Bellix

Package Leaflet: Information for the User

Bellix, 20 mg, Tablets

Bilastine

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Bellix and what is it used for

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

2. Important information before taking Bellix

When not to take Bellix:

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

Warnings and precautions

Before taking Bellix, discuss with your doctor or pharmacist if you have moderate or severe kidney problems and are taking other medicines (see "Bellix with other medicines").

Children

Do not give this medicine to children under 12 years of age.

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

Bellix with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those obtained without a prescription.
In particular, consult your doctor if you are taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for angina)
• cyclosporin (a medicine used to reduce the activity of the immune system, and thus prevent rejection of a transplant or reduce the severity of autoimmune diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (a medicine used to treat AIDS)
• rifampicin (an antibiotic)

Bellix with food, drink, and alcohol

Do nottake these tablets with food or grapefruit juice, or other fruit juices, as this reduces the effect of bilastine. To avoid reducing the effect of the medicine, you should:

• swallow the tablet and wait one hour before eating or drinking fruit juice (see section 2 "Bellix with food, drink, and alcohol").
• 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.

Pregnancy, breastfeeding, and fertility

There are no or limited data on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Before taking any medicine, consult your doctor or pharmacist.

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, each patient's response to treatment may be different. Therefore, before driving or operating machinery, check how the medicine affects you.

Bellix contains sodium

Bellix contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is essentially "sodium-free".

3. How to take Bellix

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults, including the elderly, and adolescents 12 years and older, is one tablet (20 mg) per day.

• Tablet for oral use.
• Take the tablet one hour before or two hours after eating or drinking fruit juice (see section 2 "Bellix with food, drink, and alcohol").
• Swallow the tablet with a glass of water.
• The score line on the tablet is only to facilitate breaking the tablet, if you have difficulty swallowing it whole. As for the duration of treatment, your doctor will determine the type of disease and decide how long you should take Bellix.

Use in children

Other forms 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 and weighing at least 20 kg - ask your doctor or pharmacist.

Do not give this medicine to children under 6 years of age or weighing less than 20 kg, as there are insufficient data on its use.

Overdose of Bellix

If you have taken more tablets than recommended, contact your doctor or pharmacist immediatelyor go to the emergency department of your nearest hospital. Take the medicine pack or leaflet with you.

Missed dose of Bellix

Do nottake a double dose to make up for a forgotten dose.
If you forget to take a dose at the usual time, take the forgotten dose as soon as possible, and then continue taking the medicine at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bellix can cause side effects, although not everybody gets them.

Side effects that may occur in adults and adolescents are:

Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• abnormal ECG
• blood test results indicating liver function changes
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (feeling of spinning or vertigo)
• feeling weak
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sore (herpes simplex)
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• blood test changes indicating kidney function disorders
• increased blood lipid levels

Frequency not known: cannot be estimated from the available data

palpitations (feeling of heartbeat)
tachycardia (fast heartbeat)
allergic reactions, whose symptoms may include difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin. If you experience any of these serious side effects, stop taking the medicine and seek immediate medical attention.
vomiting

Side effects that may occur in children are:

Common: may affect up to 1 in 10 people

• nasal congestion (irritation of the nose)
• allergic conjunctivitis (irritation of the eyes)
• headache
• stomach pain (abdominal pain)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (feeling sick)
• lip swelling
• rash
• hives
• fatigue

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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: www.smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Bellix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (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 with BN and 2 engraved, separated by a score line on one side and smooth on the other side.
The score line on the tablet is only to facilitate breaking the tablet, to make it easier to swallow, and not to divide it into equal doses.
Bellix 20 mg tablets are available in blisters.
Package sizes:
Blister: 10, 14, 20, 28, 30, 40, 50, 56, 60, 90, 100, and 120 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Bilastine AB 20mg tabletten /comprimés /Tabletten
Denmark:
Bilastin Aurobindo
France:
BILASTINE ARROW 20 mg, comprimé
Italy:
Bilastina Aurobindo
Poland:
Bellix
Portugal:
Bilastina Generis
Romania:
Bilastină Aurobindo 20 mg comprimate
Spain:
Bilastina Aurovitas 20 mg comprimidos EFG

Date of last revision of the leaflet: