Bilastyna hitaxa junior

Package leaflet: Information for the patient

Bilastyna Hitaxa Junior, 10 mg, orodispersible tablets
Bilastinum
For children aged 6 to 11 years weighing at least 20 kg
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, contact your doctor.

Contents of the leaflet:

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

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

Bilastyna Hitaxa Junior contains the active substance bilastinum, which has antihistaminic activity.
Bilastyna Hitaxa Junior 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. The medicine
may also be used to treat itchy skin rashes (blisters or hives).
Bilastyna Hitaxa Junior 10 mg orodispersible tablets are indicated for use in children aged 6 to 11 years weighing at least 20 kg.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important information before using Bilastyna Hitaxa Junior

When not to use Bilastyna Hitaxa Junior

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

Warnings and precautions
Before starting treatment with Bilastyna Hitaxa Junior, consult a doctor or
pharmacist if the child has moderate or severe kidney or
liver function impairment, 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, or 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. Additionally, this applies if the child is taking other medicines (see “Bilastyna Hitaxa Junior with other medicines”).
Children
This medicine must not be given to children under 6 years of age weighing less than 20 kg, due to insufficient data on use in this population.
Bilastyna Hitaxa Junior with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the child, including those obtained without a prescription, as well as any medicines the child may take in the future.
Some medicines should not be taken together, 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 Bilastyna Hitaxa Junior:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (a medicine that reduces immune system activity, used to prevent transplant rejection or to reduce severity of disease in autoimmune and allergic conditions such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic).

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

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

Pregnancy, breastfeeding and fertility
This medicine is intended for use in children aged 6 to 11 years weighing at least 20 kg. However, the following information regarding safe use of this medicine should be considered.
There are no data or limited data available on the use of bilastine in pregnant or breastfeeding women, or on its effect on fertility.
If the patient is pregnant, breastfeeding, or planning to become pregnant, she should consult a doctor before using this medicine. Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
It has been demonstrated that bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, individual responses to treatment may vary.
Therefore, the effect of this medicine on the child should be assessed before allowing the child to ride a bicycle, drive a vehicle, or operate machinery.

3. How to use Bilastyna Hitaxa Junior

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Use in children
The recommended dose for children aged 6 to 11 years weighing at least 20 kg is 10 mg of bilastyna (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 6 years of age weighing less than 20 kg, due to insufficient data on its use.

For adults, including elderly individuals and adolescents aged 12 years and older, the recommended dose of bilastyna is 20 mg once daily. For this patient population, a more suitable dosage form – tablet – is available.

• 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. Ensure that no residue remains on the spoon.
• Only water should be used to dissolve the tablet. Do not use grapefruit juice or other fruit juices.
• The orodispersible tablet should be administered to the child one hour before or two hours after any meal or consumption of fruit juice.

The duration of treatment depends on the type, duration, and course of the disease in the child.
Do not use Bilastyna Hitaxa Junior for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Taking more medicine than recommended (Bilastyna Hitaxa Junior overdose)
If a child or another person takes more than the recommended dose of Bilastyna Hitaxa Junior, contact a doctor immediately or go to the nearest hospital emergency department. Bring the medicine packaging or leaflet with you.

Missed dose of Bilastyna Hitaxa Junior
If a dose is missed for a child, administer it as soon as possible on the same day. Then, give the next dose at the usual time the following day, according to the doctor's instructions. Under no circumstances should a double dose be taken to make up for a missed dose.

Stopping Bilastyna Hitaxa Junior
No consequences are expected from discontinuing treatment with Bilastyna Hitaxa Junior.

If you have any further questions about 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 any allergic reactions occur in a child, including: difficulty breathing, dizziness,
collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) skin redness and swelling,
you should stop taking the medicine and consult a doctor or the emergency department of the nearest hospital immediately.

Other adverse reactions that may occur in children:

Common: occurring in less than 1 in 10 treated patients

• Nasal mucositis (nasal irritation)
• Allergic conjunctivitis (eye irritation)
• Headache
• Stomach pain (abdominal pain, epigastric pain)

Uncommon: occurring in less than 1 in 100 treated patients

• Eye irritation
• Dizziness
• Loss of consciousness
• Diarrhea
• Nausea
• Swelling of the lips
• Rash
• Urticaria
• Fatigue

Adverse reactions that may occur in adults and adolescents:

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
• Heart rhythm disturbances
• Weight gain
• Nausea
• Anxiety
• Dryness or discomfort in the nose
• Abdominal pain
• Diarrhea
• Gastritis (inflammation of the stomach mucosa)
• Dizziness (dizziness or sensation of spinning)
• Weakness
• Increased thirst
• Dyspnea (difficulty breathing)
• Dry mouth
• Dyspepsia
• 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 based on available data

• Palpitations (awareness of heartbeat)
• Tachycardia (rapid heartbeat)
• Vomiting

Reporting of adverse reactions

If any adverse reactions occur, 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 to provide more information on the safety of the medicine.

5. How to store Bilastyna Hitaxa Junior

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "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. This will help protect the environment.

6. Contents of the packaging and other information

What Bilastyna Hitaxa Junior contains

• The active substance is bilastine. Each orodispersible tablet contains 10 mg of bilastine.
• Other ingredients are: mannitol DC, ethylcellulose, crospovidone type A, grape flavour (main components: corn maltodextrin, gum arabic, flavouring substances), magnesium stearate, sucralose.

What Bilastyna Hitaxa Junior looks like and contents of the pack
Bilastyna Hitaxa Junior orodispersible tablets are round, biconvex, white tablets with a diameter of 8 mm.
Orodispersible tablets are packed in PA/Aluminium/PVC/Aluminium blisters contained in a cardboard box.
Pack sizes: 10 orodispersible tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
NOUCOR HEALTH, S.A.
Avinguda Camí Reial, 51-57
08184 Palau-Solità i Plegamans (Barcelona)
Spain