Package leaflet: Information for the patient

BILANT, 20 mg, tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What BILANT is and what it is used for

BILANT contains the active substance bilastinum, which has antihistaminic properties. BILANT 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. It may also be used to treat itchy skin rashes (blisters or urticaria).

2. Important information before using BILANT

When not to use BILANT

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 treatment with BILANT, consult a doctor or pharmacist if the patient has
moderate or severe kidney function impairment, 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. In addition, the patient is taking other medicines (see “BILANT with other
medicines”).
Children
This medicine must not be given to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.
BILANT with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take, including those available without a
prescription.
In particular, consult a doctor if the patient is taking any of the following medicines:

Ketoconazole (an antifungal medicine)
Erythromycin (an antibiotic)
Diltiazem (a medicine used for angina pectoris)
Cyclosporine (a medicine used to reduce immune system activity, helping to prevent transplant rejection, or to reduce disease activity in autoimmune and allergic conditions such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
Ritonavir (a medicine used in the treatment of AIDS)
Rifampicin (an antibiotic).

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

swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
wait two hours after a meal or drinking fruit juice before taking the tablet.

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

Pregnancy, breastfeeding and fertility
There are no data or only limited data on the use of bilastine during pregnancy and breastfeeding,
and on its effect 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 before using this medicine. Before taking any medicine, consult
a doctor or pharmacist.
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.
BILANT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to take BILANT

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly people and adolescents aged 12 years and older, is 1 tablet (20 mg) once daily.

This is an oral tablet.
The tablet should be taken one hour before or two hours after a meal or drinking fruit juice (see section 2, "BILANT 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 illness and decide how long you should take BILANT.

Use in children
For children aged 6 to 11 years weighing at least 20 kg, other formulations of this medicine are available – bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution. Consult your doctor or pharmacist.
Bilastine must not be given to children under 6 years of age weighing less than 20 kg,
as there is insufficient data on use in this group.
Taking more BILANT than recommended
If you take more BILANT tablets than recommended, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Take the medicine pack or leaflet with you.
If you forget to take BILANT
Do not take a double dose to make up for a missed dose.
If you miss a dose at the usual time, take the missed dose as soon as possible, then continue taking the medicine at your regular time.
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 not everyone experiences them.
If the patient experiences 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 rash and redness,
the use of the medicine should be discontinued immediately and medical advice should be sought without delay.

Adverse reactions that may occur in adults and adolescents:
Common (may occur in fewer than 1 in 10 people):

headache
drowsiness

Uncommon (may occur in fewer than 1 in 100 people):

abnormal ECG recording
blood test results indicating changes in liver function
dizziness
stomach pain
fatigue
increased appetite
irregular heartbeat
weight gain
nausea
anxiety
dryness or discomfort in the nose
abdominal pain
diarrhoea
gastritis (inflammation of the stomach lining)
vertigo (dizziness or sensation of spinning)
feeling weak
increased thirst
dyspnoea (difficulty breathing)
dry mouth
indigestion
itching
oral herpes
fever
tinnitus (ringing in the ears)
sleep problems
blood test results indicating changes in kidney function
increased blood lipid levels

Frequency not known (cannot be estimated from available data):

palpitations (awareness of heartbeat)
tachycardia (rapid heartbeat)
vomiting

Adverse reactions that may occur in children:
Common (may occur in fewer than 1 in 10 people):

rhinitis (nasal irritation)
allergic conjunctivitis (eye irritation)
headache
stomach pain (abdominal pain, epigastric pain)

Uncommon (may occur in fewer than 1 in 100 people):

eye irritation
dizziness
loss of consciousness
diarrhoea
nausea
swelling of the lips
rash
urticaria
fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for 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 the medicine BILANT

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 following "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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What BILANT contains

The active substance is bilastine. Each tablet contains 20 mg of bilastine.
The other ingredients are: mannitol, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium aluminum metasilicate, magnesium stearate, colloidal anhydrous silica.

What BILANT looks like and contents of the pack
BILANT tablets are round, biconvex, white or almost white, with a diameter of approximately 7 mm.
The tablets are packed in blisters containing 10, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer:
Saneca Pharmaceuticals a. s.
Nitrianska 100
920 27 Hlohovec
Slovakia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria: Билант 20 mg таблетки
Poland: BILANT
Sweden: Bilant, 20 mg tablett

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: +48 22 375 92 00
{logo of the Marketing Authorisation Holder}