Patient Information Leaflet

Bilaxten, 2.5 mg/mL, oral solution
For children aged 2 to 11 years weighing at least 15 kg
Bilastinum
Please read this leaflet carefully before giving the medicine to your child, as it contains important information.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific child only. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If your child experiences any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Bilaxten is and what it is used for
Important information before taking Bilaxten
How to take Bilaxten
Possible side effects
How to store Bilaxten
Contents of the pack and other information

1. What Bilaxten is and what it is used for

Bilaxten contains the active substance bilastin, which acts as an antihistamine.
Bilaxten is used to relieve symptoms of seasonal allergic rhinitis (sneezing, itching, runny nose, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (blisters or hives).
Bilaxten 2.5 mg/mL oral solution is indicated for use in children aged 2 to 11 years weighing at least 15 kg.

2. Important information before using Bilaxten

When not to use 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 starting treatment with Bilaxten, discuss with a doctor or pharmacist if the child has
moderate or severe kidney or liver problems, low levels of potassium, magnesium or calcium in the
blood, if the child has or has had heart rhythm disorders or very slow heart rate, if the child is taking
medicines that may affect heart rhythm, if the child has or has had an abnormal heart rhythm pattern
(known as QTc prolongation on electrocardiogram), which may occur in certain types of heart
diseases, or if the child is taking other medicines (see "Bilaxten with other medicines").
Children
This medicine should not be given to children under 2 years of age or with body weight below 15 kg,
due to insufficient data on use in this population.
Bilaxten with other medicines
Tell the doctor or pharmacist about all medicines the child is currently taking, has recently taken,
or might take in the future, including those available without a prescription.
Some medicines should not be taken together, while others may require dose adjustment when used
concurrently.
Always inform the doctor or pharmacist if the child is taking any of the following medicines in
addition to Bilaxten:

ketoconazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used for angina pectoris – chest pain or tightness)
cyclosporine (a medicine that reduces immune system activity, used to prevent transplant rejection or to reduce severity of autoimmune and allergic conditions such as psoriasis, atopic dermatitis or rheumatoid arthritis)
ritonavir (used in HIV treatment)
rifampicin (an antibiotic)

Bilaxten with food, drink and alcohol
Do not take this medicine with food, grapefruit juice or other fruit juices, as this may reduce
the effectiveness of Bilaxten. To avoid reduced effectiveness, you should:

give the oral solution and wait one hour before giving the child a meal or fruit juice, or
if the child has already eaten a meal or drunk fruit juice, wait two hours before giving the oral solution.

Bilastine at the recommended adult dose (20 mg) does not increase drowsiness caused by alcohol consumption.
Pregnancy, breastfeeding and fertility
This medicine is intended for use in children aged 2 to 11 years with body weight at least 15 kg.
However, consider the following information regarding safe use of this medicine. There are no data or limited data on the use of bilastine in pregnant or breastfeeding women, or on fertility.
If the patient is pregnant, breastfeeding, or planning to become pregnant, she should consult a
doctor before using this medicine.
Before using any medicine, consult a doctor or pharmacist.
Driving and using machines
It has been shown that bilastine at a dose of 20 mg does not affect the ability to drive in adults.
However, individual response to treatment may vary.
Therefore, assess how this medicine affects the child before allowing the child to ride a bicycle,
drive a vehicle or operate machinery.
Bilaxten contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216),
which may cause allergic reactions (including delayed-type reactions).
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 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 cause noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium per 4 mL, meaning the medicine is considered "sodium-free".

3. How to use Bilaxten

This medicine should always be used exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Use in children
The recommended dose for children aged 2 to 11 years with body weight of at least 15 kg is 10 mg of bilastine (4 mL of oral solution) once daily to relieve symptoms of allergic rhinitis and allergic conjunctivitis, as well as urticaria.
This medicine should not be given to children under 2 years of age or with body weight below 15 kg, as there is insufficient data on its use in these populations.
For adults, including elderly individuals and adolescents aged 12 years and older, the recommended dose of bilastine is 20 mg once daily. For this patient population, a more suitable dosage form – a tablet – is available; please consult your doctor or pharmacist.

The oral solution is intended for oral administration.
The bottle of oral solution with a child-resistant cap should be opened by pressing down on the plastic cap while turning it counterclockwise.
An oral dosing device marked with a 4 mL indication (=10 mg bilastine per dose) is provided with the packaging to ensure accurate measurement of the correct volume of oral solution.
Fill the dosing device to the 4 mL mark with oral solution.
Administer the oral solution directly using the dosing device.
After use, wash the dosing device.
The oral solution should be given to the child one hour before or two hours after any meal or fruit juice consumption.

The duration of treatment depends on the type of illness the child has. Your doctor will determine how long the child should continue taking Bilaxten.
Taking more than the recommended dose of Bilaxten
If a child or another person takes more than the recommended dose of Bilaxten, contact a doctor immediately or go to the nearest hospital emergency department.
Bring the medicine packaging or leaflet with you.
Missed dose of Bilaxten
If a dose has been missed for a child, administer it as soon as possible on the same day. Then, continue with the next dose the following day at the usual time, as directed by the doctor.
Under no circumstances should a double dose be taken to make up for a missed dose.
Stopping treatment with Bilaxten
No adverse consequences are expected from discontinuing treatment with Bilaxten.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If a child develops hypersensitivity reactions, including: difficulty breathing, dizziness,
collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and (or) swelling and redness
of the skin, the medicine should be discontinued immediately and medical advice must be sought without delay.
Other adverse reactions that may occur in children include:
Common: occurring in less than 1 in 10 treated patients

allergic conjunctivitis (eye irritation)
headache

Uncommon: occurring in less than 1 in 100 treated patients

eye irritation
dizziness
loss of consciousness
diarrhoea
nausea
lip swelling
rash
urticaria
fatigue
rhinitis (nasal irritation)
stomach pain (abdominal pain, epigastric pain)

Adverse reactions that may occur in adults and adolescents include:
Common: occurring in less than 1 in 10 treated patients

headache
somnolence

Uncommon: occurring in less than 1 in 100 treated patients

abnormal ECG recording
blood test abnormalities indicating liver function disorders
dizziness
stomach pain
fatigue
increased appetite
cardiac rhythm disturbances
weight gain
nausea
anxiety
dryness or discomfort in the nose
abdominal pain
diarrhoea
gastritis (inflammation of the stomach mucosa)
dizziness (dizziness or sensation of spinning)
weakness
increased thirst
dyspnoea (difficulty breathing)
dry mouth
dyspepsia
itching
oral herpes
fever
tinnitus (ringing in the ears)
sleep disturbances
blood test abnormalities indicating kidney function disorders
elevated blood lipid levels

Frequency not known: cannot be estimated from available data

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

Reporting of adverse reactions
If any adverse reactions occur in a child, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bilaxten

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP".
The expiry date refers to the last day of the stated 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 your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Bilaxten contains

The active substance is bilastine. One millilitre 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 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.

What Bilaxten looks like and contents of the pack

Bilaxten is a clear, colourless, slightly viscous aqueous solution with a pH of 3.0–4.0, free from sediment.

Bilaxten 2.5 mg/mL oral solution is available in an amber glass bottle closed with an aluminium cap or a child-resistant polypropylene cap, accompanied by a dosing syringe with a capacity of 15 mL or 25 mL, marked with a 4 mL dose indication. Each bottle contains 120 mL of oral solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
1611 Luxembourg
Luxembourg

Manufacturers
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Faes Farma, S.A.
Máximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain

This medicinal product is authorised in the European Economic Area and 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

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +48 22 566 21 00
Fax: +48 22 566 21 01