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EBASTINE QUALIGEN 10 mg FILM-COATED TABLETS

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About the medicine

How to use EBASTINE QUALIGEN 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 User

Ebastina Qualigen 10 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

  • 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 and should not be given to others, even if they have the same symptoms, 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 Qualigen and what is it used for
  2. What you need to know before taking Ebastina Qualigen
  3. How to take Ebastina Qualigen
  4. Possible side effects
  5. Storage of Ebastina Qualigen
  6. Contents of the pack and further information

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

Ebastina, the active ingredient of Ebastina Qualigen, belongs to a group of medications called antihistamines.

Ebastina 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.

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2. What you need to know before taking Ebastina Qualigen

Do not take Ebastina Qualigen

  • If you are allergic to ebastina or any of the other components of this medication (listed in section 6).
  • It should not be administered to children under 6 years of age, as its safety has not been established at these ages.

Warnings and Precautions

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

  • If you have an acute allergic emergency, as Ebastina Qualigen takes 1 to 3 hours to take effect.
  • Ebastina Qualigen may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days have passed since the treatment was discontinued.
  • 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 ebastina should not be exceeded.

Other Medications and Ebastina Qualigen

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

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

Taking Ebastina 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 medication.

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

It is unknown whether the medication passes into breast milk.

Driving and Using Machines

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

Ebastina Qualigen Contains Sodium

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

3. How to Take Ebastina Qualigen

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.

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

Remember to take your medication.

The recommended dose in adults and children over 12 years of age is 1 tablet (10 mg) once a day.

Use in Children

In children between 6 and 11 years of age, the normal recommended dose is half a tablet (5 mg) once a day.

The tablets of Ebastina Qualigen 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 Ebastina Qualigen is too strong or too weak, inform your doctor or pharmacist.

If You Take More Ebastina 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 medication and the amount ingested.

If You Forget to Take Ebastina Qualigen

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

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

If You Interrupt Treatment with Ebastina Qualigen

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

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4. Possible Side Effects

Like all medications, Ebastina Qualigen can cause side effects, although not everyone will experience them.

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

The side effects described in adults and children over 12 years of age are as follows:

Frequent (may affect 1 to 10 in every 100 patients):

  • headache,
  • sleepiness,
  • dry mouth.

Uncommon (may affect 1 to 10 in every 1000 patients):

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

In children under 12 years of age, the adverse events described are as follows:

Frequent (may affect 1 to 10 in every 100 patients):

  • headache,
  • dry mouth,
  • sleepiness.

Uncommon (may affect 1 to 10 in every 1000 patients):

  • increased appetite,
  • diarrhea,
  • skin rash,
  • nervousness,
  • affective imbalance,
  • excessive mobility,
  • taste disorders,
  • fatigue.

Frequency Not Known (cannot be estimated from the available data):

  • weight gain,
  • increased appetite.

If you notice side effects not mentioned in this package leaflet or if you experience any of the side effects described in a severe form, inform 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 is not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ebastina Qualigen

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Ebastina Qualigen after the expiration date stated on the packaging. 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 medications you no longer need at the SIGRE Point in your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Ebastina Qualigen

  • The active ingredient is Ebastina. Each tablet contains 10 mg of ebastina.
  • The other components are: microcrystalline cellulose (E-460i), stearoyl 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 Contents of the Pack

The tablets of Ebastina Qualigen 10 mg are oval with a score line and white in color.

The packaging contains 20 tablets.

Marketing Authorization Holder and Manufacturer

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 the Last Revision of this Package Leaflet:May 2021

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 QUALIGEN 10 mg FILM-COATED TABLETS

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

5.0 (140)
Doctor

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.

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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  • 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.
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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:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • 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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  • Lab test analysis, therapy adjustments, medication management.
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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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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.

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.

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Svetlana Kolomeeva

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Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

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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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

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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Marta Reguero Capilla

Allergology 8 years exp.

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;
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  • 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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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 10 mg FILM-COATED TABLETS?
EBASTINE QUALIGEN 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 QUALIGEN 10 mg FILM-COATED TABLETS?
The active ingredient in EBASTINE QUALIGEN 10 mg FILM-COATED TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.
How much does EBASTINE QUALIGEN 10 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for EBASTINE QUALIGEN 10 mg FILM-COATED TABLETS is around 4.4 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EBASTINE QUALIGEN 10 mg FILM-COATED TABLETS?
EBASTINE QUALIGEN 10 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 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 QUALIGEN 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.
What are the alternatives to EBASTINE QUALIGEN 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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