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FENISTIL 1 mg/ml CUTANEOUS EMULSION

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About the medicine

How to use FENISTIL 1 mg/ml CUTANEOUS EMULSION

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Contents of the leaflet

  1. Introduction
  2. What is Fenistil and what is it used for
  3. What you need to know before you start using Fenistil
  4. How to Use Fenistil Cutaneous Emulsion
  5. Possible Side Effects
  6. Storage of Fenistil
  7. Contents of the Pack and Further Information

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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/

Online doctors for FENISTIL 1 mg/ml CUTANEOUS EMULSION

Discuss questions about FENISTIL 1 mg/ml CUTANEOUS EMULSION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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€80
5.0 (22)
Doctor

Anna Moret

Dermatology 19 years exp.

Dr. Anna Moret is a board-certified dermatologist and dermatovenereologist. She specialises in adult and pediatric dermatology, venereology, aesthetic skin care, and general medicine. Her consultations are evidence-based and tailored to each patient’s dermatological needs.

Dr. Moret provides expert evaluation and treatment for:

  • Skin conditions such as eczema, acne, rosacea, dermatitis, and psoriasis.
  • Hair and scalp issues including hair loss, dandruff, and seborrheic dermatitis.
  • Pediatric skin problems — from newborns to adolescents.
  • Sexually transmitted infections (STIs) and dermatovenereology.
  • Aesthetic concerns: skin ageing, non-invasive cosmetic treatments.
  • Skin allergies and hypersensitivity reactions.
  • Mole checks, lesion evaluation, and skin cancer screening.
  • Skincare advice and personalised cosmeceutical routines.

Combining dermatology with general medical knowledge, Dr. Moret offers comprehensive care that addresses both skin health and underlying conditions. She also holds certification from the Canadian Board of Aesthetic Medicine, ensuring an internationally aligned approach to aesthetic dermatology.
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€55
5.0 (2)
Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.
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€55
0.0 (0)
Doctor

Marta Reguero Capilla

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

  • allergic rhinitis, seasonal allergies, and perennial allergy symptoms;
  • allergic conditions in adults and children;
  • bronchial asthma and allergy-related respiratory symptoms;
  • urticaria (acute and chronic) and angioedema;
  • food allergies and reactions to foods, additives, or medications;
  • atopic dermatitis, allergic rashes, and persistent itching;
  • unexplained or recurrent allergic reactions;
  • interpretation of laboratory tests, allergy testing, and immunology results;
  • immune system concerns, frequent infections, and reduced immune response;
  • ongoing medical follow-up and treatment adjustment.
Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.
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€60

Frequently Asked Questions

Is a prescription required for FENISTIL 1 mg/ml CUTANEOUS EMULSION?
FENISTIL 1 mg/ml CUTANEOUS EMULSION does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in FENISTIL 1 mg/ml CUTANEOUS EMULSION?
The active ingredient in FENISTIL 1 mg/ml CUTANEOUS EMULSION is dimetindene. This information helps identify medicines with the same composition but different brand names.
Who manufactures FENISTIL 1 mg/ml CUTANEOUS EMULSION?
FENISTIL 1 mg/ml CUTANEOUS EMULSION is manufactured by Haleon Spain S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FENISTIL 1 mg/ml CUTANEOUS EMULSION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether FENISTIL 1 mg/ml CUTANEOUS EMULSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to FENISTIL 1 mg/ml CUTANEOUS EMULSION?
Other medicines with the same active substance (dimetindene) include DERMAPIC 1 mg/g GEL, DIMESTIL 1mg/g GEL, FENISTIL 1 mg/g GEL. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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