Diprogenta

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Diprogenta, (0.64 mg + 1 mg)/g, cream
Betamethasoni dipropionas + Gentamicinum
Please read the entire 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 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

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 pack and other information

1. What Diprogenta is and what it is used for

The therapeutic properties of Diprogenta result from the action of its active substances: 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 a broad spectrum of antibacterial activity.
Indications
Diprogenta cream for topical use is indicated in the 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 (chronic simplex lichen), flat lichen, eczema (including nummular eczema, hand eczema, eczematous dermatitis), dermatitis due to insect bites, burns, sunburn, acute vesicular dyshidrosis of the palms and soles (dyshidrotic eczema), seborrheic dermatitis, exfoliative dermatitis, radiation-induced dermatitis, and venous stasis 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 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 prolonged periods;
• 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 a 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, 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 this medicine, there is a risk of systemic adverse effects typical of corticosteroids (including suppression of adrenal cortex function) and of gentamicin (such as ototoxicity and nephrotoxicity, especially in patients with impaired renal function). Therefore, avoid applying the medicine over large areas of the body, using high doses, or applying 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 (HPA) axis after topical application of corticosteroids 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 HPA 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 future 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are no data on the safety of using this medicine in pregnant women.
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 infant.
During breastfeeding, do not apply the medicine to the skin of the breasts.
When using this medicinal product during breastfeeding, care must be taken to ensure that the product does not come into contact with the breast skin, in order to avoid accidental ingestion 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.

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 a physician. If in 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 therapy, the doctor may decide to reduce the frequency of 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 is observed 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 a doctor or pharmacist immediately.
Excessive or prolonged use may suppress the hypothalamic-pituitary-adrenal axis, cause secondary adrenal insufficiency,
and lead to corticosteroid-like adverse effects, including Cushing's syndrome. It may also promote the emergence of gentamicin-resistant bacterial strains and 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 regarding 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 gets them.
During the use of Diprogenta, adverse reactions have been very rarely observed (less frequently than in 1 patient per 10,000); 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, dryness of the skin, folliculitis, excessive hair growth, steroid acne, skin discoloration, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, and sweating.
Hypersensitivity symptoms may occur. If hypersensitivity symptoms occur, treatment should be stopped immediately and a doctor should be contacted.
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 the use of corticosteroids (frequency unknown – cannot be estimated based on available data).
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 4921301, Fax: +48 22 4921309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows more information on the safety of the medicine to be collected.

5. How to store Diprogenta

Store below 25°C. Keep in the original packaging.
The medicine should be stored out of sight and reach of children.
Period of validity after first opening of the tube: 3 months.
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.
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 packaging and other information

What Diprogenta contains

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

What Diprogenta looks like and contents of the pack
Diprogenta is a cream.
Pack sizes available:
Aluminium tube with membrane and HDPE cap, in a cardboard box containing 15 g of cream.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, country of export:
Organon Bioscences S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Office 306 and Office 307, Floor 3, Sectorul 1
Bucharest
Romania
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den Berg
Belgium
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing Authorisation number in Romania, country of export: 1789/2009/01
Parallel Import Licence number: 193/23