Ibis 20 mg tablets

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Ibis 20 mg tablets

bilastine

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ibis is and what it is used for

Ibis contains bilastine as the active substance, which is an antihistamine. Ibis is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itching nose, runny nose, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis in adults and adolescents aged 12 years and older. It may also be used to treat itchy skin rashes (hives or urticaria).

2. What you need to know before taking Ibis

Do not take Ibis

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 Ibis 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 Ibis with other medicines").

Children

Do not administer Ibis 20 mg tablets to children under 12 years of age. For alternative pharmaceutical forms of bilastine suitable for use in children under 12 years of age, see section 3 "Use in children".

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Use of Ibis with other medicines

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 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 pressure)
• Cyclosporine (used to reduce activity of the immune system, to prevent transplant rejection or to reduce activity in autoimmune diseases and allergic disorders such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (used to treat HIV)
• Rifampicin (an antibiotic)

Taking Ibis 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 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 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 use of machines

It has been demonstrated that bilastine 20 mg does not affect driving performance in adults. However, individual patient response to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.

Ibis contains sodium

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

3. How to take Ibis

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 food or drinking fruit juice (see section 2, “Taking Ibis with food, drinks and alcohol”).
  • Swallow the tablet with a glass of water.
  • The score line is intended only for dividing the tablet if you have difficulty swallowing it whole.

Duration of treatment

Regarding the duration of treatment, your doctor will determine the type of illness you have and advise you on how long you should take Ibis.

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 – please consult your doctor or pharmacist.

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

If you take more Ibis 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 package or 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 Ibis

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, 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 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 and contact your doctor immediately.

Other 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
• diarrhoea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or unsteadiness)
• 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 lipids

Frequency not known: cannot be estimated from available data

• palpitations (awareness of heartbeats)
• tachycardia (rapid heartbeat)
• vomiting

Adverse effects that may occur in children:

Common: 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 pain/upper abdominal pain)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Ibis

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

Do not use this medicine after the expiry date stated after "EXP" on the packaging and 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 unused medicines and their containers at the Sigre Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibis

• 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.

See section 2 “Ibis contains sodium”

Nature of the product and contents of the pack

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

The tablets are packed in blisters of 10, 20, 30, 40 or 50 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Menarini International Operations Luxembourg, S.A.

1, Avenue de la Gare

L-1611 Luxembourg

Local representative

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona)

Manufacturer responsible

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

or

A.Menarini Manufacturing Logistics and Services S.r.l.

Campo di Pile

L’Aquila

Italy

or

Menarini - Von Heyden GmbH

Leipziger Strasse 7-13; 01097

Dresden

Germany

or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Olisir 20 mg Tabletten

Belgium: Bellozal 20 mg Tablet

Bulgaria: Fortecal 20 mg ????????

Cyprus: Bilaz 20 mg Δισκ?ο

Czech Republic: Xados

Denmark: Revitelle tabletter 20 mg

Estonia: Opexa

Finland: Revitelle 20 mg tabletti

France: Bilaska 20 mg Comprimé

Germany: Bilaxten 20 mg Tabletten

Greece: Bilaz 20 mg Δισκ?ο

Hungary: Lendin 20 mg tabletta

Iceland: Bilaxten 20 mg töflur

Ireland: Drynol 20 mg tablets

Italy: Bysabel 20 mg Compressa

Latvia: Opexa 20 mg tabletes

Lithuania: Opexa 20 mg tabletès

Luxembourg: Bellozal 20 mg Tablet

Malta: Gosall 20 mg tablets

Norway: Zilas 20 mg tablett

Poland: Clatra

Portugal: Lergonix 20 mg Comprimido

Romania: Borenar 20 mg comprimate

Slovakia: Omarit

Slovenia: Bilador 20 mg tablete

Spain: Ibis 20 mg tablets

Sweden: Bilaxten 20 mg tablett

United Kingdom (Northern Ireland): Ilaxten 20 mg tablets

Date of the most recent revision of this leaflet: February 2026

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