Package leaflet: Information for the patient

BILARGENA, 20 mg, tablets
Bilastinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet for future reference.
If you have any doubts, 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 any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet,
inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:

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

1. What Bilargena is and what it is used for

Bilargena contains the active substance bilastinum, which acts as an antihistamine.
Bilargena is used to relieve symptoms of allergic rhinitis (sneezing, itching, nasal discharge,
nasal congestion, and red, watery eyes) as well as other forms of allergic rhinitis. The medicine
may also be used to treat itchy skin rashes (hives or urticaria).

2. Important information before using Bilargena

When not to use Bilargena
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 Bilargena, discuss this with 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, 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 and the patient is taking other medicines (see "Bilargena and other medicines").

Children
This medicine should not be given to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.

Bilargena and other medicines
Tell 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, inform your doctor if the patient is taking any of the following medicines:
ketoconazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used to treat chest pain or tightness – angina)
cyclosporine (a medicine that reduces immune system activity to prevent transplant rejection or to reduce activity in autoimmune and allergic conditions such as psoriasis, atopic dermatitis or rheumatoid arthritis)
ritonavir (used in the treatment of AIDS)
rifampicin (an antibiotic)

Bilargena with food, drink and alcohol
Do not take the medicine together with food or grapefruit juice or other fruit juices,
as this may reduce the effectiveness of bilastine. To avoid this, you should:
swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
if a meal or fruit juice has been consumed, wait 2 hours 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 limited data on the use of bilastine during pregnancy, breastfeeding, or 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.

Driving and operating machinery
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, patients should assess how this medicine affects them.

3. How to take Bilargena

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
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) per day.
Tablet for oral administration.
The tablet should be taken one hour before or two hours after any meal or fruit juice (see section 2,
“Bilargena with food, drink and alcohol”).
Swallow the tablet with a glass of water.
Regarding duration of treatment, your doctor will determine the type of illness and decide how long
you should continue taking Bilargena.
Use in children
Other pharmaceutical forms of this medicine may be suitable for use in children aged 6 to 11 years.
This medicine should not be given to children under 6 years of age weighing less than 20 kg, as there
is insufficient data on its use.
Taking more Bilargena than recommended
If you take more Bilargena than you should, 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 Bilargena
Do not take a double dose to make up for a forgotten dose.
If you miss a dose, take it as soon as possible, then return to taking your regular dose at the usual time.
Stopping Bilargena
Generally, no adverse effects occur when stopping treatment with Bilargena.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects that may occur in adults and adolescents:

Common (may affect fewer than 1 in 10 people):
headache
drowsiness

Uncommon (may affect fewer than 1 in 100 people):
abnormal ECG recording
blood test changes indicating liver function disorders
dizziness
stomach pain
fatigue
increased appetite
heart rhythm disorders
weight gain
nausea
anxiety
dryness or discomfort in the nose
abdominal pain
diarrhea
gastritis (inflammation of the stomach lining)
dizziness (spinning sensation)
weakness
increased thirst
dyspnea (breathing difficulties)
dry mouth
dyspepsia
itching
oral herpes
fever
tinnitus (ringing in the ears)
sleep disturbances
blood test changes indicating kidney function disorders
elevated blood lipid levels

Frequency not known (cannot be estimated from available data):
palpitations (awareness of heartbeat)
tachycardia (rapid heartbeat)
hypersensitivity reactions, including: breathing difficulties, dizziness, collapse or loss of consciousness, facial swelling, swelling of the lips, tongue or throat, and/or skin rash and redness. If any of these severe adverse effects occur, the medicine should be discontinued immediately and medical advice must be sought without delay.
vomiting

Adverse effects that may occur in children:

Common (may affect fewer than 1 in 10 people):
nasal mucositis (nasal irritation)
allergic conjunctivitis (allergic inflammation of the eye conjunctiva)
headache
stomach pain (abdominal pain, epigastric pain)

Uncommon (may affect fewer than 1 in 100 people):
eye irritation
dizziness
loss of consciousness
diarrhea
nausea
swelling of the lips
rash
urticaria
fatigue

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Bilargena

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 precautions for storage of the medicine.
Medicines must 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 Bilargena contains
The active substance is bilastine. Each tablet contains 20 mg of bilastine (as monohydrate bilastine).
Other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal silicon dioxide, anhydrous.

What Bilargena looks like and contents of the pack
Bilargena tablets are white, round.
Each pack contains 10 or 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturers
NOUCOR HEALTH, S.A.,
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans
Barcelona
Spain

LEK farmacevtska družba d.d.
Verosvškova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Bilastin HEXAL 20 mg Tabletten
Estonia: Bilastine Sandoz
Spain: Bilastina Sandoz 20 mg comprimidos EFG
Italy: Bilastina Sandoz
Lithuania: Bilastine Sandoz 20 mg tabletės
Latvia: Bilastine Sandoz 20 mg tablets
Poland: BILARGENA

For further information on this medicinal product, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00