BILASTINA SANDOZ CARE 20 mg TABLETS

Introduction

Package Leaflet:information for the patient

Bilastina Sandoz Care 20 mg tablets

For use in adults and adolescents from 12 years of age

Read all of this leaflet carefullybefore you start taking thismedicine,because it contains important informationfor you

Follow exactly the administration instructions of 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 doctor or 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 package leaflet

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

5 Storage of Bilastina Sandoz Care

1. Contents of the pack and further information

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

Bilastina Sandoz Care contains bilastina as the active substance, which is an antihistamine.

Bilastina Sandoz Care is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy eyes) and urticaria (hives) that occur 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 Sandoz Care

Do not take Bilastina Sandoz Care

• 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 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 medicines that may affect 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 Care").

In case you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhea, dizziness, fainting, you should seek urgent medical attention 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 Sandoz Care

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 (used to treat Cushing's syndrome when the body produces an excess of cortisol),
• erythromycin (an antibiotic),
• diltiazem (to treat chest pain or tightness),
• 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 (to treat AIDS),
• rifampicin (an antibiotic).

Taking Bilastina Sandoz Care with food, drinks, and alcohol

These tablets should not be taken with food or 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 taking fruit juices, or
• if you have eaten or taken fruit juice, wait two hours before taking the tablet.

Bilastina, at the recommended dose (20 mg), does not increase the somnolence produced by alcohol.

Pregnancy,breastfeeding, andfertility

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 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.

3. How to take Bilastina Sandoz Care

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 taking any food or fruit juice (see section 2, "Taking Bilastina Sandoz Care 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

For children from 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 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 Care 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 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 Care

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 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, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, stop taking the medicine and seek medical attention immediately.

The 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:

• ECG 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),
• allergic reactions whose symptoms 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 experience any of these serious side effects, stop taking this medicine and seek medical attention immediately,
• 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: 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 Care

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

Do not use this medicine after the expiry date 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. Return the medicine pack or any unused medicine to a pharmacy for disposal. By doing so, you will help protect the environment.

6. Contents of the pack and further information

Composition of Bilastina Sandoz Care

• 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 of the product and pack contents

Bilastina 20 mg are white, round tablets.

Each pack contains 7, 10, 14, and 20 tablets in Al-Al blisters.

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.

Avinguda del. Camí Reial, 51-57

08184, Palau-solità i Plegamans,

Spain

or

Lek Pharmaceuticals d.d.

Verovskova ulica 57,

1526, Ljubljana,

Slovenia

Date of last revision of this leaflet:April 2025.

Other sources of information

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