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 Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or More Information, Ask your 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 Medication in Children and 7 Days in Adults, there is no Improvement or the Patient Feels Worse, you Should 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 Topical Use on the Skin. Fenistil Contains the Active Substance Dimetindene Maleate, which Inhibits the Action of Histamine - a Substance Responsible for Allergic Reactions.
The Medication Applied to the Skin Acts Locally as an Antihistamine, Strongly Anti-itching (excluding Cholestatic Itching), 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 Medication in Children and 7 Days in Adults, there is no Improvement or the Patient Feels Worse, you Should 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 Medication (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 Medication in Children and 7 Days in Adults, there is no Improvement or the Patient Feels Worse, you Should Consult a Doctor.

Before Starting to Use Fenistil, Discuss it with your Doctor, Pharmacist, or Nurse.
Keep the Medication out of Sight and Reach of Children.

Children

Avoid Using the Medication on Large Skin Surfaces in Young Children, especially in Cases of Injuries, Burns, and Skin Inflammations.

Fenistil and Other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking or have Recently Taken, as well as any Medications 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, Ask your Doctor or Pharmacist for Advice Before Using this Medication.
Do not Apply the Medication to Large Skin Surfaces, especially if they are Injured or Inflamed.
During Breastfeeding, do not Apply the Medication to the Nipples.
Breastfeeding Women should not Use this Medication on the Breast Skin, as it may be Ingested by the Child with Breast Milk.

Driving and Operating Machines

Fenistil Used on the Skin does not Affect the Ability to Drive or 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 Mucous Membranes.
Breastfeeding Women should not Use this Medication 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 Medication 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 Medication Should Always be Used Exactly as Described in this Patient Leaflet or as Advised by a Doctor, Pharmacist, or Nurse.
In Case of Doubt, Consult a Doctor, Pharmacist, or Nurse.
The Medication is Intended for Use on the Skin.
Usually, unless Otherwise Advised by a Doctor, the Medication 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.
If you have any Further Doubts about Using this Medication, Consult a Doctor, Pharmacist, or Nurse.

Missing a Dose of Fenistil

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

4. Possible Side Effects

Like all Medications, Fenistil can Cause Side Effects, although not Everybody gets them.

Frequency Not Known (cannot be Estimated from 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.
Reporting Side Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Fenistil

Do not Store above 25°C.
Keep the Medication out of Sight and Reach of Children.
Do not Use this Medication after the Expiry Date Stated on the Packaging. The Expiry Date is the Last Day of the Specified Month.
Medications should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medications 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 Medication is Dimetindene Maleate. One Gram of Gel Contains 1 mg of Dimetindene Maleate.
• Other Ingredients of the Medication are: Benzalkonium Chloride, Solution, Disodium Edetate, Carbomer, Sodium Hydroxide Solution 30% w/w, 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 Medication is a Tube Containing 30 g of Gel, Placed in a Cardboard Box.
For more Detailed Information, Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Lithuania, the Country of Export:

Haleon Hungary Kft.
Csörsz utca 43
1124 Budapest
Hungary

Manufacturer:

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
Lithuanian Marketing Authorization Number, in the Country of Export:LT/1/95/0933/001
Parallel Import License Number:570/15

Date of Approval of the Leaflet: 01.08.2025

[Information about the Trademark]