Patient Information Leaflet

Bilaxten Flas 20 mg Buccodispersible Tablets

Bilastina

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them..
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Bilaxten Flas

3.How to take Bilaxten Flas

4.Possible side effects

5.Storage of Bilaxten Flas

6.Contents of the pack and additional information

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

This medication is used to relieve symptoms of allergic rhinoconjunctivitis(runny nose, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

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 renal insufficiency, low blood levels of potassium, magnesium, calcium, 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 pattern of your heartbeat (known as QTc prolongation in the electrocardiogram) that may occur in some types of heart disease and are also taking other medications (see "Use of Bilaxten Flas with other medications").

Children

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

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

Other medications and Bilaxten Flas

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

Particularly, please consult with your doctor if you are taking any of the following medications:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (to treat angina pectoris – chest pain or pressure)
• Ciclosporin (to reduce the activity of your immune system, and thus prevent transplant rejection or reduce the activity of autoimmune and allergic diseases, such as psoriasis, atopic dermatitis or rheumatoid arthritis)
• Ritonavir (to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilaxten Flas with food, drinks, and alcohol

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

• Take the buccal dispersible tablet and wait one hour before eating or taking fruit juices, or
• If you have eaten food or fruit juice, wait for two hours before taking the buccal dispersible 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 these are limited, on the use of bilastine in pregnant women, during lactation, or on its effects on fertility.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Bilastine 20 mg has been shown not to affect performance during driving in adults. However, the response of each patient to the medication may be different. Therefore, check how this medication affects you before driving or operating machinery.

Bilaxten Flas contains sodium and ethanol

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

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

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

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

The recommended dose in adults, including elderly patients and adolescents 12 years of age or older, is 1 buccal dispersible tablet (20 mg of bilastina) per day.

• The buccal dispersible tablet is for oral administration.
• Please place the buccal dispersible tablet in the mouth. It will rapidly disperse in saliva and can then be easily swallowed.
• Alternatively, you can disperse the buccal dispersible tablet in water before taking it.
• You should use exclusively water for dispersion,do not use grapefruit juice or any other fruit juice.
• The buccal dispersible tablet should be taken one hour before or two hours after having taken any food or fruit juice (see section 2, “Taking Bilaxten F with food, drinks, and alcohol”).

Regarding the duration of treatment, your doctor will determine the type of disease you have and will tell you for 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, there are other more suitable pharmaceutical forms – bilastina 10 mg buccal dispersible tablets or bilastina 2.5 mg/ml oral solution – consult your doctor or pharmacist.

Do not administer bilastina to children under 6 years of age with a body weight less than 20 kg since there are not enough data available.

If you take more Bilaxten Flas than you should

If you, or anyone else, exceed the dose of this medication, inform your doctorimmediatelyor go to the nearest hospital emergency service. Please remember to bring this medication package or this leaflet with you.

For accidental overdose or ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 compensate for a missed dose.

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

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

If you interrupt treatment with Bilaxten Flas

Generally, there will be no effects after abandoning this treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience allergic reactions whose symptoms may include difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, stop taking this medicine and seek immediate medical attention.

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

Frequent: may affect up to 1 in 10 people

• headache
• drowsiness

Less frequent: may affect up to 1 in 100 people

• electrocardiogram alterations
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (urge to vomit)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (a feeling of dizziness or instability)
• sensation of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• herpes labial
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fats

Unknown frequency: cannot be estimated from available data

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

Side effects that may appear in children:

Frequent: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (inflammation of the eye due to an allergic reaction)
• headache
• stomach pain (abdominal pain / upper abdominal pain)

Less frequent: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (urge to vomit)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information aboutthe safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bilaxten Flas

• The active ingredient is bilastina. Each buccal dispersible tablet contains 20 mg of bilastina.
• The other components are mannitol (E421), sodium croscarmellose, stearate fumarate and sodium, sucralose (E955), red grape aroma (major components:gum arabic, ethyl butyrate, triacetin, antranilate of methyl, ethanol,d-limonene, linalol)

Appearance of the product and content of the container

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

Bilaxten Flas 20 mg buccal dispersible tablets are available in pre-cut blister packs of 10x1, 20x1, 30x1, 40x1, 50x1 buccal dispersible tablets.

Only some container sizes may be commercially marketed.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Antires 20 mg Schmelztabletten

Spain: Bilaxten Flas 20 mg buccal dispersible 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

Last review date of this leaflet:

April 2025

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