Diprogenta

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

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

Diprogenta

(0.64 mg + 1 mg)/g, ointment
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 package and other information

1. What is Diprogenta and what is it used for

The properties of Diprogenta result from the action of the active substances: betamethasone dipropionate and gentamicin.
Betamethasone dipropionate belongs to the 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 ointment 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, purpura on the basis of venous stasis.
The bacteria sensitive to gentamicin include strains of streptococci (group A: β-hemolytic, α-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative, and some penicillinase-producing strains), as well as 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 microorganisms and other aminoglycoside antibiotics.
Cross-allergy to aminoglycoside antibiotics has been reported.
Diprogenta should not be used in the eyes and around the eyes, as well as 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 cortex 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 surface 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 has occurred after local use of corticosteroids, due to increased absorption resulting from a large skin surface-to-body mass ratio.
In children who have used corticosteroids locally, 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

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, considering 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.

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, some patients may be advised by their doctor 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 have used 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.
During treatment with Diprogenta, very rare (in less than 1 in 10,000 patients) side effects have been observed; these include 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 contact 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 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
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 in the original packaging
The medicine should be stored 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 month stated.
The expiry date expires 3 months after the first opening of the tube.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Diprogenta contains

• The active substances of the medicine 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 what the package contains

Diprogenta is an ointment.
Available packaging:
Aluminum tube with a membrane, with an HDPE cap with a puncture device, in a cardboard box containing 15 g.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Organon Biosciences S.R.L.
Strada Av. Popişteanu, Nr. 54A, Expo Business Clădirea 2
Birou 306 şi Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania

Manufacturer:

Schering – Plough Labo. NV
Industriepark 30, B-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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Number of the marketing authorization in Romania, the country of export: 1788/2009/01

Number of the parallel import authorization: 433/22 Date of approval of the leaflet: 14.12.2022

[Information about the trademark]