BILASTINE VISO FARMACÉUTICA 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Bilastina Viso Farmacéutica20 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bilastina Viso Farmacéutica and what is it used for
2. What you need to know before taking Bilastina Viso Farmacéutica
3. How to take Bilastina Viso Farmacéutica
4. Possible side effects
5. Storage of Bilastina Viso Farmacéutica
6. Package contents and additional information

1. What is Bilastina Viso Farmacéutica and what is it used for

This medication contains the active ingredient bilastina, which is an antihistamine. Bilastina 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 skin eruptions with itching (hives or urticaria).

2. What you need to know before taking Bilastina Viso Farmacéutica

Do not take Bilastina Viso Farmacéutica

• 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 if you have moderate or severe kidney impairment, low blood potassium, magnesium, or calcium levels, 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 heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in some types of heart disease and are also taking other medications (see "Other medications and Bilastina Viso Farmacéutica").

Children

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

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

Other medications and Bilastina Viso Farmacéutica

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

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

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (for angina pectoris)
• Cyclosporine (to reduce immune system activity, to prevent transplant rejection or reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for AIDS treatment)
• Rifampicin (an antibiotic)

Taking Bilastina Viso Farmacéutica with food, beverages, and alcohol

These tablets should notbe taken with food or with grapefruit juice or other fruit juices, as this may reduce the effect of bilastina. To avoid this, you can:

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

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

Pregnancy, breastfeeding, and fertility

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

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

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 medication may be different. Therefore, check how this medication affects you before driving or using machines.

Bilastina Viso Farmacéutica contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Bilastina Viso Farmacéutica

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in 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 for oral administration.
• The tablet should be taken one hour before or two hours after eating or drinking fruit juices (see section 2, "Taking Bilastina Viso Farmacéutica with food, beverages, and alcohol").
• Swallow the tablet with a glass of water.
• The score line is only for breaking the tablet if you have difficulty swallowing it whole.

Duration of treatment

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

Use in children

Other forms of this medication, such as orodispersible tablets or oral solution, may be more suitable for children 6 to 11 years of age with a minimum body weight of 20 kg. Consult your doctor or pharmacist.

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

If you take more Bilastina Viso Farmacéutica than you should

If you or anyone else takes more of this medication than recommended, inform your doctor immediatelyor go to the emergency department of the nearest hospital. Please remember to bring this medication package 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 medication and the amount ingested).

If you forget to take Bilastina Viso Farmacéutica

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

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience symptoms of an allergic reaction, whose signs 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, stop taking this medication and go to your 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

• electrocardiogram changes
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (vomiting)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or instability)
• feeling of weakness
• 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 available data

• palpitations (feeling heartbeats)
• tachycardia (rapid heartbeats)
• 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 (vomiting)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting 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 them directly through the Spanish Medication Monitoring System for Human Use, https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilastina Viso Farmacéutica

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the package after CAD. 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 wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Bilastina Viso Farmacéutica

• The active ingredient is bilastina. Each tablet contains 20 mg of bilastina.
• The other ingredients are microcrystalline cellulose, sodium carboxymethyl starch type A (potato), anhydrous colloidal silica, magnesium stearate.

Appearance of the product and package contents

Bilastina Viso Farmacéutica 20 mg tablets EFG are white to off-white, oval, biconvex, scored tablets, marked with "Y41" on one side of the score line and scored on the other side (length 10 mm and width 5 mm).

The score line is only for breaking the tablet to facilitate swallowing, but not for dividing into equal doses.

The tablets come in the following two types of blisters:

PVC/PVDC-Aluminum:PVC/PVDC as the base film and aluminum as the cover, in a cardboard box.

Aluminum-Aluminum Blister: a multilayer aluminum blister formed in the cold, composed of oriented polyamide and PVC as the base film, and smooth aluminum as the cover, in a cardboard box.

Package sizes: 10, 20, 30, 40, or 50 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medication from the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

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

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