BILASTINA VIVANTA 20 mg TABLETS

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

This medication contains bilastina as the active ingredient, which is an antihistamine. Bilastina is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and watery eyes) and other forms of allergic rhinitis. It can also be used to treat skin eruptions with itching (hives or urticaria).

2. What you need to know before taking Bilastina Vivanta

Do not take Bilastina Vivanta

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

A

Consult your doctor or pharmacist before starting to use Bilastina Vivanta if you have moderate or severe renal impairment and are also taking other medications (see "Other medications and Bilastina Vivanta").

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 Vivanta

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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 the treatment of 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 (for the treatment of AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Vivanta with food, drinks, and alcohol

These tablets should notbe taken with foodor 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 drinking fruit juices, or
• if you have eaten or drunk fruit juice, wait two hours before taking the tablet.

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

E

There are no data, or they are limited, on the use of bilastina in pregnant women, during the lactation period, 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.

Consult your doctor or pharmacist before using any medication.

C

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.

B

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

3. How to take Bilastina Vivanta

Follow the administration instructions for this medication exactly 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 over 12 years of age, 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 juice (see section 2, "Taking Bilastina Vivanta with food, drinks, and alcohol").
• Swallow the tablet with a glass of water.
• The score line is only for breaking the tablet if you find it difficult to swallow whole.

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

Use in children

For children between 6 and 11 years old with a minimum body weight of 20 kg, there are other pharmaceutical forms more suitable - bilastina 10 mg orodispersible tablets or bilastina 2.5 mg/mL oral solution -, 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 is insufficient data.

If you take more Bilastina Vivanta than you should

If you or anyone else takes more of this medication than they should, inform your doctor immediatelyor go to the emergency department of the nearest hospital. Please remember to bring this medication package or this leaflet with you.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

S

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

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

If you have any other doubts 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 allergic reactions whose symptoms can 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.

O

Common: may affect up to 1 in 10 people

• headache
• drowsiness

P

• changes in the electrocardiogram
• 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
• dyspnea (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

F

• palpitations (feeling heartbeats)
• tachycardia (rapid heartbeats)
• vomiting

E

Common: may affect up to 1 in 10 people

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

P

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

C

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilastina Vivanta

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

Do not use this medication after the expiration date shown on the packaging and blister pack after 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bilastina Vivanta:

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

Appearance of Bilastina Vivanta and package contents

Bilastina Vivanta 20 mg are white to off-white, oval, biconvex tablets, scored and marked with "M" and "B" on either side of the score line and smooth on the other side.

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

Bilastina Vivanta is available in boxes of 10, 20, 30, 40, and 50 tablets in blister packs.

Only some pack sizes may be marketed.

Marketing authorization holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9,

Czech Republic

Manufacturer

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park

Paola, PLA3000

Malta

MSN Labs Europe Limited

KW20A Corradino Park

Paola, PLA3000

Malta

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

Local Representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

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

Portugal Bilastina Vivanta

Spain Bilastina Vivanta 20mg tablets EFG

Date of the last revision of this leaflet: February 2022

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/