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About the medicine

How to use BETAHISTINE QUALIGEN 16 mg TABLETS

Contents of the leaflet

  1. Introduction
  2. What is Betahistina Qualigen and what is it used for
  3. Before taking Betahistina Qualigen
  4. How to take Betahistina Qualigen
  5. Possible side effects
  6. Storage of Betahistina Qualigen
  7. Contents of the pack and other information

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Betahistina Qualigen 16mg tablets EFG

Dihydrochloride of betahistine

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 symptoms are the same as yours.
  • If you experience 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 Betahistina Qualigen and what is it used for
  2. What you need to know before you take Betahistina Qualigen
  3. How to take Betahistina Qualigen
  4. Possible side effects
  5. Storage of Betahistina Qualigen
  6. Contents of the pack and other information

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

Betahistina Qualigen belongs to a group of medicines called anti-vertigo preparations.

Betahistina Qualigen is used for the treatment of Meniere's Syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and tinnitus (ringing in the ears).

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Before taking Betahistina Qualigen

Do not take Betahistina Qualigen:

  • if you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6).
  • if you have a disease called pheochromocytoma.

Warnings and precautions

  • Tell your doctor or pharmacist before you start taking Betahistina Qualigen: if you have bronchial asthma,
  • if you have or have had stomach ulcers.

Other medicines and Betahistina QualigenTell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

No interactions between betahistine and other medicines are known to date.

Taking Betahistina Qualigen with food and drinks:

Food does not affect the effect of Betahistina Qualigen, so it can be taken before, during, or after meals.

If stomach upset occurs, it is recommended to take Betahistina Qualigen during meals.

Children and adolescentsThe use in children under 18 years is not recommended.

Pregnancy and lactation

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. Betahistina Qualigen should not be taken during pregnancy, unless your doctor considers it necessary.

Betahistina Qualigen should not be taken during breastfeeding.

Driving and using machines

Betahistina Qualigen does not affect your ability to drive or use machines.

Betahistina Qualigen contains lactose:This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Betahistina Qualigen

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

Remember to take your medicine.

The effect of the medicine usually does not manifest until after a few weeks.

The dose varies depending on the person and how they respond to treatment. However, a initial dose of 16 mg (1 tablet) three times a day is generally recommended, which means a maximum daily dose of 48 mg (3 tablets) divided into 3 doses.

Depending on your response, your doctor will indicate the maintenance dose.

The tablets can be taken with meals.

You should take Betahistina Qualigen for as long as your doctor recommends, so do not interrupt treatment before, as the expected results will not be obtained.

The score line is only for breaking the tablet if you find it difficult to swallow whole.

If you take more Betahistina Qualigen than you should:

Consult your doctor, pharmacist, or go to the nearest hospital immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91.562.04.20

In case you take more Betahistina Qualigen than you should, it is recommended to provide symptomatic treatment since there is no specific antidote.

If you forget to take Betahistina Qualigen:

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, wait until the next dose and continue with the normal treatment.

If you stop taking Betahistina Qualigen:

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.

Frequent side effects (at least 1 in 100 patients) are nausea and dyspepsia.

In some cases (the frequency of these side effects is not known), anaphylaxis (severe general allergic reaction) has been reported.

In some cases (the frequency of these side effects is also not known), mild stomach upset, such as vomiting, stomach pain, and abdominal bloating, have occurred, which can be alleviated by taking the medicine with meals.

Very rarely, allergic skin reactions such as angioedema (a short, violent form of edema), itching, urticaria (skin rash), and rash (generalized skin rash and itching) have been observed.

If you think any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistina Qualigen

Keep this medicine out of the sight and reach of children. Store below 25°C.

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.

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 Betahistina Qualigen 16mg tablets

  • The active substance is betahistine in the form of dihydrochloride of betahistine.
  • The other ingredients are: povidone K90 (E-1201), microcrystalline cellulose (E-460i), lactose monohydrate, colloidal anhydrous silica, crospovidone, and stearic acid (E-570).

Appearance and packaging

Betahistina Qualigen 16 mg is presented in the form of white, round, biconvex tablets, marked with B16 on one side and scored on the other.

Each pack contains 30 tablets.

Other presentations

Betahistina Qualigen 8 mg tablets Packs of 60 tablets.

Marketing authorisation holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

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 BETAHISTINE QUALIGEN 16 mg TABLETS

Discuss questions about BETAHISTINE QUALIGEN 16 mg TABLETS, including use, safety considerations and whether a prescription is appropriate, subject to medical assessment and local regulations.

