Bilastine Flas CombiX 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bilastina Flas Combix 10 mg orodispersible tablets EFG

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

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed only for your child; do not give it to others, even if they have the same symptoms, as it may harm them.
• If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

This medicine is used to relieve symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria).

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

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

Do not take Bilastina Flas Combix

• if your child is allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before your child starts taking Bilastina Flas Combix if your child has moderate or severe renal or hepatic 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 heart rhythm, or if they have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram), which may occur in certain types of heart disease and especially if they are also taking other medicines (see “Other medicines and Bilastina Flas Combix”).

Children

Do not give this medicine to children under 6 years of age weighing less than 20 kg, as sufficient data are not available.

Other medicines and Bilastina Flas Combix

Tell your doctor or pharmacist if your child is taking, has recently taken, or might need to 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 in combination.

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 (a medicine for fungal infections)
• Erythromycin (an antibiotic)
• Diltiazem (used to treat chest pain or pressure – angina pectoris)
• Cyclosporine (used to reduce the activity of the immune system, to prevent transplant rejection or to reduce disease activity in autoimmune and allergic disorders such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (used to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Flas Combix with food, drinks, and alcohol

These tablets must not be taken with food or with grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:

• administer the orodispersible tablet to your child and wait one hour before your child eats or drinks fruit juices, or
• if your child has eaten food or drunk fruit juice, wait two hours before administering the orodispersible tablet.

Bilastine, at the recommended adult dose (20 mg), does not increase the drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

This medicine is intended for use in children aged 6 to 11 years with a minimum body weight of 20 kg. However, the following information regarding safe use should be considered. There are no data or the data are very limited regarding the use of bilastine in pregnant or breastfeeding women and its effects on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 bilastine 20 mg does not affect driving performance in adults. However, individual patient responses to the medicine may vary. 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; hence, it is essentially “sodium-free”.

3. How to take Bilastina Flas Combix

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

For adults, including elderly patients and adolescents aged 12 years and older, the recommended dose is 20 mg of bilastine once daily. For this patient population, a more suitable pharmaceutical form—tablets—is available; please consult your doctor or pharmacist.

Use in children

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

Do not administer this medicine to children under 6 years of age with a body weight below 20 kg, as sufficient data are not available.

• The orodispersible tablet is for oral use.
• Place the orodispersible tablet in your child's mouth. It will rapidly disperse in saliva and can then be easily swallowed.
• Alternatively, you may disperse the orodispersible tablet in a teaspoon of water before administering it to your child. Make sure no sediment remains in the spoon.
• You should use only water for dispersion; do not use grapefruit juice or any other fruit juice.
• The orodispersible tablet should be administered to your child one hour before or two hours after taking 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 condition, your doctor will determine how long bilastine should be taken.

If you take more Bilastina Flas Combix than you should

If your child, or any other person, takes more than the prescribed dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine's packaging or the patient information leaflet with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bilastina Flas Combix

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

Under no circumstances should you give a double dose to make up for a missed dose.

If you stop taking Bilastina Flas Combix

Generally, no effects occur after discontinuation of treatment with bilastine.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 skin swelling and redness, stop administering this medicine and seek immediate medical attention.

Other adverse effects that may occur in children:

Frequent: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea (feeling of wanting to vomit)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Adverse effects that may occur in adults and adolescents:

Frequent: may affect up to 1 in 10 people

• headache
• somnolence (drowsiness)

Uncommon: may affect up to 1 in 100 people

• electrocardiogram abnormalities
• blood tests showing changes in liver function
• dizziness
• stomach ache
• tiredness
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling of wanting to vomit)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach wall)
• vertigo (a sensation of dizziness or instability)
• feeling of weakness
• thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sore (herpes labialis)
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increase in blood fats

Frequency not known: cannot be estimated from the available data

• palpitations (awareness of heartbeat)
• tachycardia (rapid heartbeat)
• vomiting

Reporting of adverse effects

If your child experiences any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilastina Flas Combix

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

Appearance of the product and contents of the pack

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

Bilastina Flas Combix is supplied in aluminum/aluminum blisters, in boxes containing 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 Pâtures

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 the most recent 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/)