Package leaflet: Information for the patient

Bilagra, 20 mg, tablets
Bilastinum
Please read all of this leaflet carefully before taking this 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 questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, 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.

Contents of the leaflet:

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

1. What Bilagra is and what it is used for

Bilagra contains the active substance bilastin, which has antihistaminic properties.
Bilagra is used to relieve symptoms of seasonal allergic rhinitis (sneezing, itching, runny or
blocked nose, red and watery eyes) and other forms of allergic rhinitis. It may also be used to treat
itchy skin rashes (hives or urticaria).

2. Important information before using the medicine Bilagra

When not to use Bilagra

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

Warnings and precautions
Before starting treatment with Bilagra, 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 heart rate,
if the patient is taking medicines that may affect heart rhythm, if the patient has or has had abnormal heart
rhythm (known as QTc prolongation on electrocardiogram), which may occur in
certain types of heart disease and the patient is taking other medicines (see “Bilagra and 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.
Bilagra 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, including those 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 in coronary artery disease)
cyclosporine (a medicine used to reduce immune system activity, thereby preventing transplant rejection or reducing disease activity in autoimmune and allergic conditions such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
ritonavir (used in the treatment of AIDS)
rifampicin (an antibiotic).

Bilagra 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 reduced effectiveness of the medicine, do the following:

swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
after eating or drinking fruit juice, wait two 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 in pregnant women, during breastfeeding, or on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
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 demonstrated that taking bilastine at a dose of 20 mg does not affect the ability to drive
in adults. However, individual patient response to treatment may vary.
Therefore, before driving or operating machinery, patients should assess how this medicine affects them.
Bilagra contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Bilagra

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose for adults, including elderly individuals, and adolescents aged 12 years
and older, is 1 tablet (20 mg) once daily.

Tablet for oral administration.
The tablet should be taken one hour before or two hours after any meal or fruit juice consumption (see section 2, "Bilagra with food, drink and alcohol").
Swallow the tablet with a glass of water. The duration of treatment will be determined by the treating physician based on the type of illness and individual circumstances.

Use in children
Other formulations of this medicine – bilastine 10 mg orodispersible tablet or bilastine
2.5 mg/mL oral solution – are intended for children aged 6 to 11 years with body weight of at least
20 kg. Please consult a doctor or pharmacist.
Bilastine must not be given to children under 6 years of age weighing less than 20 kg,
due to insufficient data on safety and efficacy.

Taking more Bilagra than recommended
If more Bilagra than recommended has been taken, immediately contact a doctor or pharmacist
or go to the nearest hospital emergency department. Bring the medicine packaging or leaflet with you.

If you miss a dose of Bilagra
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 resume the regular dosing schedule at the usual time.

If you have any further questions 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 will experience them.
If the patient experiences hypersensitivity reactions, including: difficulty breathing, dizziness,
collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and (or) skin swelling and redness,
the medicine should be discontinued immediately and medical advice must be sought without delay.

Adverse reactions that may occur in adults and adolescents include:
Common: may occur in less than 1 in 10 people

headache
drowsiness

Uncommon: may occur in less than 1 in 100 people

abnormal ECG findings
blood test abnormalities indicating liver function disorders
dizziness
stomach pain
fatigue
increased appetite
heart rhythm disturbances
weight gain
nausea
anxiety
sensation of dryness or discomfort in the nose
abdominal pain
diarrhoea
gastritis (inflammation of the stomach lining)
vertigo (dizziness or sensation of spinning)
feeling of weakness
excessive thirst
dyspnoea (difficulty breathing)
dry mouth
indigestion
itching
herpes simplex (oral herpes)
fever
tinnitus (ringing in the ears)
sleep disturbances
blood test abnormalities indicating kidney function disorders
increased blood lipid levels

Frequency not known: cannot be estimated from available data

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

Adverse reactions that may occur in children include:
Common: may occur in less than 1 in 10 people

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

Uncommon: may occur in less than 1 in 100 people

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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 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 Bilagra

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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Bilagra 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 aluminium silicate, magnesium stearate, colloidal anhydrous silica.

What Bilagra looks like and contents of the pack
Bilagra tablets are round, white or almost white, biconvex tablets with a diameter of approximately 7 mm.
Tablets are packed in blisters containing 10, 20, 30, 50 or 100 tablets, as well as in unit-dose blisters of 10x1, 20x1, 30x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

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