Fenistil

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Fenistil
1 mg/g, gel
Dimetindene maleate
Please read carefully all the information in this leaflet 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
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement within 2 days of starting treatment in children or within 7 days in adults, or if symptoms worsen, consult your doctor.

Table of contents of the leaflet:

1. What Fenistil is and what it is used for
2. Important information before using Fenistil
3. How to use Fenistil
4. Possible side effects
5. How to store Fenistil
6. 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 exerts local antiallergic and potent antipruritic effects (except for cholestatic pruritus), reduces swelling, and soothes skin irritation.
It also has local anesthetic properties. The cooling effect further helps to soothe irritated skin.
Indications:
Itching associated with skin disorders, urticaria, insect bites, sunburn, and superficial skin burns (first degree).
If there is no improvement within 2 days of starting treatment in children or within 7 days in adults, or if symptoms worsen, consult your 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 case of second- and third-degree burns.

Warnings and precautions

• When applying Fenistil to large areas of skin, 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 medicinal product 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 child, she should consult a doctor or pharmacist before using this medicine.
Do not apply the medicine to large areas of skin, especially if the skin is wounded or inflamed.
During breastfeeding, do not apply the product 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 effect on the ability to drive or operate machinery.
Fenistil contains benzalkonium chloride
Fenistil contains 0.050 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes.
Breastfeeding women should not use this medicine on 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 applied to open wounds or large areas of injured 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, itchy areas of skin.
Use of more than the recommended dose of Fenistil
There have been no reported cases of overdose with Fenistil when applied topically to the skin. In case of accidental ingestion, seek medical advice immediately.
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.
Missed application of Fenistil
Do not apply a double dose to make up for a missed application.

4. Possible adverse effects

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

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

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects 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 effects can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse effects helps to provide more information on the safety of the medicine.

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 required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fenistil contains

• The active substance is dimethindene maleate. One gram of gel contains 1 mg of dimethindene maleate.
• The 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, colorless and odorless gel.
Available pack sizes are tubes containing 30 g or 50 g of gel, placed in a cardboard box.
For further information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Greece, 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:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego Street 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
komandytowa Forteczna Street 35-37 Tymiankowa Street 24/28
Działkowa Street 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing authorization number in Greece, country of export: 42245/24-9-2008
Parallel import authorization number: 108/25