Imazol

Leaflet attached to the packaging: information for the user

Imazol, 10 mg/g, skin paste

Clotrimazole

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days (in the case of diaper rash after 3 days) there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Imazol and what is it used for

Imazol is a medicine intended for the treatment of

• fungal infections (mycoses) susceptible to clotrimazole treatment (e.g., diaper rash caused by yeast).

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

2. Important information before using Imazol

When not to use Imazol

• if the patient is allergic to clotrimazole, cetyl alcohol, the preservative butylhydroxyanisole, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Imazol, the patient should discuss it with their doctor or pharmacist.
In case the patient is allergic to cetyl alcohol, it is recommended to use a product that does not contain cetyl alcohol instead of Imazol (see section "Imazol contains cetyl alcohol and butylhydroxyanisole").
Polysorbate 20 may cause skin changes, such as pathological skin reactions (e.g., contact dermatitis).
In case of any signs of local or generalized hypersensitivity or local irritation, the use of Imazol should be stopped.
Do not use on open wounds or mucous membranes.

Children and adolescents

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

Imazol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.
Imazol 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 patient should consult their doctor, as it cannot be ruled out that the effectiveness of Imazol may be reduced.

Pregnancy and breastfeeding

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

Imazol contains cetyl alcohol and butylhydroxyanisole.

Cetyl alcohol may cause local skin reactions (e.g., contact dermatitis).
Butylhydroxyanisole may cause local skin reactions (e.g., contact dermatitis), eye irritation, and mucous membrane irritation.

3. How to use Imazol

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

• Apply a small amount of Imazol to the affected skin area once or twice a day - in the morning, or in the morning and evening.
• Spread the paste 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 paste is sufficient. Duration of treatment:Regular use of the paste for a sufficient period is crucial for the success of the treatment. The treatment should not be stopped after the inflammation and other symptoms have subsided, but the paste should be continued for at least 3 weeks. In the case of diaper rash, some improvement in symptoms should occur within 3 days. The treatment should be continued for a total of 7 days. If the symptoms worsen or do not improve after 3 days, the patient should contact their doctor.

If the symptoms worsen or do not improve after 7 days, the patient should contact their doctor.

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

4. Possible side effects

Like all medicines, Imazol can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people) side effects may include redness, burning, and a feeling of burning.
In case of hypersensitivity to the active substance or any of the other ingredients of Imazol, allergic reactions may occur (see section 2 "Imazol contains cetyl alcohol and butylhydroxyanisole").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. 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 By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Imazol

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and tube cap. The expiry date refers to the last day of the month stated.
• There are no special storage instructions for the medicine.
• Shelf life after first opening the packaging: 1 month.
• Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Imazol contains

• The active substance is: clotrimazole. 1 g of skin paste contains 10 mg of clotrimazole.
• The other ingredients are: phenylethyl alcohol, butylhydroxyanisole (E320), titanium dioxide (E171), liquid paraffin, octyldodecanol, cetyl alcohol, glycerol monostearate 40-55, polysorbate 20, disodium edetate, purified water.

What Imazol looks like and what the packaging contains

Imazol is a white, non-transparent paste with a characteristic odor.
Imazol is available in tubes containing 30 g of skin paste 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 Paste, 10mg/g Paste for cutaneous use
Austria
Imazol 10 mg/g Paste for cutaneous use
Estonia
Imazol, 10 mg/g skin paste
Hungary
ImaMono 10 mg/g external paste
Poland
Imazol, 10 mg/g, skin paste
Date of last revision of the leaflet:03.06.2024