FENISTIL

Patient Information Leaflet

Warning! Keep this leaflet. The 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
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 side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 a doctor.

Table of 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 acts locally as an antiallergic and strongly antipruritic agent (except in cholestatic pruritus), reduces swelling, and soothes skin irritation.
It also has local anaesthetic properties. Its cooling effect further helps to relieve 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 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 the 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 after 2 days of using the medicinal product in children or after 7 days in adults, or if the patient's condition worsens, consult a doctor. Discuss with your doctor, pharmacist, or nurse before starting treatment with Fenistil. Keep the medicine out of sight and reach of children.

Children
Avoid using Fenistil in young children over large areas of skin, especially in cases of wounds, burns, or inflammatory skin conditions.

Fenistil and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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 her 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 influence 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 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 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, covering the affected, itchy skin area with a thin layer.
Use of more than the recommended dose of Fenistil
There have been no reported cases of overdose with Fenistil when used topically on 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 a doctor, pharmacist, or nurse.
Missed dose of Fenistil
Do not apply a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 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
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 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 the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps 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 of dimetindene maleate.
• Other ingredients are: benzalkonium chloride solution, 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.
Pack sizes: a tube containing 30 g of gel, placed in a cardboard carton.
For more detailed information, please contact the responsible party or the 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Lithuania, country of export: LT/1/95/0933/001
Parallel import authorisation number: 131/16