PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – the packaging information in a foreign language!
Diprolene
0.64 mg/g, ointment
Betamethasone dipropionate
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
If any side effects occur in the patient, including any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Diprolene and what is it used for
Important information before using Diprolene
How to use Diprolene
Possible side effects
How to store Diprolene
Contents of the package and other information

1. What is Diprolene and what is it used for

The active substance in Diprolene is betamethasone dipropionate.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid with potent activity.
When used topically, it exerts rapid and long-lasting anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Diprolene ointment is indicated for the treatment of acute and severe inflammatory skin lesions of allergic origin that are resistant to treatment with other corticosteroids, severe psoriatic lesions, and other corticosteroid-responsive skin disorders.

2. Important information before using Diprolene

When not to use Diprolene:

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

Warnings and precautions
Before starting treatment with Diprolene, discuss this with your doctor or pharmacist.
Treatment should be discontinued if irritation or hypersensitivity occurs.
In case of bacterial or fungal infections, the doctor will initiate appropriate treatment. If signs of infection persist, contact your doctor. The doctor will decide whether to discontinue Diprolene until the infection has resolved.
Corticosteroids can be absorbed through the skin. Therefore, systemic adverse effects characteristic of general corticosteroid therapy (including suppression of adrenal cortex function) may occur during treatment with Diprolene, especially in infants and children.
Systemic absorption of topically applied corticosteroids increases when the medicine is applied over large areas of the body.
Avoid using the medicine over large areas of skin, on wounds, damaged skin, in high doses, or for prolonged periods. If treatment under such circumstances is necessary, special precautions should be taken.
Patients undergoing long-term treatment or using Diprolene over large body surface areas should be monitored periodically to exclude suppression of the hypothalamic-pituitary-adrenal (HPA) axis. If HPA axis suppression is detected, consider discontinuing the medicine, reducing the dose, or switching to a weaker corticosteroid.
Avoid using the medicine under occlusive dressings or diapers, as they may increase transdermal absorption of betamethasone.
This medicine is not intended for ophthalmic use.
Avoid contact of the medicine with eyes and mucous membranes.
Use with particular caution in children; avoid application over large skin areas. In children, suppression of the hypothalamic-pituitary-adrenal axis and corticosteroid-related adverse effects, including growth and developmental disturbances, may occur more easily than in adults.
Use with caution in psoriasis. Treatment with Diprolene in psoriasis may lead to relapse due to development of tolerance, generalized pustular psoriasis, and systemic toxic effects related to disruption of skin integrity.
If blurred vision or other visual disturbances occur, contact your doctor.

Diprolene with 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 plans to use.

Pregnancy and breastfeeding
If the patient is pregnant, 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 safety of using Diprolene in pregnant women.
Diprolene may be used only if the doctor considers that the benefits to the mother outweigh the potential risks to the mother and the fetus.
There are no data on the safety of using Diprolene during breastfeeding.
The doctor will decide whether to discontinue breastfeeding or to discontinue the medicine, taking into account the benefits of treatment for the mother and the potential adverse effects in the infant.

Driving and operating machinery
Diprolene has no influence on the ability to drive or operate machinery.

3. How to use Diprolene

This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor or pharmacist.
Usually, a thin layer of the ointment should be applied once daily (usually in the morning) to the affected areas, so as to cover the entire diseased skin surface. In some cases, the doctor may recommend applying Diprolene twice daily (in the 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
Diprolene must not be used in children under 12 years of age.
Use of a higher than recommended dose of Diprolene
Excessive or prolonged use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis, resulting in secondary adrenal insufficiency, and corticosteroid-related adverse effects, including Cushing's syndrome.
In case of overdose, the doctor will administer appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, the doctor will correct electrolyte levels, and in cases of chronic toxicity, will recommend gradual, slow tapering of the dose.
Missed dose of Diprolene
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 everybody will experience them.
The following adverse reactions may occur during treatment with Diprolene:
redness and erythema at the application site, burning sensation, irritation, itching, blistering,
folliculitis, dry skin, excessive hair growth, acne-like changes, skin discoloration, perioral dermatitis,
allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, miliaria.
Blurred vision has been observed during corticosteroid use (frequency unknown – cannot be estimated
from available data).
Systemic adverse effects of betamethasone characteristic of corticosteroids may also occur due to
absorption of the active substance into the bloodstream.
Systemic adverse effects occur primarily with prolonged use of the medicine, application over a large
skin surface area, and use in children.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 4921301, Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of medicine safety and helps to gather more information on the safety of the medicine.

5. How to store Diprolene

Do not store above 30°C.
Keep the medicine in a place 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 stated month.
Expiry after first opening: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 (0.05%) of betamethasone).
Excipients: propylene glycol stearate, propylene glycol, white wax, white petroleum jelly.

What Diprolene looks like and contents of the pack
Diprolene is an ointment.
Available pack sizes:
Aluminium tube in a cardboard box containing 15 g of ointment.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in France, the country of export:
34009 327 582 6 5
327 582-6
Parallel Import Licence number: 391/19