Bilastine Aurovitas 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bilastina Aurovitas 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could 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 Aurovitas is and what it is used for
2. What you need to know before taking Bilastina Aurovitas
3. How to take Bilastina Aurovitas
4. Possible adverse effects
5. How to store Bilastina Aurovitas
6. Contents of the pack and other information

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

Bilastina Aurovitas contains bilastine as the active substance, which is an antihistamine. This medicine 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 Aurovitas

Do not take Bilastina Aurovitas

• if you are allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking bilastine 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 Aurovitas”).

Children

Do not give 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 Aurovitas

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 angina).
• Cyclosporine (used 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 Aurovitas with food, drinks, and alcohol

These tablets must 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 the 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 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 shown that bilastine 20 mg does not affect driving performance in adults. However, individual patient response to the medicine may vary. Therefore, check how this medicine affects you before driving or operating machinery.

Bilastina Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Bilastina Aurovitas

Follow exactly the instructions for use of this medicine provided 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 Aurovitas with food, drinks and alcohol”).
• Swallow the tablet with a glass of water.
• The score line is intended solely 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 will advise you on how long you should take bilastine.

Use in children

For children aged 6 to 11 years with a minimum body weight of 20 kg, other more suitable pharmaceutical forms are 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 with a body weight below 20 kg, as sufficient data are not available.

If you take more Bilastina Aurovitas 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 Toxicology Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Bilastina Aurovitas

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

If you forget to take your dose, take it as soon as possible, and then continue with your usual 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 gets them.

Adverse effects that may occur in adults and adolescents

Common: may affect up to 1 in 10 people

• Headache,
• drowsiness.

Uncommon: may affect up to 1 in 100 people

• Changes in the 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 unsteadiness),
• feeling of weakness,
• thirst,
• dyspnoea (difficulty breathing),
• dry mouth,
• indigestion,
• itching,
• cold sores (herpes labialis),
• 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 the available data

• Palpitations (awareness of heartbeats),
• tachycardia (rapid heartbeat),
• allergic reactions, the signs of which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or skin swelling and redness. If you notice any of these serious side effects, stop taking the medicine and seek immediate medical attention,
• 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 ache (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 type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is 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 unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Bilastina Aurovitas

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other components are microcrystalline cellulose, sodium carboxymethyl starch from potato (Type-A), colloidal anhydrous silica, magnesium stearate.

Appearance of the product and contents of the container

Tablets.

Uncoated tablets, oval, biconvex, white to off-white in colour, engraved with BN and 2, separated by a score line on one side and plain on the other side.

The score line is intended solely to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

Pack sizes:

Blister packs: 10, 14, 20, 28, 30, 40, 50, 56, 60, 90, 100 and 120 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica S.A.,

Rua de João de Deus, nº 19,

Venda Nova. Amadora

2700 487 Lisboa,

Portugal

Or

Arrow Generiques

26 Avenue Tony Garnier,

69007, Lyon,

France

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Belgium: Bilastine AB 20mg tabletten / comprimés / Tabletten

Spain: Bilastina Aurovitas 20 mg tablets EFG

France: BILASTINE ARROW 20 mg, comprimé

Italy: Bilastina Aurobindo

Poland: Bellix

Portugal: Bilastina Generis

Date of the most recent review of this package leaflet: October 2025

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