Ibis 2.5 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibis 2.5 mg/ml oral solution

Bilastina

For children aged 2 to 11 years with a minimum body weight of 15 kg

Read the entire leaflet carefully before your child starts taking this medicine, as it contains important information for you.

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

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

• This medicine has been prescribed for your child only; do not give it to other people, even if they have the same symptoms as your child, as it could harm them.
  • If your child experiences any adverse effects, consult your doctor or pharmacist, even if these effects are 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 your child takes 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, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes (hives or urticaria).

Ibis 2.5 mg/ml oral solution is indicated in children aged 2 to 11 years with a minimum body weight of 15 kg.

2. What you need to know before starting to take Ibis

Do not take Ibis:

• if your child is allergic to bilastine or to any of the other components of this medicine (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 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 medicines that may affect heart rhythm, if your child has or has had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease, or if your child is taking other medicines (see “Use of Ibis with other medicines”).

Children

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

Use of Ibis with other medicines

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines should not be taken together, and other medicines 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 medicines in addition to Ibis:

• Ketoconazole (a medicine for fungal infections)
• Erythromycin (an antibiotic)
• Diltiazem (to treat angina pectoris – chest pain or pressure)
• Cyclosporine (to reduce the activity of the immune system, thus preventing transplant rejection or reducing disease activity in autoimmune and allergic disorders such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (to treat HIV)
• Rifampicin (an antibiotic)

Taking Ibis with food, drinks and alcohol

The oral solution must not be taken with food or fruit juices, especially grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:

• administer the oral solution to your child and wait one hour before your child eats or drinks fruit juices, or
• if your child has consumed food or fruit juice, wait two hours before administering the oral solution.

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

Pregnancy, breastfeeding and fertility

This medicine is intended for use in children aged 2 to 11 years with a minimum body weight of 15 kg. However, the following information on safe use should be considered. There are no data or the data are very limited regarding the use of bilastine in pregnant or breastfeeding women, and its effects on fertility.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

Bilastine 20 mg has been shown not to impair driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, check how this medicine affects your child before allowing them to 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 medicine contains 0.44 mg of alcohol (ethanol) per dose (4 ml), equivalent to 11 mg/100 ml (0.011% w/v). The amount in 4 ml of this medicine is equivalent to less than 0.02 ml of beer or 0.005 ml of wine.

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

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

3. How to take Ibis

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

Use in children

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

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

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

• The oral solution is for oral use only.
• The bottle of oral solution is equipped with a child-resistant cap and should be opened as follows: press down on the plastic screw cap while simultaneously turning it counterclockwise.
• The oral solution comes with a dosing cup marked at 4 ml (= 10 mg of bilastine per dose), which will help you accurately measure the correct amount of oral solution.
• Fill the dosing cup to the 4 ml mark with oral solution.
• Administer directly from the dosing cup.
• Wash the dosing cup after use.
• The oral solution should be given to your child one hour before or two hours after eating food or drinking fruit juice.

Since the duration of treatment depends on your child's underlying condition, your doctor will determine how long Ibis should be taken.

If you take more Ibis than you should

If your child, or anyone else, takes more than the prescribed dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine container or the package leaflet with you.

If you forget to take Ibis

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

Under no circumstances should you give a double dose to make up for a missed dose.

If you stop taking Ibis

Generally, no effects are expected after discontinuation of treatment with Ibis.

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 may cause adverse effects, although not everyone will experience 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 skin swelling and redness, stop administering this medicine and seek immediate medical attention.

Other adverse effects that may occur in 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)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue
• rhinitis (nasal irritation)
• stomach ache (abdominal/upper abdominal pain)

Adverse effects that may occur in adults and adolescents:

Common: may affect up to 1 in 10 people

• headache
• somnolence (drowsiness)

Uncommon: may affect up to 1 in 100 people

• electrocardiogram abnormalities
• blood tests showing changes in liver function
• dizziness
• stomach ache
• tiredness
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or spinning)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sore (herpes labialis)
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increase in blood fats

Frequency not known: cannot be estimated from available data

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

Reporting of adverse effects

If your child experiences 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 Medicines: 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 on the packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

After opening, use within the first 6 months.

Do not use this medicine if you notice visible particles.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Ibis

• The active substance is bilastine. Each ml of oral solution contains 2.5 mg of bilastine.
• The other components (excipients) are betadex (E459), hydroxyethylcellulose, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), sucralose (E955), raspberry flavour (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 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 an aluminum screw cap or with a child-resistant polypropylene cap; a 15 ml or 25 ml dosing cup is included, marked at 4 ml. Each bottle contains 120 ml of oral solution.

Marketing Authorization Holder

Menarini International Operations Luxembourg, S.A.
1, Avenue de la Gare
L-1611 Luxembourg

Manufacturer:

Faes Farma, S.A.
Scientific and Technological Park of Bizkaia
Ibaizabal Bidea, Building 901
48160 Derio (Bizkaia)
Spain

or

Berlin-Chemie AG
Glienicker Weg 125
D-12489 – Berlin
Germany

For further information about this medicinal product, please contact 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 medicinal product is authorized in the European Economic Area member states and 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: Билазин 2.5 mg/ml орален разтвор
Cyprus: Bilaz 2.5 mg/mL πόσιμο διάλυμα
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 πόσιμο διάλυμα
Hungary: Lendin
Iceland: Bilaxten 2.5 mg/ml mixtúra, lausn
Ireland: Drynol
Latvia: Opexa 2.5 mg/ml šķidums iekšķīgai 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 most recent review of this summary: March 2025

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