Diprosalic

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Diprosalic

(0.64 mg + 30 mg)/g, ointment
Betamethasone dipropionate + Salicylic acid

Before Using the Medication, Carefully Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Diprosalic and what is it used for
• 2. Important information before using Diprosalic
• 3. How to use Diprosalic
• 4. Possible side effects
• 5. How to store Diprosalic
• 6. Contents of the packaging and other information

1. What is Diprosalic and what is it used for

Diprosalic ointment contains the active substances: betamethasone dipropionate and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid with strong action;
when used topically, it has anti-inflammatory and antipruritic effects, as well as vasoconstrictive effects.
Salicylic acid, when used topically, softens keratin and thickened skin and exfoliates the skin, facilitating the penetration of betamethasone dipropionate into the skin.

Indications

Diprosalic is indicated for the local treatment of acute and chronic skin diseases, such as: psoriasis, more severe forms of atopic dermatitis, limited neurodermatitis, lichen planus, more severe forms of eczema (including nummular eczema and contact eczema).

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 medication (listed in section 6);
• in the case of bacterial (e.g., tuberculosis, scrofula), viral (herpes, shingles, chickenpox), or fungal skin infections;
• in common acne;
• in rosacea;
• in perioral dermatitis;
• on facial skin;
• in diaper dermatitis;
• in pruritus of the anal and genital areas;
• in children under 12 years of age.

Warnings and precautions

Before starting to use Diprosalic, discuss it with your doctor or pharmacist.
Avoid using the medication on a large area of the body, especially in children.
If, during the use of Diprosalic, symptoms of irritation, hypersensitivity, or excessive drying of the skin appear, stop using the medication immediately and contact your doctor.
If bacterial infections occur, the doctor will prescribe appropriate antibacterial treatment.
During the use of the medication, side effects similar to those that occur with the use of systemic corticosteroids may occur, including adrenal insufficiency. Therefore, avoid using the medication on a large area of skin, wounds, damaged skin, using the medication in large doses, and prolonged use.
In case of necessity to use the medication in such cases, special precautions should be taken.
Particularly careful use of the medication is required in psoriasis. The use of the medication in psoriasis may cause a relapse of the disease due to the development of tolerance, the occurrence of generalized pustular psoriasis, and general toxic effects related to skin continuity disorders.
The medication should not be used under an occlusive dressing, as it may increase the percutaneous absorption of the corticosteroid.
Do not use in the eyes.
Avoid contact of the medication with the eyes and mucous membranes.
Use with caution in children. In children, it is easier than in adults to cause inhibition of the hypothalamic-pituitary-adrenal axis and the occurrence of side effects characteristic of corticosteroids.
In children treated with topical corticosteroids, inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, decreased weight gain, and intracranial hypertension have been reported.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children

Do not use in children under 12 years of age.

Diprosalic and other medications

No data available.
Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
No data are available on the topical use of corticosteroids in pregnant women. Diprosalic can only be used if, in the doctor's opinion, the potential benefit to the mother outweighs the possible risk to the fetus.
It is not known whether topically applied corticosteroids pass into breast milk. A decision should be made to either discontinue breastfeeding or discontinue the use of Diprosalic, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and operating machinery

Diprosalic has no effect on the ability to drive and operate machinery.

3. How to use Diprosalic

This medication should always be used as directed by your doctor. In case of doubts, consult your doctor or pharmacist.
This medication is intended for use on the skin.

Adults and children over 12 years of age

Usually, a small amount of medication (0.2-0.5 cm of ointment per 10 cm of skin surface) is applied to the affected areas of the skin and gently rubbed in twice a day (morning and evening).
In some cases, the doctor may recommend less frequent use of the medication. The treatment should not last longer than 14 days. If the disease recurs, the doctor will consider whether the treatment can be repeated.
Do not use the medication in children under 12 years of age.
If you feel that the effect of Diprosalic is too strong or too weak, consult your doctor.

Using more than the recommended dose of Diprosalic

Prolonged use of the medication may lead to inhibition of the hypothalamic-pituitary-adrenal axis and, consequently, to secondary adrenal insufficiency, as well as to hypercorticism, including Cushing's syndrome.
Additionally, prolonged or high-dose use of the medication may cause salicylic acid poisoning.
In case of overdose, the doctor will provide appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, the doctor will correct the electrolyte balance, and in the case of chronic poisoning, will recommend gradual, step-by-step withdrawal of the medication.
In the case of salicylic acid poisoning, the doctor will take actions to quickly remove salicylates from the patient's body.

Missing a dose of Diprosalic

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medications, Diprosalic can cause side effects, although they may not occur in everyone.
During the use of Diprosalic, the following side effects may occur: burning, itching, irritation, dryness of the skin, folliculitis, hypertrichosis, acne-like changes, skin depigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, and furuncles.
Due to the fact that the medication contains salicylic acid, skin inflammation may occur during prolonged use.
As a result of the absorption of active substances into the blood, general side effects of betamethasone (characteristic of corticosteroids) and salicylic acid may also occur.
General side effects occur mainly in the case of prolonged use of the medication, use on a large area of skin, and use in children.
During the use of corticosteroids, blurred vision (frequency not known - cannot be determined based on available data) has been observed.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the medication.

5. How to store Diprosalic

Do not store above 25°C.
Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Diprosalic contains

• The active substances of the medication 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 petrolatum and liquid paraffin.

What Diprosalic looks like and what the packaging contains

Diprosalic is an ointment.
Available packaging: Aluminum tube with an HDPE cap containing 15 g of ointment, in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:46/061/92-S/C

Parallel import authorization number: 224/22 Date of approval of the leaflet: 20.05.2022

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