BILASTINA VIATRIS 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Bilastina Viatris20 mg tablets EFG

Read this package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• 1. If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What Bilastina Viatris is and what it is used for
2. What you need to know before you take Bilastina Viatris
3. How to take Bilastina Viatris
4. Possible side effects

5 Storage of Bilastina Viatris

1. Contents of the pack and further information

1. What Bilastina Viatris is and what it is used for

Bilastina Viatris contains bilastina as the active substance, which is an antihistamine.

This medicine is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin eruptions (hives or urticaria).

2. What you need to know before you take Bilastina Viatris

Do not take Bilastina Viatris

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

Warnings and precautions

Consult your doctor or pharmacist before taking Bilastina Viatris if you have moderate or severe kidney impairment, low blood potassium levels, magnesium, calcium, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medicines that may affect your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart disease and are also taking other medicines (see "Other medicines and Bilastina Viatris").

Children

Do not give this medicine to children under 12 years of age.

Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and Bilastina Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, please inform your doctor if you are taking any of the following medicines:

• Ketoconazole (a medicine for fungi)
• Erythromycin (an antibiotic)
• Diltiazem (to treat chest pain or tightness (angina pectoris))
• Ciclosporin (to reduce the activity of your immune system, to prevent transplant rejection or reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Viatris with food, drinks, and alcohol

These tablets should not be taken with food or with grapefruit juice or other fruit juices, as this would decrease the effect of bilastina. To avoid this, you can:

• take the tablet and wait one hour before eating or taking fruit juices, or
• if you have eaten or taken fruit juice, wait two hours before taking the tablet.

Bilastina, at the recommended dose (20 mg), does not increase the drowsiness produced by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastina in pregnant women, during breastfeeding, and on the effects on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

It has been shown that bilastina 20 mg does not affect performance during driving in adults. However, each patient's response to the medicine may be different. Therefore, check how this medicine affects you before driving or using machines.

3. How to take Bilastina Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents 12 years and older, is 1 tablet (20 mg) per day.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after having taken any food or fruit juice (see section 2, "Taking Bilastina Viatris with food, drinks, and alcohol").

• Swallow the tablet with a glass of water.

Regarding the duration of treatment, your doctor will determine the type of disease you have and indicate how long you should take this medicine.

Use in children

Other pharmaceutical forms of this medicine may be more suitable for children aged 6 to 11 years.

Do not give this medicine to children under 6 years with a body weight below 20 kg, as there are insufficient data.

If you take more Bilastina Viatris than you should

If you or anyone else has taken more of this medicine than they should, tell your doctor immediatelyor go to the casualty department of the nearest hospital. Please remember to take this medicine pack or this package leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount taken).

If you forget to take Bilastina Viatris

Do nottake a double dose to make up for forgotten doses.

If you forget to take your dose on time, take it as soon as possible, and then continue with your normal dosing schedule.

If you stop taking Bilastina Viatris

Generally, no effects will appear after stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• electrocardiogram changes
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or instability)
• feeling weak
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• cold sores
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fats

Frequency not known: cannot be estimated from the available data

• palpitations (feeling your heart beating)
• tachycardia (fast heart rate)
• allergic reactions, whose symptoms may include difficulty breathing, dizziness, collapse, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin. If you experience any of these serious side effects, stop taking this medicine and seek immediate medical attention.
• vomiting

Side effects that may occur in children:

Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (feeling sick)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) through the website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Viatris

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 CAD or EXP. The expiry date is the last day of the month stated.

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. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Bilastina Viatris

• The active substance is bilastina. Each tablet contains 20 mg of bilastina (as monohydrate).
• The other ingredients are microcrystalline cellulose (E-460i), crospovidone (type A), magnesium stearate (E-572), anhydrous colloidal silica (E-551).

Appearance and packaging

Bilastina Viatris 20 mg tablets are white, round tablets.

Each pack contains 10, 20, 30, 40, 50, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

NOUCOR HEALTH, S.A.

Avenida Camí Reial, 51-57

08184 – Palau-solità i Plegamans

Barcelona-Spain

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyBilastin Viatris 20 mg Tablets

BulgariaBilastine Viatris 20 mg tablets

SpainBilastina Viatris 20 mg tablets EFG

FranceBilastine Viatris 20 mg, tablet

ItalyBilastine Mylan

PortugalBilastine Mylan 20 mg tablets

Date of the last revision of this package leaflet:April 2025.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)