IBIS 2.5 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Ibis 2.5 mg/ml Oral Solution

Bilastine

For Children from2 to 11 Years with a Minimum Body Weight of 15 kg

Read the Entire Package Leaflet Carefully Before Your Child Starts Taking this Medication,as it Contains Important Information for You.

• Keep this package leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to your child only, and you should not give it to others, even if they have the same symptoms as your child, as it may harm them.
  • If your child experiences side effects, consult your doctor or pharmacist, even if they are 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 ingredient, 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).

Ibis 2.5 mg/ml Oral Solution is indicated in children from 2 to 11 years of age with a minimum body weight of 15 kg.

2. What You Need to Know Before Taking Ibis

Do Not Take Ibis:

• if your child is allergic to bilastine or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ibis if your child has moderate or severe kidney or liver impairment, low blood levels of potassium, magnesium, or calcium, if your child has or has had heart rhythm problems or if their heart rate is very low, if your child is taking medications that may affect heart rhythm, if your child has or has had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in some types of heart disease, or if your child is taking other medications (see "Using Ibis with Other Medications").

Children

Do not administer this medication to children under 2 years of age or with a body weight below 15 kg, as there is insufficient data available.

Using Ibis with Other Medications

Tell your doctor or pharmacist if your child is using, has recently used, or may need to use any other medication, including those obtained without a prescription.

Some medications should not be taken together, and other medications may require a dose adjustment when taken together.

Always inform your doctor or pharmacist if your child is taking or receiving any of the following medications in addition to Ibis:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (for treating chest pain - pain or pressure in the chest area)
• Cyclosporine (to reduce the activity of the 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 treating HIV)
• Rifampicin (an antibiotic)

Taking Ibis with Food, Drinks, and Alcohol

The oral solution should notbe taken with foodor withgrapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To avoid this, you can:

• administer the oral solution to your child and wait one hour before your child eats or takes fruit juices, or

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

Pregnancy, Breastfeeding, and Fertility

This medication is for use in children from 2 to 11 years of age with a minimum body weight of 15 kg. However, the following information on the safe use of this medication should be taken into account. There are limited or no data available on the use of bilastine in pregnant or breastfeeding women, and on its effects on fertility.

If you are pregnant or breastfeeding, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before taking any medication.

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 medication may be different. Therefore, check how this medication affects your child before they ride a bicycle or other vehicles or operate machinery.

Ibis 2.5 mg/ml Oral Solution may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

Ibis Contains Ethanol and Sodium

This medication contains 0.44 mg of alcohol (ethanol) per dose (4 ml), which is equivalent to 11 mg/100 ml (0.011% p/v). The amount in 4 ml of this medication is equivalent to less than 0.02 ml of beer or 0.005 ml of wine.

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

This medication contains less than 1 mmol of sodium (23 mg) per 4 ml; this is, essentially "sodium-free".

3. How to Take Ibis

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Use in Children

The recommended dose in children from 2 to 11 years of age with a minimum body weight of 15 kg is 10 mg of bilastine (4 ml of oral solution) once daily for the symptomatic relief of allergic rhinoconjunctivitis and urticaria.

Do not administer this medication to children under 2 years of age or with a body weight below 15 kg, as there is insufficient data available.

For adults, including elderly patients and adolescents 12 years of age and older, the recommended dose is 20 mg of bilastine once daily. For this patient population, a more suitable pharmaceutical form - tablets - is available; consult your doctor or pharmacist.

• The oral solution is for oral use.
• The bottle of oral solution is provided with a child-resistant cap and should be opened as follows: press the plastic screw cap down and turn it counterclockwise at the same time.
• The oral solution comes with a dosing cup with a 4 ml mark (= 10 mg of bilastine per dose), which will help you to dose the oral solution correctly.
• Fill the dosing cup with 4 ml of oral solution.
• Administer directly from the dosing cup.
• Wash the dosing cup after use.
• You should administer the oral solution to your child one hour before or two hours after they have taken any food or fruit juice.

The duration of treatment depends on your child's underlying disease, and your doctor will determine how long they should take Ibis.

