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EBASTINE ARISTO 20 mg ORALLY DISINTEGRATING TABLETS

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About the medicine

How to use EBASTINE ARISTO 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

Package Leaflet: Information for the User

Ebastina Aristo 20 mg Orodispersible 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 the Package Leaflet:

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

Ebastina Aristo is a medication that relieves the symptoms of allergic reactions (antiallergics/antihistamines).

Ebastina Aristo is indicated:

  • For the treatment of symptoms of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis.
  • To relieve itching and the formation of hives in urticaria of unknown origin.

2. What you need to know before taking Ebastina Aristo

Do not take Ebastina Aristo:

  • If you are allergic to ebastine, menthol (an ingredient in the peppermint flavor aroma) or any of the other components of this medication (listed in section 6).
  • Ebastina Aristo should not be used to treat urticaria in adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ebastina Aristo:

Special care is required when taking ebastine:

  • If you have low potassium levels in your blood.
  • In case of certain alterations in your electrocardiogram (ECG) (known prolongation of the QTc interval), which may occur in some types of heart diseases.
  • If you are concomitantly using certain antibiotics (such as erythromycin) or medications to treat fungal infections (such as ketoconazole or itraconazole) or antitubercular agents (e.g., rifampicin).
  • If you have severe liver impairment.

In some patients, prolonged treatment with ebastine may increase the risk of dental caries due to dry mouth. Therefore, the patient's oral hygiene is very important.

Other medications and Ebastina Aristo

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

Concomitant administration of ebastine (the active substance of Ebastina Aristo) and certain antibiotics (such as erythromycin) or medications used to treat fungal infections (such as ketoconazole or itraconazole) may increase ebastine blood levels. Compared to the administration of ketoconazole or erythromycin alone, more noticeable changes may occur in your electrocardiogram (approximately 10 mseg increase in QTc interval prolongation).

Concomitant administration of ebastine with rifampicin (an active principle for the treatment of tuberculosis) may cause a reduction in ebastine blood levels, thereby decreasing its effect.

No interactions were observed between ebastine and

  • Theophylline (an active principle for the treatment of asthma),
  • Warfarin (an anticoagulant),
  • Cimetidine (an active principle for the treatment of gastric ulcers),
  • Diazepam (an active principle for the treatment of anxiety and tension), or
  • Alcohol.

Taking Ebastina Aristo with food and drinks

When Ebastina Aristo is taken with food, it increases the blood concentration of the active metabolite of ebastine (carebastine). However, this does not affect the clinical efficacy.

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

To date, there are no human fetal safety data available. For this reason, during pregnancy, Ebastina Aristo should only be taken if your doctor recommends it, considering that the expected benefit is greater than the potential risk.

Breastfeeding

Do not take Ebastina Aristo during breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and using machines

Most patients treated with Ebastina Aristo may drive or perform activities that require good reaction capacity. However, you should check how you react individually to Ebastina Aristo before driving or performing complex activities to identify any unusual reactions.

You may feel drowsy or dizzy. Also, read section 4, "Possible side effects”.

Ebastina Aristo orodispersible tablets containAspartame (E951)

This medication contains1.06 mg of aspartame per orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Ebastina Aristo contains Sodium

Ebastina Aristo contains less than 1 mmol (23 mg) of sodium per orodispersible tablet; it is essentially "sodium-free”.

Medicine questions

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3. How to take Ebastina Aristo

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

Unless your doctor prescribes otherwise, the recommended dose in adults and children over 12 years is:

Indication

Age

Dose

Allergic rhinitis

In case of severe symptoms

Children over 12 years and adults

10 mg ebastine once a day*

20 mg ebastine once a day

In perennial allergic rhinitis

Children over 12 years and adults

10 - 20 mg ebastine once a day

Urticaria

In case of severe symptoms

Adults over 18 years

10 mg ebastine once a day*

20 mg ebastine once a day

  • For this dose, the 10 mg Ebastina Aristo presentation is available.

Patient with liver impairment

No dose adjustment is required in patients with mild to moderate liver impairment. In patients with severe liver impairment, the dose should not exceed 10 mg of ebastine.

Patient with renal impairment

In patients with decreased renal function, no dose adjustment is necessary for treatments of up to 5 days.

Method of administration

Ebastina Aristo can be taken with or without food.

Remove the tablet from the packaging just before taking it. With dry hands, press the orodispersible tablet to remove it from the blister pack and place the tablet on the tongue. The tablet will dissolve directly in the mouth and can be easily swallowed. It is not necessary to drink water or other liquids to take this medication.

Duration of treatment

Your doctor will decide the duration of treatment.

Consult your doctor if you think the effects of Ebastina Aristo are too strong or too weak.

If you take more Ebastina Aristo than you should

No specific antidote is known for ebastine.

In case of overdose of Ebastina Aristo, consult your doctor immediately. Depending on the severity of the poisoning, your doctor will take the necessary measures (monitoring of vital signs, including ECG with evaluation of the QT interval 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ebastina Aristo

Do not take a double dose to make up for forgotten doses. Continue treatment as usual.

If you stop taking Ebastina Aristo

If you stop or interrupt treatment prematurely, it is possible that the symptoms of your disease may recur.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Possible side effects

The following side effects have been reported very frequently (may affect more than 1 in 10 people):

  • Headache

The following side effects have been reported frequently (may affect up to 1 in 10 people):

  • Dry mouth
  • Drowsiness

The following side effects have been reported rarely (may affect up to 1 in 1,000 people):

  • Allergic reactions (such as anaphylaxis (a severe and potentially life-threatening allergic reaction that requires immediate medical attention) and swelling, for example, of the throat, lips, or hands (angioedema))
  • Nervousness, insomnia
  • Dizziness, decreased sensation of touch or sensitivity, altered taste
  • Palpitations, rapid pulse
  • Abdominal pain, vomiting, nausea, dyspepsia
  • Liver disorders, 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 of 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, Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ebastina Aristo

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

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.

Storage conditions

Store in the original packaging to protect the medication from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ebastina Aristo

The active substance is ebastine.

  • 1 orodispersible tablet contains 10 mg of ebastine.
  • The other ingredients are mannitol (Ph.Eur), cornstarch, colloidal silicon dioxide, sodium stearyl fumarate (Ph. Eur.), aspartame (E951), peppermint flavor aroma.

Appearance of the product and packaging contents

Ebastina Aristo orodispersible tablets are white and round, in Alu-PVC/PVDC blisters.

Packaging with 10, 20, 30, 50, or 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10

13435 Berlin, Germany

Manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/Solana, 26, Torrejón de Ardoz,

28850 Madrid, Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Germany

Ebastin Aristo 10/20 mg Orodispersible Tablets

Denmark

Ebastin "Aristo" 10/20 mg Orodispersible Tablets

Spain

Ebastina Aristo 10/20 mg Orodispersible Tablets EFG

Italy

Ebaric 10/20 mg Orodispersible Tablets

Date of the last revision of this package leaflet:September 2024

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/

Online doctors for EBASTINE ARISTO 20 mg ORALLY DISINTEGRATING TABLETS

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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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  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
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  • 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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Doctor

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
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • 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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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).
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  • 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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Doctor

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.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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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.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

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You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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Frequently Asked Questions

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