Patient Information Leaflet

Warning! Keep this leaflet! The packaging information in a foreign language.
Fenistil, 1 mg/g (0,1%) gel
Dimetindene maleate
Please read this 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, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 days of using the product in children and 7 days in adults, or if the patient feels worse, consult a doctor.

Table of contents:

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

1. What Fenistil is and what it is used for

Fenistil is a topical gel. Fenistil contains the active substance dimetindene maleate, which inhibits the action of histamine – a substance responsible for allergic reactions. When applied to the skin, Fenistil acts locally as an antiallergic agent, strongly counteracts itching (except cholestatic pruritus), reduces swelling, and soothes skin irritation.
It has local anaesthetic properties. It provides a cooling effect, which additionally soothes irritated skin.

Indications:
Itching associated with skin disorders, urticaria, insect bites, sunburn, superficial skin burns (first degree).
If there is no improvement after 2 days of using the product in children and 7 days in adults, or if the patient feels worse, consult a doctor.

2. Important information before using Fenistil

When not to use Fenistil

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

Warnings and precautions

When applying Fenistil over a large skin surface, avoid exposing the treated areas to sunlight.
Inform your doctor in case of severe itching or extensive skin lesions.
If there is no improvement within 2 days of using the medicinal product in children or within 7 days in adults, or if the patient feels worse, consult a doctor.

Before starting to use Fenistil, discuss it with your doctor, pharmacist, or nurse.
Keep the medicine out of sight and reach of children.

Children
Avoid using the medicine on large areas of skin in young children, especially in cases of wounds, burns, or inflammatory skin conditions.

Fenistil 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.

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 a doctor or pharmacist before using this medicine.
Do not use the medicine on large areas of skin, especially if the skin is wounded or inflamed.
During breastfeeding, do not apply the medicine to the nipples.
Breastfeeding women should not apply this medicine to the skin of the breasts, as it may be ingested by the child with breast milk.

Driving and operating machinery
Fenistil applied to the skin has no influence on the ability to drive or operate machinery.

Fenistil contains benzalkonium chloride
Fenistil contains 0.05 mg of benzalkonium chloride per gram of gel.
Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes.
Breastfeeding women should not apply this medicine to the skin of the breasts, as it may be ingested by the child with breast milk (see "Pregnancy and breastfeeding").

Fenistil contains propylene glycol
Fenistil contains 150 mg of propylene glycol per gram of gel.
Propylene glycol may cause skin irritation. Due to the presence of propylene glycol, the medicine should not be used on open wounds or large areas of wounded or damaged skin (e.g. burned skin) without consulting a doctor or pharmacist.

3. How to use Fenistil

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
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, diseased, and itchy areas of skin.
Use of more than the recommended dose of Fenistil
There have been no reported cases of overdose with Fenistil gel when applied topically to the skin.
If the medicine is swallowed, contact a doctor immediately.
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.
Missed dose of Fenistil
Do not apply a double dose to make up for a missed application.

4. Possible adverse reactions

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

Dry skin.
Skin burning sensation.
Skin allergic reactions including rash and itching.

Reporting of adverse reactions
If any adverse reactions occur, including any possible 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Fenistil

Do not store above 25°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Fenistil contains

The active substance is dimetindene maleate. One gram of gel contains 1 mg (0.1%) of dimetindene maleate.
Other ingredients are: benzalkonium chloride, solution; disodium edetate; carbomer; sodium hydroxide 30%; propylene glycol; purified water.

What Fenistil looks like and contents of the pack
Fenistil is a cooling, non-greasy, colourless and odourless gel.
The medicinal product is available in tubes containing 30 g or 50 g of gel, packed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, the country of export:
Haleon Hellas Single Member S.A.
Leof. Kifissias 11
151 23 Chalandri, Athens, Greece
Manufacturer:
Haleon Germany GmbH
Barthstrasse 4, 80339 Munich, Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, the country of export: 42245/24-9-2008
Parallel Import Licence Number: 296/25