Bilastina Hitaxa Iunior

Leaflet attached to the packaging: patient information

Bilastine Hitaxa Junior, 10 mg, orally disintegrating tablets

Bilastine

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Bilastine Hitaxa Junior and what is it used for
• 2. Important information before taking Bilastine Hitaxa Junior
• 3. How to take Bilastine Hitaxa Junior
• 4. Possible side effects
• 5. How to store Bilastine Hitaxa Junior
• 6. Contents of the pack and other information

1. What is Bilastine Hitaxa Junior and what is it used for

Bilastine Hitaxa Junior contains the active substance bilastine, which has antihistamine properties.
Bilastine Hitaxa Junior is used to relieve the symptoms of hay fever (sneezing, itching, 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).
Bilastine Hitaxa Junior 10 mg, orally disintegrating tablets, is indicated for use in children aged 6 to 11 years with a body weight of at least 20 kg.
If after 3 days there is no improvement or the patient feels worse, you should consult your doctor.

2. Important information before taking Bilastine Hitaxa Junior

When not to take Bilastine Hitaxa Junior

• 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 Bilastine Hitaxa Junior, you should discuss it with your 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 problems or a very slow heart rate, if the child is taking medicines that may affect the heart rhythm, if the child has or has had an abnormal heart rhythm (known as a prolonged QTc interval on an electrocardiogram), which can occur in some types of heart disease, and also if the child is taking other medicines (see "Bilastine Hitaxa Junior and other medicines").

Children

This medicine should not be given to children under 6 years of age with a body weight below 20 kg, as there is not enough data on the use of the medicine.

Bilastine Hitaxa Junior and other medicines

You should tell your doctor or pharmacist about all medicines the child is taking, including those obtained without a prescription, and about any medicines the child may 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 they are taken together.
You should always inform your doctor or pharmacist if the child is taking any of the following medicines in addition to Bilastine Hitaxa Junior:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporin (a medicine that reduces the activity of the immune system, used to prevent rejection of a transplant or to reduce the severity of autoimmune diseases and allergies, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat AIDS)
• rifampicin (an antibiotic).

Bilastine Hitaxa Junior with food and drink You should not take the medicine with food or with grapefruit juice or other fruit juices

because it reduces the effect of Bilastine Hitaxa Junior. To avoid reducing the effect of the medicine, you should:

• give the child an orally disintegrating tablet 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 an orally disintegrating tablet.

Pregnancy, breastfeeding, and fertility

This medicine is intended for use in children aged 6 to 11 years with a body weight of at least 20 kg. However, the following information on the safe use of this medicine should be considered.
There are no data or limited data on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility.
If the patient is pregnant or breastfeeding, or plans to have a child, she should consult her doctor before taking this medicine. Before taking any medicine, the patient should consult her doctor or pharmacist.

Driving and using machines

It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, the response to treatment may vary from patient to patient.
Therefore, you should check how the medicine affects the child before allowing them to ride a bike, drive another vehicle, or operate machinery.

3. How to take Bilastine Hitaxa Junior

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Use in children

The recommended dose for children aged 6 to 11 years with a body weight of at least 20 kg is 10 mg of bilastine (1 orally disintegrating tablet) once a day to relieve the symptoms of allergic rhinitis and conjunctivitis and hives.
This medicine should not be given to children under 6 years of age with a body weight below 20 kg, as there is not enough data on the use of the medicine.
For adults, including the elderly and adolescents aged 12 years and older, the recommended dose of bilastine is 20 mg once a day. For this patient population, a more suitable form of the medicine is available – a tablet.

• The orally disintegrating tablet is intended for oral administration.
• You should place the orally disintegrating tablet in the child's mouth. It will dissolve quickly in the saliva, and then it can be easily swallowed.
• The orally disintegrating tablet can also be dissolved in a teaspoon of water before administration to the child. You should make sure that there are no remaining particles on the spoon.
• To dissolvethe tablet, you should only use water, not grapefruit juice or other fruit juices.
• The orally disintegrating tablet should be given to the child 1 hour before or 2 hours afterany meal or fruit juice.

The duration of treatment depends on the type, duration, and course of the disease in the child.

You should not take Bilastine Hitaxa Junior for more than 10 days without consulting your doctor.

If after 3 days there is no improvement or the patient feels worse, you should consult your doctor.

Taking more than the recommended dose of Bilastine Hitaxa Junior

If the child or another person has taken more than the recommended dose of Bilastine Hitaxa Junior, you should immediately contact your doctor or go to the emergency department of the nearest hospital. You should take the packaging or leaflet with you.

Missing a dose of Bilastine Hitaxa Junior

If a dose is missed in a child, you should give it as soon as possible on the same day. Then, you should give the next dose the next day at the usual time, as directed by your doctor. In no case should you take a double dose to make up for a missed dose.

Stopping treatment with Bilastine Hitaxa Junior

You should not expect any consequences from stopping treatment with Bilastine Hitaxa Junior.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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) swelling and redness of the skin, you should stop taking the medicine and immediately consult your doctor or the emergency department of the nearest hospital.

Other side effects that may occur in children are:

Common: occurring in less than 1 in 10 treated patients

• rhinitis (irritation of the nose)
• allergic conjunctivitis (irritation of the eyes)
• headache
• stomach pain (abdominal pain, pain in the upper abdomen).

Uncommon: occurring in less than 1 in 100 treated patients

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea
• lip swelling
• rash
• hives
• fatigue.

Side effects that may occur in adults and adolescents are:

Common: occurring in less than 1 in 10 treated patients

• headache
• drowsiness.

Uncommon: occurring in less than 1 in 100 treated patients

• abnormal ECG
• changes in blood tests indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm problems
• weight gain
• nausea
• anxiety
• feeling of dryness or discomfort in the nose
• 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
• changes in blood tests indicating kidney problems
• increased lipid levels in the blood.

Frequency not known: cannot be estimated from the available data

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

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bilastine Hitaxa Junior

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bilastine Hitaxa Junior contains

• The active substance of the medicine is bilastine. Each orally disintegrating tablet contains 10 mg of bilastine.
• The other ingredients are: mannitol DC, ethylcellulose, crospovidone type A, grape flavor (main components: corn maltodextrin, gum arabic, flavoring substances), magnesium stearate, sucralose.

What Bilastine Hitaxa Junior looks like and contents of the pack

Bilastine Hitaxa Junior, orally disintegrating tablets, are round, biconvex, white tablets with a diameter of 8 mm.
The orally disintegrating tablets are packaged in a PA/Aluminum/PVC/Aluminum blister pack in a cardboard box.
Pack sizes: 10 orally disintegrating tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, Mariana Adamkiewicza 6A
05-152 Czosnów
phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Józefa Piłsudskiego 5
95-200 Pabianice
NOUCOR HEALTH, S.A.
Camí Reial, 51-57
08184 Palau-Solità i Plegamans (Barcelona)
Spain
Date of last revision of the leaflet:04.2025