Package leaflet: Information for the user

Bilant Control, 20 mg, tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if your condition worsens, contact your doctor.

Contents of the leaflet

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

1. What Bilant Control is and what it is used for

Bilant Control contains the active substance bilastin, which has antihistamine properties. Bilant Control is used to relieve symptoms of hay fever (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 (blisters or hives).
Bilant Control is indicated for use in adults and adolescents aged 12 years and older.

2. Information before using Bilant Control

When not to take Bilant Control

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 Bilant Control, consult your doctor or pharmacist if the patient has
moderate to severe kidney function impairment, low blood levels of potassium, magnesium or calcium,
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, or 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 when the patient is taking other medicines (see "Bilant Control with other
medicines").

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

Bilant Control with other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken or might take any
other medicines, including those obtained without a prescription.
In particular, inform 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 immune system activity, helping to prevent transplant rejection or to reduce severity of symptoms in autoimmune and allergic conditions such as psoriasis, atopic dermatitis or rheumatoid arthritis)
ritonavir (used in the treatment of HIV infection)
rifampicin (an antibiotic)

Taking Bilant Control with food, drink and alcohol
Do not take this medicine with food, grapefruit juice or other fruit juices, as this may reduce the effectiveness of bilastine. To avoid reduced effectiveness, the patient should:

swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
wait two hours after eating or drinking fruit juice 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 or limited data available on the use of bilastine during pregnancy, breastfeeding, or on fertility.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

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, individual response to treatment may vary.
Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.

Bilant Control contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to take Bilant Control

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly people, and adolescents aged 12 years and older, is 1 tablet (20 mg) per day.

Tablet for oral administration.
The tablet should be taken one hour before or two hours after any meal or fruit juice consumption (see section 2, "Taking Bilant Control with food, drink and alcohol").
Swallow the tablet with a glass of water.

If symptoms worsen or do not improve after 3 days, or if any adverse reactions become severe, or if you notice any adverse reactions not listed in this leaflet, consult your doctor to determine the duration of treatment.
Do not take Bilant Control for longer than 10 days without consulting a doctor.
Use in children
This medicine should not be given to children under 12 years of age.
Taking more than the recommended dose of Bilant Control
If you take more than the recommended dose of Bilant Control, immediately contact your doctor or pharmacist or go to the nearest hospital emergency department. Take the medicine packaging or leaflet with you.
Missed dose of Bilant Control
Do not take a double dose to make up for a missed 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.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences symptoms of an allergic reaction, including: difficulty breathing,
dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) swelling
and redness of the skin, the medicine should be discontinued immediately and medical advice should be sought
without delay.

Other adverse reactions that may occur in adults and adolescents include:

Common: occurring in less than 1 in 10 people

headache
drowsiness

Uncommon: occurring in less than 1 in 100 people

abnormal electrocardiogram (ECG) readings
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)
weakness
excessive thirst
dyspnoea (difficulty breathing)
dry mouth
indigestion
itching
facial rash
fever
tinnitus (ringing in the ears)
sleep disturbances
blood test abnormalities indicating kidney function disorders
increased blood lipid levels

Frequency not known: cannot be estimated from available data

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

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform 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, 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 authorisation holder or its local representative. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bilant Control

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 conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Bilant Control contains

The active substance is bilastine. Each tablet contains 20 mg of bilastine.
The other ingredients are: mannitol (E 421), microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium aluminum metasilicate, magnesium stearate, colloidal anhydrous silica.

What Bilant Control looks like and contents of the pack
Bilant Control tablets are round, white to off-white, biconvex, with a diameter of approximately 7 mm.
Blister PVC/PVDC/Aluminum or blister OPA/Aluminum/PVC/Aluminum
Pack sizes: 10 and 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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
Slovak Republic
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Sweden: Bilastine Zentiva
Poland: Bilant Control
To obtain further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00