ASTRILAX FLAS 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Astrilax Flas 20 mg Orodispersible Tablets

bilastine

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult your doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Astrilax Flas and what is it used for
2. What you need to know before taking Astrilax Flas
3. How to take Astrilax Flas
4. Possible side effects
5. Storage of Astrilax Flas
6. Package Contents and Additional Information

1. What is Astrilax Flas and what is it used for

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

Astrilax Flas is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy eyes) and other forms of allergic rhinitis with mild symptoms, in adults and adolescents from 12 years of age. It can also be used to treat skin eruptions with itching (hives or urticaria).

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Astrilax Flas

Do not take Astrilax Flas

If you are allergic to bilastine or any of the other components 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 kidney impairment, low blood potassium, magnesium, calcium levels, 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 certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart diseases and are also taking other medicines (see "Use of Astrilax Flas with other medicines").

If you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhea, dizziness, fainting, you should seek urgent assistance due to the risk of anaphylaxis.

Children

Do not administer this medicine to children under 12 years of age

Do notexceed 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 may need to take any other medicine, including those obtained without a prescription.

In particular, please discuss with your doctor if you are taking any of the following medicines:

• Ketoconazole (a medicine to treat Cushing's syndrome when the body produces an excess of cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (to treat pain or pressure in the chest area - angina pectoris)
• Ciclosporin (to reduce the activity of your immune system, to prevent transplant rejection or reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (to treat HIV)
• Rifampicin (an antibiotic)

Taking Astrilax Flas with food, drinks, and alcohol

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

• take the orodispersible tablet and wait one hour before eating or taking fruit juices, or

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

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastine in pregnant women, during the lactation period, or on its effects on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 shown that Astrilax Flas 20 mg does not affect performance during driving in adults. However, each patient's response to the medicine may be different. Therefore, check how this medicine affects you before driving or using machines.

Astrilax Flas contains sodium and ethanol

This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; this is, essentially "sodium-free".

This medicine contains 0.0030 mg of alcohol (ethanol) in each orodispersible tablet, which is equivalent to 1.6 mg/100 g (0.0016% w/w). The amount of alcohol in a 185 mg orodispersible tablet is equivalent to less than 1 ml of beer or 1 ml of wine.

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

3. How to take Astrilax Flas

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose in adults, including elderly patients and adolescents from 12 years of age, 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 disperse rapidly in the saliva and can then be swallowed easily.
• Alternatively, you can disperse the orodispersible tablet in water before taking it.
• You should use only water 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 taking any food or fruit juice (see section 2, "Taking Astrilax Flas with food, drinks, and alcohol").

You should consult a doctor if it worsens or does not improve after 7 days.

Use in children

For children from 6 to 11 years of age with a minimum body weight of 20 kg, there are other pharmaceutical forms more suitable - bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution -, consult your doctor or pharmacist.

Do not administer bilastine to children under 6 years of age with a body weight below 20 kg as there are not enough data.

If you take more Astrilax Flas than you should

If you or anyone else has taken more than the recommended dose of this medicine, inform your doctor immediatelyor go to the emergency department of the nearest hospital. Please remember to bring this medicine package or this package leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 forgotten dose.

If you forget to take your dose, take it as soon as possible, and then return to your usual dosing schedule.

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

If you stop taking Astrilax Flas

Generally, no effects will appear after stopping this treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience allergic reactions whose symptoms can include difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, stop taking this medicine and go to 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

• Electrocardiogram changes,
• blood tests showing changes in liver function,
• dizziness,
• stomach pain,
• fatigue,
• increased appetite,
• irregular heartbeat,
• weight gain,
• nausea (feeling sick),
• anxiety,
• dry or irritated nose,
• abdominal pain,
• diarrhea,
• gastritis (inflammation of the stomach lining),
• vertigo (a feeling of dizziness or instability),
• feeling of weakness,
• thirst,
• shortness of breath,
• 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 the available data

• Palpitations (feeling the heartbeat),
• tachycardia (fast heartbeat),
• vomiting.

Side effects that may occur in children:

Common: may affect up to 1 in 10 people

• Rhinitis (nasal irritation),
• allergic conjunctivitis (eye inflammation due to an allergic reaction),
• headache,
• stomach pain (abdominal pain/upper abdominal pain).

Uncommon: may affect up to 1 in 100 people

• Eye irritation,
• dizziness,
• loss of consciousness,
• diarrhea,
• nausea (feeling sick),
• lip swelling,
• eczema,
• urticaria (hives),
• fatigue.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: 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 expiration date stated on the package and blister after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the medicine packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medicine packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Astrilax Flas

The active substance is bilastine. Each orodispersible tablet contains 20 mg of bilastine.

The other ingredients are mannitol (E421), croscarmellose sodium, sodium stearyl fumarate, and 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

Astrilax Flas 20 mg orodispersible tablets are round, flat, white, engraved with "20" on one side, and 8 mm in diameter.

Astrilax Flas 20 mg orodispersible tablets are available in single-dose precut blisters of 7x1, 10x1, 14x1, 20x1 orodispersible 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

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

This medicine 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 orodispersible tablets

Portugal: Astrilax Odis 20 mg orodispersible tablet

Date of the last revision of this package leaflet:June 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/)