Bilaxten

Package Leaflet: Information for the Patient

Bilaxten, 2.5 mg/mL, Oral Solution

For Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg

Bilastine

Read the Package Leaflet Carefully Before Giving the Medicine to the Child, as it Contains Important Information for the Patient.

• Keep this package 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 a specific child. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If the child experiences any side effects, including any not listed in this package leaflet, tell the doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Bilaxten and What is it Used For
• 2. Important Information Before Taking Bilaxten
• 3. How to Take Bilaxten
• 4. Possible Side Effects
• 5. How to Store Bilaxten
• 6. Package Contents and Other Information

1. What is Bilaxten and What is it Used For

Bilaxten contains the active substance bilastine, which acts as an antihistamine.
Bilaxten is used to relieve the symptoms of hay fever (itching, sneezing, runny nose, blocked nose, and red or itchy eyes) and other forms of allergic rhinitis.
The medicine may also be used to treat itchy skin rashes (hives or urticaria).
Bilaxten, 2.5 mg/mL oral solution is indicated for use in children aged 2 to 11 years with a body weight of at least 15 kg.

2. Important Information Before Taking Bilaxten

When Not to Take Bilaxten:

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

Warnings and Precautions

Before taking Bilaxten, talk to the doctor or pharmacist if the child has:
moderate or severe kidney or liver problems,
low levels of potassium, magnesium, or calcium in the blood,
heart rhythm problems or very slow heart rate,
is taking medicines that may affect the heart rhythm,
has or has had an abnormal heart rhythm (known as QTc interval prolongation on the electrocardiogram),
which may occur in certain types of heart disease, or if the child is taking other medicines (see "Bilaxten with Other Medicines").

Children

Do not give this medicine to children under 2 years of age or weighing less than 15 kg, as there is not enough information on the use of this medicine in these children.

Bilaxten with Other Medicines

Tell the doctor or pharmacist about all medicines the child is taking or has recently taken, including those obtained without a prescription, and about any medicines the child might take in the future.
Some medicines should not be taken at the same time, and for others, the dose may need to be changed when taken together.
Always tell the doctor or pharmacist if the child is taking any of the following medicines in addition to Bilaxten:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for angina - chest pain or discomfort)
• cyclosporin (a medicine that reduces the activity of the immune system, used to prevent transplant rejection or reduce the severity of autoimmune diseases and allergies, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat HIV)
• rifampicin (an antibiotic)

Bilaxten with Food, Drink, and Alcohol Do Not Take the Medicine with Food or with Grapefruit Juice or Other Fruit Juices

asthis reduces the effect of Bilaxten. To avoid reducing the effect of the medicine, the child should:

• take the oral solution and wait for 1 hour before giving the child a meal or fruit juice or
• if the child has eaten a meal or drunk fruit juice, wait for 2 hours before giving the child the oral solution.

Bilastine at the recommended dose for adults (20 mg) does not increase the sedative effect of alcohol.

Pregnancy, Breast-feeding, and Fertility

This medicine is intended for use in children aged 2 to 11 years with a body weight of at least 15 kg. However, consider the following information for safe use of this medicine:
There are limited data on the use of bilastine in pregnant or breast-feeding women, or on its effects on fertility.
If the patient is pregnant or breast-feeding, or plans to have a baby, she should ask the doctor for advice before taking this medicine.
Before taking any medicine, ask the doctor or pharmacist for advice.

Driving and Using Machines

It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive or use machines in adults. However, the response to treatment may vary from person to person.
Therefore, check how this medicine affects the child before allowing them to ride a bicycle, drive a vehicle, or use machines.

Bilaxten Contains Methyl Parahydroxybenzoate (E 218) and Propyl Parahydroxybenzoate (E 216)

whichmay cause allergic reactions (possible late reactions).

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% v/v). The amount of alcohol 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 will not have any noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium per 4 mL, which means it is essentially "sodium-free".

3. How to Take Bilaxten

Always take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, ask the doctor or pharmacist.

Use in Children

The recommended dose for children aged 2 to 11 years with a body weight of at least 15 kg is 10 mg of bilastine (4 mL of oral solution) once daily to relieve the symptoms of allergic rhinitis and hives.
Do not give this medicine to children under 2 years of age or weighing less than 15 kg, as there is not enough information on the use of this medicine in these children.
For adults, including the elderly, and adolescents aged 12 years and older, the recommended dose of bilastine is 20 mg once daily. For this population of patients, a more suitable form of the medicine is available - a tablet; ask the doctor or pharmacist.

