Adablix

Package leaflet: Information for the patient

ADABLIX, 10 mg, orodispersible tablets
For children aged 6 to 11 years weighing at least 20 kg
Bilastinum
Please read this leaflet carefully before giving the medicine to your child, because
it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific child only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If your child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What ADABLIX is and what it is 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 ADABLIX is and what it is used for

ADABLIX contains the active substance bilastin, which acts as an antihistamine.
ADABLIX is used to relieve symptoms of hay fever (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).
ADABLIX 10 mg orodispersible tablets are indicated for use in children aged 6 to 11 years weighing at least 20 kg.

2. Important information before using ADABLIX

When not to use 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 starting treatment with ADABLIX, discuss with a doctor or pharmacist if the child has:
moderate or severe kidney or liver function disorders, low blood potassium, magnesium or calcium levels, if the patient has or has had heart rhythm disorders or very slow heartbeat, if the patient is taking medicines that may affect heart rhythm, or if the patient has or has had an abnormal heart rhythm pattern (known as QTc prolongation on electrocardiogram), which may occur in certain types of heart disease, especially when the child is also taking other medicines (see "ADABLIX with other medicines").

Children
This medicine should not be given to children under 6 years of age weighing less than 20 kg, due to insufficient data on use in this population.

ADABLIX with 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 plans to take.
Some medicines should not be taken together, while others may require dose adjustment when used concomitantly.
Always inform the doctor or pharmacist if the child is taking any of the following medicines in addition to ADABLIX:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (used to treat chest pain or pressure – angina)
• 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 the treatment of AIDS)
• rifampicin (an antibiotic).

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

• give the orally disintegrating tablet 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 orally disintegrating 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 6 to 11 years weighing at least 20 kg. However, the following information regarding safe use should be considered. There are no data or limited data on the use of bilastine in pregnant or breastfeeding women, or on its effect on fertility.
If a patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Always consult a doctor or pharmacist before using any medicine.

Driving and operating machinery
It has been shown that bilastine at a dose of 20 mg does not impair driving ability in adults. However, individual patient 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.

3. How to use ADABLIX

This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt,
consult a 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 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 with body weight below 20 kg, as there is
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. A more suitable dosage form – tablet – is available for this patient population; 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. 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 intake.

The duration of treatment depends on the child's condition. The doctor will determine how long the child
should continue taking ADABLIX.
Taking more than the recommended dose of ADABLIX
If a child or another person takes more than the recommended dose of ADABLIX, contact a doctor immediately
or go to the nearest hospital emergency department. Bring the medicine packaging or leaflet with you.
Missing a dose of ADABLIX
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, as directed by the doctor. Under no circumstances should a double dose be taken
to make up for a missed dose.
Stopping ADABLIX treatment
No consequences are expected from stopping treatment with ADABLIX.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If a child develops symptoms of an allergic reaction, including: difficulty breathing, dizziness,
collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) skin swelling and redness,
stop taking the medicine and consult a doctor immediately.

Adverse reactions that may occur in children:

Common: occurring in fewer than 1 in 10 treated individuals

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

Uncommon: occurring in fewer than 1 in 100 treated individuals

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

Adverse reactions that may occur in adults and adolescents:

Common: occurring in fewer than 1 in 10 treated individuals

• Headache
• Somnolence

Uncommon: occurring in fewer than 1 in 100 treated individuals

• Abnormal ECG findings
• 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
• 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
• Increased 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, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 ADABLIX

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 after:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should 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 pack and other information

What ADABLIX contains

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

What ADABLIX looks like and contents of the pack
ADABLIX, 10 mg, orodispersible tablets are white, biconvex, round tablets with a diameter of 8 mm.
During the shelf life, minor specks may appear.
The 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
Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A
05-152 Czosnów, Poland
tel.: +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