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EBASTINE ARISTO 10 mg ORALLY DISINTEGRATING TABLETS

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About the medicine

How to use EBASTINE ARISTO 10 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 10 mg Orodispersible Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Ebastina Aristo is a medicine 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.
Doctor consultation

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

Do not take Ebastina Aristo:

  • If you are allergic to ebastine, menthol (an ingredient of the peppermint flavor) or any of the other components of this medicine (listed in section 6).
  • Ebastina Aristo 10 mg orodispersible tablets should not be administered in the treatment of urticaria in adolescents under 18 years of age, as there is limited experience in this age group, and no experience in children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking 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, itraconazole) or antituberculars (e.g., rifampicin).
  • If you have severe liver failure.

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 medicines and Ebastina Aristo

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

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 levels in the blood. Compared to the administration of ketoconazole or erythromycin alone, more noticeable changes may occur in your electrocardiogram (an increase in the QTc interval prolongation of approximately 10 mseg).

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

No interactions were observed with 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 concentration in the blood 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

To date, there are no data on human fetal safety. 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 possible risk.

Breastfeeding

You should not take Ebastina Aristo during breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines

Most patients treated with Ebastina Aristo may drive or perform activities that require a good reaction capacity. However, you should check how you react 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 contain Aspartame (E951)

This medicine contains0.53 mg of aspartame in each 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 contains less than 1 mmol (23 mg) of sodium per orodispersible tablet; i.e., it is essentially “sodium-free”.

3. How to take Ebastina Aristo

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

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

Indication

Age

Dose

Allergic rhinitis

In case of severe symptoms

Children from 12 years of age and adults

10 mg of ebastine once a day

20 mg of ebastine once a day

In perennial allergic rhinitis

Children from 12 years of age and adults

10 - 20 mg of ebastine once a day

Urticaria

In case of severe symptoms

Adults over 18 years of age

10 mg of ebastine once a day

20 mg of ebastine once a day

Patient with liver failure

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

Patient with renal failure

In patients with reduced 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 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 medicine.

Duration of treatment

Your doctor will decide the duration of the 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 medicine 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 reappear.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

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 sense of touch or sensitivity, altered taste
  • Palpitations, rapid heartbeat
  • 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 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 Vigilance System for Human Use, Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastina Aristo

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

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

Storage conditions

Store in the original package to protect the medicine 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 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.

Appearance of the product and pack contents

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

Packs of 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 medicine 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 medicine 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 last revision of this leaflet: September 2024

Detailed and updated 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 ARISTO 10 mg ORALLY DISINTEGRATING TABLETS

Discuss questions about EBASTINE ARISTO 10 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 10 mg ORALLY DISINTEGRATING TABLETS?
EBASTINE ARISTO 10 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 10 mg ORALLY DISINTEGRATING TABLETS?
The active ingredient in EBASTINE ARISTO 10 mg ORALLY DISINTEGRATING TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.
How much does EBASTINE ARISTO 10 mg ORALLY DISINTEGRATING TABLETS cost in pharmacies?
The average pharmacy price for EBASTINE ARISTO 10 mg ORALLY DISINTEGRATING TABLETS is around 4.4 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EBASTINE ARISTO 10 mg ORALLY DISINTEGRATING TABLETS?
EBASTINE ARISTO 10 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 10 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 10 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 10 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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