Bilaxten 2.5 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bilaxten 2.5 mg/ml oral solution

Bilastine

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

Read this entire 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, consult your doctor or pharmacist.

• This medicine has been prescribed only for your child. Do not give it to other people, even if they have the same symptoms as your child, as it could harm them.
  • If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Bilaxten is and what it is used for

Bilaxten contains bilastine as the active substance, which is an antihistamine. Bilaxten is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itching nose, runny nose, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes (hives or urticaria).

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

2. What you need to know before starting Bilaxten

Do not take Bilaxten:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Bilaxten if your child has moderate or severe renal or hepatic impairment, low blood levels of potassium, magnesium, or calcium, 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 heart rhythm, or if your child has or has had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease, or if your child is taking other medicines (see “Use of Bilaxten with other medicines”).

Children

Do not give this medicine to children under 2 years of age or with a body weight below 15 kg, as sufficient data are not available.

Use of Bilaxten with other medicines

Tell your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines should not be taken together, and others may require dose adjustments when taken concurrently.

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 fungal infections)
• Erythromycin (an antibiotic)
• Diltiazem (to treat angina – chest pain or pressure)
• Cyclosporine (to reduce the activity of the immune system, thus preventing transplant rejection or reducing disease activity in autoimmune 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

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

• administer the oral solution to your child and wait one hour before your child eats or drinks fruit juices, or
• if your child has eaten food or drunk fruit juice, wait two hours before administering the oral solution.

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

Pregnancy, breastfeeding, and fertility

This medicine is intended for use in children aged 2 to 11 years with a minimum body weight of 15 kg. However, the following information on safe use should be considered. There are no data or data are very limited on the use of bilastine in pregnant or breastfeeding women, and on effects on fertility.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

Bilastine 20 mg has been shown not to impair driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, check how this medicine affects your child before allowing them to 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) per dose (4 ml), equivalent to 11 mg/100 ml (0.011% w/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 contained in this medicine does not produce any noticeable effect.

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

3. How to take Bilaxten

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

Use in children

The recommended dose for children aged 2 to 11 years or with a body weight of at least 15 kg is 10 mg of bilastine (4 ml of oral solution) once daily for 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 sufficient data are not available.

For adults, including elderly patients and adolescents aged 12 years and older, the recommended dose is 20 mg of bilastine once daily. For this patient population, a more suitable pharmaceutical form—tablets—is available; please consult your doctor or pharmacist.

• The oral solution is for oral use only.
• The oral solution bottle is equipped with a child-resistant cap and should be opened as follows: press down on the plastic screw cap while turning it counterclockwise.
• The oral solution comes with a dosing cup marked at 4 ml (= 10 mg of bilastine per dose), which will help you measure the correct dose of the oral solution.
• Fill the dosing cup to the 4 ml mark with oral solution.
• Administer directly from the dosing cup.
• Wash the dosing cup after use.
• The oral solution should be administered to your child one hour before or two hours after consuming food or fruit juice.

Since the duration of treatment depends on your child's underlying condition, your doctor will determine how long Bilaxten should be taken.

If you take more Bilaxten than you should

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

If you forget to take Bilaxten

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

Under no circumstances should you administer a double dose to make up for a missed dose.

If you stop taking Bilaxten

Generally, no effects occur after discontinuation of treatment with Bilaxten.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 giving this medicine and seek immediate medical attention.

Other adverse 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 (feeling of needing to vomit)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue
• rhinitis (nasal irritation)
• stomach pain (abdominal pain/upper abdominal pain)

Adverse effects that may occur in adults and adolescents:

Common: may affect up to 1 in 10 people

• headache
• somnolence (drowsiness)

Uncommon: may affect up to 1 in 100 people

• electrocardiogram abnormalities
• blood tests showing changes in liver function
• dizziness
• stomach pain
• tiredness
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling of needing to vomit)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or spinning)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sore (herpes labialis)
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increase in blood fats

Frequency not known: cannot be estimated from available data:

• palpitations (awareness of heartbeats)
• tachycardia (rapid heartbeat)
• vomiting

Reporting of adverse effects

If your child experiences any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

After first opening, use within the first 6 months.

Do not use this medicine if you notice visible particles.

Medicines must not be disposed of via wastewater or household waste. Return unused containers and unused medicines to the Sigre collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilaxten

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

Nature of the product and contents of the container

Bilaxten is an aqueous oral solution, clear, transparent and slightly viscous, 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 aluminium screw cap or a child-resistant polypropylene cap; a 15 ml or 25 ml dosing cup is included, marked at 4 ml. 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Antires 2.5 mg/ml solution for oral use
Spain: Bilaxten 2.5 mg/ml oral solution
France: Inorial 2.5 mg/ml oral solution
Greece: Bilargen 2.5 mg/mL π?σιμο δι?λυμα
Italy: Robilas 2.5 mg/ml oral solution
Poland: Bilaxten
Portugal: Bilaxten 2.5 mg/ml oral solution

Date of the most recent review of this leaflet: June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)