Package leaflet: Information for the user

Bellix, 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Bellix is and what it is used for

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

2. Important information before using Bellix

When not to use Bellix:
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 Bellix, consult your 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 heartbeat,
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, the patient is taking other medicines (see "Bellix 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.
Bellix 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, consult your doctor if the patient is taking any of the
following medicines:

ketoconazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used for angina)
cyclosporine (a medicine used to reduce the activity of the immune system, thereby preventing transplant rejection or reducing the severity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis)
ritonavir (a medicine used in the treatment of AIDS)
rifampicin (an antibiotic)

Bellix with food, drink and alcohol
These tablets must not be taken with food or with grapefruit juice or other fruit juices, as this may reduce the effect of bilastine. To avoid reduced effectiveness of the medicine, the following should be observed:

swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
wait two hours after a meal or after 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 or breastfeeding women and 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. 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 response to treatment may vary. Therefore,
before driving or operating machinery, the patient should assess how this medicine affects them.
Bellix contains sodium
Bellix contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Bellix

This medicine should always be taken exactly 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
above, is 1 tablet (20 mg) once daily.

This is an oral tablet.
The tablet should be taken one hour before or two hours after a meal or drinking fruit juice (see section 2, "Bellix with food, drink and alcohol").
Swallow the tablet with a glass of water.
The break line on the tablet is intended solely to facilitate breaking the tablet if the patient has difficulty swallowing it whole. The duration of treatment will be determined by the doctor based on the type of illness and the individual patient's needs.

Use in children
Other formulations of this medicine—bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution—are more suitable for children aged 6 to 11 years weighing at least 20 kg. Consult a doctor or pharmacist.
This medicine 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 Bellix than recommended
If you have taken more Bellix tablets than recommended, contact a doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Bring the medicine pack or leaflet with you.

Missing a dose of Bellix
Do not take a double dose to make up for a missed dose.
If you miss a dose at the usual time, take it as soon as possible, then continue taking the medicine at your regular time.
If you have any further doubts 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.

Adverse reactions 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 recording
blood test results indicating changes in liver function
dizziness
stomach pain
fatigue
increased appetite
irregular heartbeat
weight gain
nausea (feeling sick)
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
increased thirst
dyspnoea (difficulty breathing)
dry mouth
indigestion
itching
cold sores (oral herpes)
fever
tinnitus (ringing in the ears)
sleep problems
changes in blood tests indicating kidney function disorders
elevated blood lipid levels

Frequency unknown: cannot be estimated from the available data

palpitations (awareness of heartbeat)
tachycardia (rapid heartbeat)
allergic reactions, the symptoms of which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and (or) swelling and redness of the skin. If any of these serious adverse reactions occur, the medicine should be discontinued immediately and urgent medical advice should be sought.
vomiting

Adverse reactions that may occur in children:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

eye irritation
dizziness
loss of consciousness
diarrhoea
nausea (feeling sick)
lip swelling
rash
urticaria
fatigue

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, they should be reported to a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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: www.smz.ezdrowie.gov.pl

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

Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Bellix

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 storage instructions apply.
Medicines should 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 Bellix contains

The active substance is bilastine. Each tablet contains 20 mg of bilastine.
Other ingredients: microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Bellix looks like and contents of the pack
Tablet.
White or almost white, oval, biconvex, uncoated tablets, embossed with "BN" and "2" separated by a breakline on one side and smooth on the other side.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure an equal dose division.
Bellix 20 mg tablets are available in blister packs.
Pack sizes:
Blister: 10, 14, 20, 28, 30, 40, 50, 56, 60, 90, 100 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lok. 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Bilastine AB 20mg tabletten /comprimés /Tabletten
France: BILASTINE ARROW 20 mg, comprimé
Italy: Bilastina Aurobindo
Poland: Bellix
Portugal: Bilastina Generis
Spain: Bilastina Aurovitas 20 mg comprimidos EFG