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EBASTINE SANDOZ 10 mg FILM-COATED TABLETS

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About the medicine

How to use EBASTINE SANDOZ 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

Ebastine Sandoz 10 mg film-coated tablets EFG

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 you should not give it 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. See section 4.

Contents of thepackage leaflet:

  1. What is Ebastine Sandoz and what is it used for
  2. What you need to know before taking Ebastine Sandoz
  3. How to take Ebastine Sandoz
  4. Possible side effects
  5. Storage of Ebastine Sandoz
  6. Package contents and additional information

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

Ebastine belongs to a group of medications called antihistamines (antiallergics).

Ebastine is indicated for the symptomatic treatment 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,
  • allergic dermatitis.

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2. What you need to know before taking Ebastine Sandoz

Do not take Ebastine Sandoz

  • if you are allergic to ebastine 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 ebastine:

  • if your electrocardiogram results are altered (prolongation of the QT interval),
  • if you have high potassium levels in your blood,
  • if you have a severe liver disease (see section "How to take Ebastine Sandoz"),
  • 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 section "Taking Ebastine Sandoz with other medications"),
  • 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 ebastine (the active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastine should not be administered to children under 12 years of age.

Taking Ebastine Sandoz with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The following medications may interfere with ebastine, and it may be necessary to change the dose or discontinue treatment with one of them:

  • ebastine may increase the effect of other medications used to treat allergies (antihistamines),
  • ebastine 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 ebastine 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

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

Taking Ebastine Sandoz with food and beverages

This medication 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 ebastine. The doctor will decide whether to start treatment or not.

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 machines 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 machines.

Ebastine Sandoz 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.

3. How to take Ebastine Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

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

Ebastine is not suitable for administration of doses less than 10 mg or for patients with swallowing problems.

Dosage

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

Use in patients with severe liver disease:do not exceed the dose of 10 mg of ebastine 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 ebastine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the box, and the complete packaging so that the healthcare personnel 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 Ebastine Sandoz

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 the 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, this medication 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 or sensitivity, decreased or altered taste,
  • palpitations, tachycardia,
  • abdominal pain, vomiting, nausea, digestive problems,
  • liver inflammation (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 or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ebastine Sandoz

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the box 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 SIGRE collection point at your pharmacy. If you have any doubts, 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 Ebastine Sandoz

  • The active ingredient is ebastine. Each tablet contains 10 mg of ebastine.
  • The other components (excipients) are:

Core: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate,

Coating: hypromellose, titanium dioxide, glycerol triacetate

Appearance of the product and package contents

Ebastine Sandoz is presented in the form of white, lenticular-shaped film-coated tablets. It is packaged in PVC/Aluminum blister packs containing 20 tablets of 10 mg.

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

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the last revision of this package leaflet: May 2019.

Detailed information about this medication 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 10 mg FILM-COATED TABLETS

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

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Maria Martelli

Anaesthesiology 12 years exp.

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  • Chronic pain lasting more than 3 months (musculoskeletal, neuropathic, mixed pain).
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  • Post-operative pain and recovery support.
  • Cancer-related pain and symptom relief.
  • Palliative care support and quality-of-life improvement.
  • Adjustment and optimisation of pain medication.
  • Second opinions for complex or treatment-resistant pain.

Dr Martelli takes a structured, evidence-based approach, carefully analysing symptoms, previous treatments, and overall health status. Her consultations focus on realistic pain control goals, safety of therapy, and improving daily functioning. She is especially attentive to patients living with long-term pain or serious illness, providing clear explanations, compassionate guidance, and medically sound recommendations adapted to each individual situation.

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Sviatoslav Chekhun

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Dr. Sviatoslav Chekhun is a medical oncologist with international clinical and research experience, specializing in modern medical oncology and a personalized approach to cancer treatment.

Currently (since 2025), he works as a Medical Oncologist at Institut Català d’Oncologia (Girona, Spain). Previously, he completed his residency in Medical Oncology and was involved in clinical research at Hospital Universitari Germans Trias i Pujol.

Dr. Chekhun has a strong academic and scientific background. He served as a lecturer in Internal Medicine at O.O. Bohomolets National Medical University and conducted research in experimental oncology at the R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology.

Earlier in his career, he worked as a medical oncologist at the Kyiv City Clinical Oncological Center and contributed to regulatory evaluation of medicinal products at the State Expert Center of the Ministry of Health of Ukraine.

When to consult Dr. Chekhun:

  •  for diagnosis or clarification of a cancer diagnosis
  •  to obtain a second opinion on an existing treatment plan 
  •  when you need a personalized treatment strategy 
  •  for interpretation of test results, CT, MRI, PET-CT, and biopsies 
  •  when choosing between treatment options (chemotherapy, targeted therapy, immunotherapy) 
  •  in case of doubts about treatment strategy or disease progression 

Consultation format

Dr. Chekhun provides online consultations, where you can receive:

  •  expert second opinion 
  •  detailed case review 
  •  recommendations based on current international treatment guidelines 
  •  personalized treatment and follow-up plan 

Important:
Prescription and monitoring of medications must be carried out by your treating physician in an in-person (offline) setting. An online consultation does not replace a face-to-face visit but helps you make more informed decisions about your treatment.

Dr. Sviatoslav Chekhun combines clinical practice, research, and international experience, enabling him to provide patients with modern, evidence-based approaches in oncology.

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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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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.

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  • Mood disorders: depression, bipolar disorder, postpartum depression.
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  • Post-traumatic stress disorder (PTSD) and complex PTSD.
  • Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Assessment is provided only after an initial psychiatric evaluation and during a follow-up appointment.
  • Personality disorders and emotional instability.
  • Cyclothymia and mood fluctuations.
  • Schizophrenia spectrum and related conditions.

Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders. She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

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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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Frequently Asked Questions

Is a prescription required for EBASTINE SANDOZ 10 mg FILM-COATED TABLETS?

EBASTINE SANDOZ 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 EBASTINE SANDOZ 10 mg FILM-COATED TABLETS?

The active ingredient in EBASTINE SANDOZ 10 mg FILM-COATED TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.

How much does EBASTINE SANDOZ 10 mg FILM-COATED TABLETS cost in pharmacies?

The average pharmacy price for EBASTINE SANDOZ 10 mg FILM-COATED TABLETS is around 4.4 EUR. Prices may vary depending on the manufacturer and dosage form.

Who manufactures EBASTINE SANDOZ 10 mg FILM-COATED TABLETS?

EBASTINE SANDOZ 10 mg FILM-COATED 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 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 EBASTINE SANDOZ 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.

How to buy EBASTINE SANDOZ 10 mg FILM-COATED TABLETS in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy EBASTINE SANDOZ 10 mg FILM-COATED TABLETS in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to EBASTINE SANDOZ 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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