Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Bilagra (Bilastine Teva 20 mg)
20 mg, tablets
Bilastinum
Bilagra and Bilastine Teva 20 mg are different trade names of the same medicine.
Please read this leaflet carefully before taking the medicine, as 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, pharmacist, or nurse.
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, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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 package and other information

1. What Bilagra is and what it is used for

Bilagra contains the active substance bilastine, which acts as an antihistamine.
Bilagra is used to relieve symptoms of hay fever (sneezing, itching, runny nose, nasal congestion, and red, watery 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 using 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 levels of potassium,
magnesium, or calcium, 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 when 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 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 the doctor if the patient is taking any of the following medicines:

ketoconazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used for coronary artery disease)
cyclosporine (a medicine used to reduce immune system activity, thereby preventing transplant rejection or reducing disease activity in autoimmune and allergic disorders 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, the patient should:

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

Bilastine at the recommended dose (20 mg) does not increase alcohol-induced drowsiness.
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, 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 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, the patient should assess how this medicine affects them.
Bilagra contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, 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 people, 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 (see section 2, "Bilagra 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 take Bilagra.

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 weighing at least 20 kg. 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 use.
Taking more than the recommended dose of Bilagra
If more than the recommended dose of Bilagra has been taken, contact a 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 Bilagra
Do not take a double dose to make up for a missed dose.
If you miss a dose, take it as soon as possible, then continue taking your regular dose at the usual time.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, 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 redness and swelling,
the medicine should be discontinued immediately and medical advice should be sought urgently.

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

Frequency unknown: cannot be estimated from available data

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

Adverse effects that may occur in children:

Common: may affect fewer than 1 in 10 people

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

Uncommon: may affect fewer than 1 in 100 people

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bilagra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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.
Bilagra packaging contains 10 tablets or 30 tablets in blisters made of OPA/Aluminium/PVC/Aluminium foil, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, country of export:
Teva B.V.
Swensweg 5
2031 GA, Haarlem
The Netherlands
Manufacturer:
Saneca Pharmaceuticals A.S.
Nitrianska 100
92027 Hlohovec
Slovakia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in France, country of export: 3400930227992
Parallel import authorisation number: 373/25