Patient Information Leaflet

Imazol, 10 mg/g, cream for skin use
Clotrimazolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days of treatment (in the case of diaper dermatitis after 3 days), or if your condition worsens, you should contact your doctor.

Leaflet contents:

What Imazol is and what it is used for
Important information before using Imazol
How to use Imazol
Possible side effects
How to store Imazol
Contents of the pack and other information

1. What Imazol is and what it is used for

Imazol is a medicine intended for the treatment of

fungal infections (mycoses) susceptible to clotrimazole treatment (e.g. diaper dermatitis caused by Candida yeasts).

Fungal infections occur when fungi, normally present on healthy skin, multiply excessively. Skin reactions include burning, itching, scaling of the epidermis, and painful skin inflammation. Only a doctor can reliably diagnose a fungal infection.

2. Important information before using Imazol

When not to use Imazol

if the patient is allergic to clotrimazole, cetostearyl alcohol, the preservative butylhydroxyanisole, polysorbate 20, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Imazol, discuss this with your doctor or pharmacist.
If the patient is allergic to cetostearyl alcohol, it is recommended to use an alternative product not containing cetostearyl alcohol (see section "Imazol contains cetostearyl alcohol, butylhydroxyanisole and polysorbate 20").
If any signs of local or generalized hypersensitivity or local irritation occur, discontinue use of Imazol immediately.
Do not apply to open wounds or mucous membranes.

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

Other medicines and Imazol
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.
Imazol may reduce the effectiveness of certain antibiotics (amphotericin and other polyene antibiotics such as nystatin and natamycin).

Avoid using cosmetics
Before using any deodorant or other cosmetic products on skin areas affected by fungal infection, consult your doctor, as there is a possibility that the effectiveness of Imazol may be reduced.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult her doctor or pharmacist before using this medicine.
Imazol may be used during pregnancy and while breastfeeding only on the advice of the attending physician.
Breastfeeding mothers should not apply Imazol to the skin of the breast or surrounding areas to avoid direct contact of the infant with Imazol.

Imazol contains cetostearyl alcohol, butylhydroxyanisole and polysorbate 20
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Butylhydroxyanisole may cause local skin reactions (e.g. contact dermatitis), eye irritation and irritation of mucous membranes.
Polysorbates may cause allergic reactions.

3. How to use Imazol

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Unless otherwise prescribed by a doctor, this medicine should be used according to the following instructions:

Apply a small amount of Imazol cream to the affected areas of skin once or twice daily – in the morning, or in the morning and evening.
Spread the cream slightly beyond the edges of the infected skin areas. For an area of skin equal to the size of the palm of the hand, approximately 0.5 cm of cream is sufficient. Duration of treatment: Successful treatment depends on regular and prolonged use of the cream. Do not stop treatment once inflammation and other symptoms have subsided; continue using the cream for at least 3 weeks. In cases of diaper dermatitis, some improvement of symptoms should occur within 3 days. Treatment should be continued for a total of 7 days. If symptoms worsen or no improvement occurs after 3 days, consult a doctor.

If symptoms worsen or no improvement occurs after 7 days, consult a doctor.
Use in children and elderly patients:
No special dosage adjustment is required, as there has been no observed increase or worsening of adverse effects with the use of Imazol.
There are no available data on the efficacy and safety of use in infants under 1 month of age.
Limited data are available regarding the efficacy and safety of use in elderly patients over 65 years of age.
For any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Imazol can cause adverse reactions, although not everybody experiences them.
Uncommon (may affect up to 1 in 100 patients) adverse reactions may include redness, burning sensation, and stinging.
In case of hypersensitivity to the active substance or to any of the other ingredients of Imazol, allergic reactions may occur.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Imazol

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the end of the tube. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Shelf life after first opening the container: 1 month.
Medicines should 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 pack and other information

What Imazol contains

The active substance is: clotrimazole. 1 g of topical paste contains 10 mg of clotrimazole.
Other ingredients are: phenylethyl alcohol, butylhydroxyanisole (E 320), titanium dioxide (E 171), liquid paraffin, octyldodecanol, cetostearyl alcohol, glycerol monostearate 40-55, polysorbate 20 (E 432), disodium edetate, purified water.

What Imazol looks like and contents of the pack
Imazol is a white, opaque paste with a characteristic odour.
Imazol is available in tubes containing 30 g of topical paste, packed in a cardboard box.

Marketing Authorisation 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 authorised for sale in the European Economic Area countries under the following names:
Germany Imazol Paste, 10mg/g Paste zur Anwendung auf der Haut
Austria Imazol 10 mg/g Paste zur Anwendung auf der Haut
Estonia Imazol, 10 mg/g nahapasta
Hungary ImaMono 10 mg/g külsőleges paszta
Poland Imazol, 10 mg/g, pasta na skórę