Bilant

Package Leaflet: Information for the Patient

BILANT, 20 mg, tablets

Bilastine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is BILANT and what is it used for

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

2. Important information before taking BILANT

When not to take BILANT

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

Warnings and precautions

Before taking BILANT, discuss with your doctor or pharmacist if you have moderate or severe kidney problems, low potassium, magnesium, or calcium levels in your blood, if you have or have had heart rhythm problems or very slow heart rate, if you are taking medicines that may affect your heart rhythm, if you have or have had an abnormal heart rhythm (known as QTc interval prolongation on an electrocardiogram), which may occur in certain types of heart disease, and if you are taking other medicines (see "BILANT and 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.

BILANT and other medicines

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

• Ketoconazole (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (a medicine used for angina)
• Cyclosporin (a medicine used to reduce the activity of the immune system, to prevent transplant rejection, or to reduce the activity of the disease in cases of autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (a medicine used to treat AIDS)
• Rifampicin (an antibiotic).

BILANT with food, drink, and alcohol Do not take BILANT with food or grapefruit juice or other fruit juices

becauseit 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 "BILANT with food, drink, and alcohol").
• after eating or drinking fruit juice, wait 2 hours before taking the tablet. Bilastine at the recommended 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 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, the response to treatment may vary from person to person.
Therefore, before driving or operating machinery, check how this medicine affects you.

BILANT contains sodium

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

3. How to take BILANT

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 1 tablet (20 mg) per day.

• The tablet is for oral use.
• Take the tablet one hour before or two hours after eating or drinking fruit juice (see section 2 "BILANT with food, drink, and alcohol").
• Swallow the tablet with a glass of water. Regarding the duration of treatment, your doctor will determine the type of disease and decide how long you should take BILANT.

Use in children

For children aged 6 to 11 years, with a body weight of at least 20 kg, other forms of this medicine are available – bilastine 10 mg, orodispersible tablets, or bilastine 2.5 mg/ml, oral solution. Consult your doctor or pharmacist.

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

Overdose of BILANT

If you have taken more tablets than recommended, contactyour doctor or pharmacist immediatelyor go to the emergency department of your nearest hospital. Bring the package or leaflet with you.

Missed dose of BILANT

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 your 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, BILANT can cause side effects, although not everybody gets them.
If you experience symptoms of an allergic reaction, including difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin, stop taking the medicine and consult your doctor immediately.

Side effects 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
• blood test results indicating liver function changes
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (vomiting)
• 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
• oral thrush
• fever
• tinnitus (ringing in the ears)
• sleep problems
• blood test results indicating kidney function changes
• elevated lipid levels in the blood.

Frequency not known (cannot be estimated from the available data):

• palpitations (feeling of heartbeat)
• tachycardia (fast heartbeat)
• vomiting.

Side effects that may occur in children:

Common (may affect up to 1 in 10 people):

• rhinitis (irritation of the nose)
• allergic conjunctivitis (irritation of the eyes)
• 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 (vomiting)
• lip swelling
• rash
• hives
• fatigue.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product 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: 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 BILANT

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 that month.
This medicine does not require any special storage conditions.
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 BILANT contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium aluminometasilicate, magnesium stearate, anhydrous colloidal silica.

What BILANT looks like and contents of the pack

BILANT tablets are round, biconvex, white or almost white, with a diameter of about 7 mm.
The tablets are packed in blisters of 10, 20, 30, 50, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer/Importer:
Saneca Pharmaceuticals a. s.
Nitrianska 100
920 27 Hlohovec
Slovakia

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

Bulgaria: Билант 20 mg таблетки
Poland: BILANT
Sweden: Bilant, 20 mg tablet

For more information about this medicine, contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: + 48 22 375 92 00
{logo of the marketing authorization holder}
Date of last revision of the leaflet:February 2025