Bilaxten Flas 10 mg orodispersible tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bilaxten Flas 10 mg orodispersible tablets
Bilastine
For children aged 2 to 11 years with a minimum body weight of 15 kg
Read the entire leaflet carefully before your child starts taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed only for your child. Do not give it to other people, even if they have the same symptoms as your child, as it may harm them.
- If your child experiences any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Bilaxten Flas is and what it is used for
- What you need to know before your child takes Bilaxten Flas
- How to take Bilaxten Flas
- Possible adverse effects
- How to store Bilaxten Flas
- Contents of the pack and other information
1. What Bilaxten Flas is and what it is used for
Bilaxten Flas contains bilastine as the active substance, which is an antihistamine. Bilaxten Flas is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itching of the nose, 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).
Bilaxten Flas 10 mg orodispersible tablets are indicated in children aged 2 to 11 years with a minimum body weight of 15 kg.
2. What you need to know before starting Bilaxten Flas
Do not take Bilaxten Flas:
- if your child is allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting Bilaxten Flas if your child has moderate or severe renal or hepatic impairment, low blood levels of potassium, magnesium, or calcium, if your child has or has had heart rhythm problems or a very low heart rate, if your child is taking medicines that may affect heart rhythm, if your child has or has had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease, or if your child is taking other medicines (see “Use of Bilaxten Flas with other medicines”).
Children
Do not administer this medicine to children under 2 years of age or with a body weight below 15 kg, as sufficient data are not available.
Use of Bilaxten Flas with other medicines
Inform 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 concurrently.
Always inform your doctor or pharmacist if your child is taking or receiving any of the following medicines in addition to Bilaxten Flas:
- Ketoconazole (a medicine for fungal infections)
- Erythromycin (an antibiotic)
- Diltiazem (to treat angina – chest pain or pressure)
- Cyclosporine (to reduce the activity of the immune system, thereby preventing transplant rejection or reducing disease activity in autoimmune and allergic disorders such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
- Ritonavir (to treat HIV)
- Rifampicin (an antibiotic)
Taking Bilaxten Flas with food, drinks, and alcohol
These orodispersible 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 consumed food or fruit juice, wait two hours before administering the orodispersible tablet.
Bilastine, at the recommended adult dose (20 mg), does not increase drowsiness caused by alcohol.
Pregnancy, breastfeeding, and fertility
This medicine is intended for use in children aged 2 to 11 years with a minimum body weight of 15 kg. However, please consider the following information regarding its safe use. There are no data or data are very limited on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility.
If you are pregnant or breastfeeding, or planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Consult your doctor or pharmacist before taking any medicine.
Driving and use of machines
It has been demonstrated that bilastine 20 mg does not affect driving performance in adults. However, individual patient response to the medicine may vary. Therefore, check how this medicine affects your child before allowing them to ride a bicycle or other vehicles or operate machinery.
Bilaxten Flas contains ethanol and sodium
This medicine contains 0.0015 mg of alcohol (ethanol) per orodispersible tablet, 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 contained in this medicine does not produce any noticeable effect.
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; thus, it is essentially “sodium-free”.
3. How to take Bilaxten Flas
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Use in children
The recommended dose for children aged 2 to 11 years with a minimum body weight of 15 kg is 10 mg of bilastine (1 orodispersible tablet) once daily for symptomatic relief of allergic rhinoconjunctivitis and urticaria.
Do not administer this medicine to children under 2 years of age or with a body weight below 15 kg, as sufficient data are not available.
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.
- The orodispersible tablet is for oral use.
- Please 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. This is highly recommended for children under 6 years of age, as they are prone to choking on tablets. Make sure no residue remains in the teaspoon.
- Water should be used exclusively 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 consuming any food or fruit juice.
As the duration of treatment depends on your child's underlying condition, your doctor will determine how long Bilaxten Flas should be taken.
If you take more Bilaxten Flas than you should
If your child, or any other person, exceeds the recommended dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine package or the package leaflet with you.
If you forget to take Bilaxten Flas
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 directed by your doctor.
Under no circumstances should you administer a double dose to make up for a missed dose.
If you stop taking Bilaxten Flas
In general, no effects are expected upon discontinuation of treatment with Bilaxten Flas.
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 can cause adverse effects, although not everyone experiences them.
If your child experiences allergic reactions, the symptoms of which 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 immediately and seek medical attention without delay.
Other adverse 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
- diarrhoea
- nausea (feeling sick)
- swelling of the lips
- eczema
- urticaria (hives)
- fatigue
- rhinitis (nasal irritation)
- stomach ache (abdominal/upper abdominal pain)
Adverse effects that may occur in adults and adolescents:
Common: 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 pain
- tiredness
- increased appetite
- irregular heartbeat
- weight gain
- nausea (feeling sick)
- anxiety
- dry nose or nasal discomfort
- abdominal pain
- diarrhoea
- gastritis (inflammation of the stomach lining)
- vertigo (a sensation of dizziness or spinning)
- 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 available data
- palpitations (awareness of heartbeats)
- 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bilaxten Flas
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. Unused containers and medicines should be returned to the Sigre Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Bilaxten Flas
- The active substance is bilastine. Each orodispersible tablet contains 10 mg of bilastine.
- The other components are mannitol (E421), sodium croscarmellose, stearil fumarate and sodium, sucralose (E955), red grape flavour (main components: arabic gum, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool).
Appearance of the product and contents of the container
Bilaxten Flas 10 mg orodispersible tablets are round, slightly biconvex, white tablets, 8 mm in diameter.
The tablets are packed in blisters containing 10, 20, 30 or 50 tablets.
Only certain 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
Faes Farma, S.A.
Parque Científico y Tecnológico de Bizkaia
Ibaizabal Bidea, Edificio 901
48160 Derio (Bizkaia)
Spain
or
A.Menarini Manufacturing Logistics and Services S.r.l.
Campo di Pile
L’Aquila
Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Antires 10 mg Schmelztabletten
Spain: Bilaxten Flas 10 mg orodispersible tablets
France: Inorial 10 mg comprimé orodispersible
Greece: Bilargen 10 mg δισκεία διασπειρόμενα στο στόμα
Italy: Robilas 10 mg compressa orodispersibile
Poland: Bilaxten
Portugal: Bilaxten 10 mg comprimido orodispersível
Date of the most recent review of this leaflet: March 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)