BILASTINA NOUCOR 20 mg TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Bilastina Noucor 20 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Bilastina Noucor contains bilastina as the active ingredient, 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 may also be used to treat itchy skin eruptions (hives or urticaria).

2. What you need to know before taking Bilastina Noucor

Do not take Bilastina Noucor:

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 starting to use Bilastina Noucor 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 your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in some types of heart diseases and are also taking other medicines (see "Using Bilastina Noucor with other medicines").

Children

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

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

Using Bilastina Noucor with other medicines

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 (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (for 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 (for AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Noucor with food, drinks, and alcohol

These tablets must notbe taken with foodor with grapefruit juice or other fruit juices, as this would reduce 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 juices, wait two hours before taking the tablet.

Bilastina, 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 bilastina in pregnant women, during breastfeeding, or 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 Noucor

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 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 Noucor with food, drinks, and alcohol").
• Swallow the tablet with a glass of water.
• The score line is only for breaking the tablet if you find it difficult to swallow it whole.

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

For children 6 to 11 years of age with a minimum body weight of 20 kg, other pharmaceutical forms are more suitable - bilastina 10 mg orodispersible tablets or bilastina 2.5 mg/mL oral solution. 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 not enough data available.

If you take more Bilastina Noucor than you should

If you or anyone else takes more of this medicine than they should, tell your doctor immediately or go to the nearest hospital emergency department. 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 Noucor

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 further 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.

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

• 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)
• allergic reactions whose symptoms 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 side effects, stop taking this medicine and seek immediate medical attention.
• 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 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 (AEMPS) website: www.notificaRAM.es

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

5. Storage of Bilastina Noucor

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

Do not use this medicine after the expiry date stated on the package and blister. The expiry date is the last day of the month stated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Bilastina Noucor:

• The active ingredient 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 of the product:

Bilastina Noucor are white, round tablets, 7 mm in diameter.

The tablets are packaged in blisters of 20 or 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Noucor Health, S.A.

Avinguda Camí Reial 51-57,

Poligono Industrial Riera de Caldes

08184, Palau-solità i Plegamans (Barcelona),

Spain

Manufacturer

Noucor Health, S.A.

Avinguda Camí Reial 51-57,

Poligono Industrial Riera de Caldes

08184, Palau-solità i Plegamans (Barcelona),

Spain

Date of last revision of this leaflet: February 2025

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/