Diprogenta

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

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

Betamethasone dipropionate + Gentamicin

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

The leaflet should be kept so that it can be re-read if necessary.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Package contents 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 and are 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 simple eczema), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), erythema, burns, sudden, reactive vesicular eruption on the hands and feet (dyshidrosis), seborrheic dermatitis, exfoliative dermatitis, radiation-induced dermatitis, and stasis dermatitis.
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), 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, the patient should discuss it with their doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, the use of Diprogenta should be discontinued and the doctor should be consulted, who will apply 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 and around the eyes, as well as on mucous membranes.
The absorption of betamethasone dipropionate and gentamicin through the skin increases after the use of closed dressings (e.g., diapers).
During the use of the medicine, 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 impaired kidney function).
Therefore, the use of the medicine on a large surface area of the body, in large doses, and with closed dressings should be avoided.
If the patient experiences blurred vision or other vision disturbances, they should consult 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

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.
No interactions with other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 discontinue breastfeeding or discontinue the medicine, taking into account the benefits of treatment for the mother and the adverse effects in the child.
The medicine should not be used on the breast skin during breastfeeding.
When using the medicine during breastfeeding, care should be taken to avoid contact between the medicine and the breast skin, as accidental ingestion of the medicine by the infant and/or accidental contact between the medicine and the infant's skin should be avoided.

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 the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The 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 therapy, the doctor may decide to use the medicine less frequently in some patients.
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 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 more than the recommended dose of Diprogenta

In case of using more than the recommended dose of the medicine, the patient should immediately consult their 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

A double dose should not be used to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Diprogenta can cause side effects, although not everybody gets them.
Very rare (in less than 1 in 10,000 patients) side effects have been observed during the use of Diprogenta; these include hypersensitivity and skin discoloration.
During the local use of corticosteroids, especially under closed 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, treatment should be discontinued immediately and the doctor should be consulted.
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 the available data) has been observed.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
By reporting side effects, more information can be collected on the safety of the 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 specified month. The shelf life after first opening - 3 months.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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 packages: aluminum tube with a membrane and HDPE cap with a puncture in a cardboard box containing 15 g of ointment.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Organon Biosciences 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Romanian marketing authorization number, country of export: 1788/2009/01

Parallel import authorization number: 97/19

Date of leaflet approval: 12.02.2024