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BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS

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About the medicine

How to use BILAXTEN FLAS 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

Leaflet:information for the patient

Bilaxten Flas 10 mg orodispersible tablets

Bilastine

For children from2 to 11 years with a minimum body weight of 15 kg

Read the entire leaflet carefully before your child starts taking this medication,as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
    1. If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to your child only, and you should not give it to others, even if they have the same symptoms as your child, as it may harm them.
    • If your child experiences side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What is Bilaxten Flas and what is it used for
  2. What you need to know before taking Bilaxten Flas
  3. How to take Bilaxten Flas
  4. Possible side effects
  5. Storage of Bilaxten Flas
  6. Package contents and additional information

1. What is Bilaxten Flas and what is it used for

Bilaxten Flas contains bilastine as the active ingredient, which is an antihistamine. Bilaxten Flas is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and watery eyes) and other forms of allergic rhinitis. It can also be used to treat skin eruptions with itching (hives or urticaria).

Bilaxten Flas 10 mg orodispersible tablets are indicated in children from 2 to 11 years with a minimum body weight of 15 kg.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before taking Bilaxten Flas

Do not take Bilaxten Flas:

  • if your child is allergic to bilastine or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bilaxten Flas if your child has moderate or severe renal or hepatic impairment, low blood potassium, magnesium, or calcium levels, if your child has or has had heart rhythm problems or if their heart rate is very low, if your child is taking medications that may affect heart rhythm, if your child has or has had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in some types of heart diseases, or if your child is taking other medications (see "Use of Bilaxten Flas with other medications").

Children

Do not administer this medication to children under 2 years of age or with a body weight below 15 kg, as there is insufficient data available.

Use of Bilaxten Flas with other medications

Inform your doctor or pharmacist if your child is using, has recently used, or may need to use any other medication, including those purchased without a prescription.

Some medications should not be taken together, and other medications may require a dose adjustment when taken together.

Always inform your doctor or pharmacist if your child is taking or receiving any of the following medications in addition to Bilaxten Flas:

  • Ketoconazole (an antifungal medication)
  • Erythromycin (an antibiotic)
  • Diltiazem (for treating angina pectoris - chest pain or pressure)
  • Cyclosporine (to reduce the activity of the immune system, and thus prevent transplant rejection or reduce disease activity in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
  • Ritonavir (for treating HIV)
  • Rifampicin (an antibiotic)

Taking Bilaxten Flas with food, beverages, and alcohol

These orodispersible tablets should notbe taken with foodor with grapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To avoid this, you can:

  • administer the orodispersible tablet to your child and wait one hour before your child eats or takes fruit juices, or

Bilastine, at the recommended dose in adults (20 mg), does not increase the somnolence produced by alcohol.

Pregnancy, breastfeeding, and fertility

This medication is for use in children from 2 to 11 years of age with a minimum body weight of 15 kg. However, the following information on the safe use of this medication should be taken into account. There are no data or limited data available on the use of bilastine in pregnant or breastfeeding women, and on its effects on fertility.

If you are pregnant or breastfeeding, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

It has been shown that bilastine 20 mg does not affect performance during driving in adults. However, each patient's response to the medication may be different. Therefore, check how this medication affects your child before they ride a bicycle or other vehicles or operate machinery.

Bilaxten Flas contains ethanol and sodium

This medication contains 0.0015 mg of alcohol (ethanol) per orodispersible tablet, which is equivalent to 1 mg/100 g (0.001% w/w). The amount in one orodispersible tablet is equivalent to less than 0.00004 ml of beer or 0.00002 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

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

3. How to take Bilaxten Flas

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in children

The recommended dose in children from 2 to 11 years of age with a minimum body weight of 15 kg is 10 mg of bilastine (1 orodispersible tablet) once daily for the symptomatic relief of allergic rhinoconjunctivitis and urticaria.

Do not administer this medication to children under 2 years of age or with a body weight below 15 kg, as there is insufficient data available.

For adults, including elderly patients and adolescents 12 years of age or older, the recommended dose is 20 mg of bilastine once daily. For this patient population, a more suitable pharmaceutical form - tablets - is available; consult your doctor or pharmacist.

  • The orodispersible tablet is for oral use.
  • Please place the orodispersible tablet in your child's mouth. It will disperse rapidly in the saliva and can then be swallowed easily.
  • Alternatively, you can disperse the orodispersible tablet in a spoonful of water before administering it to your child. This is highly recommended in children under 6 years of age, as they are prone to choking on tablets. Make sure no sediment remains in the spoon.
  • You should use only water for dispersion;do not use grapefruit juice or any other fruit juice.
  • You should administer the orodispersible tablet to your child one hour before or two hours after they have taken any food or fruit juice.

