ASTRILAX 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Astrilax 20 mg 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 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 and what is it used for
2. What you need to know before taking Astrilax
3. How to take Astrilax
4. Possible side effects
5. Storage of Astrilax
6. Package Contents and Additional Information

1. What is Astrilax and what is it used for

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

Astrilax 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 your doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Astrilax

Do not take Astrilax

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 Astrilax if you have moderate or severe kidney impairment, low blood potassium levels, magnesium, calcium, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medications 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 disease and are also taking other medications (see "Use of Astrilax with other medications").

In case 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

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

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

• 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)
• Cyclosporine (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 with Food, Drinks, and Alcohol

These 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:

• take the tablet and wait one hour before eating or taking fruit juices, or
• if you have taken food or fruit juice, wait two hours before taking the tablet.

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

Pregnancy, Breastfeeding, and Fertility

There are no data or limited data on the use of bilastine in pregnant women, during breastfeeding, or 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 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 contains Sodium

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

3. How to take Astrilax

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 tablet (20 mg) per day.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after taking any food or fruit juice (see section 2, "Taking Astrilax with Food, Drinks, and Alcohol").
• Swallow the tablet with a glass of water.
• The score line is only for breaking the tablet if you find it difficult to swallow it whole.

You should consult your 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 available.

If you take more Astrilax than you should

If you or anyone else exceeds the 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

Do nottake 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.

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, 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 your 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 Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Astrilax

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

Do not use this medicine after the expiry date which is stated on the packaging and on the blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Astrilax

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

The other ingredients are microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), anhydrous colloidal silica, magnesium stearate.

Appearance of the Product and Package Contents

Astrilax are white, oval, biconvex, and scored tablets (length 10 mm, width 5 mm).

The tablets are packaged in single-dose precut blisters of 7x1, 10x1, 14x1, and 20x1 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 Tablets

Spain: Astrilax 20 mg Tablets

Portugal: Astrilax 20 mg 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/)