BILASTINA TEVA 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Bilastina Teva 20 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bilastina Teva and what is it used for
2. What you need to know before you take Bilastina Teva
3. How to take Bilastina Teva
4. Possible side effects
5. Storage of Bilastina Teva
6. Contents of the pack and further information

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

Bilastina Teva contains the active substance bilastine, which is an antihistamine. Bilastina Teva 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 may also be used to treat itchy skin eruptions (hives or urticaria).

2. What you need to know before you take Bilastina Teva

Do not take Bilastina Teva

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

Warnings and precautions

Consult your doctor or pharmacist before taking Bilastina Teva if you have moderate or severe kidney problems, low levels of potassium, magnesium, or calcium in your 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 your heart rhythm, if you have or have had a certain abnormal heart rhythm (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 Teva").

Children

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

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

Other medicines and Bilastina Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, 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 Teva with food, drinks, and alcohol

These tablets must notbe taken with foodor withgrapefruit juice or other fruit juices, as this would decrease the effect of bilastine. 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.

Bilastine, 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 bilastine in pregnant or breastfeeding women, 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 bilastine 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 Teva contains sodium

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

3. How to take Bilastina Teva

Follow exactly the administration instructions of this medicine given 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 and older, is one 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 juices (see section 2, "Taking Bilastina Teva 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 tell you how long you should take bilastine.

Use in children

Other forms of this medicine - bilastine 10 mg orodispersible tablets or bilastine 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 give this medicine to children under 6 years of age with a body weight below 20 kg, as there are insufficient data.

If you take more Bilastina Teva than you should

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

If you forget to take Bilastina Teva

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 continue with your normal dosing schedule.

If you have any further questions on 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 seek medical help immediately.

Other 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 (feeling sick)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (feeling of dizziness or instability)
• feeling of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• 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 the available data

• palpitations (feeling of heartbeats)
• tachycardia (fast 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 (feeling sick)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use, https//: www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Teva

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Bilastina Teva

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• 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 pack contents

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

The tablets are packaged in blisters of 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 authorisation holder and manufacturer

Marketing authorisation holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Teva Pharma, S.L.U.

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

Alcobendas 28108, Madrid (Spain)

Date of last revision of this package leaflet:March 2025

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