Package Leaflet: Information for the Patient

Bilaxten 2.5 mg/ml Oral Solution

Bilastina

For children aged 6 to 11 years with a minimum body weight of 20 kg

Read this leaflet carefully before your child starts 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, pharmacist.

-This medicine has been prescribed for your child only and should not be given to other people even if they have the same symptoms as your child, as it may harm them.

• If your child experiences any side effects, consult your doctor, or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Bilaxten is and what it is used for

2.What you need to know before taking Bilaxten

3.How to take Bilaxten

4.Possible side effects

5Storage 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 (stuffy or runny nose, sneezing, nasal discharge, nasal congestion, and red, itchy eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

Bilaxten2.5 mg/ml oral solutionis indicated for children aged 6 to 11 years with a minimum body weight of 20 kg.

Do not take Bilaxten:

• if your child is 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 take Bilaxten if your child has moderate or severe renal or hepatic insufficiency, low blood levels of potassium, magnesium, calcium, if your child has or has had heart rhythm problems or if your child's heart rate is very low, if your child is taking medications that may affect heart rhythm, if your child has or has had a certain abnormal pattern of heart rhythm (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart disease or if your child is taking other medications (see “Use of Bilaxten with other medications”).

Children

Do not administer this medication to children under 6 years of age with a body weight of less than 20 kg as there is insufficient data.

Use of Bilaxten with other medications

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

Some medications should not be taken together and other medications 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 medications in addition to Bilaxten:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (to treat angina – 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 HIV/AIDS)
• Rifampicin (an antibiotic)

Taking Bilaxten with food, drinks, and alcohol

The oral solution should not be taken with food or with grapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To avoid this, you can:

• administer the oral solution to your child and wait for one hour before your child eats or takes fruit juices, or
• if your child has eaten or taken fruit juice, wait for two hours before giving the oral solution.

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

Pregnancy, breastfeeding, and fertility

This medication is for use in children aged 6 to 11 years with a minimum body weight of 20 kg. However, the following information should be taken into account regarding the safe use of this medication. There are no data or these are very limited on the use of bilastine in pregnant women and during breastfeeding, and on the effects on fertility.

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

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

It has been shown 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 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 medication contains 0.44 mg of alcohol (ethanol) in each dose (4 ml) equivalent to 11 mg/100 ml (0.011% p/v). The amount in 4 ml of this medication is equivalent to less than 0.02 ml of beer or 0.005 ml of wine.

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed.In case of doubt, consult your doctor or pharmacist again.

Use in children

The recommended dose in children aged 6 to 11 years with a minimum body weight of 20 kg is 10 mg of bilastine (4 ml of oral solution) once a day for symptomatic relief of allergic rhinoconjunctivitis and urticaria.

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

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

Since the duration of treatment depends on the underlying disease of your child, your doctor will determine for how long your child should take Bilaxten.

If you take more Bilaxten than you should

If your child, or anyone else, exceeds 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.

If you forget to take Bilaxten

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

Never administer a double dose to compensate for the missed dose.

If you interrupt the treatment with Bilaxten

Generally, there will be no effects after stopping treatment with Bilaxten.

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 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 seek immediate medical attention.

Other 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 (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

Side effects that may appear 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 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)
• vertigo (a sensation of dizziness or spinning)
• weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• fever (cold sores)
• 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

Reporting of side effects

If your child experiences 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 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thecontainerand on the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Once opened, use within the first 6 months.

Do not use this medication if you observe visible particles.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines that you no longer need at the Sigre Pointof the pharmacy.In case of doubtask your pharmacisthow to disposeofthecontainers and of themedicines that you no longerneed.This will help protect the environment.

Composition of Bilaxten

• The active principle 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 aroma (major components: ethanol, triacetin, water, butyl ethanoate, linalyl acetate), hydrochloric acid 37% or 10% (for pH adjustment), sodium hydroxide (for pH adjustment), purified water.

Appearance of the product and contents of the packaging

Bilaxten is an aqueous oral solution, clear, transparent, and slightly viscous, with a pH of 3.0-4.0 without precipitation.

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

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

or

Berlin-Chemie AG

Glienicker Weg 125

D-12489 - Berlin

Germany

This medicine is authorized in the member states of the European Economic Area with 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 oral solution

Last review date of this prospectus: April 2025

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