Leaflet: information for the patient

Ibis 2.5 mg/ml oral solution

Bilastina

For children aged6 to 11 years with a minimum body weight of 20 kg

Read this leaflet carefully before your child starts 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, consult yourdoctororpharmacist.

-This medicine has been prescribedonlyfor your child, and should not be given to other people even if they havethe same symptomsas your child,as it may harm them.

• If your child experiences any side effects,consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1.What Ibis is and for what it is used

2.What you need to knowbeforestarting totake Ibis

3.How to take Ibis

4.Possible side effects

5Storage of Ibis

6.Contents of the pack and additional information

Ibis contains bilastine as the active ingredient, which is an antihistamine. Ibis is used to relieve symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

Ibis 2.5 mg/mL oral solution is indicated for children aged 6 to 11 years with a minimum body weight of 20 kg.

Do not take Ibis:

• if your child is allergic to bilastine or any of the other components 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 renal or hepatic insufficiency, low blood levels of potassium, magnesium, calcium, if your child has or has had heart rhythm problems or if your child's 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 pattern of heart rhythm (known as QTc prolongation in the electrocardiogram) that may occur in some types of heart disease or if your child is taking other medications (see “Ibis use with other medications”).

Children

Do not administer this medication to children under 6 years of age with a body weight less than 20 kg since there are not enough data available.

Ibis use with other medications

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

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

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 (to treat angina – chest pain or pressure)
• Ciclosporin (to reduce the activity of the immune system, and thus prevent transplant rejection or reduce the activity of the disease in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis or rheumatoid arthritis)
• Ritonavir (to treat HIV/AIDS)
• Rifampicin (an antibiotic)

Taking Ibis with food, drinks, and alcohol

The oral solution should not be taken with food or with orange 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 for one hour before your child eats or takes fruit juices, or
• if your child has eaten food or fruit juice, wait for two hours before giving your child the oral solution.

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 aged 6 to 11 years with a minimum body weight of 20 kg. However, the following information should be taken into account regarding the safe use of this medication. There are no data or these are very limited on the use of bilastine in pregnant women and during breastfeeding, and on the effects on fertility.

Consult your doctor or pharmacist before using this medication if you are pregnant or breastfeeding, or if you intend to become pregnant.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

It has been shown that bilastine 20 mg does not affect performance during driving in adults. However, the response of each patient 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) in each 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 contained in this medication does not produce any perceptible effect.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.This medicationindicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Use in children

The recommended dose in children aged 6 to 11 years with a minimum body weight of 20 kg is 10 mg of bilastine (4 ml of oral solution) once a day for symptomatic relief of allergic rhinoconjunctivitis and urticaria.

Do not administer this medication to children under 6 years of age with a body weight less than 20 kg since there are not enough data available.

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

Since the duration of treatment depends on the underlying disease of your child, it will be your doctor who determines for how long your child 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 nearest hospital emergency department. Please remember to bring this medication package or this leaflet with you.

If you forget to take Ibis

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

Never administer a double dose to compensate for the missed dose.

If you interrupt treatment with Ibis

Generally, there will be no effectsafter abandoningthe treatment with Ibis.

If you have any other questions about the use of thismedication, ask your doctor,orpharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If your child experiencesallergic reactions whose symptoms may include difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, stop administering this medicine and seek immediate medical attention.

Other side effects that may appearin children:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (urge to vomit)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

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 alterations
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (urge to vomit)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or spinning)
• weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• fever (herpes labial)
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fats

Unknown frequency: cannot be estimated from available data

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

Reporting of side effects

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thecontainerand on the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Once opened, use within the first 6 months.

Do not use this medication if you observe visible particles.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines that you no longer need at the Sigre Pointof the pharmacy.In case of doubtask your pharmacisthow to dispose ofthe containers and medicines that you no longerneed.By doing so, you will help protect the environment.

Composition of Ibis

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

Appearance of the product and contents of the container

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

Ibis 2.5 mg/ml oral solution is packaged in an amber glass bottle, sealed with a screw cap of aluminum or sealed with a polypropylene cap for child-resistant packaging; a 15 or 25 ml measuring cup with a 4 ml marking is included. Each bottle contains 120 ml of oral solution.

Holder of the marketing authorization

Menarini International Operations Luxembourg, S.A.

1, Avenue de la Gare

L-1611 Luxembourg

Responsible manufacturer:

FAES FARMA, S.A.

Máximo Aguirre, 14

48940 – Leioa

Spain

or

Berlin-Chemie AG

Glienicker Weg 125

D-12489 – Berlin

Germany

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

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona

(Barcelona)Phone: +34 934 628 800

Email:[email protected]

This medication is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Austria:Nasitop 2.5 mg/ml Lösung zum Einnehmen

Belgium:Bellozal2.5 mg oral solution

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

Cyprus: Bilaz2.5 mg/mL π?σιμο δι?λυμα

Czech Republic:Xados

Denmark: Revitelle, oral opløsning 2.5 mg/ml

Estonia: Opexa

Finland: Revitelle

France: Bilaska2.5 mg/ ml solution buvable

Germany:Bilaxten2,5 mg/ml Lösung zum Einnehmen

Greece: Bilaz2.5 mg/mLπ?σιμοδι?λυμα

Hungary: Lendin

Iceland: Bilaxten2,5 mg/ml mixtúra, lausn

Ireland: Drynol

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

Lithuania: Opexa

Luxembourg:Bellozal2,5 mg oral solution

Malta: Gosall2.5 mg/ml oral solution

Norway: Zilas2,5 mg/ml mikstur, oppløsning

Poland: Clatra

Portugal: Lergonix2,5 mg/ml solução oral

Romania:Borenar 2,5 mg/ml solutie orala

Slovakia: Omarit2,5 mg/ml perorálny roztok

Slovenia: Bilador2,5 mg peroralna raztopina

Spain: Ibis 2,5 mg/ml solución oral

Sweden: Bilaxten

United Kingdom (Northern Ireland): Ilaxten

Revision date of thisleaflet:April 2025

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