Bilastine Sandoz Care 20 mg tablets

Package leaflet: Information for the user

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 the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or further information, consult your doctor or pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

1. What Bilastina Sandoz Care is and what it is 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

6. Contents of the pack and other information

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

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

Bilastina Sandoz Care is used to relieve symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, runny nose, nasal congestion, and red, watery eyes) and urticaria (hives) when symptoms are mild, in adults and adolescents aged 12 years and older.

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

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

Do not take Bilastina Sandoz Care

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take bilastine if you have moderate or severe renal impairment, low blood levels of potassium, magnesium, or calcium, if you have or have had heart rhythm problems, if your heart rate is very low, if you are taking medicines that may affect heart rhythm, or if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on electrocardiogram), which may occur in certain types of heart disease and especially if you are also taking other medications (see "Other medicines and Bilastina Sandoz Care").

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

Children

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

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and Bilastina Sandoz Care

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

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

• ketoconazole (used to treat Cushing's syndrome when the body produces excess cortisol),
• erythromycin (an antibiotic),
• diltiazem (used to treat chest pain or tightness (angina pectoris)),
• ciclosporin (to reduce the activity of your immune system, to prevent transplant rejection or to reduce the activity of autoimmune diseases and allergic disorders such as psoriasis, atopic dermatitis, or rheumatoid arthritis),
• ritonavir (used to treat AIDS),
• rifampicin (an antibiotic).

Taking Bilastina Sandoz Care with food, beverages, and alcohol

These tablets should not be taken with food or grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:

• take the tablet and wait one hour before eating or drinking fruit juices, or
• if you have eaten food or drunk fruit juice, wait two hours before taking the tablet.

Bilastine, at the recommended dose (20 mg), does not increase drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or the data are limited on the use of bilastine in pregnant women, during breastfeeding, or on effects on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 demonstrated that bilastine 20 mg does not impair driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.

3. How to take Bilastina Sandoz Care

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents aged 12 years and older, is 1 tablet (20 mg) daily.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after eating 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.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Use in children

For children aged 6 to 11 years with a minimum body weight of 20 kg, other more suitable pharmaceutical forms are available—bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution. Consult your doctor or pharmacist.

Do not administer this medicine to children under 6 years of age weighing less than 20 kg, as sufficient data are not available.

If you take more Bilastina Sandoz Care than you should

If you, or anyone else, exceed the prescribed dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine package or the leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bilastina Sandoz Care

Do not take a double dose to make up for a missed 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience symptoms of an allergic reaction, which 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 the medicine and seek immediate medical attention.

Adverse 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:

• changes in electrocardiogram (ECG),
• blood tests showing changes in liver function,
• dizziness,
• stomach pain,
• fatigue,
• increased appetite,
• irregular heartbeat,
• weight gain,
• nausea (feeling sick),
• anxiety,
• dry nose or nasal discomfort,
• abdominal pain,
• diarrhoea,
• gastritis (inflammation of the stomach lining),
• vertigo (a sensation of dizziness or unsteadiness),
• feeling weak,
• thirst,
• dyspnoea (difficulty breathing),
• 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 available data

• palpitations (awareness of heartbeats),
• tachycardia (rapid heartbeat),
• allergic reactions, the symptoms of which 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 adverse effects, stop taking this medicine and seek immediate medical attention,
• vomiting.

Adverse effects that may occur in children:

Common: may affect up to 1 in 10 people:

• rhinitis (nasal irritation),
• allergic conjunctivitis (eye irritation),
• headache,
• stomach ache (abdominal pain/upper abdominal pain).

Uncommon: may affect up to 1 in 100 people:

• eye irritation,
• dizziness,
• loss of consciousness,
• diarrhoea,
• nausea (feeling sick),
• swelling of the lips,
• eczema,
• urticaria (hives),
• fatigue.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilastina Sandoz Care

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

Nature of the product and pack contents

Bilastina 20 mg are white, round tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

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 the most recent revision of this leaflet: April 2025.

Other sources of information

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