Bellix Allergi

Package Leaflet: Information for the User

Bellix Allergy, 20 mg, Tablets

Bilastine

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

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet:

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

1. What is Bellix Allergy and what is it used for

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

2. Important information before taking Bellix Allergy

When not to take Bellix Allergy

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

Children

This medicine should not be given to children under 12 years of age.

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

Bellix Allergy 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 tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
• erythromycin (an antibiotic)
• diltiazem (a medicine used to treat chest pain or discomfort - angina pectoris)
• cyclosporin (a medicine used to reduce the activity of the immune system, thereby preventing transplant rejection or reducing the severity of autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (a medicine used to treat HIV)
• rifampicin (an antibiotic)

Bellix Allergy 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, or
• after eating or drinking fruit juice, wait two hours before taking the tablet. Bilastine at the recommended dose (20 mg) does not increase sleepiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastine in pregnant or breastfeeding women, or 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, the response to treatment may vary from person to person. Therefore, before driving or operating machinery, check how the medicine affects you.

Bellix Allergy contains sodium

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

3. How to take Bellix Allergy

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult 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.
• The tablet should be taken one hour before or two hours after eating or drinking fruit juice (see section 2 "Bellix Allergy with food, drink, and alcohol").
• The tablet should be swallowed with a glass of water.
• The break line on the tablet is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

The duration of treatment depends on the type, duration, and course of the disease.
Bellix Allergy should not be taken for more than 10 days without consulting a doctor.
If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Use in children

Bellix Allergy, 20 mg, tablets should not be used in children under 12 years of age.
Other forms of this medicine - bilastine 10 mg in the form of orally disintegrating tablets or bilastine 2.5 mg/mL in the form of an oral solution - are more suitable for children aged 6 to 11 years with a body weight of at least 20 kg - ask your doctor or pharmacist.

Do not give these forms of bilastine to children under 6 years of age with a body weight below 20 kg, as there are insufficient data on use.

Overdose of Bellix Allergy

If you or someone else has taken more than the recommended dose of Bellix Allergy, you should immediatelycontact your doctor or pharmacist or go to the emergency department of the nearest hospital. Take the medicine packaging or package leaflet with you.

Missed dose of Bellix Allergy

Do nottake a double dose to make up for a missed dose.
If you miss a dose at the usual time, take the missed dose as soon as possible, and then return to your regular dosing schedule.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience symptoms of an allergic reaction, which 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, you should stop taking the medicine and consult your doctor immediately.

Other 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 heart rhythm (ECG)
• blood test results indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea
• anxiety
• dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (dizziness or feeling of spinning)
• feeling of weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• herpes simplex (cold sore)
• fever
• tinnitus (ringing in the ears)
• sleep problems
• blood test results indicating kidney problems
• increased blood lipid levels Frequency not known: cannot be estimated from available datapalpitations (feeling of heartbeat) tachycardia (fast heartbeat) vomiting

Side effects that may occur in children are:

Common: may affect up to 1 in 10 people

• rhinitis (irritation of the nose)
• allergic conjunctivitis
• headache
• stomach pain (abdominal pain, pain in the upper abdomen)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea
• lip swelling
• rash
• hives
• fatigue

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bellix Allergy

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 after EXP.
The expiry date refers to the last day of the 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. This will help protect the environment.

6. Contents of the pack and other information

What Bellix Allergy 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 Allergy looks like and contents of the pack

Tablet.
White to almost white, oval, biconvex, uncoated tablets with engraved markings "BN" and "2" separated by a break line on one side and smooth on the other side.
The break line on the tablet is only to facilitate breaking the tablet, for easier swallowing, and not to divide it into equal doses.
Bellix Allergy, 20 mg, tablets are available in blisters (i.e., transparent blisters made of PVC/Aluminum), in a cardboard box.
Package sizes: 6, 7, and 10 tablets.
Not all package 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

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

Belgium:
Bilastine Aurobindo 20 mg tablets/comprimés/Tabletten
Germany:
Bilastin PUREN 20 mg Tablets
Italy:
ALYNE
Poland:
Bellix Allergy
Portugal:
Bilastina Aurovitas

Date of last revision of the package leaflet: