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 Patient Leaflet or as Directed by a Doctor or Pharmacist.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or Further Information, Consult a Pharmacist.
• If you Experience any Side Effects, including those not Listed in the Leaflet, Tell your Doctor or Pharmacist. See Section 4.
• If, after 2 Days of Using the Medicinal Product in Children and 7 Days 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 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 Cutaneous 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:

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 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 Skin Surface, Avoid Exposure of the Treated Areas to Sunlight.
• Inform your Doctor in Case of Severe Itching or Extensive Skin Changes,
• If, after 2 Days of Using the Medicinal Product in Children and 7 Days in Adults, there is no Improvement or the Patient Feels Worse, Consult a Doctor.

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

Children

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

Fenistil and other Medicinal Products

Tell your Doctor or Pharmacist about all Medicinal Products you are Currently Taking or have Recently Taken, as well as any Medicinal Products you Plan to Take.

Pregnancy and Breastfeeding

If you are Pregnant or Breastfeeding, Think you may be Pregnant, or are Planning to have a Child, Consult your Doctor or Pharmacist Before Using this Medicinal Product.
Do not Use the Medicinal Product on a Large Skin Surface, 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 Breast Milk.

Driving and Operating Machinery

Fenistil Used on the Skin has no Influence on the Ability to Drive and Operate Machinery.

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 Mucous Membranes.
Breastfeeding Women Should not Use this Medicinal Product 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 Medicinal Product Should not be Used on Open Wounds or Large Areas of Damaged or Inflamed 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 Patient Leaflet or as Directed by a Doctor, Pharmacist, or Nurse.
In Case of Doubt, Consult a Doctor, Pharmacist, or Nurse.
The Medicinal Product is Intended for Cutaneous Use.
Usually, unless Otherwise Directed by a Doctor, 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 more than the Recommended Dose of Fenistil

No Cases of Overdose of Fenistil Gel Used Topically on the Skin have been Reported.
In Case of Ingestion, Contact a Doctor Immediately.
In Case of any Further Doubts about the Use of this Medicinal Product, Consult a Doctor, Pharmacist, or Nurse.

Missing a Dose of Fenistil

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

4. Possible Side Effects

Like all Medicinal Products, this Medicinal Product can Cause Side 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 Side Effects

If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions 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.
By Reporting Side Effects, you can Help Provide more Information on the Safety of this Medicinal Product.

5. How to Store Fenistil

Store at a Temperature below 25°C.
The Medicinal Product Should be Stored in a Place Invisible and 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 Specified Month.
Medicinal Products Should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medicinal Products you no Longer Use. 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, Propylene Glycol, Purified Water.

What Fenistil Looks like and what the Packaging Contains

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

Marketing Authorization Holder in Bulgaria, the 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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Bulgaria, the Country of Export:20020034

Parallel Import Authorization Number: 322/24

Date of Approval of the Leaflet: 07.08.2024

[Information about the Trademark]