The duration of treatment depends on your child's underlying disease, and your doctor will determine how long they should take Bilaxten Flas.

If you take more Bilaxten Flas than you should

If your child, or anyone else, exceeds the dose of this medication, inform your doctor immediately or go to the emergency department of the nearest hospital. Please remember to bring this medication package or this leaflet with you.

If you forget to take Bilaxten Flas

If you forget to administer the daily dose to your child on time, administer it on the same day as soon as you remember. Then, administer the next dose the following day at the usual time as indicated by your doctor.

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

If you stop taking Bilaxten Flas

Generally, no effects will appear after stopping treatment with Bilaxten Flas.

If you have any other questions about the use of this medication, 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 medications, this medication can cause side effects, although not everyone gets them.

If your child experiences allergic reactions whose symptoms may include difficulty breathing, dizziness, collapse, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, stop administering this medication and go to your doctor immediately.

Other side effects that may occur in children:

Common: may affect up to 1 in 10 people

  • allergic conjunctivitis (eye irritation)
  • headache

Uncommon: may affect up to 1 in 100 people

  • eye irritation
  • dizziness
  • loss of consciousness
  • diarrhea
  • nausea (vomiting)
  • lip swelling
  • eczema
  • urticaria (hives)
  • fatigue
  • rhinitis (nasal irritation)
  • stomach pain (abdominal pain/upper abdominal pain)

Side effects that may occur in adults and adolescents:

Common: may affect up to 1 in 10 people

  • headache
  • somnolence

Uncommon: may affect up to 1 in 100 people

  • electrocardiogram changes
  • blood tests showing changes in liver function
  • dizziness
  • stomach pain
  • fatigue
  • increased appetite
  • irregular heartbeat
  • weight gain
  • nausea (vomiting)
  • anxiety
  • dry nose or nasal discomfort
  • abdominal pain
  • diarrhea
  • gastritis (inflammation of the stomach lining)
  • vertigo (a feeling of dizziness or spinning)
  • feeling of weakness
  • thirst
  • dyspnea (difficulty breathing)
  • dry mouth
  • indigestion
  • itching
  • fever blister (cold sore)
  • fever
  • tinnitus (ringing in the ears)
  • difficulty sleeping
  • blood tests showing changes in kidney function
  • increased blood fats

Frequency not known: cannot be estimated from the available data

  • palpitations (feeling the heartbeat)
  • tachycardia (fast heartbeat)
  • vomiting

Reporting side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilaxten Flas

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

Do not use this medication after the expiration date stated on the package and blister after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Place the medication packages and medications you no longer need in the Sigre Collection Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medication packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bilaxten Flas

  • The active ingredient is bilastine. Each orodispersible tablet contains 10 mg of bilastine.
  • The other ingredients are mannitol (E421), croscarmellose sodium, sodium stearyl fumarate, sucralose (E955), red grape flavor (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool).

Appearance of the product and package contents

Bilaxten Flas 10 mg orodispersible tablets are round, slightly biconvex, and white, with a diameter of 8 mm.

The tablets are packaged in blisters of 10, 20, 30, or 50 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer:

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

or

A.Menarini Manufacturing Logistics and Services S.r.l.

Campo di Pile

L’Aquila

Italy

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Antires 10 mg orodispersible tablets

Spain: Bilaxten Flas 10 mg orodispersible tablets

France: Inorial 10 mg orodispersible tablets

Greece: Bilargen 10 mg οροδιασπειρ?μενα δισκ?α

Italy: Robilas 10 mg orodispersible tablets

Poland: Bilaxten

Portugal: Bilaxten 10 mg orodispersible tablets

Date of the last revision of this leaflet:March 2025

Detailed 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 BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS

Discuss questions about BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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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
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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
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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.

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Dr. Lokchiri’s professional training includes:

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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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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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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.
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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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Alina Tsurkan

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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:

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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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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:

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  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
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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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  • Active participant in international medical conferences and research.

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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Frequently Asked Questions

Is a prescription required for BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS?
BILAXTEN FLAS 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 BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS?
The active ingredient in BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS is bilastine. This information helps identify medicines with the same composition but different brand names.
How much does BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS cost in pharmacies?
The average pharmacy price for BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS is around 2.92 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS?
BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS is manufactured by Faes Farma S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BILAXTEN FLAS 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 BILAXTEN FLAS 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 BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS?
Other medicines with the same active substance (bilastine) include ABISAX 20 mg TABLETS, ABRILIA 20 mg TABLETS, ASTRILAX 20 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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