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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

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

5.0 (25)
Doctor

Lina Travkina

Family medicine 13 years exp.

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:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55

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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