Bilabella

Package Leaflet: Information for the Patient

Bilabella, 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 for the patient 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Bilabella and what is it used for

Bilabella contains the active substance bilastine, which has antihistamine (anti-allergic) properties.
Bilabella 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.
The medicine may also be used to treat itchy skin rashes (hives or urticaria).
If there is no improvement after 3 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Bilabella

When not to take Bilabella

• 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 Bilabella, 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 very slow heart rate, if they are taking medicines that may affect heart rhythm, if they 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 also if the patient is taking other medicines (see "Bilabella and 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 a doctor.

Bilabella and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, 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 heart disease)
• cyclosporin (a medicine that reduces the activity of the immune system, used to prevent transplant rejection or reduce the severity of diseases such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat AIDS)
• rifampicin (an antibiotic).

Bilabella with food, drink, and alcohol Do not take the medicine with food or grapefruit juice or other fruit juices

asthis reduces the effect of Bilabella. To avoid reducing the effect of the medicine, the patient should:

• swallow the tablet and wait for 1 hour before eating or drinking fruit juice (see section 2, "Bilabella with food, drink, and alcohol").
• after eating or drinking fruit juice, wait for 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 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. Before taking any medicine, the patient should consult their 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 patient to patient. Therefore, before driving or operating machinery, the patient should check how the medicine affects them.

Bilabella contains sodium

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

3. How to take Bilabella

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose for adults, including the elderly and adolescents from 12 years of age, is 1 tablet (20 mg) per day.

• The tablet is taken orally.
• The tablet should be taken 1 hour before or 2 hours after eating or drinking fruit juice (see section 2, "Bilabella with food, drink, and alcohol").
• The tablet should be swallowed with a glass of water.

Regarding the duration of treatment, the doctor will determine the type of disease and decide how long the patient should take Bilabella.
Bilabella should not be taken for more than 10 days without consulting a doctor.
If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Use in children

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

Overdose of Bilabella

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

Missed dose of Bilabella

Do 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 dose at the usual time.
If the patient has any further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bilabella can cause side effects, although not everybody gets them.
If the patient experiences an allergic reaction with symptoms 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: may affect up to 1 in 10 people

• headache
• drowsiness.

Uncommon: may affect up to 1 in 100 people

• abnormal ECG
• blood test abnormalities indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm problems
• weight gain
• nausea (vomiting)
• anxiety
• dryness or discomfort in the nose
• stomach pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (dizziness or feeling of spinning)
• feeling weak
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• facial rash
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• blood test abnormalities indicating kidney problems
• increased lipid levels in the blood.

Frequency not known: frequency cannot be estimated from the available data

• palpitations (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 (irritation of the eyes)
• headache
• stomach pain (abdominal pain or 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 the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. 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.: 22 49-21-301, fax: 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, more information can be gathered on the safety of the medicine.

5. How to store Bilabella

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bilabella 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 Bilabella looks like and contents of the pack

Bilabella tablets are round, white to almost white, biconvex, approximately 7 mm in diameter.
The tablets are packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters and cardboard boxes of 10 tablets.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
+48 22 855 40 93
Manufacturer/Importer
Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany
Saneca Pharmaceuticals a. s.
Nitrianska 100
920 27 Hlohovec
Slovakia
esparma GmbH
Wallenroder Straße 8 – 10
13435 Berlin
Germany

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

Spain
Bilastina Aristo
Poland
Bilabella
Portugal
Bilastina Aristo
Sweden
Bilassa
Italy
Bilastina Aristo
Date of last revision of the leaflet:February 2025