If You Take More Ibis Than You Should

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

If You Forget to Take Ibis

If you forget to administer the daily dose to your child on time, give it to them the same day as soon as you remember. Then, give the next dose the following day at the usual time as indicated by your doctor.

Never give a double dose to make up for a forgotten dose.

If You Stop Taking Ibis

Generally, no effects will appear after stopping treatment with Ibis.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If your child experiences 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 administering this medication and go to your doctor immediately.

Other Side Effects That May Appearin Children:

Common: May Affect Up to 1 in 10 People

• allergic conjunctivitis (eye irritation)
• headache

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
• rhinitis (nasal irritation)
• stomach pain (abdominal pain/upper abdominal pain)

Side Effects That May Appearin Adults and Adolescents:

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 (a feeling of dizziness or spinning)
• feeling of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• cold sore (herpes labialis)
• 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 Available Data

• palpitations (feeling the heartbeat)
• tachycardia (fast heartbeat)
• vomiting

Reporting Side Effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ibis

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

Do not use this medication after the expiration date stated on the package and bottle after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Once opened, use within the first 6 months.

Do not use this medication if you notice visible particles.

Medications should not be disposed of via wastewater or household waste. Return the medication packages and any unused medications to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medication packages and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibis

• The active ingredient is bilastine. Each ml of oral solution contains 2.5 mg of bilastine.
• The other ingredients (excipients) are betadex (E459), hydroxyethylcellulose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sucralose (E955), raspberry flavor (main components: ethanol, triacetin, water, ethyl butyrate, linalyl acetate), hydrochloric acid 37% or 10% (for pH adjustment), sodium hydroxide (for pH adjustment), purified water.

Appearance of the Product and Package Contents

Ibis is a clear, transparent, and slightly viscous aqueous oral solution, with a pH of 3.0-4.0 and no precipitate.

Ibis 2.5 mg/ml Oral Solution is packaged in a 120 ml amber glass bottle, sealed with an aluminum or child-resistant polypropylene screw cap; a 15 or 25 ml dosing cup with a 4 ml mark is included.

Marketing Authorization Holder

Menarini International Operations Luxembourg, S.A.

1, Avenue de la Gare

L-1611 Luxembourg

Manufacturer:

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

or

Berlin-Chemie AG

Glienicker Weg 125

D-12489 – Berlin

Germany

You can request more information about this medication from the local representative of the marketing authorization holder:

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona

(Barcelona) Tel.: +34 934 628 800

E-mail: [email protected]

This medication is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Austria: Nasitop 2,5 mg/ml Lösung zum Einnehmen

Belgium: Bellozal 2,5 mg oral solution

Bulgaria: ???????? ?? ???? 2.5 mg/ml ????????? ???????

Cyprus: Bilaz 2.5 mg/mL π?σιμο δι?λυμα

Czech Republic: Xados

Denmark: Revitelle, oral opløsning 2,5 mg/ml

Estonia: Opexa

Finland: Revitelle

France: Bilaska 2.5 mg/ ml solution buvable

Germany: Bilaxten 2,5 mg/ml Lösung zum Einnehmen

Greece: Bilaz 2.5 mg/mL π?σιμο δι?λυμα

Hungary: Lendin

Iceland: Bilaxten 2,5 mg/ml mixtúra, lausn

Ireland: Drynol

Latvia: Opexa 2,5 mg/ml škidums iekškigai lietošanai

Lithuania: Opexa

Luxembourg: Bellozal 2,5 mg oral solution

Malta: Gosall 2.5 mg/ml oral solution

Norway: Zilas 2,5 mg/ml mikstur, oppløsning

Poland: Clatra

Portugal: Lergonix 2,5 mg/ml solução oral

Romania: Borenar 2,5 mg/ml solutie orala

Slovakia: Omarit 2,5 mg/ml perorálny roztok

Slovenia: Bilador 2,5 mg peroralna raztopina

Spain: Ibis 2,5 mg/ml solución oral

Sweden: Bilaxten

United Kingdom (Northern Ireland): Ilaxten

Date of the Last Revision of thisPackage Leaflet:March 2025

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