Adablix

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

ADABLIX, 10 mg, orally disintegrating tablets

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

Read the leaflet carefully before giving the medicine to the child, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for this child. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is ADABLIX and what is it used for

ADABLIX contains the active substance bilastine, which has antihistamine properties.
ADABLIX 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).
ADABLIX, 10 mg, orally disintegrating tablets are indicated for use in children aged 6 to 11 years with a body weight of at least 20 kg.

2. Important information before taking ADABLIX

When not to take ADABLIX

• 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 ADABLIX, discuss 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, 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, and if the child is taking other medicines (see "ADABLIX with other medicines").

Children

Do not give this medicine 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.

ADABLIX with other medicines

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

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

ADABLIX with food, drink, and alcohol

Do not take the medicine with food or grapefruit juice, or other fruit juices
, as this reduces the effect of ADABLIX. To avoid reducing the effect of the medicine:

• give the child the orally disintegrating tablet and wait for 1 hour before giving the child food or fruit juice, or
• if the child has eaten or drunk fruit juice, wait for 2 hours before giving the child the orally disintegrating tablet.

Bilastine at the recommended dose for adults (20 mg) does not increase sleepiness caused by alcohol consumption.

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, consider the following information on the 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
Always ask your doctor or pharmacist for advice before taking any medicine.

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, check how the medicine affects the child before allowing them to ride a bike, drive another vehicle, or use machines.

3. How to take ADABLIX

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask 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 bilastine (1 orally disintegrating tablet) once daily to relieve the symptoms of allergic rhinitis and hives.
Do not give this medicine 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 daily. A more suitable form of the medicine is available for this population of patients; ask your doctor or pharmacist.

• The orally disintegrating tablet is for oral use.
• Place the orally disintegrating tablet in the child's mouth. It will dissolve quickly in the saliva and can then be swallowed easily.
• The orally disintegrating tablet can also be dissolved in a teaspoon of water before administration. Make sure there are no remaining fragments on the spoon.
• Only use waterto dissolve the tablet, do not use grapefruit juice or other fruit juices.
• Give the orally disintegrating tablet to the child 1 hour before or 2 hours after any food 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 ADABLIX.

Overdose

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

Missed dose

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

No effects are expected if treatment with ADABLIX is stopped.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ADABLIX can cause side effects, although not everybody gets them.
If the child experiences symptoms of 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, stop taking the medicine and consult a doctor immediately.

Side effects that may occur in children are:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

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

Side effects that may occur in adults and adolescents are:

Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• abnormal ECG
• changes in blood tests indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm problems
• weight gain
• nausea
• anxiety
• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly to the Department of Medicines Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 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 ADABLIX

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 blister after "EXP".
The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What ADABLIX contains

• The active substance is bilastine. Each orally disintegrating tablet contains 10 mg bilastine.
• The other ingredients are: mannitol DC, ethylcellulose, crospovidone (type A), grape flavor, sucralose, magnesium stearate.

What ADABLIX looks like and contents of the pack

ADABLIX, 10 mg, orally disintegrating tablets are white, biconvex, round tablets with a diameter of 8 mm. During the shelf life of the medicine, minor speckles may appear.
The orally disintegrating tablets are packaged in blisters.
Pack sizes: 10, 20, 30, or 50 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice, Poland
Noucor Health, S.A.
Avda. Camí Reial 51-57
08184 Palau-solità i Plegamans
Barcelona – Spain
Date of last revision of the leaflet:04.2025