PATIENT INFORMATION: INFORMATION FOR THE PATIENT

Bilaxten 20 mg tablets

bilastina

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

1.What is Bilaxten and for what it is used

2.What you need to know before starting to take Bilaxten

3.How to take Bilaxten

4.Possible side effects

5.Storage of Bilaxten

6.Contents of the pack and additional information

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

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 Bilaxten if you have moderate or severe renal insufficiency, 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 medications that may affect heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc prolongation on an electrocardiogram) that may occur in some types of heart disease and are also taking other medications (see "Use of Bilaxten 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.

Use of Bilaxten with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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)
• Ciclosporin (to reduce the activity of your immune system, to prevent transplant rejection, or to reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (to treat HIV)
• Rifampicin (an antibiotic)

Taking Bilaxten with food, drinks, and alcohol

These tabletsshould not be taken withfoodor withgrapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To avoid this, you can:

• take the tablet and wait one hour before eating or taking fruit juices, or
• if you have eaten food or taken fruit juices, wait for two hours before taking the 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

It has been demonstrated that bilastine 20 mg does not 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 contains sodium

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

Follow exactly the administration instructions for this medication as 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 tablet (20 mg) per day.

• The tablet is to be taken orally.
• The tablet should be taken one hour before or two hours after taking any food or fruit juice (see section 2, “Taking Bilaxten with food, drinks, and alcohol”).
• Swallow the tablet with a glass of water.
• The groove is only for breaking the tablet if it is difficult to swallow whole.

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 Bilaxten.

Use in children

For children aged 6 to 11 years with a minimum body weight of 20 kg, there are other more suitable pharmaceutical forms – bilastine 10 mg chewable 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 less than 20 kg since there are not enough data available.

If you take more Bilaxten than you should

If you, or anyone else, exceed the dose of this medication, inform your doctor immediately or go to the nearest hospital emergency department. 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 Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Bilaxten

Do nottake 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 return to your regular dosing schedule.

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:

Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: 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 labialis
• 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:

Common: may affect up to 1 in 10 people

• rhinitis (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 (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 on the 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 after CAD on the packaging and blister. 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 packagingand unused medications at the Sigre Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Bilaxten:

• The active ingredient is bilastina. Each tablet contains 20 mg of bilastina.
• The other components are microcrystalline cellulose, sodium carboxymethylcellulose type A (derived from potato), anhydrous colloidal silica, magnesium stearate.

Appearance of the product and content of the container:

Bilaxten tablets are white, oval, biconvex, and scored (length 10 mm, width 5 mm).

The tablets are packaged in blisters of 10, 20, 30, 40, or 50 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

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

or

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

Campo di Pile

L’Aquila

Italy

or

Menarini - Von Heyden GmbH

Leipziger Strasse 7-13; 01097

Dresden

Germany

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

Germany: Antires 20 mg Tablets

France: Inorial 20 mg Tablet

Greece: Bilargen 20 mg Δισκ?ο

Italy: Robilas 20 mg Compressa

Poland: Clatra Allergy

Portugal: Bilaxten 20 mg tablet

Spain: Bilaxten 20 mg tablets

Revision date of this leaflet:April 2025

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/