IBIS 20 mg ORALLY DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Ibis 20 mg Oral Disintegrating Tablets

bilastine

Read this package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package 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 may 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 this medicine if you have moderate or severe kidney problems, low blood potassium levels, 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 your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart disease and are also taking other medicines (see "Use of 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.

Other medicines and Ibis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 - chest pain or pressure)
• Ciclosporin (to reduce the activity of your immune system, and thus prevent transplant rejection or reduce disease activity in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for AIDS)
• Rifampicin (an antibiotic)

Taking Ibis with food, drinks, and alcohol

These oral disintegrating tablets must notbe taken with foodor withgrapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To avoid this, you can:

• take the oral disintegrating tablet and wait one hour before eating or drinking fruit juices, or

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

Pregnancy, breastfeeding, and fertility

There are no data or limited 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 and ethanol

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

This medicine contains 0.0030 mg of alcohol (ethanol) in each oral disintegrating tablet, which is equivalent to 1.6 mg/100 g (0.0016% w/w). The amount of alcohol in a 185 mg oral disintegrating tablet is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

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 from 12 years of age, is 1 oral disintegrating tablet (20 mg of bilastine) per day.

• The oral disintegrating tablet is for oral use.
• Please place the oral disintegrating tablet in the mouth. It will disperse rapidly in the saliva and can then be swallowed easily.
• Alternatively, you can disperse the oral disintegrating tablet in water before taking it.
• You should use only water for dispersion,do not use grapefruit juice or any other fruit juice.
• The oral disintegrating tablet should be taken one hour before or two hours after taking any food or fruit juice (see section 2, "Taking Ibis with food, drinks, and alcohol").

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

Use in children

For children from 6 to 11 years of age with a minimum body weight of 20 kg, there are other pharmaceutical forms more suitable - bilastine 10 mg oral disintegrating 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 not enough data.

If you take more Ibis than you should

If you or anyone else takes too much of this medicine, tell your doctor immediatelyor go to the nearest hospital emergency department. Please remember to take this medicine package or this package leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ibis

Do not take 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 return to your normal dosing schedule.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you stop taking Ibis

Generally, no effects will appear after stopping this treatment.

If you have any further questions about 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 medical attention immediately.

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

• electrocardiogram changes
• 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 (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 of heartbeats)
• tachycardia (fast heart rate)
• vomiting

Side effects that may occur in children:

Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye inflammation due to an allergic reaction)
• 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the 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 which is stated on the packaging and blister after EXP. 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibis

• The active substance is bilastine. Each oral disintegrating tablet contains 20 mg of bilastine.
• The other ingredients are: mannitol (E421), croscarmellose sodium, sodium stearyl fumarate, sucralose (E955), red grape flavor (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool)

Appearance of the product and package contents

Ibis 20 mg oral disintegrating tablets are round, flat, white, engraved with "20" on one side, and 8 mm in diameter.

Ibis 20 mg oral disintegrating tablets are available in single-dose precut blisters of 10 x 1, 20 x 1, 30 x 1, 40 x 1, 50 x 1 oral disintegrating tablets.

Not all 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

FAES FARMA, S.A.

Máximo Aguirre, 14

48940 – Leioa

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Bilaxten 20 mg Schmelztabletten

Austria: Olisir 20 mg Schmelztabletten

Belgium: Bellozal 20 mg orodispersible tablets

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

Cyprus: Bilaz 20 mg δισκ?α διασπειρ?μενα στο στ?μα

Croatia: Nixar 20 mg raspadljive tablete za usta

Slovenia: Bilador 20 mg orodisperzibilne tablete

Spain: Ibis 20 mg comprimidos bucodispersables

Estonia: Opexa

Finland: Revitelle 20 mg tabletti, suussa hajoava

France: Bilaska 20 mg comprimé orodispersible

Greece: Bilaz 20 mg δισκ?α διασπειρ?μενα στο στ?μα

Hungary: Lendin 20 mg szájban diszpergálódó tabletta

Italy: Bysabel 20 mg compressa orodispersibile

Ireland: Drynol 20 mg orodispersible tablets

Latvia: Opexa 20 mg mute dispergejamas tabletes

Lithuania: Opexa 20 mg burnoje disperguojamos tabletes

Luxembourg: Bellozal 20 mg orodispersible tablets

Malta: Gosall 20 mg orodispersible tablets

Poland: Clatra

Portugal: Lergonix 20 mg comprimido orodispersível

Czech Republic: Xados

Slovakia: Omarit 20 mg orodispergovatelné tablety

Romania: Borenar 20 mg comprimate orodispersabile

Date of last revision of this package leaflet:April 2025

Other sources of information

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/)