Fenistil

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Fenistil

1 mg/g, gel
Dimetindene maleate

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

This Medicinal Product Should Always be Used Exactly as Described in this Leaflet for the Patient or as Directed by the Doctor or Pharmacist.

• Keep this Leaflet, so that You can Read it Again if Necessary.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If the Patient Experiences any Undesirable Effects, including any Possible Undesirable Effects not Listed in the Leaflet, Tell the Doctor, Pharmacist, or Nurse. See Section 4.
• 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, Consult 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 Undesirable 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 Topical Use. Fenistil Contains the Active Substance Dimetindene Maleate, which Inhibits the Action of Histamine - a Substance Responsible for Allergic Reactions.
The Medicinal Product Applied to the Skin Acts Locally as an Antihistamine, Strongly Anti-Pruritic (with the Exception of Cholestatic Pruritus), Reduces Swelling, and Soothes Irritations.
It has Local Anesthetic Properties. It Cools, which Further Soothes the Irritated Skin.

Indications for Use:

Itch Associated with Skin Diseases, Urticaria, Insect Bites, Sunburn, Superficial Burns of the Skin (First Degree).
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, Consult 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 Medicinal Product (listed in Section 6),
• In the Case of Second and Third Degree Burns.

Warnings and Precautions

• When Using Fenistil on a Large Surface of the Skin, Avoid Exposure of the Treated Areas to Sunlight.
• Tell the Doctor in Case of Severe Itching or Extensive Skin 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, Consult a Doctor.

Before Starting to Use Fenistil, Discuss it with the Doctor, Pharmacist, or Nurse.
The Medicinal Product Should be Stored in a Place that is Inaccessible to Children.

Children

Avoid Using the Medicinal Product in Young Children on Large Areas of the Skin, especially in Cases of Injuries, Burns, and Skin Inflammations.

Fenistil and Other Medicinal Products

Tell the Doctor or Pharmacist about all Medicinal Products that the Patient is Currently Taking or has Recently Taken, as well as any Medicinal Products that the Patient Plans to Take.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks She may be Pregnant, or Plans to Have a Child, She Should Consult the Doctor or Pharmacist Before Using this Medicinal Product.
Do not Use the Medicinal Product on a Large Surface of the Skin, especially if it is Injured or Inflamed.
During Breastfeeding, do not Apply the Medicinal Product to the Nipples.
Breastfeeding Women Should not Use this Medicinal Product on the Breast Skin, as it may be Ingested by the Child with the Mother's Milk.

Driving and Operating Machines

Fenistil Used on the Skin has no Influence on the Ability to Drive and Operate 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 Apply to the Mucous Membranes.
Breastfeeding Women Should not Use this Medicinal Product on the Breast Skin, as it may be Ingested by the Child with the Mother's 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 Medicinal Product 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 Medicinal Product Should Always be Used Exactly as Described in this Leaflet for the Patient or as Directed by the Doctor, Pharmacist, or Nurse. In Case of Doubt, Consult the Doctor, Pharmacist, or Nurse.
The Medicinal Product is Intended for Topical Use.
Usually, unless the Doctor has Prescribed Otherwise, the Medicinal Product 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 Used Topically on the Skin have been Reported. In Case of Ingestion of the Medicinal Product, Consult a Doctor Immediately.
In Case of any Further Doubts about the Use of this Medicinal Product, Consult the Doctor, Pharmacist, or Nurse.

Missing a Dose of Fenistil

Do not Use a Double Dose to Make up for a Missed Dose.

4. Possible Undesirable Effects

Like all Medicinal Products, Fenistil can Cause Undesirable Effects, although not Everybody gets them.

Frequency not Known (Cannot be Estimated from the Available Data)

• Dryness of the Skin.
• Burning Sensation of the Skin.
• Skin Allergic Reactions, including Rash and Itching of the Skin.

Reporting Undesirable Effects

If any Undesirable Effects Occur, including any Possible Undesirable Effects not Listed in this Leaflet, Tell the Doctor, Pharmacist, or Nurse.
Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of 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.
Undesirable Effects can also be Reported to the Marketing Authorization Holder or the Parallel Importer.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medicinal Product.

5. How to Store Fenistil

Do not Store above 25°C.
The Medicinal Product Should be Stored in a Place that is Inaccessible to Children.
Do not Use this Medicinal Product after the Expiry Date Stated on the Packaging. The Expiry Date refers to the Last Day of the Month Indicated.
Medicinal Products Should not be Disposed of via Wastewater or Household Waste. Ask the Pharmacist how to Dispose of Medicinal Products 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 Medicinal Product is Dimetindene Maleate. One Gram of Gel Contains 1 mg of Dimetindene Maleate .
• The Other Ingredients of the Medicinal Product are: Benzalkonium Chloride, Solution, Disodium Edetate, Carbomer, Sodium Hydroxide 30%, Propylene Glycol, Purified Water.

What Fenistil Looks like and What the Packaging Contains

Fenistil is a Cooling, Non-Greasy, Colorless, and Odorless Gel.
The Medicinal Product is Available in a Tube Containing 30 g or 50 g of Gel, Placed in a Cardboard Box.
For more Detailed Information, Consult the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Greece, the Country of Export:

Haleon Hellas Single Member S.A.
Leof. Kifissias 11
151 23 Chalandri, Athens
Greece

Manufacturer:

Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany

Parallel Importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Authorization Number in Greece, the Country of Export:42245/24-9-2008

Parallel Import Authorization Number: 108/25

Date of Approval of the Leaflet: 25.03.2025

[Information about the Trademark]