BILASTINA FLAS COMBIX 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Bilastina Flas Combix 10 mg orodispersible tablets EFG

For children from 6 to 11 years old with a minimum body weight of 20 kg

Read this leaflet carefully before your child starts taking 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 your child only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If your child experiences side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

Bilastina Flas Combix contains bilastina as the active substance, which is an antihistamine.

This medicine 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 can also be used to treat itchy skin eruptions (hives or urticaria).

Bilastina Flas Combix 10 mg orodispersible tablets are indicated for children from 6 to 11 years old with a minimum body weight of 20 kg.

2. What you need to know before taking Bilastina Flas Combix

Do not takeBilastina Flas Combix

• if your child is 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 take Bilastina Flas Combix if your child has moderate or severe kidney or liver impairment, low blood levels of potassium, magnesium, or calcium, if they have or have had heart rhythm problems or if their heart rate is very low, if they are taking medicines that may affect the heart rhythm, if they 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 are also taking other medicines (see "Other medicines and Bilastina Flas Combix").

Children

Do not administer this medicine to children under 6 years old with a body weight below 20 kg, as there is not enough data available.

Other medicines and Bilastina Flas Combix

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines should not be taken together, and others may require a dose adjustment when taken together.

Always inform your doctor or pharmacist if your child is taking or receiving any of the following medicines in addition to Bilastina Flas Combix:

• Ketoconazole (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (for treating chest pain or pressure - angina pectoris)
• Cyclosporin (to reduce the activity of the immune system, and thus prevent transplant rejection or reduce disease activity in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for treating AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Flas Combix with food, drinks, and alcohol

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

• administer the orodispersible tablet to your child and wait for one hour before your child eats or takes fruit juices, or

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

Pregnancy, breastfeeding, and fertility

This medicine is for use in children from 6 to 11 years old with a minimum body weight of 20 kg. However, the following information on the safe use of this medicine should be taken into account. There are no data or limited data available on the use of bilastina in pregnant or breastfeeding women and on its effects 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 taking 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 your child before they ride a bicycle or other vehicles or operate machinery.

Bilastina Flas Combix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; i.e., it is essentially "sodium-free".

3. How to take Bilastina Flas 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.

For adults, including elderly patients and adolescents from 12 years old, the recommended dose is 20 mg of bilastina once daily. For this patient population, there is a more suitable pharmaceutical form - tablets; consult your doctor or pharmacist.

Use in children

The recommended dose in children from 6 to 11 years old with a minimum body weight of 20 kg is 1 orodispersible tablet of 10 mg once daily for the symptomatic relief of allergic rhinoconjunctivitis and urticaria.

Do not administer this medicine to children under 6 years old with a body weight below 20 kg, as there is not enough data available.

• The orodispersible tablet is for oral use.
• Place the orodispersible tablet in your child's mouth. It will disperse rapidly in the saliva and can then be swallowed easily.
• Alternatively, you can disperse the orodispersible tablet in a spoonful of water before administering it to your child. Make sure there are no sediment remains in the spoon.
• You should use only water for dispersion; do not use grapefruit juice or any other fruit juice.
• You should administer the orodispersible tablet to your child one hour before or two hours after they have taken any food or fruit juice. See section 2, "Taking Bilastina Flas Combix with food, drinks, and alcohol".

Since the duration of treatment depends on your child's underlying disease, it will be your doctor who determines how long they should take bilastina.

If you take more Bilastina Flas Combix than you should

If your child, or anyone else, exceeds the dose of this medicine, inform your doctor immediately or go to the emergency department of the nearest hospital. 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 taken.

If you forget to take Bilastina Flas Combix

If you forget to administer the daily dose to your child on time, administer it the same day as soon as you remember. Then, administer the next dose the following day at the usual time as indicated by your doctor.

Under no circumstances should you administer a double dose to make up for the forgotten dose.

If you stop taking Bilastina Flas Combix

Generally, no effects will appear after stopping treatment with bilastina.

If you have any other 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.

If your child experiences 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 administering this medicine and go to your doctor immediately.

Other side effects that may appear 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 (vomiting)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Side effects that may appear in adults and adolescents:

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 (vomiting)
• anxiety
• dry nose or nose discomfort
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or instability)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• fever blisters (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 the heartbeat)
• tachycardia (fast heartbeat)
• vomiting

Reporting of side effects

If your child experiences 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 Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Flas Combix

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the package and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Bilastina Flas Combix

• The active substance is bilastina. Each orodispersible tablet contains 10 mg of bilastina.
• The other ingredients are mannitol, croscarmellose sodium, sodium stearyl fumarate, sucralose, and red grape flavor.

Appearance of the product and package contents

Bilastina Flas Combix 10 mg orodispersible tablets are white, round, biconvex tablets, 8 mm in diameter, marked with "B1" on one side and smooth on the other.

Bilastina Flas Combix is available in aluminum/aluminum blisters, in boxes of 20 orodispersible tablets.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 - Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Netpharmalab Consulting Services

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

or

Laboratori Fundació DAU

C/ De la letra C, 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona,

Spain

or

Zydus France

ZAC des Hautes Pátures

Parc d’Activités des Peupliers

25 rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

Zac. Du Suzot

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

Date of last revision of this leaflet:March 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/)