Bilaxten 20 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Bilaxten 20 mg tablets
bilastine
Read the entire leaflet carefully before you start taking this medicine because 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 for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are not listed in this leaflet. See section 4.
Leaflet contents:
- What Bilaxten is and what it is used for
- What you need to know before taking Bilaxten
- How to take Bilaxten
- Possible side effects
- How to store Bilaxten
- Contents of the pack and other information
1. What Bilaxten is and what it is used for
Bilaxten contains bilastine as the active substance, which is an antihistamine. Bilaxten is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis in adults and adolescents aged 12 years and older. It can also be used to treat itchy skin rashes (hives or urticaria).
2. What you need to know before taking Bilaxten
Do not take Bilaxten:
If you are 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 to use Bilaxten if you have moderate or severe renal impairment, 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 medicines that may affect heart rhythm, if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease and are also taking other medicines (see "Use of Bilaxten with other medicines").
Children
Do not administer Bilaxten 20 mg tablets to children under 12 years of age. For alternative pharmaceutical forms of bilastine suitable for use in children under 12 years of age, see section 3 “Use in children”.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Use of Bilaxten with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.
In particular, please discuss with your doctor if you are taking any of the following medicines:
- Ketoconazole tablets (used to treat Cushing's syndrome when the body produces excess cortisol)
- Erythromycin (an antibiotic)
- Diltiazem (used to treat angina pectoris – chest pain or pressure)
- Cyclosporine (used 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 (used to treat HIV)
- Rifampicin (an antibiotic)
Taking Bilaxten 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:
- take the tablet and wait one hour before eating or drinking fruit juices, or
- if you have eaten food or drunk fruit juice, wait two hours before taking the tablet.
Bilastine, at the recommended dose (20 mg), does not increase the drowsiness caused by alcohol.
Pregnancy, breast-feeding, and fertility
There are no data or the data are limited on the use of bilastine in pregnant women, during breast-feeding, or on effects on fertility.
If you are pregnant or breast-feeding, 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 using any medicine.
Driving and using machines
It has been demonstrated that bilastine 20 mg does not affect driving performance in adults. However, the response to the medicine may vary from patient to patient. Therefore, check how this medicine affects you before driving or operating machinery.
Bilaxten contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.
3. How to take Bilaxten
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
The recommended dose in adults, including elderly patients and adolescents aged 12 years and older, is 1 tablet (20 mg) daily.
- The tablet is for oral use.
- The tablet should be taken one hour before or two hours after eating food or fruit juice (see section 2, “Taking Bilaxten with food, drinks and alcohol”).
- Swallow the tablet with a glass of water.
- The score line is intended only for splitting the tablet if you have difficulty swallowing it whole.
Duration of treatment
Regarding the duration of treatment, your doctor will determine the type of illness you have and advise you on how long you should take Bilaxten.
Use in children
For children aged 2 to 11 years with a minimum body weight of 15 kg, other more suitable pharmaceutical forms are available—bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution. Please consult your doctor or pharmacist.
Do not administer bilastine to children under 2 years of age or with a body weight below 15 kg, as sufficient data are not available.
If you take more Bilaxten than you should
If you, or anyone else, exceed the prescribed 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.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to take Bilaxten
Do not take 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 continue with your regular dosing schedule.
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 will experience them.
If you experience 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 rash with redness and itching, stop taking this medicine immediately and contact your doctor right away.
Other adverse effects that may occur in adults and adolescents are:
Common: may affect up to 1 in 10 people
- headache
- drowsiness
Uncommon: may affect up to 1 in 100 people
- changes in electrocardiogram
- blood tests showing changes in liver function
- dizziness
- stomach pain
- fatigue
- 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 imbalance)
- feeling of weakness
- thirst
- dyspnoea (difficulty breathing)
- dry mouth
- indigestion
- itching
- 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 available data
- palpitations (awareness of heartbeats)
- tachycardia (rapid heartbeat)
- vomiting
Adverse effects that may occur in children:
Common: may affect up to 1 in 10 people
- allergic conjunctivitis (eye inflammation due to an allergic reaction)
- 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 pain (abdominal pain/upper abdominal pain)
Reporting of adverse effects
If you experience any 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: www.notificaRAM.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bilaxten
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated after EXP on the packaging and on the blister. 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 in household waste. Unused medicines and their containers should be handed over to the Sigre Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and their containers properly. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bilaxten:
- The active substance is bilastine. Each tablet contains 20 mg of bilastine.
- The other components are microcrystalline cellulose, sodium carboxymethylstarch type A (derived from potato), anhydrous colloidal silica, magnesium stearate.
See section 2 “Bilaxten contains sodium”.
Appearance of the product and contents of the pack:
Bilaxten tablets are white, oval, biconvex and scored (length 10 mm, width 5 mm).
The tablets are packed in blisters of 10, 20, 30, 40 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
or
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13; 01097
Dresden
Germany
This medicinal product is authorized in the European Economic Area member states under the following names:
Germany: Antires 20 mg Tabletten
France: Inorial 20 mg Comprimé
Greece: Bilargen 20 mg Δισκ?ο
Italy: Robilas 20 mg Compressa
Poland: Clatra Allergy
Portugal: Bilaxten 20 mg comprimido
Spain: Bilaxten 20 mg comprimidos
Date of the most recent revision of this leaflet: February 2026
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/