Patient Information Leaflet

Diprosalic, (0.64 mg + 20 mg)/g, cutaneous solution
Betamethasone dipropionate + Salicylic acid
Please read the following information 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 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

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 cutaneous solution 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.
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 psoriasis of the scalp, severe forms of seborrhoeic dermatitis, lichen planus, severe forms of allergic dermatitis, contact eczema involving the scalp, and lichen erythematosus.

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 a doctor or pharmacist.
Avoid applying the medicine over large areas of the body, especially in children.
If signs of irritation, allergy or excessive skin dryness occur during treatment with Diprosalic, discontinue use immediately and contact a doctor.
If bacterial infections occur, the doctor will initiate appropriate antibacterial treatment.
During treatment, adverse effects similar to those observed with systemic corticosteroids may occur, including suppression of adrenal cortex function. Therefore, avoid using the medicine over large skin areas, open wounds, damaged skin, using high doses or prolonged treatment.
Special caution is required if treatment in such cases is necessary.
Particular caution is required when using the medicine in psoriasis. Treatment in psoriasis may lead to disease recurrence due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects associated with impaired skin integrity.
Do not use under occlusive dressings, as percutaneous absorption of the corticosteroid may increase.
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 axis and occurrence of adverse effects typical of corticosteroids 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 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 currently used, recently used or planned for 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 unknown whether topical 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 vehicles or operate machinery.

3. How to use Diprosalic

This medicine should always be used exactly as prescribed 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 (approximately 0.5 ml of solution per 10 cm of skin surface) should be applied to the affected areas of the skin twice daily (morning and evening).
In some cases, the doctor may recommend less frequent application. Treatment should not last
longer than 14 days. If the disease recurs, the doctor will consider whether treatment can 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 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.
Additionally, prolonged use or use in high doses may cause salicylic acid poisoning.
In case of overdose, the doctor will administer appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, the doctor will correct electrolyte imbalances, and in case 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 can cause adverse reactions, although not everybody experiences them.
The following adverse reactions may occur during treatment with Diprosalic: burning sensation,
itching, irritation, dryness of the skin, folliculitis, hypertrichosis, acneiform eruptions, skin depigmentation,
perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy,
skin striae, and miliaria.
Since the product 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 treatment, application over large skin areas, and use in children.
Blurred vision has been reported during corticosteroid use (frequency unknown – cannot be estimated from 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, 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.
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 sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after:
"EXP". 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. These measures 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 the solution contains 0.64 mg of betamethasone diprop游戏副本