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, cream
Betamethasone dipropionate + Gentamicin
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, 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 someone else, even if their symptoms are similar.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 group of 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 cream for topical use is indicated for 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), impetigo, burns, acute dyshidrotic eruption of the palms and soles (dyshidrosis), seborrheic dermatitis, exfoliative dermatitis, sunburn-induced dermatitis, and venous stasis-related purpura.

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 to any of the other components 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 treatment with Diprogenta, consult a doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, discontinue use of Diprogenta and contact your doctor, who will initiate appropriate therapy.
Prolonged use of the medicine may lead to the overgrowth of microorganisms resistant to gentamicin and other aminoglycoside antibiotics.
Cross-allergy to aminoglycoside antibiotics has been reported.
Diprogenta must not be used in the eyes, 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 hearing and kidney damage, especially in patients with impaired kidney function).
Therefore, the medicine should not be used over large areas of the body, in high doses, or under occlusive dressings.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
Children and adolescents
Suppression of the hypothalamic-pituitary-adrenal (HPA) axis after topical application of corticosteroids occurs 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, suppression of the hypothalamic-pituitary-adrenal axis, 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 any other medicines the patient is currently taking, has recently taken, or might take in the future.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a 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 potential risk to the mother, fetus, or newborn.
The doctor will decide whether breastfeeding should be discontinued or treatment stopped, taking into account the benefit of therapy for the mother and the potential adverse effects in the infant.
During breastfeeding, Diprogenta should not be applied to the breast skin.
When using Diprogenta during breastfeeding, care should be taken to avoid contact of the medicine with the breast skin, in order to prevent accidental ingestion by the infant and (or) accidental contact with the infant's skin.
Driving and operating machinery
There are no available data on the effect of Diprogenta on the ability to drive vehicles or operate machinery.
Diprogenta cream contains cetostearyl alcohol and chlorocresol
Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g. contact dermatitis). Due to the presence of chlorocresol, the medicine may cause allergic reactions.

3. How to use Diprogenta

This medicine should always be used as directed by the physician. In case of doubts, consult a doctor or pharmacist.
This medicine is intended for topical use on the skin.
A thin layer of Diprogenta is usually applied to affected areas and surrounding skin twice daily, in the morning and evening.
In maintenance therapy, the physician may decide on less frequent application in some patients.
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 physician 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 larger than recommended dose of Diprogenta
If a larger than recommended dose is used, seek immediate medical advice from a doctor or pharmacist.
Excessive or prolonged use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis, secondary adrenal insufficiency, corticosteroid-like 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.
In case of any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
During the use of Diprogenta, adverse reactions have been very rarely observed (less frequently than in 1 patient out of 10,000); 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, dryness of the skin, folliculitis, excessive hair growth, steroid acne, skin depigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, and hypertrichosis.
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 reported during the use of corticosteroids (frequency unknown – cannot be estimated based on available data).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department for Monitoring Adverse Drug Reactions, 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 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 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.
After first opening the tube, the medicine should be used within 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Diprogenta contains

The active substances in Diprogenta are betamethasone dipropionate and gentamicin. Each gram of cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) and 1 mg (1000 IU) gentamicin (as gentamicin sulphate).
Other ingredients are: chlorocresol, disodium dihydrogen phosphate dihydrate, phosphoric acid, liquid paraffin, cetostearyl alcohol, cetostearyl macrogol ether, white soft paraffin, sodium hydroxide, purified water.

What Diprogenta looks like and contents of the pack
Diprogenta is a cream.
Diprogenta is available in an aluminium tube containing 15 g of cream.
For more detailed 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
Birou 306 și Birou 307 Etaj 3, Sectorul 1, Bucharest, Romania
Manufacturer:
Schering-Plough Labo NV
Industriepark 30
B-2220 Heist-op-den-Berg
Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Romania, country of export: 1789/2009/01
Parallel import authorisation number: 370/17