Bilastine Viatris 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bilastina Viatris 20 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents

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

5 Storage of Bilastina Viatris

1. Contents of the pack and other information

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

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

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

2. What you need to know before taking Bilastina Viatris

Do not take Bilastina Viatris

• if you are allergic to bilastine or to 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 renal impairment, 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 medicines that may affect heart rhythm, or if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease and are also taking other medicines (see “Other medicines and Bilastina Viatris”).

Children

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

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

Other medicines and Bilastina Viatris

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

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

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

Taking Bilastina Viatris with food, drinks, and alcohol

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

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

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

Pregnancy, breastfeeding, and fertility

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It has been demonstrated that bilastine 20 mg does not affect driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.

3. How to take Bilastina Viatris

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents aged 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 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 illness you have and advise you on 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 administer this medicine to children under 6 years of age with a body weight below 20 kg, as sufficient data are not available.

If you take more Bilastina Viatris than you should

If you, or anyone else, exceed the recommended dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine package or the package leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Bilastina Viatris

Do not take a double dose to make up for missed doses.

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

If you stop taking Bilastina Viatris

In general, no effects are expected after discontinuation of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects that may occur in adults and adolescents are:

Frequent: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• changes in electrocardiogram
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or instability)
• feeling weak
• thirst
• dyspnoea (difficulty breathing)
• 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 available data

• palpitations (awareness of heartbeats)
• tachycardia (rapid heartbeat)
• allergic reactions, which may include symptoms such as difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin swelling and redness. If you experience any of these serious adverse effects, stop taking this medicine immediately and contact your doctor without delay
• vomiting

Adverse effects that may occur in children:

Frequent: 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
• diarrhoea
• nausea (feeling sick)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to properly discard containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilastina Viatris

• The active substance 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), anhydrous colloidal silica (E-551).

Appearance of the product and contents of the pack

Bilastina Viatris 20 mg tablets are white, round-shaped tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorization 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under 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

Date of the most recent review of this product information: April 2025.

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