Diprolene

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Diprolene

0.64 mg/g, ointment

Betamethasone dipropionate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness 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 Diprolene and what is it used for
• 2. Important information before using Diprolene
• 3. How to use Diprolene
• 4. Possible side effects
• 5. How to store Diprolene
• 6. Contents of the packaging and other information

1. What is Diprolene and what is it used for

The active substance of Diprolene is betamethasone dipropionate.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid with strong action,
used locally, it has a quick and long-lasting anti-inflammatory, anti-itching and vasoconstrictive effect.

Indications

Diprolene ointment is indicated for the treatment of acute and severe inflammatory skin changes
of allergic origin, resistant to treatment with other corticosteroids, severe psoriatic changes and other diseases that respond to corticosteroids.

2. Important information before using Diprolene

When not to use Diprolene:

• if the patient is allergic to betamethasone dipropionate or other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6);
• in rosacea;
• in common acne;
• in perioral dermatitis;
• in bacterial, viral (herpes, shingles, chickenpox) or fungal skin infections;
• on the face;
• in itching in the anal and genital area;
• in children under 12 years of age.

Warnings and precautions

Before starting to use Diprolene, you should discuss it with your doctor or pharmacist.
You should stop using the medicine if irritation or hypersensitivity occurs.
In the case of bacterial or fungal infections, the doctor will use appropriate treatment. If the symptoms of the infection persist, you should contact your doctor. The doctor will decide whether to stop using Diprolene until the infection is cured.
Corticosteroids are absorbed through the skin. Therefore, when using Diprolene, systemic side effects characteristic of corticosteroids (including adrenal cortex suppression) may occur, especially in infants and children.
After applying the medicine to a large area of the skin, the systemic absorption of topically applied corticosteroids increases.
You should avoid using the medicine on a large area of skin, wounds, damaged skin, in large doses, and for prolonged treatment. If it is necessary to use the medicine in such cases, you should take special precautions.
Patients who have been treated for a long time or who use Diprolene on large areas of the skin should be periodically examined to rule out suppression of the hypothalamic-pituitary-adrenal axis. If suppression of the hypothalamic-pituitary-adrenal axis is found, you should consider stopping the use of the medicine, reducing the dose, or using another, less potent corticosteroid.
You should avoid using the medicine under an occlusive dressing and diaper, as they may increase the percutaneous absorption of betamethasone.
The medicine is not intended for use in ophthalmology.
You should avoid contact between the medicine and the eyes and mucous membranes.
Particular caution should be exercised when using the medicine in children, avoiding the use of the medicine on a large area of skin. In children, it is easier than in adults to suppress the hypothalamic-pituitary-adrenal axis and to experience side effects characteristic of corticosteroids, including growth and development disorders.
The medicine should be used with caution in psoriasis. Using the medicine 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.
If the patient experiences blurred vision or other vision disorders, they should contact their doctor.

Diprolene and other medicines

No data available.
You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
No data are available on the safety of using the medicine in pregnant women.
Diprolene can only be used if your doctor considers that the benefits of treatment for the mother outweigh the potential risk to the mother and fetus.
No data are available on the safety of using the medicine in breastfeeding women.
Your doctor will decide whether to stop breastfeeding or stop using the medicine, taking into account the benefits of treatment for the mother and the potential side effects in the child.

Driving and using machines

Diprolene does not affect the ability to drive and use machines.

3. How to use Diprolene

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Usually, a thin layer of ointment is applied once a day (usually in the morning) to the affected areas, so as to cover the entire affected skin surface. In some cases, your doctor may recommend using Diprolene twice a day (morning and evening).
If you feel that the effect of Diprolene is too strong or too weak, you should consult your doctor.

Use in children and adolescents

The medicine should not be used in children under 12 years of age.

Using a higher dose of Diprolene than recommended

Excessive or prolonged use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis, causing secondary adrenal insufficiency and side effects of corticosteroids, including Cushing's syndrome.
In the event of an overdose, your doctor will use appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, your doctor will correct the electrolyte balance, and in the case of chronic poisoning, will gradually reduce the dose of the medicine.

Missing a dose of Diprolene

You should not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Diprolene can cause side effects, although not everybody gets them.
During the use of Diprolene, the following side effects may occur:
redness and erythema at the application site, burning, irritation, itching, blistering, folliculitis, dryness of the skin, excessive hair growth, acne-like changes, skin discoloration, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae.
During the use of corticosteroids, blurred vision (frequency not known - cannot be estimated from the available data) has been observed.
Due to the absorption of the active substance into the blood, general side effects of betamethasone, characteristic of corticosteroids, may also occur.
General side effects occur mainly in the case of prolonged use of the medicine, use on a large area of skin, and use in children.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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:
Aleje 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 medicine.

5. How to store Diprolene

Do not store above 30°C.
The medicine should be stored out of 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 month.
Shelf life after first opening: 3 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Diprolene contains

• The active substance of the medicine is betamethasone dipropionate. Each gram of ointment contains 0.64 mg of betamethasone dipropionate (which corresponds to 0.5 mg (0.05%) of betamethasone).
• Excipients: propylene glycol stearyl ester, propylene glycol, white wax, white petrolatum.

What Diprolene looks like and contents of the pack

Diprolene is an ointment.
Available packaging:
Aluminum tube in a cardboard box containing 15 g of ointment.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

ORGANON FRANCE
106 Boulevard Haussmann
75008 Paris
France

Manufacturer:

ORGANON HEIST BV
Industriepark 30
2220 Heist-op-den-Berg
Belgium
CENEXI HSC
2 rue Louis Pasteur
14200 Hérouville-Saint-Clair
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in France, the country of export:
34009 327 582 6 5
327 582-6
Parallel import authorization number: 391/19

Date of approval of the leaflet: 26.09.2024

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