Package leaflet: Information for the patient

ADABLIX, 20 mg, tablets
Bilastinum
Please read this leaflet carefully before using the medicine, 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 individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

What ADABLIX is and what it is used for
Important information before taking ADABLIX
How to take ADABLIX
Possible side effects
How to store ADABLIX
Contents of the pack and other information

1. What ADABLIX is and what it is used for

ADABLIX contains the active substance bilastinum, which belongs to a group of medicines known as antihistamines.
ADABLIX is used to relieve symptoms of seasonal allergic rhinitis (sneezing, itching or runny nose, nasal congestion, as well as red, watery eyes) and other forms of allergic rhinitis. It may also be used in the treatment of itchy urticaria (rash).

2. Important information before using ADABLIX

When not to use ADABLIX

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

Warnings and precautions
Before starting to take ADABLIX, consult your doctor or
pharmacist if the patient has moderate or severe kidney problems,
low levels of potassium, magnesium, or calcium in the blood, 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, if the patient has or has had an abnormal heart rhythm pattern (known as QTc prolongation on the electrocardiogram), which may occur in certain types of heart disease, and additionally if the patient is taking other medicines (see "ADABLIX and other medicines").
Children
Do not use in children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.
ADABLIX and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This includes also medicines available without a prescription.
In particular, inform your doctor if you are taking any of the following
medicines:
ketoconazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used to treat chest pain or pressure – angina pectoris)
cyclosporine (a medicine used to reduce immune system activity to prevent transplant rejection or to reduce the severity of symptoms in autoimmune diseases or allergies, including psoriasis, atopic dermatitis, rheumatoid arthritis)
ritonavir (used in the treatment of AIDS)
rifampicin (an antibiotic)
ADABLIX with food, drink, and alcohol
ADABLIX should not be taken with food or grapefruit juice, or with other fruit juices, as this may reduce the effectiveness of bilastine. To avoid this, you should:
take the tablet one hour before a planned meal or drinking fruit juice, or
if the patient has already eaten a meal or drunk fruit juice, wait two hours before taking the tablet.
Bilastine, when taken at the recommended dose of 20 mg, does not increase alcohol-induced drowsiness.
Pregnancy, breastfeeding, and fertility
There are no data or insufficient data on the use of bilastine in pregnant women, during breastfeeding, or on the effect of bilastine on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. Before taking any medicine, consult a doctor.
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, individual response to treatment may vary. Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.

3. How to take ADABLIX

ADABLIX must always be taken exactly as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
The recommended dose for adults, including elderly people and adolescents aged 12 years and older, is:
1 tablet (20 mg bilastine) once daily.
The tablet is intended for oral administration.
The tablet should be taken one hour before or two hours after a meal or drinking fruit juice (see section 2, "ADABLIX with food, drink and alcohol").
Swallow the tablet with a glass of water.
Regarding duration of treatment, the treating physician will determine the patient's condition and decide how long ADABLIX should be taken.

Use in children
Other pharmaceutical forms of this medicine may be suitable for children aged 6 to 11 years. Due to insufficient data, ADABLIX should not be given to children under 6 years of age or weighing less than 20 kg.

Taking more than the recommended dose of ADABLIX
If a patient or anyone else takes more than the recommended dose of ADABLIX, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department. Bring the medicine packaging or leaflet with you.

Missed dose of ADABLIX
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as possible, then continue taking the medicine at the usual time.

Stopping ADABLIX
Generally, no adverse effects occur after stopping ADABLIX.
If you have any further doubts 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 they do not occur in everyone.

Adverse reactions that may occur in adults and adolescents:

Common: occurs in less than 1 in 10 people
headache
drowsiness

Uncommon: occurs in less than 1 in 100 people
abnormal ECG recording
blood test changes indicating liver function abnormalities
dizziness
stomach pain
feeling of fatigue
increased appetite
heart rhythm disturbances
weight gain
nausea
anxiety
feeling of dryness or discomfort in the nose
abdominal pain
diarrhoea
gastritis (inflammation of the stomach lining)
dizziness (dizziness or spinning sensation)
weakness
increased thirst
dyspnoea (difficulty breathing)
dry mouth
dyspepsia
itching
cold sores
fever
tinnitus
difficulty falling asleep
blood test changes indicating kidney function abnormalities
elevated blood lipid levels

Frequency unknown: cannot be estimated based on available data
palpitations (strong heartbeat)
tachycardia (rapid heartbeat)
allergic reactions: symptoms which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin rash and redness. If any of these severe adverse reactions occur, the medicine should be discontinued immediately and medical advice must be sought without delay.
vomiting

Adverse reactions that may occur in children:

Common: occurs in less than 1 in 10 people
nasal mucositis (irritation of the nasal mucosa)
allergic conjunctivitis (allergy-related eye conjunctivitis)
headache
stomach pain (abdominal pain, epigastric pain)

Uncommon: occurs in less than 1 in 100 people
eye irritation
dizziness
loss of consciousness
diarrhoea
nausea
swelling of the lips
rash
urticaria
feeling of fatigue

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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 authorisation 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 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 stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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 (in the form of bilastine monohydrate).
The other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal silicon dioxide, 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 Authorisation 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 medicinal product is authorised in the European Economic Area member states under the following names:
Poland: ADABLIX