FENISTIL 1 mg/ml CUTANEOUS EMULSION

Introduction

Package Leaflet: Information for the User

Fenistil 1 mg/ml Cutaneous Emulsion

Dimetindene Maleate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this 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 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 you start using Fenistil
3. How to use Fenistil
4. Possible side effects
5. Storage of Fenistil
6. Contents of the pack and further information

1. What is Fenistil and what is it used for

Fenistil cutaneous emulsion contains dimetindene maleate, an active ingredient belonging to the group of medicines called antihistamines.

Fenistil cutaneous emulsion is indicated for the relief of itching of the skin associated with skin reactions such as small skin eruptions, urticaria, insect bites, minor sunburn, and minor superficial burns, for adults and children from 1 month onwards.

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

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

2. What you need to know before you start using Fenistil

Do not use Fenistil:

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

Warnings and Precautions

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

Avoid prolonged exposure to the sun of the treated skin areas.

Do not apply to large areas of the skin or to mucous membranes.

Consult your doctor if the 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 complementing the local application of dimetindene maleate with an oral antihistamine.

Children

In infants and small children, do not use on large areas of the skin, particularly if the skin is inflamed or damaged.

Other Medicines and Fenistil

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

During pregnancy and breast-feeding, Fenistil cutaneous emulsion should not be applied to large areas of the skin, especially if the skin is inflamed or raised.

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

Driving and Using Machines

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

Fenistil emulsion contains propylene glycol (E-1520), benzalkonium chloride, benzyl alcohol

and butylhydroxytoluene (E-321).

This medicine contains 150 mg of propylene glycol in each ml.

This medicine contains 0.1 mg of benzalkonium chloride in each ml. Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes.

Do not apply this medicine to the breast during breast-feeding as it could pass to the baby.

This medicine contains 5 mg of benzyl alcohol in each ml. Benzyl alcohol may cause allergic reactions and moderate local irritation.

This medicine contains butylhydroxytoluene, which may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to Use Fenistil Cutaneous Emulsion

Follow exactly the administration instructions of the medicine contained in this 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 medicine to the affected area. The operation can be repeated 2 to 4 times a day, if necessary.

Children over 1 month to 2 years old: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 cutaneous emulsion is a medicine for cutaneous use.

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

Slide the applicator over the area to be treated, forming a thin layer on the skin, and massage gently. Do not use with occlusive dressings

If you use more Fenistil than you should

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When using this product, you may experience:

• Dryness of the skin
• Burning sensation on the skin
• Rash and itching.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenistil

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

Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Fenistil

The active ingredient is dimetindene maleate. Each gram of emulsion contains 1 mg of dimetindene maleate.

The other ingredients (excipients) are benzalkonium chloride, benzyl alcohol, butylhydroxytoluene (E-321), disodium edetate, cocoyl caprylate/caprate, liquid paraffin, cetomacrogol, carbomer, propylene glycol (E-1520), sodium hydroxide, purified water.

Appearance of the Product and Contents of the Pack

Roll-on container with 8 ml of emulsion.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Haleon Spain, S.A.

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

28046 Madrid, Spain

Manufacturer:

Lichtenheldt GmbH

Justus-Liebig-Weg, 1

Wahlstedt/Holstein - D-23812 – Germany

Haleon Germany GmbH

Barthstrasse, 4

80339 Munich (Germany)

Date of the Last Revision of this Leaflet: January 2020

Other Sources of Information

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