Package Insert: Information for the User

Fenistil 1 mg/g Gel

Dimetindeno Maleate

Read this entire package insert carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor, pharmacist, or nurse.

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

Fenistil gel contains dimetindeno maleate, an active ingredient that belongs to a group of medicines called antihistamines.

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

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.

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 babies and premature babies.

Warnings and precautions

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

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

In case of very severe itching or extensive injuries, consult your doctor or pharmacist about the possibility of complementing local dimetindene maleate application 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 used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

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

During pregnancy and breastfeeding, do not apply Fenistil gel 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 chest as it contains benzalkonium chloride, which may pass to the baby.

Driving and operating machines

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

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

This medication contains 0.1 mg of benzalkonium chloride in each 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 chest during breastfeeding as it may pass to the baby.

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 procedure 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. Use on intact skin, without wounds.

Do not use on extensive areas of the skin or mucous membranes.

Apply a small amount of the medication to the affected area. Then, give a gentle 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 characteristic symptoms of an H1 antihistamine overdose: central nervous system depression with drowsiness (mainly in adults), central nervous system stimulation (excitability) and antimuscarinic effects (especially in children and the elderly), including, difficulty coordinating movements (ataxia), hallucinations, involuntary muscle contractions (tonic-clonic spasms), dilated pupils (mydriasis), dry mouth, flushing on the face, urinary retention, and fever. Hypotension may also occur.

In case of overdose or accidental ingestion, seek immediate medical attention or contact the pharmacist, or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

When using this product, you may experience:

• Dry skin
• Burning sensation on the skin
• Rash and itching

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

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

Do not store at a temperature above25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fenistil

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

Appearance of the product and contents of the packaging

Colourless, odourless, and non-greasy gel.

Fenistil gel is available in packaging of30 gand50 g.

Holder of the marketing authorization

Haleon Spain, S.A.

C/ Severo Ochoa, 2

28760 Tres Cantos – Madrid

Spain

Responsible for manufacturing

Haleon Germany GmbH

Barthstrasse, 4 - 80339

Munich (Germany)

Date of the last review of this leaflet:January 2020

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/