BILASTINA TEVAGEN 20 mg TABLETS

Introduction

Patient Information Leaflet

Bilastina Tevagen 20 mg tablets EFG

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

• Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Leaflet

1. What is Bilastina Tevagen and what is it used for
2. What you need to know before taking Bilastina Tevagen
3. How to take Bilastina Tevagen
4. Possible side effects
5. Storage of Bilastina Tevagen
6. Package contents and additional information

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

Bilastina Tevagen is used for the relief of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy eyes) and urticaria (hives) with mild symptoms, in adults and adolescents from 12 years of age.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Bilastina Tevagen

Do not take Bilastina Tevagen

If you are allergic to bilastina or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bilastina Tevagen if you have moderate or severe kidney impairment, low potassium, magnesium, or calcium levels in the blood, 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 the heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some forms of heart disease and are also taking other medicines (see "Other medicines and Bilastina Tevagen").

In case you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhea, dizziness, fainting, you should seek urgent assistance due to the risk of anaphylaxis.

Children

Do not administer this medicine to children under 12 years of age.

Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and Bilastina Tevagen

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

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

• Ketoconazole (a medicine for fungi)
• Erythromycin (an antibiotic)
• Diltiazem (for 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 AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Tevagen with food, drinks, and alcohol

These tablets should notbe taken with foodor 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 produced by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastina in pregnant women and during the breastfeeding 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 using this medicine.

Consult your doctor or pharmacist before using any medicine.

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 medicine may be different. Therefore, check how this medicine affects you before driving or using machines.

Bilastina Tevagen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Bilastina Tevagen

Follow the administration instructions for this medicine 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 from 12 years of age, 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 Tevagen with food, drinks, and alcohol").
• Swallow the tablet with a glass of water.

You should consult a doctor if it worsens or does not improve after 7 days.

Use in children

Other forms of this medicine - bilastina 10 mg orodispersible tablets or bilastina 2.5 mg/ml oral solution - may be more suitable for children from 6 to 11 years of age with a minimum body weight of 20 kg. 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 there are not enough data available.

If you take more Bilastina Tevagen than you should

If you or anyone else takes more of this medicine than they should, inform your doctor immediatelyor go to the emergency department of the nearest hospital. Please remember to take this medicine 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 medicine and the amount ingested).

If you forget to take Bilastina Tevagen

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

If you forget to take your dose on time, take it as soon as possible, and then return to your usual dosing schedule.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience symptoms of an 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, stop taking this medicine and go to your doctor immediately.

Other 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 the available data

• palpitations (feeling the heartbeat)
• tachycardia (fast heartbeat)
• 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 or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, https//: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Tevagen

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

Do not use this medicine after the expiration date stated on the package after CAD/EXP. The expiration date refers to the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bilastina Tevagen

• The active ingredient is bilastina. Each tablet contains 20 mg of bilastina.
• The other ingredients are: mannitol (E421), microcrystalline cellulose, sodium starch glycolate (type A), magnesium aluminometasilicate, magnesium stearate, anhydrous colloidal silica.

Appearance of the product and package contents

Bilastina Tevagen tablets are round, white to off-white, biconvex, approximately 7 mm in diameter.

The tablets are packaged in blisters of 7, 10, 20, 30, 50, or 100 tablets or unit-dose blisters of 10 x 1, 20 x 1, 30 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas 28108, Madrid (Spain)

Manufacturer

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

Date of the last revision of this leaflet:March 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85922/P_85922.html