BILASTINA KERN PHARMA 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

1. What is Bilastina Kern Pharma and what is it used for

This medicinal product contains bilastine as the active substance, which is an antihistamine. Bilastine 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 Kern Pharma

Do not take Bilastina Kern Pharma:

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

Warnings and precautions

Consult your doctor or pharmacist before taking bilastine if you have moderate or severe kidney impairment, low blood potassium levels, magnesium, calcium, 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 diseases and you are also taking other medicines (see "Other medicines and Bilastina Kern Pharma").

Children

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

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

Other medicines and Bilastina Kern Pharma

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 the treatment of 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 the treatment of AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Kern Pharma with food, drinks, and alcohol

These tablets must notbe taken with foodor with grapefruit 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 women, during breastfeeding, or on fertility.

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

Ask your doctor or pharmacist for advice before taking 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 Kern Pharma contains sodium:

This medicinal product contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Bilastina Kern Pharma

Follow exactly the administration instructions of this medicinal product 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 from 12 years of age, 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 Kern Pharma 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 are suffering from and will tell you how long you should take Bilastina Kern Pharma.

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 - bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution. Consult your doctor or pharmacist.

Do not give this medicinal product 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 Kern Pharma than you should

If you, or anyone else, have taken more of this medicinal product than you should, tell your doctor or pharmacist immediatelyor go to the casualty department of the nearest hospital. Please remember to take this package leaflet and the medicine with you.

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

If you forget to take Bilastina Kern Pharma

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

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

If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicinal product 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 medicinal product and seek immediate medical attention.

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
• 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

• rinitis (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 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 medicinal product.

5. Storage of Bilastina Kern Pharma

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the packaging and blister after EXP. The expiry date refers to the last day of the month shown.

This medicinal product 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 Kern Pharma

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: mannitol (E-421), microcrystalline cellulose, sodium carboxymethyl starch type A (derived from potato), aluminum magnesium silicate, and anhydrous colloidal silica.

Appearance of the product and pack contents

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

The tablets are available in blister packs of 10, 20, 30, 50, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovakia

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

Spain: Bilastina Kern Pharma 20 mg tablets EFG

Portugal: Bilastina Pharmakern 20 mg tablets

Sweden: Bilastin Kern Pharma 20 mg tablets

Date of last revision of this package leaflet:February 2025

Detailed and up-to-date 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/