Fenistil 1 mg/ml cutaneous emulsion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fenistil 1 mg/ml cutaneous emulsion
Dimetindene maleate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet:
- What Fenistil is and what it is used for
- What you need to know before using Fenistil
- How to use Fenistil
- Possible side effects
- How to store Fenistil
- Contents of the pack and other information
1. What Fenistil is and what it is used for
Fenistil cutaneous emulsion contains maleate of dimetindene, an active substance belonging to a group of medicines called antihistamines.
Fenistil cutaneous emulsion is indicated for the relief of skin itching associated with skin reactions such as minor rashes, hives, insect bites, mild sunburns, and minor superficial burns, in adults and children from 1 month of age.
Children older than 1 month to 2 years: under medical supervision.
Consult a doctor if symptoms worsen or do not improve after 7 days.
2. What you need to know before using Fenistil
Do not use Fenistil:
- If you are allergic to dimethindene maleate or to any of the other ingredients of this medicine (listed in section 6).
- In newborn and premature infants.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Fenistil cutaneous emulsion.
Avoid prolonged sun exposure of treated skin areas.
Do not apply over large areas of skin or on mucous membranes.
Consult your doctor if symptoms do not improve within one week.
In case of severe itching or extensive skin lesions, consult your doctor or pharmacist about the possibility of combining topical dimethindene maleate application with an oral antihistamine.
Children
In infants and young children, do not use on large areas of skin, particularly if the skin is inflamed or damaged.
Other medicines and Fenistil
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, Fenistil cutaneous emulsion should not be applied to large areas of skin, especially if the skin is inflamed or broken.
During breastfeeding, do not apply the product to the nipples. Also avoid application on the breast area, as it contains benzalkonium chloride, which may pass to the infant.
Driving and use of machines
The application of Fenistil cutaneous emulsion to the skin does not affect the ability to drive or operate machinery.
Fenistil emulsion contains propylene glycol (E-1520), benzalkonium chloride, benzyl alcohol, and butylhydroxytoluene (E-321).
This medicine contains 150 mg of propylene glycol per ml.
This medicine contains 0.1 mg of benzalkonium chloride per ml. Benzalkonium chloride may cause skin irritation. Do not apply on mucous membranes.
Do not apply this medicine to the breast during breastfeeding, as it may pass to the infant.
This medicine contains 5 mg of benzyl alcohol per 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 instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.
The recommended dose is:
Adults and children over 2 years of age:
Apply a small amount of the medicine to the affected area. This may be repeated 2 to 4 times daily, if necessary.
Children over 1 month to 2 years of age: use under medical supervision.
If symptoms worsen or do not improve after 7 days of treatment, consult your doctor. In case of severe itching or extensive skin lesions, consult your doctor or pharmacist.
How to use
Fenistil cutaneous emulsion is for topical use only.
Do not use on large areas of skin or on mucous membranes.
Glide the applicator over the area to be treated, forming a thin layer on the skin, and gently massage. Do not use with occlusive dressings.
If you use more Fenistil than you should
Accidental ingestion of a significant amount of Fenistil emulsion may cause symptoms characteristic of an overdose of H1 antihistamines: central nervous system (CNS) depression with drowsiness (mainly in adults), CNS stimulation and antimuscarinic effects (especially in children and elderly people), including excitability, difficulty in coordinating movements (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, seek immediate medical advice from your doctor or pharmacist, or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
When using this product you may experience:
- Dry skin
- Skin burning sensation
- Rash and itching
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es. By reporting adverse 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 refers to the last day of the month indicated.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fenistil
The active substance is dimethindene maleate. Each gram of emulsion contains 1 mg of dimethindene maleate.
The other components (excipients) are benzalkonium chloride, benzyl alcohol, butylhydroxytoluene (E-321), disodium edetate, cococaprate/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 Authorization Holder and Manufacturer
Marketing Authorization Holder:
Haleon Spain, S.A.
Paseo de la Castellana, 259D, planta 32,
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 most recent revision of this package leaflet: January 2020
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/