Astrilax Flas 20 mg orodispersible tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
Astrilax Flas 20 mg orodispersible tablets
bilastine
Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.
Always follow the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult your doctor if your condition worsens or if you do not improve after 7 days.
Leaflet Contents
- What Astrilax Flas is and what it is used for
- What you need to know before taking Astrilax Flas
- How to take Astrilax Flas
- Possible side effects
- How to store Astrilax Flas
- Package contents and additional information
1. What Astrilax Flas is and what it is used for
Astrilax Flas contains bilastine as the active substance, which is an antihistamine.
Astrilax Flas 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 with mild symptoms, 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 Astrilax Flas
Do not take Astrilax Flas
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 this medicine 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, if your heart rate is very low, if you are taking medicines that may affect heart rhythm, or if you 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 you are also taking other medications (see "Use of Astrilax Flas with other medicines").
If you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhea, dizziness, or fainting, seek urgent medical assistance due to the risk of anaphylaxis.
Children
Do not administer this medicine to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Astrilax Flas
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 tightness)
- 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 Astrilax Flas with food, drinks, and alcohol
These orodispersible tablets must not be taken with food or consumption of grapefruit or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:
- take the orodispersible 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 orodispersible tablet.
Bilastine, at the recommended dose (20 mg), does not increase the drowsiness caused by alcohol.
Pregnancy, breastfeeding, and fertility
There are no data or the data are limited regarding the use of bilastine in pregnant women, during breastfeeding, or 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 using any medicine.
Driving and using machines
It has been demonstrated that Astrilax Flas 20 mg does not affect driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.
Astrilax Flas contains sodium and ethanol
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; hence, it is essentially "sodium-free".
This medicine contains 0.0030 mg of alcohol (ethanol) in each orodispersible tablet, equivalent to 1.6 mg/100 g (0.0016% w/w). The amount of alcohol in an 185 mg orodispersible tablet is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol contained in this medicine does not produce any noticeable effect.
3. How to take Astrilax Flas
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly patients and adolescents aged 12 years and older, is 1 orodispersible tablet (20 mg of bilastine) per day.
- The orodispersible tablet is for oral use.
- Please place the orodispersible tablet in the mouth. It will rapidly disperse in saliva and can then be swallowed easily.
- Alternatively, you may disperse the orodispersible tablet in water before taking it.
- Water should be used exclusively for dispersion; do not use grapefruit juice or any other fruit juice.
- The orodispersible tablet should be taken one hour before or two hours after consuming any food or fruit juice (see section 2, "Taking Astrilax Flas with food, drinks and alcohol").
Consult a doctor if symptoms worsen or do not improve after 7 days.
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 Astrilax Flas than you should
If you or anyone else 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 container or the package leaflet with you.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Astrilax Flas
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, then return to your regular dosing schedule.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
If you stop taking Astrilax Flas
Generally, no effects are expected upon discontinuation of this treatment.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets 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 swelling and redness, stop taking this medicine and contact your doctor immediately.
Other side 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,
- diarrhea,
- gastritis (inflammation of the stomach lining),
- vertigo (a sensation of dizziness or instability),
- feeling of weakness,
- thirst,
- dyspnea (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.
Side 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,
- diarrhea,
- nausea (feeling sick),
- swelling of the lips,
- eczema,
- urticaria (hives),
- fatigue,
- rhinitis (nasal irritation),
- stomach pain (abdominal pain / upper abdominal pain).
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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 side effects, you can help provide more information on the safety of this medicine.
5. Storage of Astrilax 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. Dispose of empty containers and unused medicines at the Sigre collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Astrilax Flas
The active substance is bilastine. Each orodispersible tablet contains 20 mg of bilastine.
The other components are mannitol (E421), sodium croscarmellose, stearic fumarate and sodium, sucralose (E955), red grape flavour (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool).
See section 2 “Astrilax Flas contains sodium and ethanol”.
Appearance of the medicinal product and contents of the container
Astrilax Flas 20 mg orodispersible tablets are round, flat, white tablets, engraved with “20” on one side and 8 mm in diameter.
Astrilax Flas 20 mg orodispersible tablets are available in unit-dose pre-cut blisters of 7x1, 10x1, 14x1, and 20x1 orodispersible 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
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Alergolaxten 20 mg Schmelztabletten
Spain: Astrilax Flas 20 mg film-coated tablets
Portugal: Astrilax Odis 20 mg orodispersible tablet
Date of the most recent review of this leaflet: December 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)