Bilaxten

Package leaflet: Information for the patient

Bilaxten, 10 mg, orodispersible tablets
For children aged 2 to 11 years weighing at least 15 kg
Bilastinum
Please read this leaflet carefully before administering the medicine to the child, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific child only. Do not give it to others. It may harm other people, even if their symptoms are the same.
• If the child experiences any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Bilaxten is and what it is used for
2. Important information before taking 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 the active substance bilastin, which has antihistaminic properties.
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 10 mg orodispersible tablets are 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 function disorders, low blood levels of
potassium, magnesium, or calcium, 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 disease, or if the child is taking other medicines (see
"Bilaxten and other medicines").

Children
This medicine should not be given to children under 2 years of age or weighing less than 15 kg,
due to insufficient data on use in this population.

Bilaxten and other medicines
Tell the doctor or pharmacist about all medicines the child is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the child may take in the future.
Some medicines should not be taken at the same time, while for others, a dose adjustment may be necessary when used concomitantly.
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 discomfort)
• cyclosporine (a medicine that reduces immune system activity, used to prevent transplant rejection or to reduce severity of autoimmune and allergic diseases 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 together with food, grapefruit juice, or other fruit juices,
as this may reduce the effectiveness of Bilaxten. To avoid reduced effectiveness,
you should:

• give the child the orodispersible tablet and wait one hour before giving the child food or fruit juice, or
• if the child has already eaten a meal or drunk fruit juice, wait two hours before giving the child the orodispersible tablet.

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 weighing at least
15 kg. However, the following information regarding safe use should be considered. There are no data or limited data available on the use of bilastine in pregnant women, during breastfeeding, or its effect on fertility.
If the patient is pregnant, breastfeeding, or planning to have a child, she should consult a
doctor before using this medicine. Before using any medicine, consult a
doctor or pharmacist.

Driving and operating machinery
It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive
in adults. However, individual responses to treatment may vary.
Therefore, assess how this medicine affects the child before allowing the child to ride a
bicycle, drive another vehicle, or operate machinery.

Bilaxten contains ethanol and sodium
This medicine contains 0.0015 mg of alcohol (ethanol) in each orodispersible tablet,
equivalent to 1 mg/100 g (0.001% w/w). The amount of alcohol in the orodispersible
tablet is equivalent to less than 0.00004 ml of beer or 0.00002 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet; therefore,
the medicine is considered "sodium-free".

3. How to take Bilaxten

This medicine should always be taken exactly as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.

Use in children
The recommended dose for children aged 2 to 11 years weighing at least 15 kg is 10 mg of bilastine
(1 orodispersible tablet) once daily to relieve symptoms of allergic rhinitis and conjunctivitis, as well as urticaria.
This medicine should not be given to children under 2 years of age or weighing less than 15 kg,
due to insufficient data on its use.

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 a doctor or pharmacist.

• The orodispersible tablet is intended for oral administration.
• Place the orodispersible tablet in the child's mouth. It will rapidly dissolve in saliva and can then be easily swallowed.
• The orodispersible tablet may also be dissolved in a teaspoon of water before administration to the child. This is highly recommended for children under 6 years of age, as they have an increased risk of choking on the tablet. Ensure that no residue remains on the spoon.
• Only water should be used to dissolve the tablet; grapefruit juice or other fruit juices must not be used.
• The orodispersible tablet should be administered to the child one hour before or two hours after any meal or fruit juice consumption.

The duration of treatment depends on the child's condition. The doctor will determine how long the child should continue taking Bilaxten.

Taking more Bilaxten than recommended
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 is missed for a child, administer it as soon as possible on the same day. Then, continue with the next dose at the usual time the following day, as directed by the doctor. Under no circumstances should a double dose be taken to make up for a missed dose.

Stopping Bilaxten
No consequences are expected from stopping 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 will experience 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, stop taking the medicine and consult a doctor immediately.
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
• nasal mucositis (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 arrhythmia
• weight gain
• nausea
• anxiety
• dryness or discomfort in the nose
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach mucosa)
• vertigo (dizziness or sensation of spinning)
• weakness
• excessive thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• oral herpes
• fever
• tinnitus (ringing in the ears)
• sleep disturbances
• blood test abnormalities indicating kidney function disorders
• increased blood lipid levels

Frequency unknown: cannot be estimated from available data

• palpitations (awareness of heart beating)
• 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, 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 authorisation holder.
Reporting adverse reactions helps to 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 blister pack following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Bilaxten contains

• The active substance is bilastine. Each orodispersible tablet contains 10 mg of bilastine.

The other ingredients are: mannitol (E 421), sodium croscarmellose, sodium stearyl fumarate, sucralose (E 955), red grape flavour (main components: arabic gum, ethyl butyrate, triacetin, methyl anthranilate, ethanol, D-limonene, linalool).
What Bilaxten looks like and contents of the pack
Bilaxten orodispersible tablets are round, slightly biconvex, white tablets with a diameter of 8 mm.
Orodispersible tablets are packed in blisters. Pack sizes: 10, 20, 30, or 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
1611 Luxembourg
Luxembourg
Manufacturers
Faes Farma, S.A.
Máximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain
A. Menarini Manufacturing Logistics and Services S.r.l.
Via Campo di Pile, 67100 L’Aquila
Italy
Faes Farma, S.A., Parque Cientifico y Tecnologico de Bizkaia
Ibaizabal Bidea, Edificio 901
48160 Derio (Bizkaia)
Spain
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany: Antires 10 mg Schmeltztabletten
France: Inorial 10 mg comprimé orodispersible
Greece: Bilargen 10 mg δισκία διασπειρόμενα στο στόμα
Italy: Robilas 10 mg compressa orodispersibile
Poland: Bilaxten
Portugal: Bilaxten 10 mg comprimido orodispersível
Spain: Bilaxten Flas 10 mg comprimidos bucodispersables
For further 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