Diprogenta

Package Leaflet: Information for the Patient

Diprogenta, (0.64 mg + 1 mg)/g, Ointment

Betamethasone dipropionate+ Gentamicin

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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Diprogenta and what is it used for
• 2. Important information before using Diprogenta
• 3. How to use Diprogenta
• 4. Possible side effects
• 5. How to store Diprogenta
• 6. Contents of the pack and other information

1. What is Diprogenta and what is it used for

The properties of Diprogenta result from the action of its active substances: betamethasone dipropionate and gentamicin.
Betamethasone dipropionate belongs to a group of corticosteroids with strong action. When used topically, it has a quick and long-lasting anti-inflammatory, anti-itching, and vasoconstrictive effect.
Gentamicin is an aminoglycoside antibiotic with a broad spectrum of antibacterial action.

Indications

Diprogenta ointment is indicated for the symptomatic treatment of inflammatory skin changes responding to corticosteroids, complicated by secondary infections caused by gentamicin-sensitive microorganisms.
These diseases include: psoriasis, contact dermatitis (toxic dermatitis), atopic dermatitis (childhood eczema, allergic dermatitis), neurodermatitis (chronic eczema), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis),
dyshidrosis, burns, acute, reactive vesicular eruption on hands and feet (dyshidrotic eczema), seborrheic dermatitis, exfoliative dermatitis, radiation-induced dermatitis, stasis dermatitis.

2. Important information before using Diprogenta

When not to use Diprogenta:

• in viral (e.g., chickenpox, herpes) and fungal skin infections;
• in primary bacterial skin infections;
• in rosacea;
• in acne;
• on wounds, on damaged skin;
• in the anal and genital areas;
• in perioral dermatitis;
• for a long time;
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Diprogenta, discuss it with your doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, discontinue use of Diprogenta and contact your doctor, who will provide appropriate treatment.
Long-term use of the medicine may lead to the growth of gentamicin-resistant microorganisms and other aminoglycoside antibiotics.
Cross-allergy to aminoglycoside antibiotics has been reported.
Diprogenta should not be used in the eyes or around the eyes, or on mucous membranes.
Absorption of betamethasone dipropionate and gentamicin through the skin increases after using occlusive dressings (e.g., diapers).
During treatment, there is a risk of systemic side effects characteristic of corticosteroids (including adrenal suppression) and gentamicin (such as hearing loss, kidney damage, especially in people with impaired kidney function).
Therefore, it is recommended to avoid using the medicine on a large surface area, using high doses, and using occlusive dressings.
If you experience blurred vision or other vision disturbances, contact your doctor.

Children and adolescents

In children, more often than in adults, suppression of the hypothalamic-pituitary-adrenal axis has been reported after topical use of corticosteroids, due to increased absorption resulting from a large skin surface-to-body mass ratio.
In children who have used topical corticosteroids, the following have been reported: suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, decreased body weight gain, and increased intracranial pressure (e.g., bulging fontanelle, headaches).

Diprogenta and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
No interactions with other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
There are no data on the safety of using the medicine in pregnant women.
The medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the risk to the mother, fetus, or newborn.
The doctor will decide whether to stop breastfeeding or stop using the medicine, considering the benefits of treatment for the mother and the adverse effects on the child.
Do not use the medicine on the breast skin during breastfeeding.
When using the medicinal product during breastfeeding, be careful not to let the medicinal product come into contact with the breast skin, as this may cause accidental ingestion by the infant and (or) accidental contact of the medicine with the infant's skin.

Driving and using machines

There are no available data on the effect of Diprogenta on the ability to drive and use machines.

3. How to use Diprogenta

Always use this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
This medicine is for use on the skin.
A thin layer of Diprogenta is usually applied to the affected areas and surrounding skin twice a day, in the morning and evening.
In maintenance therapy, in some patients, the doctor may decide to use the medicine less frequently.
The duration of treatment depends on the size and location of the lesions and the patient's response to treatment. If no improvement occurs after 3-4 weeks, the doctor will verify the diagnosis.

Use in children and adolescents

Do not use in children under 2 years of age.
In children over 2 years of age, do not use for more than 5 days.

Using more than the recommended dose of Diprogenta

If you use more than the recommended dose, contact your doctor or pharmacist immediately.
Excessive or prolonged use of the medicine may cause suppression of the hypothalamic-pituitary-adrenal axis, secondary adrenal insufficiency, side effects characteristic of corticosteroids, including Cushing's syndrome, and may lead to the development of gentamicin-resistant bacterial strains and hearing and kidney damage.

Missing a dose of Diprogenta

Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diprogenta can cause side effects, although not everybody gets them.
Very rare (affecting less than 1 in 10,000 patients) side effects have been reported during the use of Diprogenta; these include hypersensitivity and skin discoloration.
During topical use of corticosteroids, especially under occlusive dressings (e.g., diapers), the following side effects have been observed: burning sensation, itching, irritation, dryness of the skin, folliculitis, hypertrichosis, post-steroid acne, skin discoloration, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, and dyshidrotic eczema.
Hypersensitivity symptoms may occur. If hypersensitivity symptoms occur, discontinue treatment and contact your doctor immediately.
Due to the gentamicin content in the medicine, skin irritation (redness and itching) may occur, which usually does not require discontinuation of treatment.
During the use of corticosteroids, blurred vision (frequency not known - cannot be estimated from available data) has been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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:
Aleje 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diprogenta

Store below 25°C. Store in the original package.
Keep this 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 Diprogenta contains

• The active substances are betamethasone dipropionate and gentamicin. Each gram of ointment contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) and 1 mg of gentamicin (as gentamicin sulfate).
• The other ingredients are: liquid paraffin, white petrolatum.

What Diprogenta looks like and contents of the pack

Diprogenta 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.
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