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EBASTEL 10 mg FILM-COATED TABLETS

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About the medicine

How to use EBASTEL 10 mg FILM-COATED TABLETS

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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 10 mg Film-Coated Tablets

ebastina

  • Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
  • Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

  1. What is Ebastel and what is it used for
  2. What you need to know before taking Ebastel
  3. How to take Ebastel
  4. Possible side effects
  5. Storage of Ebastel
  6. Package Contents and Additional Information

1. What is Ebastel and what is it used for

Ebastel belongs to a group of medications 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.

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2. What you need to know before taking Ebastel

Do not take Ebastel

  • if you are allergic to ebastina or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ebastel.

This medication 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" section).
  • if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see "Taking Ebastel with other medications" section).
  • if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

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

Children

Ebastel 10 mg Film-Coated Tablets should not be administered to children under 12 years of age.

Other Medications and Ebastel

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

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

  • Ebastel may increase the effect of other medications 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 ebastina 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 discontinuing treatment.

Taking Ebastel with Food and Drinks

The tablets can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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 unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and Using Machines

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

Ebastel contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Ebastel

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

Ebastel 10 mg Film-Coated Tablets are not suitable for administration of doses less than 10 mg of ebastina or for patients with swallowing problems.

Dosage

Use in Adults and Children over 12 years:The recommended dose is 1 tablet (10 mg of ebastina) once a day.

Use in Patients with Severe Liver Disease:Do not exceed the dose of 10 mg of ebastina per day (1 tablet).

Method of Administration

This medication is for oral administration.

The tablets can be taken with or without food, with the help of a glass of 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 medication and the amount ingested), or go to the nearest hospital. Bring the remaining tablets, the box, and the complete packaging so that the healthcare staff can more easily identify the medication you have taken.

Treatment of poisoning with this medication consists of gastric lavage and administration of the 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 other questions about the use of this medication, ask your doctor or pharmacist.

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4. Possible Side Effects

Like all medications, Ebastel can cause side effects, although not everyone will experience 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):

  • Drowsiness
  • 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 of touch 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 available data):

  • Weight gain
  • Increased appetite

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ebastel

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

Do not store above 30°C.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ebastel

  • The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.
  • The other components (excipients) are: Core of the tablet:microcrystalline cellulose (E-460i), pregelatinized corn starch, lactose monohydrate, sodium croscarmellose (E-468), and magnesium stearate (E-572). Coating:hypromellose (E-464), macrogol 6,000, and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Ebastel is presented in the form of film-coated tablets for oral administration, packaged in PVC/Aluminum blisters. The tablets are circular, white, and marked with E10 on one side.

Each package contains 20 film-coated tablets.

Other Presentations

Ebastel 1 mg/ml Oral Solution

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)

Date of the Last Revision of this Package Leaflet: May 2019

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

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Discuss questions about EBASTEL 10 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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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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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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Experience and qualifications:

  • 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 10 mg FILM-COATED TABLETS?
EBASTEL 10 mg FILM-COATED TABLETS 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 10 mg FILM-COATED TABLETS?
The active ingredient in EBASTEL 10 mg FILM-COATED TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.
How much does EBASTEL 10 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for EBASTEL 10 mg FILM-COATED TABLETS is around 4.4 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EBASTEL 10 mg FILM-COATED TABLETS?
EBASTEL 10 mg FILM-COATED TABLETS is manufactured by Almirall S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EBASTEL 10 mg FILM-COATED TABLETS 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 10 mg FILM-COATED TABLETS 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 10 mg FILM-COATED TABLETS?
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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