Fenistil

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Fenistil, 1 mg/g, 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
your 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 side effects 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 in adults, or if your condition worsens, consult your doctor.

Leaflet Contents:

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 for skin application. 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 strong antipruritic effects (except in cholestatic pruritus), reduces swelling, and soothes skin irritations.
It also has local anesthetic properties. Its cooling effect further relieves irritated skin.

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

If there is no improvement after 2 days of treatment in children or 7 days in adults, or if your condition worsens, 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 cases of second- and third-degree burns.

Warnings and precautions

• When applying Fenistil over a large area 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 treatment in children or 7 days of treatment 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 with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan 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 apply the medicine to 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 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 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 per gram of gel.
Propylene glycol may cause skin irritation. Due to the presence of propylene glycol, this 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, 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 skin area.
Use of more Fenistil than recommended
There have been no reported cases of overdose with Fenistil gel when applied topically to the skin.
If the gel is swallowed, contact a doctor immediately.
If you have any further doubts concerning the use of this medicine, consult your doctor, pharmacist, or nurse.
If you forget to apply Fenistil
Do not apply 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 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 side effects
If any side effects occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 side 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 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 packaging and other information

What Fenistil contains

• The active substance is dimethindene maleate. One gram of gel contains 1 mg of dimethindene maleate.
• Other ingredients are: benzalkonium chloride, disodium edetate, carbomer, sodium hydroxide 30% w/w solution, propylene glycol, purified water.

What Fenistil looks like and contents of the pack
Fenistil is a colourless, odourless, cooling, non-greasy gel.
The medicine is available in a tube containing 30 g of gel, packed in a cardboard box.
For further information, please contact the responsible party or parallel importer.

Responsible party in Lithuania, country of export:
Haleon Hungary Kft.
Csörsz utca 43
1124 Budapest
Hungary

Manufacturer:
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Lithuania, country of export: LT/1/95/0933/001
Parallel import authorisation number: 570/15