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EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS

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About the medicine

How to use EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS

Translated with AI

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

Ebastine Qualigen 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

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

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

Ebastine, the active ingredient of Ebastine Qualigen, belongs to a group of medicines called antihistamines. Ebastine Qualigen does not have sedative effects or potentiate the effects of alcohol.

Ebastine Qualigen is indicated for the treatment of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, itching of the nose, itching of the eyes, tearing, sneezing), chronic urticaria, and allergic dermatitis.

Doctor consultation

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2. What you need to know before you take Ebastine Qualigen

Do not take Ebastine Qualigen

  • If you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
  • If you have severe hepatic insufficiency (see warnings).
  • It should not be administered to children under 12 years of age, as its safety has not been established at these ages.

Warnings and precautions

Consult your doctor or pharmacist before taking Ebastine Qualigen:

  • If you have an acute allergic emergency, as Ebastine Qualigen takes 1 to 3 hours to take effect.
  • Due to the content of ebastine, it is advised not to perform skin allergy tests until 5-7 days have passed since the treatment was interrupted. Treatment with antihistamines may interfere with the results of these tests.
  • It may potentiate the effects of other antihistamines.
  • In patients with mild or moderate hepatic insufficiency, it is not necessary to adjust the dose. In patients with severe hepatic insufficiency, the dose of 10 mg/day of ebastine should not be exceeded, so it is recommended to use Ebastina Qualigen 10 mg tablets.

Other medicines and Ebastine Qualigen

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Ebastine may interact with erythromycin (an antibiotic) or ketoconazole (a medicine for the treatment of fungal infections).

Taking Ebastine Qualigen with food and drinks

The tablets 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 medicine.

There is no experience in pregnant women, so it is recommended to consult with a doctor before taking this medicine.

It is not known whether the medicine passes into breast milk.

Driving and using machines

In humans, no effects on psychomotor function or the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, observe your response to the medication because in some cases, somnolence has occurred at usual doses. If this happens, refrain from driving and operating hazardous machinery.

Ebastine Qualigen contains sodium

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

3. How to take Ebastine Qualigen

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

Your doctor will indicate the duration of your treatment with Ebastine Qualigen. Do not stop treatment before, as your symptoms may worsen.

Remember to take your medicine.

The recommended dose in adults and children over 12 years of age is 1 tablet (20 mg) once a day.

The Ebastina Qualigen tablets are for oral administration. The tablets should be swallowed whole, without chewing, with the help of a glass of liquid, preferably water.

If you think the effect of Ebastine Qualigen is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine Qualigen than you should

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.

Medicine questions

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If you forget to take Ebastine Qualigen

In case of forgetting a dose, wait for the next one.

Do not take a double dose to make up for forgotten doses.

If you stop taking Ebastine Qualigen

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

4. Possible side effects

Like all medicines, Ebastine Qualigen can cause side effects, although not everybody gets them.

In the studies carried out, this medicine was well tolerated. The adverse reactions were mild or moderate, transient, and resolved spontaneously without specific treatment.

The side effects described are the following:

Common (may affect up to 1 in 10 people):

  • somnolence,
  • dry mouth,
  • headache,
  • pharyngitis,
  • rhinitis,
  • fatigue.

Uncommon (may affect up to 1 in 100 people):

  • abdominal pain,
  • digestive disorders,
  • nasal bleeding,
  • sinusitis,
  • nausea,
  • insomnia.

Frequency not known (cannot be estimated from the available data):

  • weight gain,
  • increased appetite.

If you notice any side effects not mentioned in this leaflet or if you suffer from one of the side effects described in a severe form, tell your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Qualigen

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Ebastine Qualigen after the expiry date stated on the pack. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the empty pack and any unused medicine in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastine Qualigen

  • The active ingredient is Ebastine. Each tablet contains 20 mg of ebastine.
  • The other ingredients are microcrystalline cellulose (E-460i), stearyl macrogol glyceride, sodium starch glycolate (from potato), magnesium stearate (E-572), purified water, and white opadry [hydroxypropyl methyl cellulose (E-464), polyethylene glycol (E-1521), titanium dioxide (E-171)].

Appearance of the product and pack contents

The Ebastine Qualigen 20 mg tablets are white and round.

The packs contain 20 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Generis Farmacêutica, S.A.

Rua João de Deus nº 19, Venda Nova

2700-487 Amadora (Portugal)

Date of last revision of this leaflet:May 2021

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 QUALIGEN 20 mg FILM-COATED TABLETS

Discuss questions about EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Yevgen Yakovenko

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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.
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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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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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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:

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Endocrinology – Diabetes, thyroid, metabolism:
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  • Individual treatment plans including oral medications and insulin therapy.
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Gastroenterology – Digestive health:
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  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
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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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Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
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  • 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.
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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.

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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.
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  • 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.
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  • 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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Alexander Nazarchuk

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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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Marta Reguero Capilla

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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;
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  • interpretation of laboratory tests, allergy testing, and immunology results;
  • immune system concerns, frequent infections, and reduced immune response;
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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 QUALIGEN 20 mg FILM-COATED TABLETS?
EBASTINE QUALIGEN 20 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 QUALIGEN 20 mg FILM-COATED TABLETS?
The active ingredient in EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.
How much does EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS is around 8.79 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS?
EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS is manufactured by Neuraxpharm Spain S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EBASTINE QUALIGEN 20 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 QUALIGEN 20 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.
What are the alternatives to EBASTINE QUALIGEN 20 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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