• The oral solution is for oral use.
• To open the bottle with a child-resistant closure, press the plastic cap down and turn it in the opposite direction of the arrow.
• A measuring cup is provided with the pack to help measure the correct dose. The measuring cup has a mark for 4 mL (= 10 mg bilastine per dose) to help measure the correct amount of oral solution.
• Fill the measuring cup to the 4 mL mark.
• Give the oral solution directly from the measuring cup.
• Wash the measuring cup after use.
• Give the oral solution to the child 1 hour before or 2 hours after any meal or fruit juice.

The duration of treatment depends on the type of disease in the child. The doctor will decide how long the child should take Bilaxten.

Overdose of Bilaxten

If the child takes more Bilaxten than they should, or if someone else takes the child's medicine by mistake, contact a doctor or go to the nearest hospital emergency department immediately. Take the medicine package or package leaflet with you.

Missing a Dose of Bilaxten

If a dose is missed, give it to the child as soon as possible on the same day. Then, give the next dose at the usual time the next day, as recommended by the doctor.
Never give a double dose to make up for a missed dose.

Stopping Treatment with Bilaxten

No effects are expected after stopping treatment with Bilaxten.
If you have any further questions on the use of this medicine, ask the doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Bilaxten can cause side effects, although not everybody gets them.
If the child experiences an allergic reaction, including:
difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or redness and swelling of the skin, stop taking the medicine and consult a doctor immediately.

Other Side Effects that May Affect 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
• lip swelling
• rash
• hives
• fatigue
• rhinitis (nasal irritation)
• abdominal pain (stomach pain, pain in the upper abdomen)

Side Effects that May Affect Adults and Adolescents:

Common: May Affect Up to 1 in 10 People

• headache
• drowsiness

Uncommon: May Affect Up to 1 in 100 People

• abnormal ECG
• blood test changes indicating liver problems
• dizziness
• abdominal pain
• fatigue
• increased appetite
• heart rhythm problems
• weight gain
• nausea
• anxiety
• nose dryness or discomfort
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (dizziness or feeling of spinning)
• weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• oral thrush
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• blood test changes indicating kidney problems
• increased blood lipid levels

Frequency Not Known: Cannot be Estimated from the Available Data

• palpitations (feeling of heartbeat)
• tachycardia (fast heartbeat)
• vomiting.

Reporting Side Effects

If the child experiences any side effects, including any not listed in the package leaflet, tell the doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store 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 bottle after "EXP".
The expiry date refers to the last day of that month.
Do not store above 30°C.
The shelf life after first opening is 6 months.
Do not use the medicine if the patient notices any visible particles.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Bilaxten Contains

• The active substance is bilastine. One milliliter of oral solution contains 2.5 mg of bilastine.
• The other ingredients are: betadex (E 459), hydroxyethylcellulose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucralose (E 955), raspberry flavor (main components are: ethanol, triacetin, water, ethyl acetate, linalool acetate), hydrochloric acid 37% or 10% (to adjust pH), sodium hydroxide (to adjust pH), purified water.

What Bilaxten Looks Like and Contents of the Pack

Bilaxten is a clear, colorless, slightly viscous aqueous solution with a pH of 3.0-4.0 and no sediment.
Bilaxten, 2.5 mg/mL oral solution, is available in a brown glass bottle with an aluminum or polypropylene child-resistant closure and a measuring cup with a capacity of 15 mL or 25 mL and a 4 mL dose mark. Each bottle contains 120 mL of oral solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
1611 Luxembourg
Luxembourg
Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
Faes Farma, S.A.
Màximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain

This Medicine is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Germany: Antires 2.5 mg/ml Lösung zum Einnehmen
France: Inorial 2.5 mg/ ml solution buvable
Greece: Bilargen 2.5 mg/mL πόσιμο διάλυμα
Italy: Robilas 2,5 mg/ml soluzione orale
Poland: Bilaxten
Portugal: Bilaxten 2,5 mg/ml solução oral
Spain: Bilaxten 2,5 mg/ml solución oral
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01
Date of Last Revision of the Package Leaflet:03/2025