damaged skin, using high doses or prolonged treatment.
If use in such cases is necessary, special precautions should be taken.
Particular caution is required when using the medicine in psoriasis. Treatment in psoriasis 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 percutaneous absorption of corticosteroids may increase.
Do not apply to the eyes.
Avoid contact of the medicine with eyes and mucous membranes.
Use with caution in children. Suppression of the hypothalamic-pituitary-adrenal axis and adverse effects typical of corticosteroids may 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 intracranial hypertension 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 taking or has recently taken, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 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 effect 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
Usually, a small amount of the medicine (0.2–0.5 cm of ointment per 10 cm² of skin surface) should be applied to the affected skin areas and gently rubbed in twice daily (morning and evening).
In some cases, the physician may recommend less frequent application. Treatment should not last longer than 14 days. If the disease recurs, the physician will consider whether treatment may be repeated.
Do not use 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 the 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 or high-dose use 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 imbalances 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 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 everybody will experience them.
The following adverse reactions may occur during the use of Diprosalic: burning sensation,
itching, irritation, skin dryness, folliculitis, hypertrichosis, acneiform eruptions, skin pigment changes,
perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy,
skin striae, and miliaria.
Since the medicine contains salicylic acid, dermatitis may 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 are mainly observed during prolonged use of the medicine, application over large areas of skin, and use in children.
Blurred vision has been reported during corticosteroid use (frequency unknown – cannot be estimated based on available data).
Reporting of adverse reactions
If any adverse reactions occur, including any 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, 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

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. 1 g 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. The medicine is available in an aluminium tube containing 30 g of ointment, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Spain, country of export:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid, Spain
Manufacturer:
Schering-Plough Labo N.V.
Industriepark, 30
B-2220 – 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 Spain, country of export: 656810.1
Parallel import authorisation number: 16/23