Allertec Foxill

Leaflet attached to the packaging: patient information

ALLERTEC FOXILL, 1 mg/g, gel

Dimetindene maleate

Read the 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 according to
the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Allertec Foxill is a gel for topical use. Allertec Foxill contains the active substance dimetindene maleate, which inhibits the action of histamine - a substance responsible for allergic reactions.
The medicine acts locally as an antihistamine, strongly anti-itching (excluding cholestatic itching), reduces swelling, and soothes skin irritations. It has local anesthetic properties. It cools, which further soothes irritated skin.

Indications for use:

Itching associated with skin diseases, hives, insect bites, sunburn, superficial skin burns (first degree).

2. Important information before using Allertec Foxill

When not to use Allertec Foxill

• if the patient is allergic to dimetindene maleate or any of the other ingredients of this medicine (listed in section 6),

Warnings and precautions

Before starting to use Allertec Foxill, the patient should discuss it with their doctor or pharmacist.
In case of applying the Allertec Foxill gel to a large area of skin, the patient should avoid exposing the treated areas to sunlight.
The patient should inform their doctor in case of very strong itching or extensive changes.

Children

The use of Allertec Foxill should be avoided in infants and young children (under 2 years of age) on large areas of skin, especially in cases of injuries and skin inflammation.

Allertec Foxill and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

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.
During pregnancy and breastfeeding, the medicine should not be used on large areas of skin, especially in cases of injuries or skin inflammation.
During breastfeeding, the medicine should not be applied to the nipples.

Driving and using machines

Allertec Foxill does not affect the ability to drive or operate machines.

Allertec Foxill contains benzalkonium chloride and propylene glycol

The medicine contains 0.05 mg of benzalkonium chloride in each gram of gel. Benzalkonium chloride may irritate the skin.
Breastfeeding women should not apply this medicine to the breast skin, as it may be ingested by the child with breast milk.
The medicine contains 150 mg of propylene glycol in each gram of gel. Propylene glycol may cause skin irritation.
This medicine should not be used in children under 4 weeks of age on open wounds or large areas of damaged skin (e.g., burned) without consulting a doctor or pharmacist.

3. How to use Allertec Foxill

This medicine should always be used exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for topical use.
Usually, unless the doctor advises otherwise, the medicine should be applied 2 to 4 times a day, applying a thin layer of gel to the affected and itchy skin surface.

Use in children

The use of Allertec Foxill should be avoided in infants and young children (under 2 years of age) on large areas of skin (see section 2).

Using a higher dose of Allertec Foxill than recommended

No cases of dimetindene maleate overdose have been reported when used topically on the skin.
In case of ingestion, the patient should immediately contact their doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (cannot be estimated from the available data):

• skin burning sensation,
• skin dryness,
• skin allergic reactions including rash and skin itching.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they 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 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Allertec Foxill

The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Allertec Foxill contains

• The active substance of the medicine 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 what the packaging contains

Allertec Foxill is a colorless and homogeneous gel.
An aluminum tube with a membrane and a HDPE screw cap with a piercer, coated with an epoxy-phenolic lacquer, placed in a cardboard box.
Packaging sizes:
5 g, 20 g, 30 g, or 50 g of gel
Not all packaging sizes may be available.

Marketing authorization holder

Polpharma S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A. Pharmaceutical Works
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last update of the leaflet: