BILAXTEN FLAS 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Bilaxten Flas 20 mg Oral Disintegrating Tablets

bilastine

Read this leaflet carefully before starting to take this medication because 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 medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

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

Bilaxten Flas contains bilastine as the active ingredient, which is an antihistamine.

This medication is used to relieve 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 skin eruptions with itching (hives or urticaria).

2. What you need to know before taking Bilaxten Flas

Do not take Bilaxten Flas

If you are 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 use this medication if you have moderate or severe kidney impairment, low blood potassium, magnesium, or calcium levels, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medications that may affect heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that can occur in some types of heart disease and are also taking other medications (see "Using Bilaxten Flas with other medications").

Children

Do not administer this medication to children under 12 years of age

Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Other medications and Bilaxten Flas

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

In particular, please inform your doctor if you are taking any of the following medications:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (for treating angina pectoris - chest pain or pressure)
• Cyclosporine (to reduce immune system activity and 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 Bilaxten Flas with food, drinks, and alcohol

These oral disintegrating tablets should notbe taken with foodorgrapefruit juice or other fruit juices, as this may reduce the effect of bilastine. To avoid this, you can:

• take the oral disintegrating tablet and wait one hour before eating or drinking fruit juice, or
• if you have eaten or drunk fruit juice, wait two hours before taking the oral disintegrating tablet.

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

Pregnancy, breastfeeding, and fertility

There are limited or no data on the use of bilastine in pregnant women, during breastfeeding, or 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 medication.

Consult your doctor or pharmacist before using 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 you before driving or using machines.

Bilaxten Flas contains sodium and ethanol

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

This medication contains 0.0030 mg of alcohol (ethanol) in each oral disintegrating tablet, equivalent to 1.6 mg/100 g (0.0016% w/w). The amount of alcohol in a 185 mg oral disintegrating tablet is equivalent to less than 1 ml of beer or 1 ml of wine.

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

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.

The recommended dose in adults, including elderly patients and adolescents 12 years of age and older, is 1 oral disintegrating tablet (20 mg of bilastine) per day.

• The oral disintegrating tablet is for oral use.
• Please place the oral disintegrating tablet in your mouth. It will disintegrate rapidly in saliva and can then be swallowed easily.
• Alternatively, you can disperse the oral disintegrating tablet in water before taking it.
• You should use only water for dispersion;do not use grapefruit juice or any other fruit juice.
• The oral disintegrating tablet should be taken one hour before or two hours after eating or drinking fruit juice (see section 2, "Taking Bilaxten Flas with food, drinks, and alcohol").

Regarding the duration of treatment, your doctor will determine the type of disease you have and indicate how long you should take this medication.

Use in children

For children 6 to 11 years of age with a minimum body weight of 20 kg, other pharmaceutical forms are more suitable - bilastine 10 mg oral disintegrating tablets or bilastine 2.5 mg/ml oral solution - consult your doctor or pharmacist.

Do not administer bilastine to children under 6 years of age with a body weight below 20 kg, as there are insufficient data.

If you take more Bilaxten Flas than you should

If you or anyone else exceeds the dose of this medication, inform your doctor immediatelyor go to the emergency department of the nearest hospital. Please remember to bring this medication 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 medication and the amount ingested.

If you forget to take Bilaxten Flas

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

If you forget to take your dose, take it as soon as possible, and then return to your regular dosing schedule.

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

If you stop taking Bilaxten Flas

Generally, no effects will appear after stopping this treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience 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 taking this medication and go to your doctor immediately.

Other side effects that may occur in adults and adolescents are:

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 or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach wall)
• vertigo (a feeling of dizziness or instability)
• feeling of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• herpes simplex
• 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 available data

• palpitations (feeling heartbeats)
• tachycardia (rapid heartbeats)
• vomiting

Side effects that may occur in children:

Common: may affect up to 1 in 10 people

• rinitis (nasal irritation)
• allergic conjunctivitis (eye inflammation due to an allergic reaction)
• 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

Reporting side effects

If you experience 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 Medication 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 sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister pack 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. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging 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 oral disintegrating tablet contains 20 mg of bilastine.
• The other ingredients are mannitol (E421), croscarmellose sodium, sodium stearyl fumarate, and 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 20 mg oral disintegrating tablets are round, flat, white, engraved with "20" on one side, and 8 mm in diameter.

Bilaxten Flas 20 mg oral disintegrating tablets are available in single-dose blister packs of 10x1, 20x1, 30x1, 40x1, 50x1 oral disintegrating 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

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

Germany: Antires 20 mg Schmelztabletten

Spain: Bilaxten Flas 20 mg oral disintegrating tablets

France: Inorial 20 mg orodispersible tablet

Greece: Bilargen 20 mg δισκία διασπειρόμενα στο στόμα

Italy: Robilas 20 mg orodispersible tablet

Poland: Clatra Allergy Fast

Portugal: Bilaxten 20 mg orodispersível tablet

Date of the last revision of this leaflet:

April 2025

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