Bilant Control

Leaflet attached to the packaging: information for the user

Bilant Control, 20 mg, tablets

Bilastine

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Bilant Control contains the active substance bilastine, which has antihistamine properties. Bilant Control is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, nasal congestion, and red and itchy eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (hives or urticaria). Bilant Control is indicated for use in adults and adolescents 12 years of age and older.

2. Important information before taking Bilant Control

When not to take Bilant Control

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

Warnings and precautions

Before taking Bilant Control, the patient should discuss it with their doctor or pharmacist if they have moderate to severe kidney problems, low potassium, magnesium, or calcium levels in the blood, if they have or have had heart rhythm problems or a very slow heart rate, if they are taking medicines that may affect the heart rhythm, or if they have or have had an abnormal heart rhythm (known as a prolonged QTc interval on an electrocardiogram), which may occur in certain types of heart disease, and the patient is taking other medicines (see "Bilant Control and other medicines").

Children

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

Bilant Control and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, including those obtained without a prescription. In particular, the patient should inform their doctor about 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, which helps to prevent rejection of a transplanted organ or reduce the severity of symptoms in autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat HIV infection)
• rifampicin (an antibiotic)

Taking Bilant Control with food, drink, and alcohol

The patient should not take Bilant Control with food, grapefruit juice, or other fruit juices, as this may reduce the effect of bilastine. To avoid reducing the effect of the medicine, the patient should:

• swallow the tablet and wait one hour before eating 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 the sedative effect of alcohol.

Pregnancy, breastfeeding, and fertility

There are limited data on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking 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, the response to treatment may vary from patient to patient. Therefore, before driving or operating machinery, the patient should check how the medicine affects them.

Bilant Control 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 Control

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist. The recommended dose for adults, including the elderly, and adolescents 12 years of age and older is one tablet (20 mg) per day.

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

If after 3 days the symptoms worsen or do not improve, or if any side effects become serious, or if the patient notices any side effects not listed in the leaflet, they should contact their doctor to determine the duration of treatment. Bilant Control should not be taken for more than 10 days without consulting a doctor.

Use in children

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

Overdose of Bilant Control

In case of overdose, the patient should immediately contact their doctor or pharmacist or go to the emergency department of the nearest hospital. They should take the packaging or leaflet with them.

Missing a dose of Bilant Control

The patient should nottake a double dose to make up for a missed dose. If a dose is missed, the patient should take the missed dose as soon as possible and then continue with their regular dosing schedule. If the patient has any further questions on the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bilant Control can cause side effects, although not everybody gets them. If the patient experiences 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, they should stop taking the medicine and consult their doctor immediately.

Other side effects that may occur in adults and adolescents are:

Common: occurring in less than 1 in 10 people

• headache
• drowsiness

Uncommon: occurring in less than 1 in 100 people

• abnormal electrocardiogram (ECG) readings
• changes in blood tests indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm problems
• weight gain
• nausea
• anxiety
• dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis
• dizziness (feeling of spinning or vertigo)
• weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• facial rash
• fever
• ringing in the ears (tinnitus)
• sleep disturbances
• changes in blood tests indicating kidney problems
• increased lipid levels in the blood

Frequency not known: cannot be estimated from the available data

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 or local representative of the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Bilant Control

The medicine should be stored 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 month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 carboxymethylcellulose (type A), magnesium aluminometasilicate, magnesium stearate, anhydrous colloidal silica.

What Bilant Control looks like and contents of the pack

Bilant Control tablets are round, white to off-white, biconvex, approximately 7 mm in diameter. PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blister packs. Pack size: 10 tablets.

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:

Sweden: Bilastine Zentiva, Poland: Bilant Control

For further information about this medicine, the patient should contact their 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

Date of last revision of the leaflet: