Diprosalic
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Diprosalic (Diprosalic Ointment), (0.64 mg + 30 mg)/g, ointment
Betamethasone dipropionate + Salicylic acid
Diprosalic and Diprosalic Ointment are different trade names of the same medicine.
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 doubts, 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 vasoconstrictive action.
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 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 the 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 this with your doctor or pharmacist.
Avoid applying the medicine over a large area 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 infection occurs, your 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. For this reason, avoid applying the medicine over large skin areas, open wounds, or damaged skin, as well as using high doses or prolonged treatment.
Special caution is required if treatment is necessary under such circumstances.
Particular caution is advised 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 disruption of 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 intracranial hypertension 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 have a child, she should consult her doctor or pharmacist before using this medicine.
There are no data on the topical use of corticosteroids in pregnant women. Diprosalic may 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 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 (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 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 a larger than recommended dose of Diprosalic
Prolonged use of the 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 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 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 eruptions, depigmentation of the skin, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria.
Because the medicine contains salicylic acid, dermatitis may occur during prolonged use.
Due to systemic absorption of the active substances, general adverse reactions of betamethasone dipropionate (typical of corticosteroids) and salicylic acid may also occur.
General adverse effects occur primarily during prolonged use, application over large areas of skin, and use in children.
Blurred vision has been observed during the use of corticosteroids (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, 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
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 using this medicine.
5. How to store Diprosalic medicine
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Period of use 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the pack and other information
What Diprosalic contains
- The active substances in the 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 soft paraffin and liquid paraffin.
What Diprosalic looks like and contents of the pack
Diprosalic is an ointment.
Available pack sizes:
Aluminium tube in a cardboard box containing 30 g of ointment.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Spain, country of export:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
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
Spanish Marketing Authorisation Number, country of export: 656810.1
Parallel Import Licence Number: 133/25