IBIS 20 mg TABLETS

Introduction

Patient Information Leaflet

Ibis 20 mg tablets

bilastine

Read this leaflet carefully before starting to take 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Ibis and what is it used for
2. What you need to know before taking Ibis
3. How to take Ibis
4. Possible side effects
5. Storage of Ibis
6. Package contents and additional information

1. What is Ibis and what is it used for

Ibis contains bilastine as the active substance, which is an antihistamine. Ibis 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. It can also be used to treat itchy skin eruptions (hives or urticaria).

2. What you need to know before taking Ibis

Do not take Ibis

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 Ibis if you have moderate or severe kidney impairment, low blood potassium, magnesium, or calcium levels, 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 your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that can occur in some types of heart diseases and are also taking other medicines (see "Using Ibis with other medicines").

Children

Do not give this medicine to children under 12 years of age

Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Using Ibis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

In particular, please inform your doctor if you are taking any of the following medicines:

• Ketoconazole (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (for angina pectoris)
• Ciclosporin (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 (for HIV)
• Rifampicin (an antibiotic)

Taking Ibis 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 drinking fruit juices, or
• if you have eaten or drunk fruit juices, wait two hours before taking the tablet.

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

Pregnancy, breastfeeding, and fertility

There are limited or no 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 bilastine 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.

Ibis contains sodium

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

3. How to take Ibis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents 12 years of age 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 or drinking fruit juices (see section 2, "Taking Ibis 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.

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

Use in children

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

Do not give bilastine to children under 6 years of age with a body weight below 20 kg, as there are insufficient data.

If you take more Ibis than you should

If you or anyone else takes more of this medicine than they should, tell your doctor immediately or go to the nearest hospital emergency department. Please remember to take this medicine package or this 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 Ibis

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 continue with your regular dosing schedule.

If you have any further questions on 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 may include difficulty breathing, dizziness, collapse, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, stop taking this medicine and seek immediate medical attention.

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

?changes in the electrocardiogram

• 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 irritation)
• 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 leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side 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 on the package and blister. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition of Ibis

• 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), colloidal anhydrous silica, magnesium stearate.

Appearance and package contents

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

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

Not all pack sizes may be marketed.

Marketing authorisation 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

Faes Farma, S.A.

Máximo Aguirre, 14

48940 – Leioa

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

This medicine is authorised 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 comprimidos

Sweden: Bilaxten 20 mg tablett

United Kingdom (Northern Ireland): Ilaxten 20 mg tablets

Date of last revision of this leaflet:April 2025

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