Package leaflet: Information for the patient

ALLERTEC FOXILL, 1 mg/g, gel
Dimetindene maleate
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 doctor or pharmacist.

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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if your condition worsens, contact your doctor.

Table of contents

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

1. What Allertec Foxill is and what it is used for

Allertec Foxill is a topical gel. Allertec Foxill contains the active substance dimethindene maleate, which inhibits the action of histamine—a substance responsible for allergic reactions.
The medicine acts locally as an antiallergic and strongly antipruritic (except in cholestatic pruritus), reduces swelling, and soothes skin irritation. It exhibits local anesthetic properties. Its cooling effect additionally soothes irritated skin.
Indications:
Itching associated with skin diseases, urticaria, insect bites, sunburn, and superficial skin burns (first degree).

2. Important information before using Allertec Foxill

When not to use Allertec Foxill

if the patient is allergic to dimethindene maleate or any of the other ingredients of this medicine (listed in section 6),
in cases of second- and third-degree burns.

Warnings and precautions
Before starting to use Allertec Foxill, discuss it with your doctor or pharmacist.
When applying Allertec Foxill gel to large areas of skin, avoid exposing the treated areas to sunlight.
Inform your doctor if you experience severe itching or extensive skin lesions.
Children
Avoid use in infants and young children (under 2 years of age) on large skin areas, especially in cases of skin injuries or inflammatory skin conditions.
Allertec Foxill and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, do not apply the medicine to large skin areas, especially in cases of skin injuries or inflammatory skin conditions.
During breastfeeding, do not apply the medicine to the nipples.
Driving and operating machinery
Allertec Foxill has no effect on the ability to drive or operate machinery.
Allertec Foxill contains benzalkonium chloride and propylene glycol
The medicine contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may cause skin irritation.
Breastfeeding women should not use this medicine on the breast skin, as it may be ingested by the infant through breast milk.
The medicine contains 150 mg of propylene glycol per gram of gel. Propylene glycol may cause skin irritation.
Do not use this medicine in children under 4 weeks of age on open wounds or large areas of injured or damaged skin (e.g., burned skin) without consulting a doctor or pharmacist.

3. How to use Allertec Foxill
Always use this medicine exactly as described in this patient leaflet or as instructed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for topical use on the skin.
Usually, unless otherwise advised by a doctor, apply the gel 2 to 4 times daily, spreading a thin layer over the affected, itchy skin area.
Use in children
Avoid use in infants and young children (under 2 years of age) on large skin areas (see section 2).
Overdose of Allertec Foxill
No cases of overdose have been reported with topical dimethindene maleate applied to the skin.
If the medicine is swallowed, contact a doctor immediately.

4. Possible adverse reactions

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

skin burning sensation,
dry skin,
skin allergic reactions including rash and itching.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: + 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 provide more information on the safety of this medicine.

5. How to store ALLERTEC FOXILL

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Allertec Foxill contains

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

What Allertec Foxill looks like and contents of the pack
Allertec Foxill is a clear, homogeneous gel.
Aluminium tube with a membrane and a screw cap made of HDPE, equipped with a piercing device, internally coated with epoxy-phenolic varnish, placed in a cardboard box.
Pack sizes:
5 g, 20 g, 30 g or 50 g of gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Tel.: +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz