Package Insert: Information for the Patient

Bilastina Viatris20 mg Tablets

Read this package insert carefully before starting to take this medication,because it contains important information for you.

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

-This medication has been prescribedonlyfor you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2.What you need to know beforestartingto take Bilastina Viatris

3.How to take Bilastina Viatris

4.Possible side effects

5Storage of Bilastina Viatris

6.Contents of the package and additional information

Bilastina Viatriscontains bilastine as the active ingredient, which is an antihistamine.

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

Do not take Bilastina Viatris

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

Warnings and precautions

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

Children

Do not administer this medication to children under 12 years of age.

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medications and Bilastina Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Particularly, please consult with your doctor if you are taking any of the following medications:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (to treat chest pain or pressure (angina pectoris))
• Cyclosporine (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 juices, wait for two hours before taking the tablet.

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

It has been demonstrated that bilastina 20 mg does not affect performance during driving in adults. However, the response of each patient to the medication may be different. Therefore, check how this medication affects you before driving or operating machines.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

• The tablet is to be taken orally.
• The tablet should be taken one hour before or two hours after taking 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 will inform you for how long you should take this medication.

Use in children

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

Do not administer this medication to children under 6 years of age with a body weight of less than 20 kg, as there is insufficient data.

If you take more Bilastina Viatris than you should

If you, or anyone else, exceed the dose of this medication, inform your doctor immediately or go to the nearest hospital emergency service. Please remember to bring this medication packaging or this leaflet with you.

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

If you forget to take Bilastina Viatris

Do not take a double dose to compensate for the missed doses.

If you forget to take your dose on time, take it as soon as possible, and then return to your usual dosing schedule.

If you interrupt treatment with Bilastina Viatris

Generally, there will be no effects after abandoning treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 alterations
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (urge to vomit)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (a feeling of dizziness or instability)
• sense of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• herpes labial
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fats

Unknown frequency: cannot be estimated from available data

• palpitations (feeling the heartbeat)
• tachycardia (rapid heartbeat)
• allergic reactions, whose symptoms may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin hives and redness. If you experience any of these severe 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 (urge to vomit)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and blisterpack after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at thePharmaceutical Take-Back Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose ofthe packaging and medications you no longerneed.By doing so, you will help protect the environment.

Composition of Bilastina Viatris

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

Appearance of the product and contents of the packaging

Bilastina Viatris 20 mg tablets are white, round tablets.

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

Only some package sizes may be commercially available.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

NOUCOR HEALTH, S.A.

Avenida Camí Reial, 51-57

08184 – Palau-solità i Plegamans

Barcelona-Spain

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany Bilastin Viatris 20 mg Tabletten

Bulgaria Bilastine Viatris 20 mg tablets

Spain Bilastina Viatris 20 mg comprimidos EFG

France Bilastine Viatris 20 mg, comprimé

Italy Bilastine Mylan

Portugal Bilastine Mylan 20 mg tablets

Last review date of this leaflet: April 2025.

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( https://www.aemps.gob.es/ )