Package leaflet: Information for the patient

Bilabella, 20 mg, tablets
Bilastinum
Please read this 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 the physician or pharmacist.

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 adverse reactions 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, consult your doctor.

Table of contents:

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

1. What Bilabella is and what it is used for

Bilabella contains the active substance bilastinum, which has antihistaminic (antiallergic) properties.
Bilabella is used to relieve symptoms of allergic rhinitis (hay fever), such as sneezing, itching, runny nose, nasal congestion, and red, watery eyes, as well as 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 if your condition worsens, consult your doctor.

2. Important information before using Bilabella

When not to use 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 starting to take Bilabella, consult a 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, if the patient has or has had an abnormal heart rhythm
(known as QTc prolongation on electrocardiogram), which may occur in certain types of heart disease,
and additionally if the patient is taking other medicines (see "Bilabella and other medicines").
Children
This medicine must not be given to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.
Bilabella and 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 ischaemic heart disease)
cyclosporine (a medicine that reduces immune system activity, used to prevent transplant rejection or to reduce severity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis)
ritonavir (used in the treatment of AIDS)
rifampicin (an antibiotic).

Bilabella with food, drink and alcohol
Do not take the medicine together with food or grapefruit juice or other fruit juices, as this may reduce the effectiveness of Bilabella. To avoid reduced effectiveness, the following should be observed:

swallow the tablet and wait one hour before eating a meal 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 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 effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. Before taking any medicine, consult a 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, individual response to treatment may vary.
Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.
Bilabella contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Bilabella

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

The tablet is taken orally.
The tablet should be taken one hour before or two hours after a meal or drinking fruit juice (see section 2, "Bilabella with food, drink and alcohol").
Swallow the tablet with a glass of water.

Regarding duration of treatment, your doctor will determine the type of illness and decide how long you should take Bilabella.
Bilabella should not be used for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.
Use in children
This medicine must not be given to children under 12 years of age.
Taking more Bilabella than recommended
If you take more than the recommended dose of Bilabella, immediately contact a doctor or pharmacist or go to the nearest hospital emergency department. Take the medicine pack or leaflet with you.
If you miss a dose of Bilabella
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 continue 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 effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If the patient experiences hypersensitivity reactions with symptoms including:
difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat
and (or) skin swelling and redness, the medicine should be discontinued immediately
and medical advice should be sought immediately.

Other adverse effects which may occur in adults and adolescents include:
Common: may occur in less than 1 in 10 patients

headache
drowsiness

Uncommon: may occur in less than 1 in 100 patients

abnormal ECG trace
changes in blood tests 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)
dizziness (dizziness or sensation of spinning)
feeling of weakness
increased thirst
shortness of breath (difficulty breathing)
dry mouth
indigestion
itching
facial rash
fever
tinnitus (ringing in the ears)
sleep disturbances
changes in blood tests indicating kidney function disorders
increased blood lipid levels

Frequency not known: frequency cannot be determined from available data

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

Adverse effects which may occur in children include:
Common: may occur in less than 1 in 10 patients

rhinitis (nasal irritation)
allergic conjunctivitis (eye irritation)
headache
stomach pain (abdominal pain or epigastric pain)

Uncommon: may occur in less than 1 in 100 patients

eye irritation
dizziness
loss of consciousness
diarrhoea
nausea
lip swelling
rash
urticaria
fatigue

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects
can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bilabella

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 pack following "EXP".
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you 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.
Other ingredients are: mannitol, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium aluminum metasilicate, magnesium stearate, colloidal anhydrous silica.

What Bilabella looks like and contents of the pack
Bilabella tablets are round, white to almost white, biconvex, with a diameter of approximately 7 mm.
The tablets are packed in PVC/PVDC/Aluminum blisters or OPA/Aluminum/PVC/Aluminum blisters, and cardboard boxes containing 10 tablets.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa Street 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 medicinal product is authorised in the European Economic Area countries under the following names:
Spain Bilastina Aristo
Poland Bilabella
Portugal Bilastina Aristo
Sweden Bilassa
Italy Bilastina Aristo