Package leaflet: Information for the patient

Warning!
Keep this leaflet. Information on the immediate packaging in a foreign language.
Diprosalic, (0.64 mg + 30 mg)/g, ointment
Betamethasone dipropionate + Salicylic acid
Please read the entire leaflet carefully before using this 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 pass it on to others. It 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, pharmacist, or nurse. 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, antipruritic, and vasoconstrictive effects.
Salicylic acid, when applied topically, 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 local 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 pompholyx, 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, hypersensitivity 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 corticosteroids, including suppression of adrenal cortex function, may occur during treatment. Therefore, avoid applying the medicine over large skin areas, open wounds, or damaged skin, as well as avoid high doses and prolonged use.
If treatment in such cases 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 disease recurrence 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 corticosteroid-related adverse effects 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 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 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 doctor, 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 effect on the ability to drive or operate machinery.

3. How to use Diprosalic

This medicine should always be used exactly as directed by the doctor. In case of 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 cm² 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 doctor may recommend less frequent application. Treatment should not last
longer than 14 days. If symptoms recur, the doctor 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 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, the doctor will administer appropriate symptomatic treatment.
Acute symptoms of adrenal corticosteroid overdose are usually reversible. If necessary, the doctor 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 doctor 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 medicinal product may cause adverse reactions, although not everybody experiences them.
The following adverse reactions may occur during the use of Diprosalic: burning,
itching, irritation, dryness of the skin, folliculitis, hypertrichosis, acneiform eruptions, depigmentation of the skin, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria.
Since Diprosalic contains salicylic acid, dermatitis may occur during prolonged use.
Systemic adverse reactions of betamethasone (typical of corticosteroids) and salicylic acid may also occur due to absorption of the active substances into the bloodstream.
Systemic adverse effects are mainly observed during prolonged use of the medicine, application over large areas of skin, and use in children.
During corticosteroid use, blurred vision has been observed (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, pharmacist or nurse. 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
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of additional information on the safety of medicine use.

5. How to store Diprosalic

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
Shelf-life after first opening of the tube: 3 months.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging 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.
The other ingredients are: white soft paraffin and liquid paraffin.

What Diprosalic looks like and contents of the pack
Diprosalic is a white or almost white ointment.
Pack sizes:
Aluminium tube internally coated with epoxy resin, with a tamper-evident seal and a closure cap made of HDPE,
packaged in a cardboard box containing 15 g of ointment.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Romania, country of export:
Organon BioSciences S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Office 306 and Office 307, Floor 3, Sector 1, Bucharest, Romania
Manufacturer:
Organon Heist bv
Industriepark 30, 2220 Heist-op-den-Berg
Belgium
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Romania, country of export: 9127/2016/01
Parallel import licence number: 583/15