Patient Information

Bilastina Vivanta 20 mg Tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as 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 leaflet. See section 4.

This medication contains bilastine as the active ingredient, which is an antihistamine. Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (runny nose, nasal itching, nasal discharge, nasal congestion, and red, watery 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 Vivanta

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 use Bilastina Vivanta if you have moderate or severe renal insufficiency 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 not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medications and Bilastina Vivanta

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

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

• Ketoconazol (an antifungal medication)
• Eritromicina (an antibiotic)
• Diltiazem (to treat angina pectoris)
• Ciclosporina (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)
• Rifampicina (an antibiotic)

Taking Bilastina Vivanta with food, drinks, and alcohol

These tabletsshould not be taken withfood or withgrapefruit juice or other fruit juices, as this would reduce 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 food or fruit juice, 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, or on its effects on fertility.

If you are pregnant or breastfeeding, believe 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.

Bilastina Vivanta contains sodium

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

Follow exactly the administration instructions for this medication 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.

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

Use in Children

For children 6 to 11 years of age with a minimum body weight of 20 kg, there are other more suitable pharmaceutical forms – bilastina 10 mg chewable 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 less than 20 kg as there is insufficient data.

If You Take More Bilastina Vivanta Than You Should

If you, or anyone else, exceed the dose of this medication, inform your doctorimmediatelyor go to the nearest hospital emergency department. 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.

I Forgot to Take Bilastina Vivanta

Do nottake a double dose to compensate for a missed dose.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.If you experience allergic reactions whose symptoms may include difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, stop taking this medicine and seek immediate medical attention.

Orother side effects that may occur in adults and adolescents are:

Frequent: may affect up to 1 in 10 people

Less frequent: may affect up to 1 in 100 people

Unknown frequency: cannot be estimated from available data

Side effects that may occur in children:

Frequent: may affect up to 1 in 10 people

Less frequent: may affect up to 1 in 100 people

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the Sigrecollection point of the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Bilastina Vivanta:

Appearance of Bilastina Vivanta and content of the container

Bilastina Vivanta 20 mg are non-coated white to off-white oval-shaped, biconvex tablets, engraved with "M" and "B" on either side of the groove and smooth on the other side.

The groove is only for facilitating the break 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 blisters.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9,

Czech Republic

Responsible for manufacturing

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 Rejas 2, 1st floor

28821 Coslada, Madrid

Spain

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

PortugalBilastina Vivanta

SpainBilastina Vivanta 20mg tablets EFG

Last review date of this leaflet: February 2022

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