Fenistil

Leaflet attached to the packaging: patient information

Fenistil, 1 mg/g, gel

Dimetindene maleate

Please read the contents of 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.

• Please keep this leaflet, so 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 inform 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 a 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 substance 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 exhibits 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 a 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 skin surface, avoid exposing the areas covered with it to sunlight.
• Please 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 a 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

Avoid using the medicine in small children on large skin surfaces, especially in cases of injuries, burns, and skin inflammation.

Fenistil and other medicines

Please tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use the medicine on a large skin surface, especially if it is injured or inflamed. During breastfeeding, do not apply the medicine 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 as directed by a doctor, pharmacist, or nurse. In case of doubts, you should consult a doctor, pharmacist, or nurse. The medicine is intended for use on the skin. Usually, unless otherwise directed by a doctor, the medicine should be applied 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 with Fenistil gel used locally on the skin have been reported. If the medicine is swallowed, you should immediately contact a doctor. If you have any further doubts about using this medicine, you should consult a doctor, pharmacist, or nurse.

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, Fenistil 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 itching of the skin.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fenistil

Do not store above 25°C. Protect from light. 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 month stated. Medicines should not be disposed of via wastewater or household waste. You should 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 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 solution, sodium edetate, carbomer, sodium hydroxide 30%, propylene glycol, purified water.

What Fenistil looks like and contents of the packaging

Fenistil is a cooling, non-greasy, colorless, and odorless gel. The medicine is available in tubes containing 20 g, 30 g, 50 g, 80 g, or 100 g of gel, placed in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Importer:

Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany

Date of last revision of the leaflet: November 2024