Diprogenta

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

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

Betamethasone dipropionate+ Gentamicin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 locally, it has a rapid and long-lasting anti-inflammatory, anti-itching, and vasoconstrictive effect.
Gentamicin is an aminoglycoside antibiotic with a broad spectrum of antibacterial action.

Indications

Diprogenta cream is indicated for the symptomatic treatment of inflammatory skin changes that respond 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), erythema, burns, acute, reactive vesicular eruption on the hands and feet (dyshidrosis), seborrheic dermatitis, exfoliative dermatitis, solar dermatitis, and stasis dermatitis.
The bacteria sensitive to gentamicin include streptococci (group A: β-hemolytic, α-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative, and some penicillinase-producing strains), and Gram-negative bacteria, such as: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, and Klebsiella pneumoniae.

2. Important information before using Diprogenta

When not to use Diprogenta:

• if the patient is allergic to betamethasone dipropionate or gentamicin, or to other corticosteroids, aminoglycoside antibiotics, or any of the other ingredients of this medicine (listed in section 6);
• in viral (e.g., chickenpox, herpes) and fungal skin infections;
• in primary bacterial skin infections;
• in rosacea;
• in acne vulgaris;
• 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 to use Diprogenta, you should discuss it with your doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, you should stop using Diprogenta and contact your doctor, who will provide appropriate treatment.
Long-term use of the medicine may lead to the growth of gentamicin-resistant and other aminoglycoside antibiotic-resistant microorganisms.
Cross-allergy to aminoglycoside antibiotics has been reported.
Diprogenta should not be used in the eyes or around the eyes, or on mucous membranes.
The 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 kidney function disorders). For this reason, you should avoid using the medicine on a large area of the body, using it in large doses, and using occlusive dressings.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children and adolescents

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

Diprogenta and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as 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 have a child, you should 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, taking into account the benefits of treatment for the mother and the adverse effects on the child.
During breastfeeding, you should not use the medicine on the breast skin.
When using the medicinal product during breastfeeding, you should be careful not to let the medicinal product come into contact with the breast skin, as you should avoid accidental ingestion of the product 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.

Diprogenta cream contains cetostearyl alcohol and chlorocresol

Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis). Due to the presence of chlorocresol, the medicine may cause allergic reactions.

3. How to use Diprogenta

This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
This medicine is intended 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 treatment, 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 there is no improvement after three to four 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 a higher dose of Diprogenta than recommended

If you use a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.
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 damage to hearing and kidneys.

Missing a dose of Diprogenta

You should not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diprogenta can cause side effects, although not everybody gets them.
Very rarely (less than 1 in 10,000 patients) during treatment with Diprogenta, the following side effects have been observed: hypersensitivity and skin discoloration.
During local 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 dyshidrosis.
Hypersensitivity symptoms may occur. If hypersensitivity symptoms occur, you should stop treatment immediately and consult your doctor.
Due to the presence of gentamicin in the medicine, skin irritation (redness and itching) may occur, which usually does not require discontinuation of treatment.
During corticosteroid treatment, blurred vision (frequency not known - cannot be estimated from the available data) has been observed.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
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 packaging.
The medicine should be stored out of sight and reach of children.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Diprogenta contains

• The active substances of the medicine are betamethasone dipropionate and gentamicin. Each gram of cream 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: chlorocresol, sodium dihydrogen phosphate dihydrate, phosphoric acid, liquid paraffin, cetostearyl alcohol, macrogol cetostearyl ether, white petrolatum, sodium hydroxide, purified water.

What Diprogenta looks like and contents of the packaging

Diprogenta is a cream.
Available packaging:
Aluminum tube with a membrane and HDPE cap, in a cardboard box containing 15 g of cream.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Organon Bioscences S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1
Bucharest
Romania

Manufacturer:

Organon Heist bv
Industriepark 30
2220 Heist-op-den Berg
Belgium

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Romania, the country of export: 1789/2009/01
Parallel import authorization number: 193/23

Date of approval of the leaflet: 13.09.2023

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