BILASTINA AUROVITAS 20 mg TABLETS

Introduction

Leaflet:information for the patient

Bilastina Aurovitas 20 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it 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 side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 side effects
5. Storage of Bilastina Aurovitas
6. Package contents and additional information

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

Bilastina Aurovitas contains bilastina as the active ingredient, which is an antihistamine. This medication 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 Aurovitas

Do not take Bilastina Aurovitas

• 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 and are also taking other medications (see "Other medications and Bilastina Aurovitas").

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 Aurovitas

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

In particular, please inform 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 Aurovitas with food, drinks, and alcohol

These tablets should notbe taken with food or 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 juices, wait 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 limited data on the use of bilastina in pregnant women, 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. Consult your doctor or pharmacist before using any 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 Aurovitas 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 Aurovitas

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 use.
• The tablet should be taken one hour before or two hours after eating or drinking 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 only for breaking the tablet to make it easier to swallow.

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

For children between 6 and 11 years of age 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 are insufficient data.

If you take more Bilastina Aurovitas than you should

If you or anyone else exceeds the dose of this medication, 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, 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 Aurovitas

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 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.

Side effects that may occur in children and adolescents

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 wall),
• vertigo (a feeling of dizziness or instability),
• feeling of weakness,
• thirst,
• dyspnea (difficulty breathing),
• dry mouth,
• indigestion,
• itching,
• fever blisters (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),
• allergic reactions 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. If you notice any of these serious side effects, stop taking the medication and seek immediate medical attention,
• 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 side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilastina Aurovitas

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

Do not use this medication after the expiration date shown on the package and blister 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 medications you no longer need at the SIGRE collection point in the pharmacy. 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 Aurovitas

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

Appearance of the product and package contents

Tablets.

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

The score line is only for breaking the tablet to make it easier to swallow and not for dividing into equal doses.

Package sizes:

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Belgium: Bilastine AB 20mg tablets / comprimés / Tabletten

Denmark: Bilastin Aurobindo

Spain: Bilastina Aurovitas 20 mg tablets EFG

France: BILASTINE ARROW 20 mg, tablet

Italy: Bilastina Aurobindo

Poland: Bellix

Portugal: Bilastina Generis

Romania: Bilastina Aurobindo 20 mg tablets

Date of the last revision of this leaflet:June 2022

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