ASTRILAX 20 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Astrilax 20 mg tablets

bilastine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or if you do not improve after 7 days.

Contents of the leaflet

1. What Astrilax is and what it is used for
2. What you need to know before taking Astrilax
3. How to take Astrilax
4. Possible adverse effects
5. Storage of Astrilax
6. Contents of the pack and other information

1. What Astrilax is and what it is used for

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

Astrilax 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 (wheals or urticaria).

2. What you need to know before starting to take Astrilax

Do not take Astrilax

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 Astrilax 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, or 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 Astrilax with other medicines”).

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

Children

Do not give 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

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 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 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, breastfeeding, and fertility

There are no data or the data are limited on the use of bilastine in pregnant women, during breastfeeding, or on 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 demonstrated that Astrilax 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 contains sodium

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

3. How to take Astrilax

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 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 Astrilax with food, drinks and alcohol").
• Swallow the tablet with a glass of water.
• The break line is intended solely to facilitate tablet splitting if you have difficulty swallowing it whole.

Consult a doctor if your 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. Consult your doctor or pharmacist.

Do not administer bilastine to children under 2 years of age or with body weight below 15 kg, as sufficient data are not available.

If you take more Astrilax than you should

If you or anyone else 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 pack or the leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Astrilax

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.

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 swelling and redness, stop taking this medicine immediately and contact your doctor without delay.

Other adverse effects that may occur in adults and adolescents are:

Frequent: may affect up to 1 in 10 people

• Headache,
• drowsiness.

Uncommon: may affect up to 1 in 100 people

• Electrocardiogram abnormalities,
• 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 instability),
• 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:

Frequent: 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 ache (abdominal/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 can 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 Astrilax

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 is 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 Point located at your pharmacy. If you are in doubt, ask your pharmacist how to properly 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

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

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

See section 2 “Astrilax contains sodium”

Appearance of the product and contents of the pack

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

The tablets are packaged in single-dose pre-cut blisters of 7x1, 10x1, 14x1 and 20x1 tablets.

Only some pack sizes may be commercially available.

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 European Economic Area member states under the following names:

Germany: Alergolaxten 20 mg Tabletten

Spain: Astrilax 20 mg tablets

Portugal: Astrilax 20 mg tablet

Date of the most recent review of this leaflet: December 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)