BILAXTEN FLAS 10 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Bilaxten Flas

Do not take Bilaxten Flas:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bilaxten Flas if your child has moderate or severe renal or hepatic impairment, low blood potassium, magnesium, or calcium levels, if your child has or has had heart rhythm problems or if their heart rate is very low, if your child is taking medications that may affect heart rhythm, if your child has or has had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in some types of heart diseases, or if your child is taking other medications (see "Use of Bilaxten Flas with other medications").

Children

Do not administer this medication to children under 2 years of age or with a body weight below 15 kg, as there is insufficient data available.

Use of Bilaxten Flas with other medications

Inform your doctor or pharmacist if your child is using, has recently used, or may need to use any other medication, including those purchased without a prescription.

Some medications should not be taken together, and other medications 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 medications in addition to Bilaxten Flas:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (for treating angina pectoris - chest pain or pressure)
• Cyclosporine (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 HIV)
• Rifampicin (an antibiotic)

Taking Bilaxten Flas with food, beverages, and alcohol

These orodispersible tablets should notbe taken with foodor with grapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To avoid this, you can:

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

Bilastine, at the recommended dose in adults (20 mg), does not increase the somnolence produced by alcohol.

Pregnancy, breastfeeding, and fertility

This medication is for use in children from 2 to 11 years of age with a minimum body weight of 15 kg. However, the following information on the safe use of this medication should be taken into account. There are no data or limited data available on the use of bilastine in pregnant or breastfeeding women, and on its effects on fertility.

If you are pregnant or breastfeeding, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before taking any medication.

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 medication may be different. Therefore, check how this medication affects your child before they ride a bicycle or other vehicles or operate machinery.

Bilaxten Flas contains ethanol and sodium

This medication contains 0.0015 mg of alcohol (ethanol) per orodispersible tablet, which is equivalent to 1 mg/100 g (0.001% w/w). The amount in one orodispersible tablet is equivalent to less than 0.00004 ml of beer or 0.00002 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

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

3. How to take Bilaxten Flas

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

Use in children

The recommended dose in children from 2 to 11 years of age with a minimum body weight of 15 kg is 10 mg of bilastine (1 orodispersible tablet) once daily for the symptomatic relief of allergic rhinoconjunctivitis and urticaria.

Do not administer this medication to children under 2 years of age or with a body weight below 15 kg, as there is insufficient data available.

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

• The orodispersible tablet is for oral use.
• Please 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. This is highly recommended in children under 6 years of age, as they are prone to choking on tablets. 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.
• You should administer the orodispersible tablet to your child one hour before or two hours after they have taken any food or fruit juice.

The duration of treatment depends on your child's underlying disease, and your doctor will determine how long they should take Bilaxten Flas.

If you take more Bilaxten Flas than you should

If your child, or anyone else, exceeds the dose of this medication, inform your doctor immediately or go to the emergency department of the nearest hospital. Please remember to bring this medication package or this leaflet with you.

If you forget to take Bilaxten Flas

If you forget to administer the daily dose to your child on time, administer it on 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.

Do not administer a double dose to make up for the forgotten dose.

If you stop taking Bilaxten Flas

Generally, no effects will appear after stopping treatment with Bilaxten Flas.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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 medication and go to your doctor immediately.

Other side effects that may occur in children:

Common: may affect up to 1 in 10 people

• allergic conjunctivitis (eye irritation)
• headache

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (vomiting)
• lip swelling
• eczema
• urticaria (hives)
• fatigue
• rhinitis (nasal irritation)
• stomach pain (abdominal pain/upper abdominal pain)

Side effects that may occur in adults and adolescents:

Common: may affect up to 1 in 10 people

• headache
• somnolence

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 nasal discomfort
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or spinning)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• fever blister (cold sore)
• 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 side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilaxten Flas

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

Do not use this medication after the expiration date stated on the package and blister after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Place the medication packages and medications you no longer need in the Sigre Collection Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medication packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bilaxten Flas

• The active ingredient is bilastine. Each orodispersible tablet contains 10 mg of bilastine.
• The other ingredients are mannitol (E421), croscarmellose sodium, sodium stearyl fumarate, sucralose (E955), red grape flavor (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool).

Appearance of the product and package contents

Bilaxten Flas 10 mg orodispersible tablets are round, slightly biconvex, and white, with a diameter of 8 mm.

The tablets are packaged in blisters of 10, 20, 30, or 50 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer:

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

or

A.Menarini Manufacturing Logistics and Services S.r.l.

Campo di Pile

L’Aquila

Italy

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Antires 10 mg orodispersible tablets

Spain: Bilaxten Flas 10 mg orodispersible tablets

France: Inorial 10 mg orodispersible tablets

Greece: Bilargen 10 mg οροδιασπειρ?μενα δισκ?α

Italy: Robilas 10 mg orodispersible tablets

Poland: Bilaxten

Portugal: Bilaxten 10 mg orodispersible tablets

Date of the last revision of this leaflet:March 2025

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