Imazol plus

Package Leaflet: Information for the User

Imazol plus, (10 mg + 2.5 mg)/g, cream

Clotrimazole + Hexamidine diisethionate

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

• This leaflet should be kept, so that it can be read again if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 7 days there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet:

• 1. What is Imazol plus and what is it used for
• 2. Important information before using Imazol plus
• 3. How to use Imazol plus
• 4. Possible side effects
• 5. How to store Imazol plus
• 6. Contents of the pack and other information

1. What is Imazol plus and what is it used for

Imazol plus is a medicine indicated for the treatment of:

• skin infections caused by fungi (mycoses) sensitive to clotrimazole treatment with accompanying bacterial superinfections, for which hexamidine is recommended (e.g., fungal infections between the toes and fingers, known as interdigital mycoses).

Fungal infections occur when there is an excessive growth of fungi that also occur on healthy skin. Skin reactions include burning, itching, peeling, and painful skin inflammation. A reliable diagnosis of mycosis can only be made by a doctor.

2. Important information before using Imazol plus

When not to use Imazol plus

• on the glans penis.

Warnings and precautions

Before starting to use Imazol plus, the doctor or pharmacist should be consulted. Imazol plus should not be used on the skin around the eyes. Due to limited clinical experience, it is not recommended to use Imazol plus under a dressing that prevents air from reaching the skin (e.g., patches, diapers). If any symptoms of local or generalized hypersensitivity or local irritation occur, the use of the medicine should be stopped.

Children and adolescents

Imazol plus is indicated for use in adults, adolescents, and children from 1 month of age.

Imazol plus and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any medicines planned to be used. Imazol plus reduces the effectiveness of certain antibiotics (amphotericin and other polyene antibiotics, such as nystatin and natamycin).

Avoid using cosmetics

Before using any deodorant or other cosmetics on the skin area affected by the fungal infection, the doctor should be consulted, as it cannot be ruled out that the effectiveness of Imazol plus may be reduced.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Imazol plus may be used during pregnancy and breastfeeding only on the advice of the attending doctor. Breastfeeding mothers should not use Imazol plus on the breast skin and surrounding skin to prevent direct contact between the child and Imazol plus.

3. How to use Imazol plus

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted. Unless the doctor has prescribed otherwise, the medicine should be used according to the following instructions:

• A small amount of Imazol plus should be applied to the affected skin area once or twice a day - in the morning, or in the morning and evening.
• The cream should be spread slightly beyond the edges of the affected skin area. For an area of skin the size of the palm of the hand, about 0.5 cm of cream is sufficient.

Duration of treatment:
The regular use of the cream for a sufficient period is crucial for the effectiveness of the treatment. The treatment should not be stopped after the inflammation and other symptoms have subsided, but the cream should be continued for at least 3 weeks.

If the symptoms worsen or do not improve after 7 days, a doctor should be consulted.

Use in children and elderly patients:
No special use is required, as there is no evidence of increased or enhanced side effects after using Imazol plus. There are no available data on the efficacy and safety of use in infants under 1 month of age. There are limited data on the efficacy and safety of use in people over 65 years of age. If there are any further questions about using the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Imazol plus can cause side effects, although not everybody gets them. Very rarely (may affect up to 1 in 10,000 patients), redness, burning, or a feeling of burning, as well as contact dermatitis, may occur. Post-marketing data indicate that the following side effects may occur with an "unknown" frequency (frequency cannot be estimated from the available data): allergic contact dermatitis, contact dermatitis, rash, mucosal edema, erythema of the genital area, skin burning sensation, rash, urticaria, and itching.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C, PL-02-222 Warsaw Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Imazol plus

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the carton and tube. The expiry date refers to the last day of the month stated.
• Store at a temperature below 30°C.
• Shelf life after first opening the package: 1 month.
• Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Imazol plus contains

• The active substances of the medicine are clotrimazole and hexamidine diisethionate. 1 g of cream contains 10 mg of clotrimazole and 2.5 mg of hexamidine diisethionate.
• The other ingredients are octyldodecanol, dimethicone 350 CST, mono- and diglycerides of palmitic and stearic acid, polyethylene glycol-5-stearyl ether stearate, macrogol ether stearate 20, glacial acetic acid, anhydrous sodium acetate, purified water.

What Imazol plus looks like and contents of the pack

Imazol plus is a white, homogeneous, non-transparent cream with a weak characteristic odor. Imazol plus is available in tubes containing 30 g of cream, in a cardboard box.

Marketing authorization holder

Laboratoires Bailleul S.A. 14-16 Avenue Pasteur L-2310 Luxembourg LUXEMBOURG

Manufacturer

Thepenier Pharma & Cosmetics Route Départementale 912 61400 Saint-Langis Les Mortagne FRANCE

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Germany Imazol Creme plus Austria Imazol duo 10 mg/g + 2.5 mg/g Creme Estonia Imazol plus 10 mg/2.5 mg/g cream Hungary ImaDuo 10 mg/g + 2.5 mg/g krém Poland Imazol Plus

Date of last revision of the leaflet: 03.06.2024