Bilastine Vivanta 20 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Bilastina Vivanta 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 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Bilastina Vivanta is and what it is used for
2. What you need to know before taking Bilastina Vivanta
3. How to take Bilastina Vivanta
4. Possible side effects
5. How to store Bilastina Vivanta
6. Contents of the pack and other information

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

This medicine contains bilastine as the active substance, which is an antihistamine. Bilastine is used to relieve 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 starting to take Bilastina Vivanta

Do not take Bilastina Vivanta

If you are allergic to bilastina or to any of the other components of this medicine (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 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 medications 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 you are also taking other medications (see "Other medicines and Bilastina Vivanta").

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 Bilastine Vivanta

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 (to treat angina pectoris)
• 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 (to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Vivanta with food, drinks, and alcohol

These tablets should not be taken with food or with 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 the data are limited, on the use of bilastine in pregnant women, during breastfeeding, or on 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 medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Bilastina Vivanta contains sodium

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

3. How to take Bilastina Vivanta

Follow exactly the instructions for using 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) daily.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after eating any food or 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 intended only for breaking the tablet if you have difficulty swallowing it whole.

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

Use in children

For children aged 6 to 11 years weighing at least 20 kg, there are more suitable pharmaceutical forms available—bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution—please consult your doctor or pharmacist.

Do not administer this medicine to children under 6 years of age weighing less than 20 kg, as sufficient data are not available.

If you take more Bilastina Vivanta than you should

If you, or anyone else, take more than the prescribed 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, go to a medical center or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Bilastina Vivanta

Do not take a double dose to make up for a forgotten dose.

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

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. If you experience 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 redness and swelling, stop taking this medicine and seek immediate medical attention.

Other adverse effects that may occur in adults and adolescents are:

Frequent: may affect up to 1 in 10 people

• headache
• somnolence

Uncommon: may affect up to 1 in 100 people

• electrocardiogram abnormalities
• blood tests showing changes in how the liver functions
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling like vomiting)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation 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 how the kidneys function
• increased blood lipids

Frequency not known: cannot be estimated from the available data

• palpitations (feeling your heartbeat)
• tachycardia (rapid heartbeat)
• vomiting

Adverse 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/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (feeling sick)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Vivanta

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after 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 packaging and any unused medicines at the Sigre Point located at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilastina Vivanta:

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

Appearance of Bilastina Vivanta and contents of the pack

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

The breakline is intended only to facilitate tablet splitting for ease of swallowing and is not intended to divide the tablet into equal doses.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9,

Czech Republic

Manufacturer Responsible

Pharmadox Healthcare Ltd,
KW20A Kordin Industrial Park
Paola, PLA3000
Malta

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA3000
Malta

You can request further information about this medicinal product 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 medicine is authorized in the European Economic Area member states under the following names:

Portugal Bilastina Vivanta

Spain Bilastina Vivanta 20 mg tablets EFG

Date of the most recent review of this leaflet: February 2025

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