Adablix

Package Leaflet: Information for the Patient

ADABLIX, 20 mg, tablets

Bilastine

Read the package leaflet carefully before taking the medicine, 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 for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those 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 belongs to a group of antihistamine medicines.
ADABLIX is used to relieve the symptoms of hay fever (itchy or runny nose, sneezing, itchy or watery eyes) and other allergic conditions.
It may also be used to treat itchy hives (urticaria).

2. Important information before taking ADABLIX

When not to take ADABLIX

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

Warnings and precautions

Before taking ADABLIX, tell your doctor or pharmacist if you have:
moderate or severe kidney problems,
low levels of potassium, magnesium, or calcium in your blood,
heart rhythm problems or a very slow heart rate,
are taking medicines that may affect your heart rhythm,
have or have had abnormal heart rhythms (known as QT interval prolongation on an electrocardiogram),
which can occur in some heart conditions, and also if you are taking other medicines (see "ADABLIX and other medicines").

Children

Do not give ADABLIX to children under 12 years of age.

Do not exceedthe recommended dose. If symptoms persist, consult your doctor.

ADABLIX and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
This includes medicines obtained without a prescription.
In particular, tell your doctor about:
ketokonazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used to treat chest pain or discomfort – angina pectoris)
cyclosporin (a medicine used to reduce the activity of the immune system to prevent rejection of a transplanted organ or to reduce the severity of symptoms in autoimmune diseases or allergies, including psoriasis, atopic dermatitis, rheumatoid arthritis)
ritonavir (used to treat AIDS)
rifampicin (an antibiotic)

ADABLIX with food, drink, and alcohol

Do not take ADABLIX with food, grapefruit juice, or other fruit juices, as this reduces the effect of bilastine.
To avoid this, take the tablet:
1 hour before a planned meal or fruit juice, or
if you have eaten or drunk fruit juice, wait 2 hours before taking the tablet.
Bilastine at the recommended dose of 20 mg does not increase the sedative effect of alcohol.

Pregnancy, breastfeeding, and fertility

There are no or limited data on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility.
If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this 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 person to person.
Therefore, before driving or operating machinery, check how this medicine affects you.

3. How to take ADABLIX

Always take ADABLIX exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults, including the elderly and adolescents from 12 years, is:
1 tablet (20 mg bilastine) per day.
The tablet is for oral use.
Take the tablet 1 hour before or 2 hours after eating or drinking fruit juice (see section 2 "ADABLIX with food, drink, and alcohol").
Swallow the tablet with a glass of water.
Regarding the duration of treatment, your doctor will determine the type of disease you have and decide how long you should take ADABLIX.

Use in children

Other pharmaceutical forms of this medicine may be suitable for children from 6 to 11 years old.
Due to the lack of sufficient data, this medicine should not be given to children under 6 years old or weighing less than 20 kg.

Overdose

If you or someone else has taken more ADABLIX than recommended, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.
Take the package or leaflet with you.

Missed dose

Do not take a double dose to make up for a forgotten dose.
If you forget a dose, take it as soon as possible, then continue with your regular schedule.

Stopping treatment

Generally, after stopping treatment with ADABLIX, no side effects occur.
If you have any further questions about 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.

Side effects that may occur in adults and adolescents:

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 spinning)
weakness
increased thirst
shortness of breath (difficulty breathing)
dry mouth
indigestion
itching
cold sore
fever
ringing in the ears
difficulty sleeping
changes in blood tests indicating kidney problems
high levels of lipids in the blood
Frequency not known: cannot be estimated from the available data
palpitations (strong heartbeat)
tachycardia (fast heartbeat)
allergic reactions: symptoms that may include difficulty breathing, dizziness, fainting, swelling of the face, lips, tongue, or throat, and (or) redness and swelling of the skin.
If you experience any of these severe side effects, stop taking the medicine and consult your doctor immediately.
vomiting

Side effects that may occur in children:

Common: may affect up to 1 in 10 people
rhinitis (irritation of the nasal mucosa)
allergic conjunctivitis (allergic eye inflammation)
headache
stomach pain (abdominal pain, upper abdominal pain)
Uncommon: may affect up to 1 in 100 people
eye irritation
dizziness
loss of consciousness
diarrhea
nausea
swelling of the lips
hives
fatigue

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Pharmacovigilance 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.
Reporting side effects will help to gather 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 stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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 tablet contains 20 mg of bilastine (as bilastine monohydrate).
• The other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal silica, anhydrous.

What ADABLIX looks like and contents of the pack

ADABLIX 20 mg is a white, round tablet.
Each pack contains 10, 30, or 50 tablets.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland
NOUCOR HEALTH, S.A.
Avenida Cami Reial, 51-57

• 08184 – Palau-solità i Plegamans Barcelona Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:

ADABLIX
Date of last revision of the leaflet:04.2025