BILAXTEN 2.5 mg/ml ORAL SOLUTION

Introduction

Leaflet:information for the patient

Bilaxten 2.5 mg/ml oral solution

Bilastine

For children from 2 to 11 years old with a minimum body weight of 15 kg

Read the entire leaflet carefully before your child starts taking this medicine,as 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 to your child only, and you should not give it to others, even if they have the same symptoms as your child, as it may harm them.
  • If your child experiences side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Bilaxten and what is it used for
2. What you need to know before taking Bilaxten
3. How to take Bilaxten
4. Possible side effects

5 Conservation of Bilaxten

1. Package contents and additional information

1. What is Bilaxten and what is it used for

Bilaxten contains bilastina 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 watery eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

Bilaxten 2.5 mg/ml oral solution is indicated in children from 2 to 11 years old with a minimum body weight of 15 kg.

2. What you need to know before taking Bilaxten

Do not take Bilaxten:

• if your child is allergic to bilastina or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bilaxten if your child has moderate or severe kidney or liver impairment, low blood potassium, magnesium, or calcium levels, if your child has or has had heart rhythm problems or if their heart rate is very low, if your child is taking medicines that may affect the heart rhythm, if your child has or has had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart diseases, or if your child is taking other medicines (see "Using Bilaxten with other medicines").

Children

Do not administer this medicine to children under 2 years of age or with a body weight below 15 kg, as there is not enough data available.

Using Bilaxten with other medicines

Tell your doctor or pharmacist if your child is using, has recently used, or may need to use any other medicine, including those obtained without a prescription.

Some medicines should not be taken together, and others may require a dose adjustment when taken together.

Always inform your doctor or pharmacist if your child is taking or receiving any of the following medicines in addition to Bilaxten:

• Ketoconazole (a medicine for fungi)
• Erythromycin (an antibiotic)
• Diltiazem (for treating chest pain - pain or pressure in the chest area)
• Cyclosporine (to reduce the activity of the immune system, and thus prevent transplant rejection or reduce disease activity in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for treating HIV)
• Rifampicin (an antibiotic)

Taking Bilaxten with food, drinks, and alcohol

The oral solution should notbe taken with foodor with grapefruit juice or other fruit juices, as this would decrease the effect of bilastina. To avoid this, you can:

• administer the oral solution to your child and wait one hour before your child eats or takes fruit juices, or

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

Pregnancy, breastfeeding, and fertility

This medicine is for use in children from 2 to 11 years old with a minimum body weight of 15 kg. However, the following information on the safe use of this medicine should be taken into account. There are no data or limited data on the use of bilastina in pregnant women and during breastfeeding, and on its effects on fertility.

If you are pregnant or breastfeeding, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

It has been shown that bilastina 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 your child before they ride a bicycle or other vehicles or operate machinery.

Bilaxten 2.5 mg/ml oral solution may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

Bilaxten contains ethanol and sodium

This medicine contains 0.44 mg of alcohol (ethanol) in each dose (4 ml), which is equivalent to 11 mg/100 ml (0.011% p/v). The amount in 4 ml of this medicine is equivalent to less than 0.02 ml of beer or 0.005 ml of wine.

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

This medicine contains less than 1 mmol of sodium (23 mg) per 4 ml; this is, essentially "sodium-free".

3. How to take Bilaxten

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

Use in children

The recommended dose in children from 2 to 11 years old or with a minimum body weight of 15 kg is 10 mg of bilastina (4 ml of oral solution) once a day for the symptomatic relief of allergic rhinoconjunctivitis and urticaria.

Do not administer this medicine to children under 2 years of age with a body weight below 15 kg, as there is not enough data available.

For adults, including elderly patients and adolescents 12 years of age or older, the recommended dose is 20 mg of bilastina once a day. For this patient population, there is a more suitable pharmaceutical form - tablets; consult your doctor or pharmacist.

• The oral solution is for oral use.
• The bottle of oral solution is provided with a child-resistant cap and should be opened as follows: press the plastic screw cap down and at the same time turn it counterclockwise.
• The oral solution comes with a dosing cup with a 4 ml mark (= 10 mg of bilastina per dose), which will help you dose the oral solution correctly.
• Fill the dosing cup with 4 ml of oral solution.
• Administer directly from the dosing cup.
• Wash the dosing cup after use.
• You should administer the oral solution to your child one hour before or two hours after they have eaten or taken fruit juice.

Since the duration of treatment depends on your child's underlying disease, it will be your doctor who determines how long they should take Bilaxten.

If you take more Bilaxten than you should

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

If you forget to take Bilaxten

If you forget to administer the daily dose to your child on time, administer it the same day as soon as you remember. Then, administer the next dose the following day at the usual time as indicated by your doctor.

Never administer a double dose to make up for the forgotten dose.

If you stop taking Bilaxten

In general, no effects will appear after stopping treatment with Bilaxten.

If you have any other questions about 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 your child experiences 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 administering this medicine and go to your doctor immediately.

Other side effects that may occur in children:

Common: may affect up to 1 in 10 people

• allergic conjunctivitis (eye irritation)
• headache

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (vomiting)
• lip swelling
• eczema
• urticaria (hives)
• fatigue
• rhinitis (nasal irritation)
• stomach pain (abdominal pain/upper abdominal pain)

Side effects that may occur in adults and adolescents:

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 lining)
• vertigo (a feeling of dizziness or spinning)
• feeling of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• fever blisters (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 the heartbeat)
• tachycardia (fast heartbeat)
• vomiting

Reporting side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Bilaxten

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

Do not use this medicine after the expiration date stated on the packaging and on the bottle after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Once opened, use within the first 6 months.

Do not use this medicine if you notice visible particles.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Bilaxten

• The active substance is bilastina. Each ml of oral solution contains 2.5 mg of bilastina.
• The other components (excipients) are betadex (E459), hydroxyethylcellulose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sucralose (E955), raspberry flavor (main components: ethanol, triacetin, water, ethyl butyrate, linalyl acetate), hydrochloric acid 37% or 10% (for pH adjustment), sodium hydroxide (for pH adjustment), purified water.

Appearance and package contents of the product

Bilaxten is a clear, transparent, and slightly viscous aqueous oral solution, with a pH of 3.0-4.0 and no precipitate.

Bilaxten 2.5 mg/ml oral solution is packaged in an amber glass bottle, sealed with an aluminum screw cap or a child-resistant polypropylene cap; a 15 or 25 ml dosing cup with a 4 ml mark is included. Each bottle contains 120 ml of oral solution.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer:

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

or

Berlin-Chemie AG

Glienicker Weg 125

D-12489 - Berlin

Germany

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

Germany: Antires 2.5 mg/ml Lösung zum Einnehmen

Spain: Bilaxten 2.5 mg/ml oral solution

France: Inorial 2.5 mg/ml solution buvable

Greece: Bilargen 2.5 mg/mL π?σιμο δι?λυμα

Italy: Robilas 2.5 mg/ml soluzione orale

Poland: Bilaxten

Portugal: Bilaxten 2.5 mg/ml solução oral

Date of the last revision of this leaflet:June 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/)