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EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS

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About the medicine

How to use EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING 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

Patient Information Leaflet

Ebastina Sandoz 10 mg orodispersible tablets EFG

Ebastina Sandoz 20 mg orodispersible tablets EFG

Read 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 symptoms are the same as yours.
  • If you experience 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

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

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

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

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

Ebastina 10 mg tablets are also used in adults over 18 years of age to relieve the symptoms of itching and hives in cases of urticaria (hives).

Doctor consultation

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2. What you need to know before you take Ebastina Sandoz

Do not take Ebastina Sandoz:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebastina Sandoz if:

  • you are already taking certain antibiotics or medicines used to treat fungal infections: see section "Taking Ebastina Sandoz with other medicines"later,
  • you have severely impaired liver function (liver failure).

Children and adolescents

This medicine should only be used in children over 12 years of age. Do not give this medicine to children under 12 years of age as the safety and efficacy in this age group have not been established.

Taking Ebastina Sandoz with other medicines

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

If you take ebastina with erythromycin (an antibiotic), ketoconazole or itraconazole (active substances for the treatment of fungal infections), it may increase the levels of ebastina in your blood.

Taking ebastina and rifampicin (an antitubercular agent) together may lead to a decrease in the levels of ebastina in your blood and therefore a decrease in its effect.

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

Taking Ebastina Sandoz with food and drink

Ebastina Sandoz can be taken with or without food.

Pregnancy, breastfeeding and fertility

There are no sufficient data on the safety of this medicine in human pregnancy. For this reason, ebastina should only be taken during pregnancy if your doctor considers that the benefit outweighs the potential risks.

Do not take ebastina if you are breastfeeding, as it is not known whether the active substance is excreted in 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 taking ebastina can drive or perform other activities that require attention. However, as with other medicines, you should check your individual reaction after taking ebastina before driving or performing complex activities, as some patients may experience drowsiness or dizziness.

Ebastina Sandoz contains lactose, aspartame and sodium.

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

This medicine contains 2.5 mg of aspartame (E951) per 10 mg tablet and 5 mg of aspartame (E951) per 20 mg tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly).

This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet, which is essentially "sodium-free".

3. How to take Ebastina Sandoz

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is:

Indication

Age

Dose

Allergic rhinitis

In case of intense symptoms

Children over 12 years of age and adults

One 10 mg ebastina tablet (10 mg of ebastina) once a day.

Two 10 mg ebastina tablets or one 20 mg ebastina tablet (20 mg of ebastina) once a day.

Urticaria

Adults over 18 years of age

One 10 mg ebastina tablet (10 mg of ebastina) once a day.

In patients with impaired renal function, no dose adjustment is necessary.

In patients with mild or moderate liver impairment, no dose adjustment is necessary.

There is no experience with doses greater than 10 mg in patients with severe liver failure, therefore the dose should not exceed 10 mg in these patients.

Do not press the tablet to remove it from the blister, as it may break.

Each blister contains the tablets separately in separate alveoli separated by a perforation line.

Cut one of the alveoli along the dotted line (Figure 1)

Hand applying a medicinal patch to the skin with a black arrow indicating the direction of application and the number one

Then, carefully remove the aluminum foil, separating it at the corner indicated by an arrow (Figures 2 and 3).

Two fingers holding a device with a button and a black arrow indicating the direction to pressHands holding a white rectangular device with a black arrow pointing upwards number three down

Keep your hands dry to remove the tablet from the alveolus.

Place your tablet on your tongue where it dissolves in a matter of seconds, you do not need to take water or any other liquid.

Ebastina can be taken with or without food.

Your doctor will indicate the duration of the treatment.

If you take more Ebastina Sandoz than you should

There is no specific antidote for the active substance ebastina.

In case of overdose with ebastina, please consult your doctor. Depending on the severity of the poisoning, your doctor will initiate the necessary measures (monitoring of vital functions, including ECG monitoring for at least 24 hours, symptomatic treatment, and gastric lavage) if necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ebastina Sandoz

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

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ebastina Sandoz and contact your doctor immediately or go to the nearest hospital if you experience:

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

Severe allergic reactions with ebastina are rare (may affect up to 1 in 1000 people).

Other side effects include:

Very common side effectsmay affect more than 1 in 10 people

  • headache.

Common side effectsmay affect up to 1 in 10 people

  • drowsiness
  • dry mouth.

Rare side effectsmay affect up to 1 in 1,000 people

  • nervousness, insomnia,
  • dizziness, decreased sense of touch, altered taste,
  • palpitations, rapid pulse,
  • abdominal pain, vomiting, nausea, indigestion,
  • liver inflammation (hepatitis), bile elimination problems (cholestasis), abnormal liver function tests,
  • skin rash, hives, skin inflammation,
  • menstrual disorders,
  • edema (swelling due to fluid accumulation in tissues), weakness (asthenia).

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

5. Storage of Ebastina Sandoz

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 blister and carton after EXP. The expiry date is the last day of the month stated.

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 Sandoz

  • The active substance is ebastina.
    • Ebastina Sandoz 10 mg: each orodispersible tablet contains 10 mg of ebastina.
    • Ebastina Sandoz 20 mg: each orodispersible tablet contains 20 mg of ebastina.
  • The other ingredients are microcrystalline cellulose, lactose monohydrate, corn starch, sodium croscarmellose, aspartame (E951), peppermint flavor, colloidal anhydrous silica, and magnesium stearate.

Appearance and packaging

Orodispersible tablet.

Ebastina Sandoz 10 mg:

White, biconvex, round tablets, approximately 6.7 mm in diameter, marked with "E10" on one face and smooth on the other face.

Ebastina Sandoz 20 mg:

White, biconvex, round tablets, approximately 9.2 mm in diameter, marked with "E20" on one face and smooth on the other face.

The tablets are packaged in OPA/Alu/PVC/Alu blisters packaged in cartons.

Package sizes:

Ebastina Sandoz 10 mg:

10, 20, 30, 40, 50, 90, 98, or 100 orodispersible tablets.

Ebastina Sandoz 20 mg:

10, 15, 20, 30, 40, 50, 98, or 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor, Alcobendas, 28108

Madrid

Spain

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

Belgium:Ebastine Sandoz 10 mg orodispersible tablets

Italy:Ebastina Sandoz

Sweden:Ebastine Sandoz, 10 mg orodispersible tablets

Ebastine Sandoz, 20 mg orodispersible tablets

Date of last revision of this leaflet:August 2020

Detailed 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 EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS

Discuss questions about EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

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.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Doctor

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.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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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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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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Frequently Asked Questions

Is a prescription required for EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS?
EBASTINE SANDOZ 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.
What is the active substance in EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS?
The active ingredient in EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.
How much does EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS cost in pharmacies?
The average pharmacy price for EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS is around 8.79 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS?
EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS is manufactured by Sandoz Farmaceutica S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING 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 EBASTINE SANDOZ 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.
What are the alternatives to EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING 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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