BILASTINA COMBIX 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

Bilastina Combix 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 may also be used to treat itchy skin eruptions (hives or urticaria).

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

Do not takeBilastina Combix:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine 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 slow, 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 you are also taking other medicines (see "Other medicines and Bilastina Combix").

Children

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

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

Other medicines and Bilastina Combix

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 (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 HIV)
• Rifampicin (an antibiotic)

Taking Bilastina Combix 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 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.

Bilastina Combix contains sodium

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

3. How to take Bilastina Combix

Follow exactly the administration instructions of this medicine given 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 12 years of age and older, 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 Combix with food, drinks, and alcohol").
• Swallow the tablet with a glass of water.
• The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Regarding the duration of treatment, your doctor will determine the type of disease you have and indicate 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 insufficient data.

If you take more Bilastina Combix than you should

If you or anyone else takes more of this medicine than they should, talk to a doctor immediately or go to the nearest hospital emergency department. Please remember to take this medicine package or this package leaflet 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 Combix

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 continue with your regular dosing schedule.

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.

If you experience 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, stop taking this medicine and seek medical help immediately.

Other 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 (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 heart beating)
• rapid heartbeat
• 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, 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 Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Combix

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 packaging after EXP. The expiry date is the last day of the month shown.

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 Combix

• The active substance is bilastina. Each tablet contains 20 mg of bilastina.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch type A (potato), colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and pack contents

Bilastina Combix 20 mg are white to off-white, oval, scored tablets, engraved with a "2" on one side of the score line and "0" on the other side of the score line, smooth on the other side. The tablet dimensions are approximately 10.2 mm in length and 5.2 mm in width.

The tablets are packaged in aluminum/aluminum blisters, in packs of 20 and 30 tablets.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Netpharmalab Consulting Services S.L.

Polígono Vereda De Los Pobres

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

or

Centre Specialites Pharmaceutiques

Z.A.C. des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

or

Laboratori Fundació DAU

Calle Lletra C De La Zona França 12-14,

Polígono Industrial de la Zona Franca de Barcelona,

08040, Barcelona,

Spain

Date of last revision of this package leaflet:February 2025

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