Iczill

Package leaflet: information for the patient

Iczill, 1 mg/g, gel
Dimetindene maleate
For adults, adolescents and children aged 1 month and older
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 7 days of treatment (2 days in children), consult your doctor.

Leaflet contents:

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

1. What Iczill is and what it is used for

Iczill contains the active substance dimetindene maleate, which has antihistaminic properties.
Histamine is a substance released in the body upon contact with an allergen and causes allergic reactions. Iczill is an antiallergic medicine for topical treatment and relief of itching in adult, adolescent and pediatric patients aged 1 month and older.
Iczill is used for short-term relief of itching caused by minor, itchy insect bites on intact skin. Itching associated with skin disorders such as chronic eczema, urticaria, and other allergic skin conditions; itching due to first-degree burns and sunburn.
If there is no improvement or if symptoms worsen after 7 days of treatment (2 days in children), consult your doctor.

2. Important information before using Iczill medicine

When not to use Iczill

• if the patient is allergic to dimethindene maleate or any of the other ingredients of this medicine (listed in section 6)
• in infants under 1 month of age, particularly in premature infants
• when applied over large areas of skin
• on damaged skin
• on wounded skin

Warnings and precautions
Before starting to use Iczill, discuss it with your doctor or pharmacist.
Do not apply over large areas of skin. Avoid prolonged exposure of treated areas to direct sunlight.
Iczill is not intended for use on large, particularly damaged or inflamed areas of skin; this especially applies to infants and young children.
Inform your doctor about very severe itching or extensive skin diseases.
Systemic dosage forms are available for the treatment of diagnosed insect venom allergy.

Children
Iczill must not be used in children under 1 month of age.
It must not be applied over large areas of skin in infants from 1 month of age onwards and in young children.

Iczill and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions with other medicines are expected when the medicine is used according to recommendations.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, Iczill must not be used over large areas of skin, especially in cases of skin damage or inflammatory conditions.
This medicine should not be applied to the breasts or nipples during breastfeeding.

Driving and operating machinery
Iczill has no effect or has negligible effect on the ability to drive and operate machinery.

Iczill contains propylene glycol and benzalkonium chloride
Iczill contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may cause skin irritation. Breastfeeding women should not apply this medicine to the breast area, as it may be ingested by the infant with breast milk. This medicine is not intended for use on mucous membranes.
Iczill contains 150 mg of propylene glycol per gram of gel.
Propylene glycol may cause skin irritation.

3. How to use Iczill

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Iczill is intended for topical use and should be applied in a thin layer to the affected, itchy area up to 3 times daily. During application, do not press or scratch the skin. The medicine should be applied only to intact skin and must not be applied to open wounds.
If you feel that the effect of Iczill is too strong or too weak, consult a doctor or pharmacist.
Method of administration
For topical use. Gently rub in the gel.
Do not use bandages.
Consult a doctor if there is no improvement after 7 days or if symptoms worsen.
Do not use the medicine for longer than 7 days without medical advice.
Use in children
Do not use on large areas of skin in infants from 1 month of age and older, and in young children.
Iczill must not be used in children under 1 month of age.
Iczill should be used under medical supervision in children from 1 month to 2 years of age.
Use of a higher than recommended dose of Iczill
If too much gel has been applied, wipe off the excess with a tissue.
If Iczill is accidentally swallowed by the patient or their child, contact a doctor immediately.
In case of intentional or accidental overdose, contact a doctor or pharmacist immediately so that they can assess the degree of overdose and determine any necessary actions.
Missed dose of Iczill
Do not use a double dose to make up for a missed dose.
Stopping treatment with Iczill
If treatment is interrupted or the gel is discontinued prematurely, the desired effect may not be achieved or the patient's condition may worsen again. If the patient wishes to stop treatment, they should consult a doctor or pharmacist.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Frequency unknown (cannot be estimated from available data):

• skin burning sensation, dry skin, skin allergic reactions

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 of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Iczill

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and tube after:
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Shelf-life after first opening of the tube: 1 year.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Iczill contains

• The active substance is dimetindene maleate. Each gram of gel contains 1 mg of dimetindene maleate.
• The other components are: purified water, propylene glycol, carbomer (type 974P), sodium hydroxide 30%, disodium edetate, benzalkonium chloride.

What Iczill looks like and contents of the pack
Iczill is a homogeneous, colorless and odorless gel.
Aluminium tube with a membrane, internal coating made of epoxy-phenolic lacquer, and a white cap made of high-density polyethylene.
Pack sizes: 30 g or 50 g of gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
tel: +48 22 855 40 93
Manufacturer
Galenica Pharmaceutical Industry S.A.
Asklipiou 4-6
145 68 Kryoneri (Attiki)
Greece
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Dimetinden Aristo 1 mg/g Gel
Poland Iczill 1 mg/g gel