Label:patient information

Bilastina Aurovitas 20 mg tablets EFG

Read this label carefully before starting to take this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctor,orpharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, or pharmacist,evenif they are not listed in this label. See section 4.

Bilastina Aurovitas contains bilastine as the active ingredient, which is an antihistamine. This medication is used to relieve symptoms of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, nasal congestion, and red, itchy 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 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 renal insufficiency 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 not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medications and Bilastina Aurovitas

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

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

• Ketoconazole (an antifungal medication).
• Erythromycin (an antibiotic).
• Diltiazem (to treat 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 (to treat HIV/AIDS).
• Rifampicin (an antibiotic).

Taking Bilastina Aurovitas 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 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 taken fruit juices, 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, think 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 machinery

It has been shown 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 machinery.

Bilastina Aurovitas contains sodium

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

Follow exactly the administration instructions for this medication 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 12 years of age or older, is 1 tablet (20 mg) per day.

• The tablet is to be taken orally.
• The tablet should be taken one hour before or two hours after taking 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 groove is only for breaking the tablet if it is difficult to swallow whole.

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.

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 since there are not enough data available.

If you take more Bilastina Aurovitas than you should

If you, or anyone else, exceed the dose of this medication, inform your doctor immediately or go to the nearest hospital emergency service. 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 Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to take Bilastina Aurovitas

Do not take 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 regular dosing schedule.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effectsthat may appear in children and adolescents

Common: may affect up to 1 in 10 people

• Headache,
• drowsiness.

Uncommon: may affect up to 1 in 100 people

• Alterations in the electrocardiogram,
• blood tests showing changes in liver function,
• dizziness,
• stomach pain,
• fatigue,
• increased appetite,
• irregular heartbeat,
• weight gain,
• nausea (urge to vomit),
• anxiety,
• dry or irritated nose,
• abdominal pain,
• diarrhea,
• gastritis (inflammation of the stomach lining),
• vertigo (a sensation of dizziness or instability),
• sensation of weakness,
• thirst,
• shortness of breath,
• dry mouth,
• indigestion,
• itching,
• fever (herpes labial),
• fever,
• tinnitus (ringing in the ears),
• difficulty sleeping,
• blood tests showing changes in kidney function,
• increased blood fats.

Unknown frequency:cannot be estimated from available data

• palpitations (feeling the heartbeat),
• tachycardia (rapid heartbeat),
• 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 medicine and seek immediate medical attention,
• vomiting.

Side effects that may appear 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 (urge to vomit),
• swelling of the lips,
• eczema,
• urticaria (hives),
• fatigue.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse>, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging and blisterafter 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 drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacisthow to dispose ofthe packaging and medications you no longerneed.By doing so, you will help protect the environment.

Bilastina Aurovitas Composition

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

Appearance of the product and contents of the package

Tablets.

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

The groove is only for splitting and facilitating swallowing, but not for dividing into equal doses.

Packaging sizes:

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Responsible 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 medicine is authorized in the member states of the European Economic Area with the following names:

Bélgica:Bilastine AB 20mg tablets / tablets / Tabletten

Dinamarca:Bilastin Aurobindo

España:Bilastina Aurovitas 20 mg tablets EFG

Francia:BILASTINE ARROW 20 mg, tablet

Italia:Bilastina Aurobindo

Polonia:Bellix

Portugal:Bilastina Generis

Rumanía:Bilastina Aurobindo 20 mg tablets

Last review date of thisleaflet:June 2022

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