ABRILIA 20 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Abrilia 20 mg tablets EFG

Bilastine

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

Always follow exactly the instructions for use of this medicine contained in this leaflet or those provided by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more 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 a doctor if you worsen or do not improve after 7 days.

Contents of the leaflet

1. What Abrilia 20 mg tablets are and what they are used for
2. What you need to know before taking Abrilia 20 mg tablets
3. How to take Abrilia 20 mg tablets
4. Possible adverse effects
5. Storage of Abrilia 20 mg tablets
6. Contents of the pack and other information

1. What Abrilia 20 mg tablets is and what it is used for

Abrilia 20 mg tablets contain bilastina as the active substance, which is an antihistamine.

Abrilia 20 mg tablets are used to relieve allergic rhinoconjunctivitis (sneezing, nasal itching, runny nose, nasal congestion, and red, watery eyes) and urticaria (hives) when symptoms are mild, in adults and adolescents aged 12 years and older.

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

2. What you need to know before taking Abrilia 20 mg tablets

Do not take Abrilia 20 mg tablets

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 Abrilia 20 mg tablets 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 you are also taking other medicines (see "Use of Abrilia 20 mg tablets with other medicines").

If you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhoea, dizziness, or fainting, seek urgent medical 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 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 Abrilia 20 mg tablets

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 (a medicine for fungal infections)
• Erythromycin (an antibiotic)
• Diltiazem (used to treat angina)
• 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 AIDS)
• Rifampicin (an antibiotic)

Taking Abrilia 20 mg tablet 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, breast-feeding and fertility

There are no data or the data are limited on the use of bilastine in pregnant women, during breastfeeding, or on its effects 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 Abrilia 20 mg does not affect driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, check how this medicine affects you before driving or operating machinery.

3. How to take Abrilia 20 mg tablets

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose in adults, including elderly patients and adolescents aged 12 years and older, 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 eating 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 break line is intended only for splitting the tablet if you have difficulty swallowing it whole.

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

Use in children

For children aged 6 to 11 years with a minimum body weight of 20 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 this medicine to children under 6 years of age with a body weight below 20 kg, as sufficient data are not available.

If you take more Abrilia 20 mg tablets than you should

If you, or anyone else, exceed the prescribed dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine’s packaging or this leaflet with you.

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

If you forget to take Abrilia 20 mg tablets

Do not take a double dose to make up for the missed dose.

If you forget to take your dose, take it as soon as possible, and 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 experiences them.

Adverse 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 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
• 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 lipids

Frequency unknown: cannot be estimated from available data

• palpitations (awareness of heartbeats)
• tachycardia (rapid heartbeat)
• allergic reactions, the symptoms of which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin swelling and redness. If you experience any of these serious adverse effects, stop taking this medicine immediately and seek medical help without delay.
• vomiting

Adverse effects that may occur in children:

Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach ache (abdominal pain/upper abdominal pain)

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abrilia 20 mg tablets

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

Do not use this medicine after the expiry date which is stated after EXP on the packaging and on the blister. 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 Point in your pharmacy. If you are in doubt, please 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 Abrilia 20 mg tablets

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

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

Appearance of the medicine and contents of the pack:

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

The tablets are presented in packs containing 7, 10, 14 and 20 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

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

Other sources of information

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85180/P_85180.html