Doctor

Svitlana Medvedkova

Neurology23 years of experience

Neurologist of the highest qualification category, Doctor of Medical Sciences and Professor, with 23 years of clinical experience and 19 years of teaching experience. Areas of expertise include general neurology, physical and rehabilitation medicine, and medical psychology.

Conditions and areas of care:

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The doctor follows an evidence-based approach and has participated in international clinical research (GCP) for over 20 years. Their work includes developing personalised prevention, rehabilitation and cognitive programmes.

Consultation format: online consultations and remote follow-up care.

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Doctor
5.0(7)

Anastasiia Hladkykh

Psychiatry15 years of experience

Dr Anastasiia Hladkykh is a physician-psychotherapist and psychologist with over 14 years of experience working with individuals struggling with various types of addictions and their families. She provides online consultations for adults, combining medical knowledge with deep psychological support and practical tools.

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Doctor

Elizaveta Marinicheva

Psychiatry5 years of experience

Elizaveta Marinicheva is a psychiatrist who has been practising since 2022. She received her medical degree from the University of Milan (Università degli Studi di Milano, UNIMI) and holds official authorisation to practise medicine in Italy (Abilitazione all'esercizio della professione medica). She is a member of the Milan Medical Association (Ordine dei Medici di Milano).

She is currently completing her specialist training in psychiatry at Sapienza University of Rome (Sapienza Università di Roma). She has also received additional training in psychoanalysis and has completed more than 500 hours of personal psychoanalytic therapy.

In her practice, Dr Marinicheva combines a modern medical approach to mental health with careful consideration of each patient's individual history and current condition. When pharmacotherapy is required, treatment decisions are based on the principles of evidence-based medicine and current international clinical guidelines, including NICE, APA, WFSBP and CANMAT.

Dr Marinicheva provides online psychiatry consultations for anxiety, low mood, emotional instability, sleep problems, chronic stress and other conditions affecting mental wellbeing and quality of life. During a consultation, she assesses the patient's symptoms and overall condition, discusses potential treatment approaches and, when clinically appropriate, recommends medication and an appropriate follow-up plan.

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Doctor
5.0(1)

Daria Portnova

Psychiatry31 years of experience

Dr Daria Portnova is a psychiatrist and psychotherapist with over 30 years of clinical experience. She works with adults and adolescents aged 14 and over, providing online psychiatric and psychotherapeutic consultations. In her practice, Dr Portnova supports patients facing the onset of mental health conditions, chronic psychiatric disorders, psychotic symptoms, trauma-related states, and complex emotional crises. Her work is structured and safety-focused, with an emphasis on stabilisation, accurate diagnosis, and long-term improvement in quality of life. Patients consult Dr Daria Portnova for the following concerns: 

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Dr Portnova combines psychiatric assessment with a psychotherapeutic approach. She works with evidence-based methods, including cognitive behavioural therapy (CBT) and third-wave approaches such as ACT, FACT, and CFT. Consultations are focused on clear clinical understanding, practical recommendations, and ongoing support over time.

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Doctor
5.0(24)

Taisiia Proida

Psychiatry7 years of experience
Licence no. 70352

Taisiia Proida is a general practitioner with a specialization in mental health and a cognitive behavioral therapist (CBT), a member of the European Psychiatric Association. She offers online consultations for adults aged 18 and over, combining evidence-based medicine with an individualised approach to mental health care. She specialises in consultations and ongoing support for a wide range of mental health concerns, including: 

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Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders. She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

Book a video appointment
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Frequently Asked Questions

BETAHISTINE QUALIGEN 16 mg TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in BETAHISTINE QUALIGEN 16 mg TABLETS is betahistine. This information helps identify medicines with the same composition but different brand names.

The average pharmacy price for BETAHISTINE QUALIGEN 16 mg TABLETS is around 2.73 EUR. Prices may vary depending on the manufacturer and dosage form.

BETAHISTINE QUALIGEN 16 mg TABLETS is manufactured by Neuraxpharm Spain S.L.. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Psychiatrists, Neurologists, General medicine doctors, Pain medicine doctors, Anaesthesiologists may assess whether BETAHISTINE QUALIGEN 16 mg TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, BETAHISTINE QUALIGEN 16 mg TABLETS is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (betahistine) include BETAHISTINE ACCORD 24 mg TABLETS, BETAHISTINE AUROVITAS 16 mg TABLETS, BETAHISTINE AUROVITAS 8 mg 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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