FENISTIL

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Fenistil
1 mg/g, gel
Dimetindene maleate
Please 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 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 possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 days of treatment in children or 7 days of treatment in adults, or if symptoms worsen, consult a 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 acts locally as an antiallergic agent with strong antipruritic effects (except in cholestatic pruritus), reduces swelling, and soothes skin irritation.
It also has local anaesthetic properties. Its cooling effect provides additional relief for irritated skin.

Indications:
Itching associated with skin disorders, urticaria, insect bites, sunburn, and superficial skin burns (first degree).

If there is no improvement after 2 days of treatment in children or 7 days of treatment in adults, or if symptoms worsen, 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 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 after 2 days of using the medicinal product in children or after 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, and 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 planned for future use.

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 use the medicine on large areas of skin, especially if the skin is injured 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 does not affect the ability to drive or operate machinery.

Fenistil contains benzalkonium chloride
Fenistil contains 0.050 mg of benzalkonium chloride in each gram of gel.
Benzalkonium chloride may cause skin irritation. Do not use on 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 in each 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 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 or pharmacist.
If in doubt, consult a 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, covering the affected, diseased, and itchy skin area with a thin layer.
Using more Fenistil than you should
No cases of overdose have been reported with topical application of Fenistil gel to the skin.
If the medicine is swallowed, seek immediate medical advice from a doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
If you forget to use Fenistil
Do not use a double amount to make up for a forgotten application.

4. Possible adverse reactions

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

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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
By reporting adverse reactions, additional information on the safety of this medicinal product can 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 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, disodium edetate, carbomer, propylene glycol, sodium hydroxide, purified water.

What Fenistil looks like and contents of the pack
Fenistil is a cooling, non-greasy, colourless and odourless gel.
The tube contains 30 g of gel and is placed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Lithuania, country of export:
GlaxoSmithKline Dungarvan Limited
Knockbrack
Dungarvan
Co Waterford
Ireland
Manufacturer
GSK Consumer Healthcare GmbH & Co. KG
Barthstraße 4
80339 Munich
Germany
Novartis Consumer Health GmbH
Zielstattstrasse 40
DE-81379 Munich
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorization number in Lithuania, country of export: LT/1/95/0933/001
Parallel import licence number: 257/19