Patient Information Leaflet

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

Keep this leaflet so that 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 pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Diprolene is and what it is used for

The active substance in Diprolene is betamethasone dipropionate.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid with potent activity,
exerting rapid and prolonged anti-inflammatory, antipruritic, and vasoconstrictive effects when applied topically.
Indications
Diprolene ointment is indicated for the treatment of acute and severe inflammatory skin lesions of allergic origin resistant to treatment with other corticosteroids, severe psoriatic lesions, and other conditions responsive to corticosteroids.

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, consult 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 are absorbed through the skin. Therefore, when using Diprolene, systemic adverse effects typical of general-acting corticosteroids (including suppression of adrenal cortex function) may occur, 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 on large skin areas, 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 areas of the body should be monitored periodically to exclude suppression of the hypothalamic-pituitary-adrenal (HPA) axis. If suppression of the HPA axis is detected, consider discontinuing the medicine, reducing the dose, or switching to a less potent 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 the eyes and mucous membranes.
Use with particular caution in children; avoid applying the medicine over large skin areas.
In children, suppression of the hypothalamic-pituitary-adrenal (HPA) axis and adverse effects typical of corticosteroids, including growth and developmental disorders, may occur more easily than in adults.
Use with caution in psoriasis. Treatment in psoriasis may lead to disease recurrence due to development of tolerance, generalized pustular psoriasis, and systemic toxic effects related to impaired skin integrity.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Diprolene 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 plans to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There are no data on the safety of using Diprolene during pregnancy.
Diprolene may be used only if the doctor determines 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 stop administering the medicine, taking into account the benefits of treatment for the mother and potential adverse effects in the child.

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 exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Usually, a thin layer of the ointment should be applied once daily (typically in the morning) to the affected areas, covering the entire diseased skin surface. In some cases, your 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 this medicine may suppress the hypothalamic-pituitary-adrenal (HPA) axis, leading to secondary adrenal insufficiency, and may cause 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 imbalances, and in cases of chronic toxicity, will recommend gradual, stepwise dose reduction.
Missed dose of Diprolene
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicinal product, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur during the use of Diprolene:
redness and erythema at the application site, burning, irritation, itching, blistering, folliculitis, dry skin,
hypertrichosis, acne-like changes, skin discoloration, perioral dermatitis, allergic contact dermatitis,
skin maceration, secondary infections, skin atrophy, striae, miliaria.
Blurred vision has been observed during the use of corticosteroids (frequency unknown – cannot be
estimated based on available data).
Systemic adverse effects of betamethasone, typical of corticosteroids, may also occur due to absorption
of the active substance into the bloodstream.
Systemic adverse effects occur primarily with prolonged use, application over a large surface area,
and use in children.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
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 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine.

5. How to store Diprolene

Store below 30°C.
After first opening the tube, the medicine should be used within 3 months.
Keep the medicine 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.
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 package 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).
Other ingredients are: propylene glycol stearate (E 477), propylene glycol (E 1520), white wax, and white petrolatum. This medicine contains 100.0 mg of propylene glycol (E 1520) and 20.0 mg of propylene glycol stearate (E 477) in each gram of ointment, corresponding to 1566 mg of propylene glycol per unit (15 g tube).

What the medicine 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 more detailed information, please contact the responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
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 Authorisation Number in France, the country of export: 34009 327 582 6 5
327 582-6
Parallel Import Authorisation Number: 344/18