Fenistil

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Fenistil

1 mg/g, gel

Dimetindene maleate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 2 days of using the medicinal product in children and 7 days of using the medicine in adults, there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Fenistil and what is it 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 packaging and other information

1. What is Fenistil and what is it used for

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

Indications for use:

Itching associated with skin diseases, urticaria, insect bites, sunburn, superficial skin burns (first degree).
If after 2 days of using the medicinal product in children and 7 days of using the medicine in adults, there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before using Fenistil

When not to use Fenistil

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

Warnings and precautions

• When using Fenistil on a large area of skin, you should avoid exposing the areas covered with it to sunlight.
• You should inform your doctor in case of very severe itching or extensive changes.
• If after 2 days of using the medicinal product in children and 7 days of using the medicinal product in adults, there is no improvement or the patient feels worse, they should contact their doctor.

Before starting to use Fenistil, you should discuss it with your doctor, pharmacist, or nurse. The medicinal product should be stored in a place that is out of sight and reach of children.

Children

You should avoid using the medicine in small children on large areas of skin, especially in cases of injuries, burns, and skin inflammation.

Fenistil and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. You should not use the medicine on a large area of skin, especially if it is injured or inflamed. During breastfeeding, you should not apply it to the nipples.
Breastfeeding women should not use this medicine on the breast skin, as it may be ingested by the child with breast milk.

Driving and using machines

Fenistil used on the skin does not affect the ability to drive and use machines.

Fenistil contains benzalkonium chloride

Fenistil contains 0.050 mg of benzalkonium chloride per gram of gel.
Benzalkonium chloride may irritate the skin. Do not use on mucous membranes.
Breastfeeding women should not use this medicine on the breast skin, 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 injured or damaged skin (e.g., burned) 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 according to the doctor's or pharmacist's instructions.
In case of doubts, you should consult a doctor or pharmacist.
The medicine is intended for use on the skin.
Usually, unless the doctor recommends otherwise, the medicine should be used 2 to 4 times a day, covering the affected and itchy skin surface with a thin layer of gel.

Using a higher dose of Fenistil than recommended

No cases of overdose of Fenistil gel used locally on the skin have been reported.
If the medicine is swallowed, you should immediately contact a doctor.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

Missing a dose of Fenistil

You should not use a double dose to make up for a missed dose.

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)

• Dry skin.
• Burning sensation of the skin.
• Skin allergic reactions including rash and skin itching.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Fenistil

Do not store above 25°C.
The medicine should be stored in a place that is 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 specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fenistil contains

• The active substance of the medicine is dimetindene maleate. One gram of gel contains 1 mg of dimetindene maleate.
• The other ingredients of the medicine are: benzalkonium chloride, disodium edetate, carbomer, propylene glycol, sodium hydroxide, purified water.

What Fenistil looks like and what the pack contains

Fenistil is a cooling, non-greasy, colorless, and odorless gel.
The tube contains 30 g of gel and is placed in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the 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 by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Lithuania, the country of export: LT/1/95/0933/001
Parallel import authorization number: 257/19

Date of leaflet approval: 04.07.2024

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