Diprolene

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information is in a foreign language.
Diprolene (Diprolène), 0.64 mg/g, ointment
Betamethasone dipropionate
Diprolene and Diprolène are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Diprolene is and what it is 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 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 strong activity.
When applied 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 conditions of allergic origin that are resistant to treatment with other corticosteroids, severe psoriatic lesions, and other disorders 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 (e.g. herpes simplex, herpes zoster, varicella) or fungal infections of the skin;
• on the 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 treatment with Diprolene until the infection has resolved.
Corticosteroids are absorbed through the skin. Therefore, when using Diprolene, systemic adverse effects characteristic of corticosteroids with general action (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 a large surface area of the body.
Avoid using the medicine over large areas of skin, open wounds, damaged skin, in high doses, or for prolonged periods. If treatment under such conditions is necessary, special precautions should be taken.
Patients undergoing long-term treatment or using Diprolene over large areas of skin should be monitored periodically to rule out suppression of the hypothalamic-pituitary-adrenal (HPA) axis. If suppression of the HPA axis is detected, discontinuation of the medicine, dose reduction, or switching to a less potent corticosteroid should be considered.
Avoid using the medicine under occlusive dressings or diapers, as these 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 applying the medicine over large areas of skin.
In children, suppression of the hypothalamic-pituitary-adrenal axis and corticosteroid-related adverse effects, including disturbances in growth and development, may occur more easily than in adults.
Use with caution in psoriasis. Treatment with Diprolene in psoriasis may lead to disease recurrence due to development of tolerance, generalized pustular psoriasis, or 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 any other medicines the patient is currently taking or has recently taken, 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 become pregnant, 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 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 treatment with 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.

Diprolene ointment contains propylene glycol and propylene glycol stearate
Due to the presence of propylene glycol and propylene glycol stearate, this medicine may cause skin irritation.

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, so as to cover 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 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 corticosteroid overdose symptoms are usually reversible. If necessary, the doctor will correct
electrolyte imbalances, 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 gets them.
The following adverse reactions may occur during treatment with Diprolene:
redness and erythema at the application site, burning, irritation, itching, blistering, folliculitis,
dryness of the skin, excessive hair growth, acneiform eruptions, skin discoloration, perioral dermatitis,
allergic contact dermatitis, maceration of the skin, 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, typical of corticosteroids, may also occur due to absorption
of the active substance into the bloodstream.
Systemic adverse effects occur primarily after 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, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of
Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diprolene

Do not store above 30°C.
Keep the medicine out of sight and reach of children.
The shelf-life after first opening the tube – 3 months.
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 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 (0.05%) of betamethasone).
• Other ingredients: propylene glycol, propylene glycol stearate, white wax, white petrolatum.

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 or 30 g of ointment.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in France, 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:
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
Marketing Authorisation numbers in France, country of export:
327 582-6
34009 327 582 6 5
327 583-2
34009 327 583 2 6
Parallel Import Licence Number: 12/17