DIPROGENTA

PACKAGE LEAFLET: 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
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 give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Diprogenta is and what it is 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 Diprogenta is and what it is used for

The therapeutic effects of Diprogenta result from the action of its active ingredients: betamethasone dipropionate and gentamicin.
Betamethasone dipropionate belongs to a group of medicines called corticosteroids with potent 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 in the symptomatic treatment of corticosteroid-responsive inflammatory skin conditions 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 eczema, eczematous dermatitis), dermatitis, burns, acute dyshidrotic vesicular eruption of the palms and soles (dyshidrosis), seborrheic dermatitis, exfoliative dermatitis, sunburn, and venous 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 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 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 to use Diprogenta, discuss it with your doctor or pharmacist.
If irritation, hypersensitivity, 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 microorganisms resistant to gentamicin and other aminoglycoside antibiotics.
Cross-allergies to aminoglycoside antibiotics have been reported.
Diprogenta must not be used in the eyes 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.
During treatment, 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 areas of the body, in high doses, or with occlusive dressings.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children and adolescents
In children, suppression of the hypothalamic-pituitary-adrenal axis after topical corticosteroid use occurs more frequently 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
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 to discontinue breastfeeding or discontinue the medicine, taking into account the benefits of treatment for the mother and the potential adverse effects on the child.
During breastfeeding, Diprogenta should not be applied to the breast skin.
When using the medicinal product during breastfeeding, care should be taken to avoid contact of the product with the breast skin, to prevent accidental ingestion 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 or operate machinery.

3. How to use Diprogenta

This medicine should always be used as directed by a physician. In case of doubt, consult a doctor or pharmacist.
This medicine is intended for topical use only.
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 physician may decide on less frequent application 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 physician 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
In case of application of a higher than recommended dose, seek immediate advice from a doctor or pharmacist.
Excessive or prolonged use may suppress the hypothalamic-pituitary-adrenal axis, lead to secondary adrenal insufficiency, cause corticosteroid-type adverse effects including Cushing's syndrome, and may promote the development of gentamicin-resistant bacterial strains as well as cause 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 doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Very rare adverse reactions (in less than 1 in 10,000 patients) have been observed during the use of Diprogenta; these include hypersensitivity and skin discoloration.
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 discoloration, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae and sweating.
Hypersensitivity reactions 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 determined from 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diprogenta

Store below 25°C in the original packaging.
Keep the medicine 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 stated month.
The expiry date expires 3 months after first opening the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Diprogenta contains

• The active substances in this 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).
• Other ingredients: liquid paraffin, white soft paraffin.

What Diprogenta looks like and contents of the pack
Diprogenta is an ointment.
Available pack:
Aluminium tube with a membrane, with a screw cap made of HDPE with a piercing device, in a cardboard box containing 15 g.
For more detailed information, please contact the responsible entity or the parallel importer.

Marketing Authorisation Holder in Romania, 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
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Romania, country of export: 1788/2009/01
Parallel Import Authorisation Number: 433/22