Package Insert: Information for the Patient

Abrilia 20 mg Tablets EFG

Bilastina

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those provided by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• For advice or more information, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Abrilia 20 mg tablets contain bilastine as the active ingredient, which is an antihistamine.

Abrilia 20 mg tablets are used for the relief of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, nasal congestion, and red, itchy eyes) and urticaria (hives) with mild symptoms in adults and adolescents 12 years of age and older.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not takeAbrilia 20 mg tablets

If you are allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Abrilia 20 mg tablets if you have moderate or severe renal insufficiency, low blood levels of potassium, magnesium, 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 certain abnormal pattern of your heartbeat (known as QTc prolongation in the electrocardiogram) that may occur in some types of heart disease and you are also taking other medicines (see "Use of Abrilia 20 mg tablets with other medicines").

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

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

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 andAbrilia 20 mg tablets

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

Particularly, please consult your doctor if you are taking any of the following medicines:

TakingAbrilia 20 mg tabletswith food, drinks, and alcohol

These tabletsshould not be taken withfood or withgrapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you can:

• take the tablet and wait an hour before eating or taking fruit juices, or
• if you have eaten food or fruit juices, wait for 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 these are limited, on the use of bilastine in pregnant women, during lactation, or on its effects on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Abrilia 20 mg has been shown not to affect performance during driving in adults. However, the response of each patient to the medicine may be different. Therefore, check how this medicine affects you before driving or operating machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose in adults, including elderly patients and adolescents 12 years of age or older, is 1 tablet (20 mg) per day.

• The tablet is to be taken orally.
• The tablet should be taken one hour before or two hours after taking any food or fruit juice (see section 2, “Taking Abrilia 20 mg tablets with food, drinks, and alcohol”).

• Swallow the tablet with a glass of water.
• The groove is only for breaking the tablet if it is difficult to swallow whole.

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

Use in children

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

Do not administer this medication to children under 6 years of age with a body weight less than 20 kg as there is insufficient data available.

If you take more Abrilia 20 mg tablets than you should

If you, or anyone else, exceed the dose of this medication, inform your doctor immediately or go to the nearest hospital emergency service. Please remember to bring this medication package or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Abrilia 20 mg tablets

No take a double dose to compensate for the missed 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects that may occur in adults and adolescents are:

Frequent: may affect up to 1 in 10 people

• Headache
• Drowsiness

Less frequent: may affect up to 1 in 100 people

• Electrocardiogram alterations
• Blood tests showing changes in liver function
• Dizziness
• Stomach pain
• Fatigue
• Increased appetite
• Irregular heartbeat
• Weight gain
• Nausea (urge to vomit)
• Anxiety
• Dry or irritated nose
• Abdominal pain
• Diarrhea
• Gastritis (inflammation of the stomach lining)
• Dizziness (a feeling of dizziness or instability)
• Weakness
• Thirst
• Shortness of breath
• Dry mouth
• Indigestion
• Itching
• Herpes labial
• Fever
• Tinnitus (ringing in the ears)
• Difficulty sleeping
• Blood tests showing changes in kidney function
• Increased blood fats

Unknown frequency: cannot be estimated from available data

• Palpitations (feeling the heartbeat)
• Tachycardia (rapid heartbeat)
• 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 hives and redness. If you experience any of these severe side effects, stop taking this medicine and seek immediate medical attention.
• Vomiting

Side effects that may occur in children:

Frequent: may affect up to 1 in 10 people

• Runny nose
• Allergic conjunctivitis (eye irritation)
• Headache
• Stomach pain (abdominal pain/upper abdominal pain)

Less frequent: may affect up to 1 in 100 people

• Eye irritation
• Dizziness
• Loss of consciousness
• Diarrhea
• Nausea (urge to vomit)
• Swelling of the lips
• Eczema
• Urticaria (hives)
• Fatigue

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears after CAD on the packaging and blister. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Abrilia 20 mg tablets

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

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

Appearance of the product and content of the packaging:

Abrilia 20 mg tablets are white or almost white, elongated, biconvex, scored, and printed.

The tablets are presented in packs of 7, 14, and 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Last review date of this leaflet:February 2025

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).