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About the medicine

How to use EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS

Contents of the leaflet

  1. Introduction
  2. What is Ebastina Viatris and what is it used for
  3. What you need to know before you take Ebastina Viatris
  4. How to take Ebastina Viatris
  5. Possible side effects
  6. Storage of Ebastina Viatris
  7. Contents of the pack and other information

Introduction

Package Leaflet: Information for the User

Ebastina Viatris 20 mg Oral Dispersible Tablets EFG

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. See section 4.

Contents of the pack and other information

  1. What is Ebastina Viatris and what is it used for
  2. What you need to know before you take Ebastina Viatris
  3. How to take Ebastina Viatris
  4. Possible side effects
  5. Storage of Ebastina Viatris

Contents of the pack and other information

1. What is Ebastina Viatris and what is it used for

Ebastina is an antihistamine that helps to relieve the symptoms of allergy such as sneezing, runny nose, itchy eyes, and itchy skin rashes.

In adults and children aged 12 years and over, ebastina is used to relieve the symptoms of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including cases with allergic conjunctivitis.

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 take Ebastina Viatris

Do not take Ebastina Viatris

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

Warnings and precautions

Consult your doctor before taking Ebastina Viatris

  • If you are already taking certain antibiotics or medicines used to treat fungal infections: see section "Other medicines and Ebastina Viatris" below.
  • If you have severe liver function disorders (liver failure).

Ebastina may cause dry mouth. Therefore, for long-term treatment, good oral hygiene (brushing teeth with fluoride toothpaste twice a day) is important to prevent the risk of caries.

Children and adolescents

This medicine can only be taken by children from 12 years of age. Do not give to children under 12 years of age, as safety and efficacy have not been established in this age group.

Other medicines and Ebastina Viatris

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

Taking ebastina at the same time as erythromycin (an antibiotic) or ketoconazole, itraconazole (active substances for the treatment of fungal infections) may lead to higher levels of ebastina in the blood.

Taking ebastina at the same time as rifampicin (a medicine against tuberculosis) may reduce the levels of ebastina in the blood and, therefore, reduce its effects.

It is not recommended to use ebastina at the same time as clarithromycin or josamycin (antibiotics).

Taking Ebastina Viatris with food and drinks

You can take ebastina independently of meal times.

Pregnancy and breastfeeding

To date, the existing experience regarding safety for the fetus in humans is limited. For this reason, you should only take this medicine during pregnancy if the expected benefit outweighs the possible risks.

Do not take ebastina if you are breastfeeding, as it is not known whether the active substance passes into breast milk.

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.

Driving and using machines

Most patients treated with ebastina can drive or perform other activities that require good reaction ability. However, as with other medicines, you should check your individual reaction after taking ebastina before driving or performing complex activities, as some patients experience drowsiness or dizziness.

Ebastina Viatris contains lactose

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

Ebastina Viatris contains aspartame (E-951)

This medicine contains 5 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly).

3. How to take Ebastina Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Indication

Age

Dose

Allergic rhinitis

In case of severe symptoms

Children aged 12 years and over and adults

One 10 mg ebastina tablet (10 mg of ebastina) per day.

Two 10 mg ebastina tablets or one 20 mg Ebastina Viatris tablet (20 mg of ebastina) per day.

In patients with renal insufficiency, no dose adjustment is necessary.

In patients with mild to moderate liver insufficiency, no dose adjustment is necessary.

There is no experience with doses above 10 mg in patients with severe liver insufficiency, so these patients should not take more than 10 mg per day.

Do not push the tablet out of the blister, as this will crush it.

Each strip contains separate tablets in blisters. Separate one blister with its tablet along the dotted line (Figure 1).

Hand holding a pen injector with a black arrow indicating the direction of insertion into the skin

Carefully remove the blister sheet from the indicated corner (Figures 2 and 3).

Hands holding and pinching the skin to form a fold for injection with an arrow indicating the directionHands holding a circular medicinal patch with a black arrow indicating the direction of application

Keep your hands dry and take the tablet from the strip.

Place the tablet on the tongue where it will disperse in a matter of seconds: no water or other liquid is needed.

You can take ebastina independently of meal times.

Your doctor will decide the duration of treatment.

If you take more Ebastina Viatris than you should

There is no specific antidote for the active substance ebastina.

If you have taken a dose higher than that prescribed by your doctor or in case of overdose, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used. Depending on the severity of the poisoning, they will initiate the necessary measures (control of the body's vital functions, including ECG monitoring for at least 24 hours, symptomatic treatment, and gastric lavage), if necessary.

