IMAZOL PLUS

Package leaflet: Information for the user

Imazol plus, (10 mg + 2.5 mg)/g, cream
Clotrimazolum + Hexamidini diisetionas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet:

1. What Imazol plus is and what it is used for
2. What you need to know 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 Imazol plus is and what it is used for

Imazol plus is a medicine indicated for the treatment of:

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

Fungal infections occur when there is excessive growth of fungi that are normally present on healthy skin. Skin reactions include burning, itching, scaling of the epidermis, and painful skin inflammation. Only a doctor can make a reliable diagnosis of dermatomycosis.

2. Important information before using Imazol plus

When not to use Imazol plus

• if the patient is allergic to clotrimazole, hexamidine diisethionate, or related active substances (amidines), or to any of the other ingredients of this medicine (listed in section 6).
• on the glans penis.

Warnings and precautions
Before starting to use Imazol plus, consult your doctor or pharmacist.
Imazol plus must not be applied to the skin around the eyes.
Due to limited clinical experience, the use of Imazol plus under an occlusive dressing (e.g. plasters, diapers) is not recommended.
If any signs of local or generalized hypersensitivity or local irritation occur, treatment with Imazol plus should be discontinued.
Children and adolescents
Imazol plus is indicated for use in adults, adolescents, and children from 1 month of age.
Imazol plus and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Imazol plus 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 on skin areas affected by fungal infection, consult your doctor, as there is a possibility that the efficacy of Imazol plus 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 plus may be used during pregnancy and breastfeeding only on the advice of the attending physician.
Breastfeeding mothers should not apply Imazol plus to the skin of the breasts or surrounding areas to avoid direct contact of the infant with Imazol plus.

3. How to use Imazol plus

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your 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 plus cream to the affected skin areas 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. Approximately 0.5 cm of cream is sufficient for an area of skin equal to the size of the palm of the hand.

Treatment duration:
Effective treatment depends on regular and sufficiently 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.
If symptoms worsen or there is no improvement after 7 days, consult a doctor.

Use in children and elderly patients:
No special dosage adjustments are required, as no increase or intensification of adverse effects has been observed with the use of Imazol plus.
There are no available data on the efficacy and safety of use in infants under 1 month of age.
Limited data are available on the efficacy and safety of use in elderly patients over 65 years of age.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Imazol plus can cause adverse reactions, although they do not occur in all patients.
Very rarely (may affect up to 1 in 10,000 patients), redness, burning sensation or stinging sensation, and contact dermatitis may occur.
According to post-marketing data, the following adverse reactions may occur with "Not known" frequency (frequency cannot be estimated from the available data): allergic dermatitis, contact dermatitis, rash, angioedema, erythema of genital organs, skin burning sensation, eruption, urticaria, and pruritus.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Imazol plus

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and tube end. The expiry date refers to the last day of the stated month.
• Store below 30°C.
• Shelf life after first opening of the container: 1 month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Imazol plus contains

• The active substances are: clotrimazole and hexamidine diisethionate. 1 g of cream contains 10 mg of clotrimazole and 2,5 mg of hexamidine diisethionate.
• Other components are: octyldodecanol, dimethicone 350 CST, mono- and diglycerides of palmitic and stearic acids, polyethylene glycol-5 stearyl stearate, macrogol stearate ether 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, opaque cream with a faint characteristic odour.
Imazol plus is available in tubes containing 30 g of cream, 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 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