Package Insert: Information for the Patient

Bilastina Combix 20 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Bilastina Combix contains bilastine as the active ingredient, which is an antihistamine.

Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, nasal congestion, and red, itchy eyes) and other forms of allergic rhinitis. It may also be used to treat skin rashes with itching (hives or urticaria).

Do not takeBilastina Combix:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication if you have moderate or severe kidney failure, low blood levels of potassium, magnesium, or calcium, if you have or have had heart rhythm problems, or if your heart rate is very low, if you are taking medications that may affect heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc prolongation on an electrocardiogram) that may occur in certain types of heart disease and are also taking other medications (see “Other medications and Bilastina Combix”).

Children

Do not administer this medication to children under 12 years of age

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

Other medications and Bilastina Combix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Particularly, please consult with your doctor if you are taking any of the following medications:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (to treat 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 (to treat HIV)
• Rifampicin (an antibiotic)

Taking Bilastina Combix with food, drinks, and alcohol

These tabletsmust not be taken withfood or withorange 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 taking fruit juices, or
• if you have eaten food or fruit juices, wait for 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 these are limited, on the use of bilastina in pregnant women, during lactation, or on its effects on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It has been shown that bilastina 20 mg does not affect performance during driving in adults. However, the response of each patient to the medication may be different. Therefore, check how this medication affects you before driving or operating machinery

Bilastina Combix contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents 12 years of age or older, is 1 tablet (20 mg) per day.

• The tablet is to be taken orally.
• The tablet should be taken one hour before or two hours after taking any food or fruit juice (see section 2, “Taking Bilastina Combix with food, drinks, and alcohol”).
• Swallow the tablet with a glass of water.
• The groove is only for breaking the tablet if it is difficult to swallow whole.

Regarding the duration of treatment, your doctor will determine the type of disease you have and will tell you for how long you should take bilastina.

Use in children

There are other pharmaceutical forms more suitable for children aged 6 to 11 years.

Do not administer this medication to children under 6 years of age with a body weight less than 20 kg as there is insufficient data.

If you take more Bilastina Combix than you should

If you, or anyone else, exceed the dose of this medication, inform your doctor immediately or go to the nearest hospital emergency service. Please remember to bring this packaging or this leaflet with you.

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

If you forgot to take Bilastina Combix

Do nottake 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 usual dosing schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience 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, stop taking this medicine and seek immediate medical attention.

Other side effects that may occur in adults and adolescents are:

Frequent(may affect up to 1 in 10 people)

• headache
• drowsiness

Less frequent(may affect up to 1 in 100 people)

• electrocardiogram alterations
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (urge to vomit)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (a sensation of dizziness or instability)
• sensation of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• herpes labialis
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fats

Unknown frequency:cannot be estimated from available data

• palpitations (feeling the heartbeat)
• tachycardia (rapid heartbeat)
• vomiting

Side effects that may appear in children:

Frequent(may affect up to 1 in 10 people)

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

Less frequent(may affect up to 1 in 100 people)

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (urge to vomit)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bilastina Combix

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

Appearance of the product and content of the container

Bilastina Combix 20 mg are white to off-white, oval, scored, and 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 dimensions of the tablet are approximately 10.2 mm long and 5.2 mm wide.

The tablets are presented in Aluminio/Aluminio blisters, in containers of 20 and 30 tablets.

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: February 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ ) .