DIPROGENTA

Package leaflet: Information for the patient

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 this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, 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 adverse reactions
5. How to store Diprogenta
6. Contents of the package and other information

1. What is Diprogenta and what is it used for

The therapeutic properties of Diprogenta result from the action of its active substances: betamethasone dipropionate and gentamicin (as gentamicin sulfate).
Betamethasone dipropionate belongs to a class of drugs known as corticosteroids with potent activity. When applied topically, it exerts rapid and long-lasting anti-inflammatory, antipruritic, and vasoconstrictive effects.
Gentamicin is an aminoglycoside antibiotic with broad-spectrum antibacterial activity.
Indications
Diprogenta ointment for topical application is indicated for symptomatic treatment of inflammatory skin lesions responsive to corticosteroids, complicated by secondary infections caused by microorganisms sensitive to gentamicin.
Such conditions include: psoriasis, contact dermatitis (toxic dermatitis), atopic dermatitis (infantile eczema, allergic dermatitis), neurodermatitis (lichen simplex chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), dermatitis, burns, sunburn, dyshidrosis (acute vesicular dyshidrosis of hands and feet), seborrheic dermatitis, exfoliative dermatitis, solar dermatitis, stasis dermatitis.
Bacteria sensitive to gentamicin include strains of streptococci (group A: β-haemolytic, α-haemolytic), 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 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 long-term use;
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with 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 development of microbial strains resistant to gentamicin and other aminoglycoside antibiotics.
Cross-allergy to aminoglycoside antibiotics has been reported.
Diprogenta must not be used in the eyes or around the eyes, or on mucous membranes.
Skin absorption of betamethasone dipropionate and gentamicin increases when occlusive dressings (e.g. diapers) are used.
During treatment, there is a risk of systemic adverse effects typical of corticosteroids (including suppression of hypothalamic-pituitary-adrenal axis function) and of gentamicin (such as ototoxicity, nephrotoxicity, particularly in patients with impaired renal function).
Therefore, avoid using the medicine over large areas of the body, in high doses, or with occlusive dressings.
If the patient experiences blurred vision or other visual disturbances, consult a doctor.

Children and adolescents
In children, suppression of the hypothalamic-pituitary-adrenal axis has occurred more frequently than in adults after topical corticosteroid use, 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
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for 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 available 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 to discontinue breastfeeding or to discontinue/abstain from administering the medicine, 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 skin of the breasts.
If Diprogenta is used during breastfeeding, care should be taken to avoid contact of the medicine with the skin of the breasts, 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 recommended by the doctor. In case of doubt, consult
your doctor or pharmacist.
This medicine is 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, the doctor may decide on less frequent use in some patients.
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 occurs after three to four weeks, the doctor will reassess 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 of this medicine may suppress the hypothalamic-pituitary-adrenal axis,
lead to secondary adrenal insufficiency, cause corticosteroid-related adverse effects including Cushing's syndrome,
and may promote the development of gentamicin-resistant bacterial strains as well as result in hearing and kidney damage.

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 everyone will experience them.
Very rare adverse reactions (in less than 1 patient per 10,000) have been observed during the use of Diprogenta; these include hypersensitivity and skin depigmentation.

When corticosteroids are used topically, especially under occlusive dressings (e.g. diapers), the following adverse reactions have been observed: burning sensation, itching, irritation, dry skin, folliculitis, excessive hair growth, steroid acne, skin depigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, and miliaria.

Signs of hypersensitivity may occur. If symptoms of hypersensitivity occur, treatment should be stopped 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 observed during corticosteroid use (frequency unknown – cannot be estimated based on available data).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 continuous monitoring of the benefit-risk balance of the medicine and helps to gather additional information on its safety.

5. How to store Diprogenta

Store below 25°C in the original packaging.
Keep the medicine out of sight and reach of children.
Shelf life after first opening of the immediate packaging: 3 months.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Diprogenta contains

• The active substances in the medicine 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).
• The other ingredients are: liquid paraffin, white soft paraffin.

What Diprogenta looks like and contents of the pack
Diprogenta is an ointment.
Pack size available:
Aluminium tube with membrane and cap made of HDPE with puncture device, containing 15 g of ointment, in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Romania, country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Office 306 and Office 307, Floor 3, Sector 1, Bucharest, Romania
Manufacturer:
Organon Heist bv
Industriepark 30, 2220 Heist-op-den-Berg, Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in Romania, country of export: 1788/2009/01
Parallel import licence number: 740/15