Diprolene

Package Leaflet: Information for the Patient

Diprolene, 0.64 mg/g, Ointment

Betamethasone Dipropionate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please 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 pack 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 topically, 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 conditions
of allergic origin, resistant to treatment with other corticosteroids, severe psoriatic conditions
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 to other corticosteroids, or to 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 the face;
• in itching of 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 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, contact your doctor. The doctor will decide whether to
stop using Diprolene until the infection is cured.
Corticosteroids are absorbed through the skin. Therefore, during the use of Diprolene, systemic
side effects characteristic of corticosteroids (including adrenal gland suppression) may occur,
especially in infants and children.
After applying the medicine to a large area of the body, the systemic absorption of topically
applied 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 body should
be periodically examined to rule out adrenal gland suppression. If adrenal gland 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 gland suppression and side effects characteristic of corticosteroids may occur
more easily than in adults, including growth and development disorders.
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, contact your doctor.

Diprolene and other medicines

No data available.
Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 risks for 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 risk for the baby.

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, 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, ask your doctor.

Use in children and adolescents

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

Using more than the recommended dose of Diprolene

Excessive or prolonged use of the medicine may lead to adrenal gland suppression, causing secondary adrenal insufficiency and corticosteroid side effects, including Cushing's syndrome.
In case of overdose, your doctor will use appropriate symptomatic treatment.
Acute symptoms of corticosteroid overdose are usually reversible. If necessary, your doctor will correct the electrolyte levels, and in the case of chronic poisoning, will recommend a gradual, step-by-step reduction of the medicine dose.

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.
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 not listed in this leaflet, please tell 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:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Diprolene

Store below 25°C. Store in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and aluminum tube after: "EXP". 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diprolene contains

• The active substance is betamethasone dipropionate. Each gram of ointment contains 0.64 mg of betamethasone dipropionate (which corresponds to 0.5 mg of betamethasone).
• The other ingredients are: propylene glycol monostearate (E477), propylene glycol (E1520), white wax, white petrolatum. This medicine contains 100.0 mg of propylene glycol (E1520) and 20.0 mg of propylene glycol monostearate (E477) per gram of ointment, which corresponds to 1566 mg of propylene glycol per unit (15 g tube) or 3132 mg of propylene glycol per unit (30 g tube).

What Diprolene looks like and contents of the pack

Diprolene is an ointment.
Pack sizes:
Aluminum tube in a cardboard box containing 15 g or 30 g of ointment.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: + 48 22 105 50 01
[email protected]
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Date of last revision of the leaflet: 11/2022