Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Diprogenta, (0.64 mg + 1 mg)/g, ointment
Betamethasone dipropionate + Gentamicin
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
Keep this leaflet for future reference.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Diprogenta is and what it is used for
Important information before using Diprogenta
How to use Diprogenta
Possible side effects
How to store Diprogenta
Contents of the pack and other information

1. What Diprogenta is and what it is used for

The therapeutic properties of Diprogenta result from the combined action of its active ingredients: betamethasone dipropionate and gentamicin.
Betamethasone dipropionate belongs to the class of corticosteroids with potent anti-inflammatory activity. When applied topically, it exerts rapid and prolonged anti-inflammatory, antipruritic, and vasoconstrictive effects.
Gentamicin is an aminoglycoside antibiotic with broad-spectrum antibacterial activity.

Indications
Diprogenta ointment for topical use is indicated for the symptomatic treatment of inflammatory skin conditions responsive to corticosteroids, complicated by secondary infections caused by microorganisms sensitive to gentamicin.

These conditions include: psoriasis, contact dermatitis (toxic dermatitis), atopic dermatitis (infantile eczema, allergic dermatitis), neurodermatitis (lichen simplex chronicus), lichen planus, eczema (including nummular eczema, hand dermatitis, eczematous dermatitis), dermatitis, burns, urticaria, dyshidrotic eruption (pompholyx), seborrheic dermatitis, exfoliative dermatitis, radiation-induced dermatitis, and stasis dermatitis.

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 medicines in
the corticosteroid group, aminoglycoside antibiotics, or to any of the other
ingredients of this medicine (listed in section 6);
in viral (e.g. chickenpox, herpes simplex) and fungal skin infections;
in primary bacterial skin infections;
in rosacea;
in acne vulgaris;
on wounds or damaged skin;
in the anal and genital areas;
in perioral dermatitis;
for prolonged periods;
in children under 2 years of age.

Warnings and precautions
Before starting to use Diprogenta, discuss this with your doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, discontinue use of Diprogenta and contact your doctor, who will initiate appropriate treatment.
Prolonged use of the medicine may lead to the growth of microorganisms resistant to gentamicin and other aminoglycoside antibiotics.
Cross-allergy to aminoglycoside antibiotics has been reported.
Diprogenta must not be used in or around the eyes or on mucous membranes.
Absorption of betamethasone dipropionate and gentamicin through the skin increases when occlusive dressings (e.g. diapers) are used.
When using the medicine, there is a risk of systemic adverse effects typical of corticosteroids (including suppression of adrenal cortex function) and of gentamicin (such as ototoxicity, nephrotoxicity, particularly in patients with impaired renal function).
Therefore, avoid using the medicine over large body surface areas, in high doses, or with occlusive dressings.
If blurred vision or other visual disturbances occur, contact your doctor.

Children and adolescents
Suppression of the hypothalamic-pituitary-adrenal axis after topical application of corticosteroids has been observed more frequently in children than in adults, due to increased absorption resulting from a higher skin surface area to body weight ratio.
In children treated with topical corticosteroids, cases of hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, growth retardation, reduced weight gain, and increased intracranial pressure (e.g. bulging fontanelle, headache) have been reported.

Diprogenta with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There are no data on the safety of using Diprogenta during pregnancy.
The medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the mother, fetus, or newborn.
The doctor will decide whether breastfeeding should be discontinued or treatment stopped, taking into account the benefits of treatment for the mother and the potential adverse effects in the infant.
During breastfeeding, Diprogenta should not be applied to the breast skin.
When using the medicine during breastfeeding, care should be taken to avoid contact of the medicine with the breast skin, in order to prevent accidental ingestion of the medicine by the infant and (or) accidental contact of the medicine with the infant's skin.

Driving and operating machinery
There are no available data on the effect of Diprogenta on the ability to drive or operate machinery.

3. How to use Diprogenta

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
This medicine is intended for topical use on the skin.
A thin layer of Diprogenta is usually applied to the affected areas and surrounding skin twice daily,
in the morning and evening.
For maintenance treatment in some patients, the doctor may decide on less frequent application.
The duration of treatment depends on the size and location of the lesions, as well as the patient's
response to therapy. If no improvement is observed after three to four weeks, the doctor will
re-evaluate 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 longer than 5 days.
Use of a higher than recommended dose of Diprogenta
If more than the recommended dose is used, consult your doctor or pharmacist immediately.
Excessive or prolonged use may suppress the hypothalamic-pituitary-adrenal (HPA) axis, lead to
secondary adrenal insufficiency, cause corticosteroid-like adverse effects including Cushing's syndrome,
and may promote the development of gentamicin-resistant bacterial strains as well as result in
ototoxicity and nephrotoxicity.
Missed dose of Diprogenta
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Very rare adverse reactions (occurring in less than 1 in 10,000 patients) have been observed during the use of Diprogenta; these include hypersensitivity and skin depigmentation.
Local application of corticosteroids, especially under occlusive dressings (e.g. diapers), has been associated with the following adverse reactions: burning sensation, itching, irritation, dryness of the skin, folliculitis, hypertrichosis, perioral dermatitis, skin depigmentation, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.
Hypersensitivity reactions may occur. If symptoms of hypersensitivity occur, treatment should be discontinued immediately and a doctor should be consulted.
Due to the presence of gentamicin in the medicine, skin irritation (erythema and itching) may occur, which usually does not require discontinuation of treatment.
Blurred vision has been reported during corticosteroid use (frequency unknown - cannot be estimated from available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse reactions enables continued monitoring of the safety of the medicine.

5. How to store Diprogenta

Store below 25°C 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 container. The expiry date refers to the last day of the stated month.
Expiry date after first opening – 3 months.
Medicines must 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 packaging and other information

What Diprogenta contains

The active substances in Diprogenta are betamethasone dipropionate and gentamicin. Each gram of ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) and 1 mg gentamicin (as gentamicin sulphate).
Other ingredients: liquid paraffin, white soft paraffin.

What Diprogenta looks like and contents of the packaging
Diprogenta is an ointment.
Available packaging: aluminium tube with a membrane and a cap made of HDPE with a piercing device, in a cardboard box containing 15 g of ointment.
For more detailed information, please contact the responsible entity or the parallel importer.
Responsible entity in Romania, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, country of export: 1788/2009/01
Parallel import authorization number: 97/19