Diprolene

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Diprolene, 0.64 mg/g, ointment

Betamethasone dipropionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 rapid 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 you are allergic to betamethasone dipropionate or other corticosteroids, or any of the other ingredients of this medicine (listed in section 6);
• in rosacea;
• in acne;
• in perioral dermatitis;
• in bacterial, viral (herpes, shingles, chickenpox) or fungal skin infections;
• on facial skin;
• in itching in the anal and genital areas;
• in children under 12 years of age.

Warnings and precautions

Before starting to use Diprolene, discuss it with your doctor or pharmacist.
Stop using the medicine if you experience irritation or hypersensitivity.
In the case of bacterial or fungal infections, the doctor will use appropriate treatment. If the symptoms of infection persist, consult 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 topical corticosteroids increases.
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, take special precautions.
Patients who have been treated for a long time or use Diprolene on large areas of the skin should be periodically examined to rule out adrenal cortex suppression. If adrenal cortex suppression is found, consider stopping the medicine, reducing the dose, or using another, less potent corticosteroid.
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.
Avoid contact of the medicine with the eyes and mucous membranes.
Use with special caution in children, avoid using the medicine on a large area of skin. In children, adrenal cortex suppression and side effects characteristic of corticosteroids, including growth and development disorders, may occur more easily than in adults.
Use 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 you experience blurred vision or other vision disturbances, consult your doctor.

Diprolene and other medicines

No data available.
Tell your doctor or pharmacist about all the medicines you are 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, 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 decides that the benefits of treatment for the mother outweigh the potential risks 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

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Usually, a thin layer of ointment is applied once a day (usually in the morning) to the affected areas, covering 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, 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 adrenal cortex suppression, causing secondary adrenal insufficiency and corticosteroid side effects, 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

Do 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.
When using 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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 provide more information on the safety of this medicine.

5. How to store Diprolene

Store below 30°C.
After opening the tube, use the medicine within 3 months.
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 month.
Medicines should not be disposed of via wastewater or household waste. 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 is betamethasone dipropionate. Each gram of ointment contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone).
• The other ingredients are: propylene glycol stearate (E 477), propylene glycol (E 1520), white wax, white petrolatum. This medicine contains 100.0 mg of propylene glycol (E 1520) and 20.0 mg of propylene glycol stearate (E 477) per gram of ointment, equivalent to 1566 mg of propylene glycol per unit (15 g tube).

What Diprolene looks like and contents of the pack

Diprolene is an ointment.
Packaging available:
Aluminum tube in a cardboard box containing 15 g of ointment.
For more detailed information, contact the marketing authorization holder or 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:34009 327 582 6 5
327 582-6
Parallel import authorization number:344/18

Date of approval of the leaflet: 24.11.2023

[Information about the trademark]