Package leaflet: Information for the patient

Bilagra ORO, 20 mg, orodispersible 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, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

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

1. What Bilagra ORO is and what it is used for

Bilagra ORO contains the active substance bilastinum, which has antihistaminic properties.
Bilagra ORO 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. The medicine may also be used to treat itchy skin rashes (wheals or urticaria).
Bilagra ORO, 20 mg, orodispersible tablets is indicated for use in adults and adolescents aged 12 years and older.

2. Important information before using Bilagra ORO

When not to use Bilagra ORO

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 Bilagra ORO, 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 an abnormal
heart rhythm pattern (known as QTc prolongation on electrocardiogram), which may occur in
certain types of heart disease, and additionally if the patient is taking other medicines (see "Bilagra ORO
and other medicines").
Children
This medicine should not be given to children under 12 years of age.
Bilagra ORO 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 the doctor if the patient is taking any of the following medicines:

ketoconazole tablets (used in the treatment of Cushing's syndrome, when the body produces excess cortisol)
erythromycin (an antibiotic)
diltiazem (a medicine used to treat chest pain or pressure in coronary artery disease)
cyclosporine (a medicine used to reduce the activity of the immune system, 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 ORO with food, drink, and alcohol
Do not take this 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
after eating a meal or drinking fruit juice, wait two hours before taking the tablet.

Bilastine at the recommended adult 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 have a
child, she should consult a doctor before using this medicine. Before using 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, the response to treatment may vary from patient to patient.
Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.
Bilagra ORO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Bilagra ORO

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

Use in children
Other forms 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 your doctor or pharmacist.
Bilastine should not be given to children under 6 years of age with body weight below 20 kg, as
there is insufficient data on its use.

Tablet for oral administration.
Place the tablet in the mouth, where it dissolves rapidly in saliva and can be easily swallowed.
The orodispersible tablet may also be dissolved in a teaspoon of water before administration. In this case, ensure that no residue of the medicine remains on the spoon.
Only water should be used to dissolve the tablet. Do not use grapefruit juice or any other fruit juice.
The tablet should be taken one hour before or two hours after a meal or drinking fruit juice (see section 2. "Bilagra ORO with food, drink and alcohol").

Regarding the duration of treatment, your doctor will determine the type of illness and decide
how long you should take Bilagra ORO.

Taking more Bilagra ORO than you should
If you take more Bilagra ORO 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 Bilagra ORO
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.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Stopping Bilagra ORO
Usually, stopping treatment with Bilagra ORO does not cause any adverse effects.
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 experiences 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 must be sought without delay.

Adverse reactions which may occur in adults and adolescents:

Common: may affect less than 1 in 10 people

headache
somnolence

Uncommon: may affect 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
dryness or discomfort in the nose
abdominal pain
diarrhoea
gastritis (inflammation of the stomach lining)
vertigo (dizziness or sensation of spinning)
feeling of weakness
increased thirst
dyspnoea (difficulty breathing)
dry mouth
dyspepsia
itching
oral herpes (cold sores)
fever
tinnitus (ringing in the ears)
sleep disturbances
blood test abnormalities indicating kidney function disorders
increased blood lipid levels

Frequency unknown: cannot be estimated from the available data

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

Adverse reactions which may occur in children:

Common: may affect less than 1 in 10 people

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

Uncommon: may affect less 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 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 provide more information on the safety of this medicine.

5. How to store Bilagra ORO

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 pack after "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 you no longer use. Such measures help protect the environment.

6. Contents of the pack and other information

What Bilagra ORO contains

The active substance is bilastine. Each tablet contains 20 mg of bilastine.
The other ingredients are: mannitol, microcrystalline cellulose, sodium croscarmellose (see section 2, "Bilagra ORO contains sodium"), magnesium aluminosilicate, sucralose, strawberry flavour, magnesium stearate, colloidal anhydrous silica.

What Bilagra ORO looks like and contents of the pack
Bilagra ORO 20 mg orodispersible tablets are oval, white or almost white, smooth to marbled, biconvex tablets measuring approximately 10.3 mm x 5.5 mm, with the imprint "20" on one side and plain on the other.
The tablets are packed in blisters containing 10, 20, 30 or 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
For further information regarding this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., Emilii Plater 53, 00-113 Warsaw, Poland
Tel.: (22) 345 93 00
Manufacturer/Importer
Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia
This medicinal product is authorised for marketing in the European Economic Area
under the following names:
Bulgaria: БиластинТева20 mg таблетки, диспергиращисевустата
Spain: Bilastina Teva 10 mg comprimidos bucodispersables EFG
Poland: Bilagra ORO
Portugal: Bilastina Teva
Sweden: Bilastine Teva