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EBASTEL 1 mg/ml ORAL SOLUTION

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About the medicine

How to use EBASTEL 1 mg/ml ORAL SOLUTION

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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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Introduction

Package Leaflet: Information for the Patient

Ebastel 1 mg/ml Oral Solution

ebastine

  • Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

  1. What is Ebastel and what is it used for
  2. What you need to know before you take Ebastel
  3. How to take Ebastel
  4. Possible side effects
  5. Storage of Ebastel
  1. Contents of the pack and further information

1. What is Ebastel and what is it used for

Ebastel belongs to a group of medicines called antihistamines (antiallergics).

Ebastel is indicated for the treatment of symptoms of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, sneezing), chronic urticaria, and allergic dermatitis.

Doctor consultation

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2. What you need to know before you take Ebastel

Do not take Ebastel

  • if you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Ebastel.

This medicine should be used with caution:

  • if your electrocardiogram results are altered (prolongation of the QT interval).
  • if you have altered potassium levels in your blood.
  • if you have severe liver disease (see "How to take Ebastel")
  • if you are being treated with a type of antifungal medication called azoles or with antibiotics called macrolides (see "Taking Ebastel with other medicines").
  • if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medicine if you have an acute allergic emergency, as ebastine (the active ingredient of this medicine) takes 1 to 3 hours to take effect.

Children

Ebastel 1 mg/ml Oral Solution should not be administered to children under 2 years of age.

Other medicines and Ebastel

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

The following medicines may interfere with Ebastel; in these cases, it may be necessary to change the dose or interrupt treatment with one of them:

  • Ebastel may increase the effect of other medicines used to treat allergies (antihistamines).
  • Ebastel should be used with caution in patients being treated with medications called ketoconazole and itraconazole used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause an alteration in your electrocardiogram).
  • The antihistamine effect of Ebastel may be reduced in patients being treated with a medication called rifampicin used to treat tuberculosis.

No interactions have been described between ebastine and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastel may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after stopping treatment.

Taking Ebastel with food and drinks

The solution can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking Ebastel. The doctor will decide whether or not to start treatment.

Breastfeeding

It is not known whether the medicine passes into breast milk, so it should not be used during breastfeeding.

Driving and using machines

In humans, no effects on psychomotor function or the ability to drive or use machinery have been observed at the recommended therapeutic doses. However, since somnolence and dizziness are among the side effects, observe your response to the medication before driving or using machinery.

Ebastel containsmethyl parahydroxybenzoate (E-219), propyl parahydroxybenzoate (E-217), sorbitol (E-420), hydrogenated castor oil, and benzoic acid (E-210)

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-219) and propyl parahydroxybenzoate (E-217).

This medicine contains 700 mg of sorbitol (E-420) per 10 ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

This medicine contains 0.00028 mg of benzoic acid (E-210) (contained in the simethicone emulsion) in each 10 ml.

This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml; it is essentially "sodium-free".

3. How to take Ebastel

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Ebastel.

Posology

Use in adults and children over 12 years:The recommended dose is 1 dose of 10 ml (10 mg of ebastine) once a day.

Use in children from2 to12 years:

Use in children from 6 to 11 years: the recommended dose is 1 dose of 5 ml (5 mg of ebastine) once a day.

Use in children from 2 to 5 years: the recommended dose is 2.5 ml (2.5 mg of ebastine) once a day.

Use in patients with severe liver disease:The dose should not exceed 10 mg of ebastine per day (1 dose of 10 ml).

Method of administration

This medicine is for oral administration.

A measuring cup is included in the package to measure the amount of medicine to be taken. Take the dose and wash the cup after each use.

It can be administered directly or mixed with water.

If you think the effect of Ebastel is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastel than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service, phone 915 620 420 (indicating the medicine and the amount taken), or go to the nearest hospital. Take the bottle and the complete box so that the healthcare staff can more easily identify the medicine you have taken.

Treatment of poisoning with this medicine consists of gastric lavage and administration of appropriate medication.

If you forget to take Ebastel

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow your regular schedule. However, if it is almost time for your next dose, do not take the forgotten dose, and wait for your next scheduled dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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, Ebastel can cause side effects, although not everybody gets them.

The following side effects have been observed in clinical trials and post-marketing experience:

Very common (may affect more than 1 in 10 people):

  • Headache

Common (may affect up to 1 in 10 people):

  • Somnolence
  • Dry mouth

Rare (may affect up to 1 in 1,000 people):

  • Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema)
  • Nervousness, insomnia
  • Dizziness, decreased sensation or sensitivity, decreased or altered taste
  • Palpitations, tachycardia
  • Abdominal pain, vomiting, nausea, digestive problems
  • Hepatitis, cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
  • Urticaria, skin rash, dermatitis
  • Menstrual disorders
  • Edema (swelling due to fluid accumulation), fatigue

Frequency not known (cannot be estimated from the available data):

  • Weight gain
  • Increased appetite

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastel

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Ebastel

  • The active substance is ebastine. Each ml of oral solution contains 1 mg of ebastine.
  • The other ingredients (excipients) are lactic acid (E-270), hydrogenated castor oil, sucralose, anethole, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), glycerol (E-422), 70% sorbitol solution (E-420), simethicone emulsion (purified water, simethicone, polyoxyethylene sorbitan trioleate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glycerol monostearate (E-471), xanthan gum (E-415), benzoic acid (E-210), sulfuric acid (E-513), sorbic acid (E-200)), sodium hydroxide (E-524), and purified water.

Appearance of the product and contents of the pack

Ebastel is a clear, almost colorless liquid with an aniseed odor for oral administration.

Each pack contains a bottle with 120 ml of oral solution and a measuring cup.

Other presentations

Ebastel 10 mg Film-Coated Tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

or

Manufacturer

ALMIRALL HERMAL GMBH Scholtzstrasse 3 D-21465 Reinbek (Germany)

Date of last revision of this leaflet: May 2019

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 EBASTEL 1 mg/ml ORAL SOLUTION

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

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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
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  • 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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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
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Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

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Frequently Asked Questions

Is a prescription required for EBASTEL 1 mg/ml ORAL SOLUTION?
EBASTEL 1 mg/ml ORAL SOLUTION requires 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 EBASTEL 1 mg/ml ORAL SOLUTION?
The active ingredient in EBASTEL 1 mg/ml ORAL SOLUTION is ebastine. This information helps identify medicines with the same composition but different brand names.
How much does EBASTEL 1 mg/ml ORAL SOLUTION cost in pharmacies?
The average pharmacy price for EBASTEL 1 mg/ml ORAL SOLUTION is around 2.64 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EBASTEL 1 mg/ml ORAL SOLUTION?
EBASTEL 1 mg/ml ORAL SOLUTION is manufactured by Almirall S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EBASTEL 1 mg/ml ORAL SOLUTION 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 EBASTEL 1 mg/ml ORAL SOLUTION 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 EBASTEL 1 mg/ml ORAL SOLUTION?
Other medicines with the same active substance (ebastine) include BACTIL 10 mg FILM-COATED TABLETS, BACTIL FLAS 10 mg ORAL LYOPHILIZED, BACTIL FORTE 20 mg FILM-COATED TABLETS. 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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