Fenistil

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or additional information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after 2 days of using the product in children and after 7 days in adults, or if the patient feels worse, contact a physician.

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 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, the medicine acts locally as an antiallergic agent, strongly antipruritic (except in cholestatic pruritus), reduces swelling, and soothes skin irritation.
It exhibits local anesthetic properties. It has a cooling effect, which additionally soothes irritated skin.
Indications:
Itching associated with skin disorders, urticaria, insect bites, sunburn, superficial skin burns (first degree).
If there is no improvement after 2 days of using the product in children and after 7 days in adults, or if the patient feels worse, contact a physician.

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's condition worsens, 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 with 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 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 medicine to the nipples.
Breastfeeding women should not use this medicine on 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 in each 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 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 information leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
The medicine is intended for topical application to 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 a higher than recommended dose of Fenistil
No cases of overdose have been reported with topical Fenistil gel.
If the medicine is swallowed, seek immediate medical advice.
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.
Missed dose of Fenistil
Do not apply a double dose to make up for a missed dose.

4. Possible adverse reactions

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fenistil

Store below 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Fenistil contains

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

What Fenistil looks like and contents of the pack
Fenistil is a cooling, non-greasy, colourless and odourless gel.
The available pack is a tube containing 30 g of gel, placed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Bulgaria, country of export:
Haleon Hungary Kft.
Csörsz utca 43
1124 Budapest, Hungary
Manufacturer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4, 80339 Munich, Germany
Haleon Germany GmbH
Barthstrasse 4, 80339 Munich, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Bulgaria, country of export: 20020034
Parallel import licence number: 322/24