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BILASTINA FLAS COMBIX 10 mg ORALLY DISINTEGRATING TABLETS

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About the medicine

How to use BILASTINA FLAS COMBIX 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

Patient Information Leaflet

Bilastina Flas Combix 10 mg orodispersible tablets EFG

For children from 6 to 11 years old with a minimum body weight of 20 kg

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

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

Contents of the package leaflet

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

Bilastina Flas Combix contains bilastina as the active substance, which is an antihistamine.

This medicine is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy eyes) and other forms of allergic rhinitis. It can also be used to treat itchy skin eruptions (hives or urticaria).

Bilastina Flas Combix 10 mg orodispersible tablets are indicated for children from 6 to 11 years old with a minimum body weight of 20 kg.

2. What you need to know before taking Bilastina Flas Combix

Do not takeBilastina Flas Combix

  • if your child is allergic to bilastina or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bilastina Flas Combix if your child has moderate or severe kidney or liver impairment, low blood levels of potassium, magnesium, or calcium, if they have or have had heart rhythm problems or if their heart rate is very low, if they are taking medicines that may affect the heart rhythm, if they have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart diseases and are also taking other medicines (see "Other medicines and Bilastina Flas Combix").

Children

Do not administer this medicine to children under 6 years old with a body weight below 20 kg, as there is not enough data available.

Other medicines and Bilastina Flas Combix

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines should not be taken together, and others 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 medicines in addition to Bilastina Flas Combix:

  • Ketoconazole (an antifungal medicine)
  • Erythromycin (an antibiotic)
  • Diltiazem (for treating chest pain or pressure - angina pectoris)
  • Cyclosporin (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 AIDS)
  • Rifampicin (an antibiotic)

Taking Bilastina Flas Combix with food, drinks, and alcohol

These tablets should not be taken with food or with grapefruit juice or other fruit juices, as this would decrease the effect of bilastina. To avoid this, you can:

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

Bilastina, at the recommended dose in adults (20 mg), does not increase the drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

This medicine is for use in children from 6 to 11 years old with a minimum body weight of 20 kg. However, the following information on the safe use of this medicine should be taken into account. There are no data or limited data available on the use of bilastina in pregnant or breastfeeding women and on its effects on fertility.

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.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Bilastina Flas Combix contains sodium

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

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3. How to take Bilastina Flas Combix

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

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

Use in children

The recommended dose in children from 6 to 11 years old with a minimum body weight of 20 kg is 1 orodispersible tablet of 10 mg once daily for the symptomatic relief of allergic rhinoconjunctivitis and urticaria.

Do not administer this medicine to children under 6 years old with a body weight below 20 kg, as there is not enough data available.

  • The orodispersible tablet is for oral use.
  • 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. Make sure there are 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. See section 2, "Taking Bilastina Flas Combix with food, drinks, and alcohol".

Since the duration of treatment depends on your child's underlying disease, it will be your doctor who determines how long they should take bilastina.

If you take more Bilastina Flas Combix than you should

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

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 taken.

If you forget to take Bilastina Flas Combix

If you forget to administer the daily dose to your child on time, administer it 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.

Under no circumstances should you administer a double dose to make up for the forgotten dose.

If you stop taking Bilastina Flas Combix

Generally, no effects will appear after stopping treatment with bilastina.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 medicine and go to your doctor immediately.

Other side effects that may appear in children:

Common: may affect up to 1 in 10 people

  • rinitis (nasal irritation)
  • allergic conjunctivitis (eye irritation)
  • headache
  • stomach pain (abdominal pain/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

  • eye irritation
  • dizziness
  • loss of consciousness
  • diarrhea
  • nausea (vomiting)
  • lip swelling
  • eczema
  • urticaria (hives)
  • fatigue

Side effects that may appear in adults and adolescents:

Common: may affect up to 1 in 10 people

  • headache
  • drowsiness

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 nose discomfort
  • abdominal pain
  • diarrhea
  • gastritis (inflammation of the stomach lining)
  • vertigo (a feeling of dizziness or instability)
  • feeling of weakness
  • thirst
  • dyspnea (difficulty breathing)
  • dry mouth
  • indigestion
  • itching
  • fever blisters (cold sores)
  • 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 of side effects

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

5. Storage of Bilastina Flas Combix

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

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

This medicine does not require special storage conditions.

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

6. Package contents and additional information

Composition of Bilastina Flas Combix

  • The active substance is bilastina. Each orodispersible tablet contains 10 mg of bilastina.
  • The other ingredients are mannitol, croscarmellose sodium, sodium stearyl fumarate, sucralose, and red grape flavor.

Appearance of the product and package contents

Bilastina Flas Combix 10 mg orodispersible tablets are white, round, biconvex tablets, 8 mm in diameter, marked with "B1" on one side and smooth on the other.

Bilastina Flas Combix is available in aluminum/aluminum blisters, in boxes of 20 orodispersible tablets.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 - Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Netpharmalab Consulting Services

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

or

Laboratori Fundació DAU

C/ De la letra C, 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona,

Spain

or

Zydus France

ZAC des Hautes Pátures

Parc d’Activités des Peupliers

25 rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

Zac. Du Suzot

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

Date of last revision of this leaflet:March 2025.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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Anna Biriukova

General medicine 6 years exp.

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:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
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.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
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Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
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.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • 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.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • 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.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Svetlana Kolomeeva

Cardiology 18 years exp.

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.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • 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.
  • Second opinion and decision-making support.
  • 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.

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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;
  • 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 BILASTINA FLAS COMBIX 10 mg ORALLY DISINTEGRATING TABLETS?
BILASTINA FLAS COMBIX 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 BILASTINA FLAS COMBIX 10 mg ORALLY DISINTEGRATING TABLETS?
The active ingredient in BILASTINA FLAS COMBIX 10 mg ORALLY DISINTEGRATING TABLETS is bilastine. This information helps identify medicines with the same composition but different brand names.
Who manufactures BILASTINA FLAS COMBIX 10 mg ORALLY DISINTEGRATING TABLETS?
BILASTINA FLAS COMBIX 10 mg ORALLY DISINTEGRATING TABLETS is manufactured by Laboratorios Combix S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BILASTINA FLAS COMBIX 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 BILASTINA FLAS COMBIX 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 BILASTINA FLAS COMBIX 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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