Fenistil 1 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fenistil 1 mg/g gel
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.
Leaflet contents:
- 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 gel contains dimethindene maleate, an active substance belonging to a group of medicines called antihistamines.
Fenistil gel is indicated for the relief of skin itching associated with skin reactions such as minor rashes, urticaria, 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.
You should consult a doctor if symptoms worsen or do 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 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 gel.
- Avoid prolonged sun exposure of the 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 cases of severe itching or extensive skin lesions, consult your doctor or pharmacist about the possibility of combining topical dimethindene maleate 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 using, have recently used, or might need to use any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, Fenistil gel should not be applied to large areas of skin, especially if the skin is inflamed or damaged.
During breastfeeding, do not apply the product to the nipples. Also avoid applying this medicine to the breast area, as it contains benzalkonium chloride, which may pass to the baby.
Driving and using machines
The application of Fenistil gel to the skin does not affect the ability to drive or operate machinery.
Fenistil gel contains benzalkonium chloride and propylene glycol (E-1520)
This medicine contains 0.1 mg of benzalkonium chloride per gel dose, equivalent to 0.05 mg per gram of gel. 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 baby.
This medicine contains 300 mg of propylene glycol per gel dose, equivalent to 150 mg per gram of gel.
3. How to use Fenistil gel
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.
Recommended dose:
Adults and children over 2 years:
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: use under medical supervision.
If symptoms worsen or do not improve after 7 days of treatment, consult your doctor.
If severe itching or extensive lesions occur, consult your doctor or pharmacist.
How to use
Fenistil gel is for cutaneous use only. Apply only to intact, unbroken skin.
Do not use on large areas of skin or on mucous membranes.
Apply a small amount of the medicine to the area to be treated. Then gently massage with your hand to aid penetration of the medicine into the skin.
If you use more Fenistil than you should
Accidental ingestion of a significant amount of Fenistil gel may cause symptoms typical of H1 antihistamine overdose: central nervous system (CNS) depression with drowsiness (mainly in adults), CNS stimulation (excitability), and antimuscarinic effects (especially in children and elderly people), including impaired coordination of movement (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 contact 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 may 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 can 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the tube after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Fenistil
- The active substance is dimethindene maleate. Each gram of gel contains 1 mg of dimethindene 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 container
Colourless, odourless and non-greasy gel.
Fenistil gel is available in 30 g and 50 g tubes.
Marketing Authorization Holder
Haleon Spain, S.A.
Paseo de la Castellana, 259D, planta 32,
28046 Madrid, Spain
Manufacturer
Haleon Germany GmbH
Barthstrasse, 4 - 80339
Munich (Germany)
Date of the most recent revision of this 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/