BILASTINA ARISTO 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Bilastina Aristo 20 mg Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bilastina Aristo and what is it used for
2. What you need to know before taking Bilastina Aristo
3. How to take Bilastina Aristo
4. Possible side effects
5. Storage of Bilastina Aristo
6. Package Contents and Additional Information

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

Bilastina Aristo contains bilastina as the active ingredient, which is an antihistamine.

Bilastina is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy 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 Aristo

Do not take Bilastina Aristo

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, low blood potassium, magnesium, or calcium levels, 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 your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that can occur in some types of heart disease and are also taking other medications (see "Other Medications and Bilastina Aristo").

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 Aristo

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

In particular, please inform your doctor if you are taking any of the following medications:

medicines:

• 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 Aristo with Food, Drinks, and Alcohol

These tablets should notbe taken with foodor 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 juice, wait two hours before taking the tablet.

Bilastina, at the recommended dose (20 mg), does not increase the drowsiness produced 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 Aristo contains sodium.

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

3. How to Take Bilastina Aristo

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 administration.
• The tablet should be taken one hour before or two hours after eating or drinking fruit juice (see section 2, "Taking Bilastina Aristo with Food, Drinks, and Alcohol").
• Swallow the tablet with a glass of water.

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 6 to 11 years of age with a minimum body weight of 20 kg, there are other pharmaceutical forms that are 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 Aristo 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 package 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 Aristo

Do nottake a double dose to make up for the forgotten dose.

If you forget to take your dose on time, 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.

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 swelling and redness of the skin, stop taking this medication and go to your doctor immediately.

Side effects that may occur in adults and adolescents are:

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 lining)
• vertigo (a feeling 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 kidney function
• increased blood fat levels

Frequency not known: cannot be estimated from available data

• palpitations (feeling heartbeats)
• tachycardia (rapid heartbeats)
• 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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilastina Aristo

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated 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 any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bilastina Aristo 20 mg Tablets

The active ingredient is bilastina. Each tablet contains 20 mg of bilastina.

The other ingredients are: mannitol (E 421), microcrystalline cellulose, sodium carboxymethyl starch type A (derived from potato), magnesium aluminometasilicate, anhydrous colloidal silica, magnesium stearate.

Appearance of the Product and Package Contents:

The tablets are round, biconvex, white to off-white in color, and approximately 7 mm in diameter.

The tablets are presented in packages with:

PVC/PVdC-aluminum or OPA-Al-PVC/Al blisters in boxes of 10, 20, 30, 50, or 100 tablets.

OPA-Al-PVC/Al unit dose blister in boxes of 20x1.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer:

SANECA PHARMACEUTICALS, A.S.

Nitranska 100 - Hlohovec - 920 27

Slovakia

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Or

Esparma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication from the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Spain Bilastina Aristo 20 mg tablets EFG

Italy Bilastina Aristo 20 mg tablets

Poland Bilabella 20 mg tablets

Portugal Bilastina Aristo 20 mg tablets

Date of the Last Revision of this Package Leaflet:February 2025

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