BILASTINA SANDOZ 20 mg TABLETS

Introduction

Package Leaflet:information for the patient

Bilastina Sandoz 20 mg tablets EFG

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

• Keep this leaflet, you may need to read it again.
• 1. If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

5 Storage of Bilastina Sandoz

1. Contents of the pack and other information

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

Bilastina Sandoz contains bilastina as the active substance, 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 itchy skin eruptions (hives or urticaria).

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

Do not take Bilastina Sandoz

• if you are allergic to bilastina or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Bilastina Sandoz.

Consult your doctor or pharmacist before taking bilastina if you have moderate or severe kidney problems, low blood potassium levels, low blood magnesium levels, low blood calcium levels, 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 pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart disease and are also taking other medicines (see "Other medicines and Bilastina Sandoz").

Children

Do notgive this medicine to children under 12 years of age.

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

Other medicines and Bilastina Sandoz

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 (to treat pain or pressure in the chest - 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 (to treat AIDS).
• Rifampicin (an antibiotic).

Taking Bilastina Sandoz 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 drowsiness caused by alcohol.

Pregnancy,breast-feeding, and fertility

There are no data or limited data on the use of bilastina in pregnant women, during breast-feeding, and on the effects on fertility.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Consult your doctor before taking this 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 machinery.

3. How to take Bilastina Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose in adults, including elderly patients and adolescents 12 years of age and older, 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 Sandoz 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 bilastina.

Use in children

There are other pharmaceutical forms more suitable for children from 6 to 11 years of age.

Do not give 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 Sandoz than you should

If you, or anyone else, have taken too much bilastina, tell your doctor immediatelyor go to the casualty department of the nearest hospital. Please remember to take this medicine pack 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 taken.

If you forget to take Bilastina Sandoz

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

If you forget to take your dose, take it as soon as possible, and then continue with your normal dosing schedule.

If you stop taking Bilastina Sandoz

Generally, there are no consequences when stopping treatment with bilastina.

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.

The side effectsthat can 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 (a feeling of dizziness or instability),
• feeling weak,
• 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 your heartbeat),
• tachycardia (fast heartbeat),
• allergic reactions with symptoms that may include difficulty breathing, dizziness, fainting, 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 urgent medical attention immediately,
• vomiting.

Side effects that may occurin children are:

Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation),
• allergic conjunctivitis (allergic irritation of the eye),
• headache,
• stomach pain (abdominal pain up to 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton and blister after CAD/EXP. The expiry date is 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 other information

Composition of Bilastina Sandoz

• The active substance is bilastina. Each tablet contains 20 mg of bilastina (as monohydrate).
• The other ingredients are microcrystalline cellulose, crospovidone (type A), magnesium stearate, anhydrous colloidal silica.

Appearance and packaging

Bilastina Sandoz are white, round tablets.

Each pack contains 10, 20, 30, 40, 50, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Noucor Health, S.A

Avda. Cami Reial, 51-57

08184 Palau Solita I Plegamans

Barcelona

Spain

or

Lek Pharmaceuticals d.d

Verovskova 57

1526 Ljubljana

Slovenia

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Bilastin HEXAL 20 mg tablets

Estonia: Bilastine Sandoz

Spain: Bilastina Sandoz 20 mg tablets EFG

Italy: Bilastina Sandoz

Latvia: Bilastine Sandoz 20 mg tablets

Lithuania: Bilastine Sandoz 20 mg tablets

Poland: BILARGIN

Date of last revision of thisleaflet:April 2025

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