BILAXTEN 20 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Bilaxten 20 mg tablets

bilastine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Bilaxten and what is it used for
2. What you need to know before you take Bilaxten
3. How to take Bilaxten
4. Possible side effects
5. Storage of Bilaxten
6. Contents of the pack and other information

1. What is Bilaxten and what is it used for

Bilaxten contains bilastine as the active substance, which is an antihistamine. Bilaxten 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 may also be used to treat itchy skin eruptions (hives or urticaria).

2. What you need to know before you take Bilaxten

Do not take Bilaxten:

If you are allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Bilaxten if you have moderate or severe kidney problems, low blood potassium levels, low blood magnesium levels, low blood calcium levels, if you have or have had heart rhythm problems or if your heart rate is very slow, if you are taking medicines that may affect your heart rhythm, if you 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 disease and are also taking other medicines (see "Using Bilaxten with other medicines").

Children

Do not give this medicine to children under 12 years of age.

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

Using Bilaxten with other medicines

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

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

• Ketoconazole (a medicine for fungi)
• Erythromycin (an antibiotic)
• Diltiazem (for angina pectoris)
• Ciclosporin (to reduce the activity of your immune system, to prevent transplant rejection or reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for HIV)
• Rifampicin (an antibiotic)

Taking Bilaxten with food, drinks, and alcohol

These tablets must notbe taken with foodor with grapefruit 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 drinking fruit juice, or
• if you have eaten or drunk fruit juice, wait 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 limited 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 medicine.

Consult your doctor or pharmacist before using any medicine.

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 medicine may be different. Therefore, check how this medicine affects you before driving or using machines.

Bilaxten contains sodium

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

3. How to take Bilaxten

Follow exactly the administration instructions of this medicine given 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 and older, is 1 tablet (20 mg) per day.

• The tablet is for oral use.
• 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 score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

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

Use in children

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

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

If you take more Bilaxten than you should

If you or anyone else takes more of this medicine than they should, tell your doctor immediately or go to the nearest hospital emergency department. Please remember to take this medicine pack 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 ingested).

If you forget to take Bilaxten

Do nottake 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 usual dosing schedule.

If you have any further questions on 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 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 medicine 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 (feeling sick)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or instability)
• feeling weak
• thirst
• shortness of breath
• 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 the available data

• palpitations (feeling your heartbeat)
• rapid heartbeat
• vomiting

Side effects that may occur 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 (feeling sick)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

5. Storage of Bilaxten

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Bilaxten:

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are microcrystalline cellulose, sodium carboxymethyl starch type A (derived from potato), anhydrous colloidal silica, magnesium stearate.

Appearance and packaging:

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.

Not all pack sizes may be marketed.

Marketing authorisation 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

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 medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Antires 20 mg tablets

France: Inorial 20 mg tablets

Greece: Bilargen 20 mg tablets

Italy: Robilas 20 mg tablets

Poland: Clatra Allergy

Portugal: Bilaxten 20 mg tablets

Spain: Bilaxten 20 mg tablets

Date of last revision of this leaflet:April 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/