FENISTIL 1 mg/g GEL

Introduction

Package Leaflet: Information for the User

Fenistil 1 mg/g gel

Dimetindene maleate

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet:

1. What is Fenistil and what is it used for
2. What you need to know before using Fenistil
3. How to use Fenistil
4. Possible side effects
5. Storage of Fenistil
6. Package contents and additional information

1. What is Fenistil and what is it used for

Fenistil gel contains dimetindene maleate, an active ingredient belonging to the group of medications called antihistamines.

Fenistil gel is indicated for the relief of skin itching associated with skin reactions such as minor skin eruptions, urticaria, insect bites, minor sunburns, and minor superficial burns, for adults and children from 1 month of age.

Children over 1 month to 2 years : under medical supervision.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before using Fenistil

Do not use Fenistil:

• If you are allergic to dimetindene maleate or any of the other components of this medication (listed in section 6).
• Newborn and premature infants.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Fenistil gel.

• Avoid prolonged exposure to the sun of the treated skin areas.
• Do not apply to extensive skin areas or mucous membranes.
• Consult your doctor if symptoms do not improve within a week.

In case of very severe itching or extensive lesions, consult your doctor or pharmacist about the possibility of supplementing the local application of dimetindene maleate with an oral antihistamine.

Children

In infants and young children, do not use on extensive skin areas, particularly if the skin is inflamed or damaged.

Other medications and Fenistil

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

During pregnancy and breastfeeding, Fenistil gel should not be applied to extensive skin areas, especially if the skin is inflamed or damaged.

During breastfeeding, do not apply the product to the nipples. Also, do not apply this medication to the breast as it contains benzalkonium chloride, which could pass to the baby.

Driving and using machines

The application of Fenistil gel to the skin does not affect the ability to drive or use machines.

Fenistil gel contains benzalkonium chloride and propylene glycol (E-1520)

This medication contains 0.1 mg of benzalkonium chloride per dose of gel, equivalent to 0.05 mg per gram of gel. Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes.

Do not apply this medication to the breast during breastfeeding as it could pass to the baby.

This medication contains 300 mg of propylene glycol per dose of gel, equivalent to 150 mg per gram of gel.

3. How to use Fenistil gel

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is:

Adults and children over 2 years:

Apply a small amount of the medication to the affected area. The operation can be repeated 2 to 4 times a day, if necessary.

Children over 1 month to 2 years : use under medical supervision

If it worsens or does not improve after 7 days of treatment, consult your doctor.

In case of very severe itching or extensive lesions, consult your doctor or pharmacist.

How to use

Fenistil gel is a topical medication. For use on intact skin, without wounds.

Do not use on extensive skin areas or mucous membranes.

Apply a small amount of the medication to the area to be treated. Then, gently massage with your hand to facilitate the penetration of the medication into the skin.

If you use more Fenistil than you should

Accidental ingestion of a considerable amount of Fenistil gel may induce some symptoms characteristic of an overdose of H1 antihistamines: central nervous system depression with drowsiness (mainly in adults), central nervous system stimulation (excitability), and antimuscarinic effects (especially in children and the elderly), including coordination difficulties (ataxia), hallucinations, involuntary muscle contractions (tonic-clonic spasms), pupil dilation (mydriasis), dry mouth, facial flushing, urinary retention, and fever. Hypotension may also occur.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

When using this product, you may experience:

• Skin dryness
• Skin burning sensation
• Rash and itching

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fenistil

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and tube after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fenistil

• The active ingredient is dimetindene maleate. Each gram of gel contains 1 mg of dimetindene maleate.
• The other components (excipients) are benzalkonium chloride, disodium edetate, carbomer, sodium hydroxide, propylene glycol, and purified water.

Appearance of the product and package contents

Colorless, odorless, and non-greasy gel.

Fenistil gel is available in 30 g and 50 g packages.

Marketing authorization holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor,

28046 Madrid, Spain

Manufacturer

Haleon Germany GmbH

Barthstrasse, 4 - 80339

Munich (Germany)

Date of the last revision of this package leaflet: January 2020

Other sources of information

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/