Bilaxten Flas 20 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bilaxten Flas 20 mg orodispersible tablets

bilastine

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 adverse effects
5. How to store Bilaxten Flas
6. Contents of the pack and other information

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

Bilaxten Flas contains bilastine 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, watery eyes) and other forms of allergic rhinitis in adults and adolescents aged 12 years and older. It can also be used to treat itchy skin rashes (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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine if you have moderate or severe renal impairment, low blood levels of potassium, magnesium, or calcium, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medicines 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 may occur in some types of heart disease and are also taking other medicines (see “Use of Bilaxten Flas with other medicines”).

Children

Do not administer Bilaxten Flas 20 mg orodispersible tablets to children under 12 years of age. For alternative pharmaceutical forms of bilastine suitable for use in children under 12 years of age, see section 3 “Use in children”.

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and Bilaxten Flas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, please discuss with your doctor if you are taking any of the following medicines:

• Ketoconazole tablets (used to treat Cushing's syndrome when the body produces excess cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (used to treat angina pectoris – chest pain or pressure)
• Cyclosporine (used to reduce the activity of your immune system, to prevent transplant rejection or to reduce disease activity in autoimmune and allergic disorders such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (used to treat HIV)
• Rifampicin (an antibiotic)

Taking Bilaxten Flas with food, drinks, and alcohol

These orodispersible tablets must not be taken with food or consumption of grapefruit or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:

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

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It has been demonstrated that bilastine 20 mg does not affect driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.

Bilaxten Flas contains sodium and ethanol

This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; this is essentially “sodium-free”.

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

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

3. How to take Bilaxten Flas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Duration of treatment

Regarding the duration of treatment, your doctor will determine the type of illness you have and advise you on how long you should take this medicine.

Use in children

For children aged 2 to 11 years with a minimum body weight of 15 kg, other more suitable pharmaceutical forms are available – bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution – please consult your doctor or pharmacist.

Do not administer bilastine to children under 2 years of age or with a body weight below 15 kg, as sufficient data are not available.

If you take more Bilaxten Flas than you should

If you, or anyone else, exceed the recommended dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine packaging or this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bilaxten Flas

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

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

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

If you stop treatment with Bilaxten Flas

Generally, no effects will occur after discontinuing this treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 skin swelling and redness, stop taking this medicine and contact your doctor immediately.

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

Frequent: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• changes in electrocardiogram
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or instability)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• 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 available data

• palpitations (awareness of heartbeats)
• tachycardia (rapid heartbeat)
• vomiting

Adverse effects that may occur in children:

Frequent: may affect up to 1 in 10 people

• allergic conjunctivitis (eye inflammation due to an allergic reaction)
• headache

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (feeling sick)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue
• rhinitis (nasal irritation)
• stomach ache (abdominal pain / upper abdominal pain)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilaxten Flas

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilaxten Flas

• The active substance is bilastine. Each orodispersible tablet contains 20 mg of bilastine.
• The other components are mannitol (E421), sodium croscarmellose, stearil fumarate and sodium, sucralose (E955), red grape flavour (main components: arabic gum, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool).

See section 2 “Bilaxten Flas contains sodium and ethanol”.

Appearance of the product and contents of the pack

Bilaxten Flas 20 mg orodispersible tablets are round, flat, white tablets, engraved with “20” on one side and 8 mm in diameter.

Bilaxten Flas 20 mg orodispersible tablets are available in single-dose pre-perforated blisters containing 10x1, 20x1, 30x1, 40x1, 50x1 orodispersible tablets.

Only certain 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

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

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

Germany: Antires 20 mg Schmeltztabletten
Spain: Bilaxten Flas 20 mg orodispersible tablets
France: Inorial 20 mg orodispersible tablet
Greece: Bilargen 20 mg δισκ?α διασπειρ?μενα στο στ?μα
Italy: Robilas 20 mg orodispersible tablet
Poland: Clatra Allergy Fast
Portugal: Bilaxten 20 mg orodispersible tablet

Date of the most recent revision of this leaflet: February 2026

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