Diprosalic

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Diprosalic, (0.64 mg + 20 mg)/g, solution for the skin
Betamethasone dipropionate + Salicylic acid
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, 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

1. What Diprosalic is and what it is 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 pack and other information

1. What Diprosalic is and what it is used for

Diprosalic solution contains the active substances: betamethasone dipropionate and salicylic acid.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid with potent anti-inflammatory activity; when applied topically, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Salicylic acid, when applied topically, softens keratin and keratinized epidermis, and promotes desquamation of the skin, thereby facilitating the 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 affecting the hairy scalp, and discoid lupus erythematosus.

2. Important information before using Diprosalic

When not to use Diprosalic:

• if the patient is allergic to betamethasone dipropionate, 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 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 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 occurs during treatment with Diprosalic, discontinue use immediately and contact your doctor.
If bacterial infection develops, 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, avoid using high doses and prolonged treatment.
If use under such circumstances is necessary, special precautions should be taken.
Particular caution is required when using the medicine in psoriasis. Treatment of psoriasis may lead to rebound of the disease due to development of tolerance, generalized pustular psoriasis, and systemic toxic effects related to disruption of 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 the eyes and mucous membranes.
Use with caution in children. Suppression of the hypothalamic-pituitary-adrenal axis is more likely in children than in adults, and adverse effects typical of corticosteroids may occur.
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 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 become pregnant, 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 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 a 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 cm² of skin surface) should be applied to the affected areas of the skin 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 condition recurs, the physician 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 higher 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 physician will administer appropriate symptomatic treatment.
Acute symptoms of 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 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 everyone experiences them.
The following adverse reactions may occur during the use of Diprosalic: burning sensation,
itching, irritation, skin dryness, folliculitis, hypertrichosis, acneiform changes, 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.
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, application over large skin surface 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 those 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 helps to gather further information on the safety of this medicine.

5. How to store Diprosalic

Store below 25°C in the original packaging.
Use within 6 weeks after opening.
Keep the medicine out of the sight and reach of children.
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 Diprosalic are betamethasone dipropionate and salicylic acid. Each gram of solution contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) and 20 mg salicylic acid.
• Other components are: edetic acid disodium salt, hypromellose, sodium hydroxide, isopropyl alcohol, purified water.

What Diprosalic looks like and contents of the pack
Diprosalic is a solution for the skin.
Available pack sizes:
Bottle in a cardboard box.
1 LDPE bottle containing 30 ml of solution.

For further information, please contact the responsible party or the parallel importer:
Responsible party 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, Sectorul 1, Bucharest, Romania
Manufacturer:
Organon Heist bv, Industriepark 30, 2220 Heist-op-den Berg, Belgium
Cenexi HSC, 2, rue Louis Pasteur, 14200, Herouville-Saint-Clair, France
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
Authorization number in Romania, country of export: 10102/2017/01
Parallel import authorization number: 349/18