Bilargena

Package Leaflet: Information for the Patient

BILARGENA, 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.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor and should not be given to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Bilargena and what is it used for
• 2. Important information before taking Bilargena
• 3. How to take Bilargena
• 4. Possible side effects
• 5. How to store Bilargena
• 6. Contents of the pack and other information

1. What is Bilargena and what is it used for

Bilargena contains the active substance bilastine, which has antihistamine properties.
Bilargena is used to relieve symptoms of hay fever (sneezing, itching, runny nose, blocked nose, and red and itchy eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (hives or urticaria).

2. Important information before taking Bilargena

When not to take Bilargena

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

Warnings and precautions

Before taking Bilargena, the patient should discuss it with their doctor or pharmacist if they have moderate or severe kidney problems, low potassium, magnesium, or calcium levels in the blood, if they have or have had heart rhythm problems or very slow heart rate, if they are taking medicines that may affect heart rhythm, if they have or have had an abnormal heart rhythm (known as QTc interval prolongation on an electrocardiogram), which may occur in certain heart conditions, and if they are taking other medicines (see "Bilargena and other medicines").

Children

This medicine should not be given to children under 12 years of age.

Do notexceed the recommended dose. If symptoms persist, consult a doctor.

Bilargena and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.
In particular, the patient should inform their doctor about taking any of the following medicines:
ketokonazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used to treat chest pain or angina)
cyclosporine (a medicine that reduces the activity of the immune system to prevent transplant rejection or to treat autoimmune diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
ritonavir (used to treat AIDS)
rifampicin (an antibiotic)

Bilargena with food, drink, and alcohol Do not take the medicine with food, grapefruit juice, or other fruit juices

asthis reduces the effect of bilastine. To avoid this, the patient should:
swallow the tablet and wait for one hour before eating or drinking fruit juice or
wait for 2 hours after eating 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 limited data on the use of bilastine in pregnant or breastfeeding women, and on its effects on fertility.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor 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 patient to patient.
Therefore, before driving or operating machinery, the patient should check how the medicine affects them.

3. How to take Bilargena

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The recommended dose for adults, including the elderly and adolescents over 12 years of age, is 1 tablet (20 mg) per day.
The tablet is for oral use.
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").
The tablet should be swallowed with a glass of water.
Regarding the duration of treatment, the doctor will determine the type of disease and decide how long to take Bilargena.

Use in children

Other pharmaceutical forms of this medicine may be suitable for use in children aged 6 to 11 years.
Do not give this medicine to children under 6 years of age or weighing less than 20 kg, as there is limited data on its use.

Overdose of Bilargena

In case of overdose, the patient should immediatelycontact a doctor or pharmacist or go to the emergency department of the nearest hospital. They should take the medicine packaging or leaflet with them.

Missed dose of Bilargena

Do nottake a double dose to make up for a missed dose.
If a dose is missed, the patient should take the missed dose as soon as possible and then continue with their regular dose at the usual time.

Stopping Bilargena treatment

Generally, there are no effects after stopping treatment with Bilargena.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Bilargena 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 (feeling of spinning or vertigo)
weakness
increased thirst
shortness of breath (difficulty breathing)
dry mouth
indigestion
itching
oral thrush
fever
tinnitus (ringing in the ears)
sleep disorders
changes in blood tests indicating kidney problems
increased lipid levels in the blood

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

palpitations (feeling of heartbeat)
tachycardia (fast heartbeat)
hypersensitivity reactions, including: difficulty breathing, dizziness, fainting or loss of consciousness, facial swelling, lip, tongue, or throat swelling, and (or) skin redness and swelling. If the patient experiences any of these severe side effects, they should stop taking the medicine and consult a doctor immediately.
vomiting

Side effects that may occur in children:

Common (may affect up to 1 in 10 people):

nasal congestion (runny nose)
allergic conjunctivitis (allergic eye inflammation)
headache
stomach pain (abdominal pain)

Uncommon (may affect up to 1 in 100 people):

eye irritation
dizziness
loss of consciousness
diarrhea
nausea
lip swelling
rash
hives
fatigue

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
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 Bilargena

Keep the 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.
Store the medicine without special precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This 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 bilastine monohydrate).
The other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal silica, anhydrous.

What Bilargena looks like and contents of the pack

Bilargena tablets are white, round.
Each pack contains 10 or 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
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 medicine is authorized 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 about this medicine, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
{Logo Sandoz}
Date of last revision of the leaflet:02/2025