BILASTINA PENSA 20 mg TABLETS

Introduction

Package Leaflet:information for the patient

Bilastina pensa 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 side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Bilastina pensa and what is it used for
2. What you need to know before taking Bilastina pensa
3. How to take Bilastina pensa
4. Possible side effects

5 Conservation of Bilastina pensa

1. Contents of the packaging and additional information

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

This medication 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 watery eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

2. What you need to know before taking Bilastina pensa

Do not take Bilastina pensa

• 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 pensa").

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 pensa

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

In particular, please discuss with 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)
• Ciclosporin (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 pensa with food, beverages, and alcohol

These tabletsshould notbe taken withfoodor withgrapefruit 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 caused by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastina in pregnant women, during the lactation period, 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 before taking 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.

3. How to take Bilastina pensa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, 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 pensa with food, beverages, 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 pensa.

Use in children

For children 6 to 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 available.

If you take more Bilastina pensa than you should

If you or anyone else takes more of this medication than they should, inform your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Please remember to bring this medication packaging 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 pensa

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 further 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 adults and adolescents are:

Frequent: 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
• shortness of breath
• dry mouth
• indigestion
• itching
• herpes simplex
• 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 the heartbeat)
• tachycardia (rapid heartbeat)
• allergic reaction 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 experience any of these serious side effects, stop taking this medication and seek immediate medical attention.
• vomiting

Side effects that may occur in children:

Frequent: 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, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Bilastina pensa

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

Do not use this medication after the expiration date shown on the packaging 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 pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Bilastina pensa

• The active ingredient is bilastina. Each tablet contains 20 mg of bilastina (as monohydrate).
• The other components are: microcrystalline cellulose grade 102, crospovidone type A, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

The Bilastina pensa tablets are round and white.

They are available in packs of 20 tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Noucor Health, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

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

Spain: Bilastina pensa 20 mg tablets EFG

Portugal: Bilastina Tolife

Italy: Bilastina pensa

Date of the last revision of thispackage leaflet: July 2021

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/)