Ibis 10 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibis 10 mg orodispersible tablets

Bilastine

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, because 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 only for your child; 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 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 itchy skin rashes (hives or urticaria).

Ibis 10 mg orodispersible tablets are indicated in children aged 2 to 11 years with a minimum body weight of 15 kg.

2. What you need to know before your child starts taking Ibis

Do not take Ibis:

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

Warnings and precautions

Talk to your doctor or pharmacist before your child starts taking 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 give 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

Tell 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 others 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 (used to treat angina – 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 (used to treat HIV)
• Rifampicin (an antibiotic)

Taking Ibis with food, drinks and alcohol

These orodispersible tablets must not be taken with food or with grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:

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

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, please consider the following information regarding its safe use. There are no data or data are very limited on the use of bilastine in pregnant or breastfeeding women, and on 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 using machines

It has been demonstrated that bilastine 20 mg does not affect driving performance in adults. However, individual patient response 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 contains ethanol and sodium

This medicine contains 0.0015 mg of alcohol (ethanol) in each orodispersible tablet, equivalent to 1 mg/100 g (0.001% w/w). The amount in one orodispersible tablet is equivalent to less than 0.00004 ml of beer or 0.00002 ml of wine.

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

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

3. How to take Ibis

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

Use in children

The recommended dose in children aged 2 to 11 years with a minimum body weight of 15 kg is 10 mg of bilastine (1 orodispersible tablet) 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 orodispersible tablet is for oral use.
• Please place the orodispersible tablet in your child's mouth. It will rapidly disperse in saliva and can then be easily swallowed.
• Alternatively, you may disperse the orodispersible tablet in a teaspoon of water before administering it to your child. This is highly recommended for children under 6 years of age, as they are more prone to choking on tablets. Make sure no residue remains in the teaspoon.
• Water should be used exclusively for dispersion; do not use grapefruit juice or any other fruit juice.
• The orodispersible tablet should be administered to your child one hour before or two hours after consuming any food or 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 any other person, exceeds the recommended dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine package or the 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 as soon as you remember, on the same day. Then administer 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 can 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
• diarrhoea
• 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 pain
• tiredness
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or spinning)
• feeling of weakness
• thirst
• dyspnoea (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 the 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibis

• The active substance is bilastine. Each orodispersible tablet contains 10 mg of bilastine.
• The other components are mannitol (E421), sodium croscarmellose, stearic fumarate and sodium, sucralose (E955), red grape flavour (main components: arabic gum, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool).

Appearance of the product and contents of the pack

Ibis 10 mg orodispersible tablets are round, slightly biconvex, white tablets, 8 mm in diameter.

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder

Menarini International Operations Luxembourg, S.A.

1, Avenue de la Gare

L-1611 Luxembourg

Manufacturer:

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

or

A.Menarini Manufacturing Logistics and Services S.r.l.

Campo di Pile

L’Aquila

Italy

or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona

(Barcelona) T. +34 934 628 800

E-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Nasitop 10 mg Schmelztabletten

Belgium: Bellozal 10 mg orodispersible tablets

Bulgaria: ???????? ?? ???? 10 mg ???????????? ?? ? ?????? ????????

Cyprus: Bilaz 10 mg δισκ?α διασπειρ?μενα στο στ?μα

Czech Republic: Xados

Denmark: Revitelle, smeltetabletter 10 mg

Estonia: Opexa

Finland: Revitelle

France: Bilaska 10 mg comprimé orodispersible

Germany: Bilaxten 10 mg Schmelztabletten

Greece: Bilaz 10 mg δισκ?α διασπειρ?μενα στο στ?μα

Hungary: Lendin

Iceland: Bilaxten 10 mg munndreifitöflur

Ireland: Drynol

Latvia: Opexa 10 mg mute dispergejamas tabletes

Lithuania: Opexa

Luxembourg: Bellozal 10 mg orodispersible tablets

Malta: Gosall 10 mg orodispersible tablets

Norway: Zilas 10 mg smeltetablett

Poland: Clatra

Portugal: Lergonix 10 mg comprimido orodispersível

Romania: Borenar 10 mg comprimate orodispersabile

Slovakia: Omarit 10 mg orodispergovatelné tablety

Slovenia: Bilador 10 mg orodispersibilne tablete

Spain: Ibis 10 mg comprimidos bucodispersables

Sweden: Bilaxten

United Kingdom (Northern Ireland): Ilaxten

Date of the most recent review of this package leaflet: March 2025

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