If you forget to take Ebastina Viatris

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, 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, this medicine can cause side effects, although not everybody gets them.

Stop taking ebastina and contact your doctor immediately or go to the nearest hospital if the following occurs:

  • Severe allergic reaction that causes swelling of the face, tongue, or throat and may cause difficulty swallowing or breathing.

Other side effects include:

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

  • Headache.

Common (may affect up to 1 in 10 people)

  • Somnolence.
  • Dry mouth.

Uncommon (may affect up to 1 in 100 people)

  • Sore throat (pharyngitis), nasal discharge (rhinitis), nosebleeds.

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

  • Nervousness, insomnia.
  • Abnormal or decreased sense of touch.
  • Taste disorders.
  • Palpitations, rapid pulse.
  • Abdominal pain, nausea, indigestion.
  • Vomiting.
  • Abnormal liver function test.
  • Liver inflammation.
  • Bile flow disorders causing itching, yellow eyes, and skin.
  • Rash, annoying rash, skin inflammation.
  • Menstrual disorders.
  • Edema (water retention in tissues), weakness (asthenia).
  • Dizziness.

Very rare(may affect up to 1 in 10,000 people)

  • Hives, eczema.
  • Painful menstruation.

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

  • Increased appetite.
  • Weight gain.

Reporting of side effects

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

5. Storage of Ebastina Viatris

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

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

Store in the original package to protect from light.

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 other information

Composition of Ebastina Viatris

The active substance is ebastina. Each dispersible tablet contains 20 mg of ebastina.

The other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch, sodium croscarmellose, aspartame (E-951), peppermint flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance and packaging of the product

Oral dispersible tablets.

White, biconvex, round tablets, engraved with "E20" on one face and flat on the other.

Available pack sizes:

Continuous blisters containing 10, 15, 20, 30, 40, 50, 98, and 100 oral dispersible tablets.

Perforated unit dose blisters containing 10, 15, 20, 30, 40, 50, 98, and 100 oral dispersible tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

4042 Debrecen

Hungary

or

Teva Pharma, S.L.U.

C/ C, 4 - Polígono Industrial Malpica

50016 – Zaragoza

Spain

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain Ebastina Viatris 20 mg oral dispersible tablets EFG

Italy Ebastina Mylan Pharma

Sweden Ebastine Generics 20 mg oral dispersible tablets

Date of last revision of this leaflet:November 2020

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

  • EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS
    Image: AEMPS – CIMA
  • Country of registration
  • Dosage form
    ORALLY DISINTEGRATING TABLET/LIOTAB, 20 mg
  • ATC code
    R06AX22
  • Average pharmacy price
    8.79 EUR
  • Active substance
  • Prescription required
    Yes
  • Manufacturer
  • Composition
    LACTOSA MONOHIDRATO (59,4 mg mg), CROSCARMELOSA SODICA (30,0 mg mg), ASPARTAMO (E-951) (5,0 mg mg)
  • Alternatives to EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS
    Dosage form: TABLET, 10 mg ebastine
    Active substance: ebastine
    Prescription not required
    Dosage form: ORALLY DISINTEGRATING TABLET/LIOTAB, 10 mg
    Active substance: ebastine
    Prescription not required
    Dosage form: TABLET, 20 mg ebastine
    Active substance: ebastine
    Prescription not required

Online doctors for EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS

Discuss questions about EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS, including use, safety considerations and whether a prescription is appropriate, subject to medical assessment and local regulations.

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5.0(6)

Jorge Correa Bellido

General medicine7 years of experience
Licence no. 464626297

Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

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Book a video appointment
€86
Doctor

Chikeluo Okeke

General medicine4 years of experience

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

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Nuno Tavares Lopes

General medicine18 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

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Lina Travkina

General medicine13 years of experience

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.Areas of medical care include:

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4.7(11)

Anastasiia Shalko

General medicine13 years of experience
Licence no. 52891

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

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5.0(1)

Tomasz Grzelewski

DermatologyAllergology21 years of experience

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: 

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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.

Book a video appointment
€106

Frequently Asked Questions

EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.

The average pharmacy price for EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS is around 8.79 EUR. Prices may vary depending on the manufacturer and dosage form.

EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS is manufactured by Viatris Limited. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Family doctors, Pulmonologists, Allergists, ENT doctors, General medicine doctors, Anaesthesiologists may assess whether EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

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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