ILAXTEN 2.5MG/ML ORAL SOLUTION

PACKAGE LEAFLET
Package leaflet: Information for the patient
Ilaxten 2.5 mg/ml oral solution
For children aged 6 to 11 years with a body weight of at least 20 kg
bilastine

Read all of this leaflet carefully before your child starts taking this medicine because it contains
important information for you.
Keep this 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 your child. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as your child’s.
If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
What Ilaxten is and what it is used for
2.
What you need to know before you take Ilaxten
3.
How to take Ilaxten
4.
Possible side effects
5.
How to store Ilaxten
6.
Contents of the pack and other information

1.

What Ilaxten is and what it is used for

Ilaxten contains the active substance bilastine which is an antihistamine.
Ilaxten is used to relieve the symptoms of hayfever (sneezing, itchy, runny, blocked-up nose and red and
watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or
urticaria).
Ilaxten 2.5 mg/ml oral solution is indicated in children aged 6 to 11 years with a body weight of at least 20
kg.

2.

What you need to know before you use Ilaxten

Do not use Ilaxten:
if your child is allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Ilaxten if your child has moderate or severe renal or hepatic
impairment or if your child is taking other medicines (see”Other medicines and Ilaxten”).
Children
Do not give this medicine to children under 6 years of age with a body weight below 20 kg since no
sufficient data are available.

Other medicines and Ilaxten
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines,
including medicines obtained without a prescription. Some medicines should not be taken together and
others may need their doses to be altered when taken together.
Always inform your doctor or pharmacist if your child is using or receiving any of the following medicines
in addition to Ilaxten:


Ketoconazole (an antifungal medicine)



Erythromycin (an antibiotic)



Diltiazem (to treat angina)



Cyclosporine (to reduce the activity of your immune system, thus avoiding transplant rejection or
reducing disease activity in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis or
rheumatoid arthritis)



Ritonavir (to treat AIDS)



Rifampicin (an antibiotic)

Ilaxten with food, drink and alcohol
The oral solution should not be taken with food or with grapefruit juice or other fruit juices, as this will
decrease the effect of bilastine. To avoid this, you can:


give your child the oral solution and wait for one hour before your child takes food or fruit juice or



if your child has taken food or fruit juice, wait for two hours before giving him the oral solution.

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

Pregnancy, breast-feeding and fertility
This medicine is for use in children from 6 to 11 years of age with a body weight of at least 20 kg. However,
following information should be noted regarding the safe use of this medicine. There are no or limited
amount of data from the use of bilastine in pregnant women and during breast-feeding and on the effects on
fertility.
In case of pregnancy or breast-feeding, or when planning to have a baby, it is recommended to ask to the
doctor for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It has been demonstrated that bilastine 20 mg does not affect the driving performance in adults. However the
response from each patient to the medicine may be different. Therefore you should check how this medicine
affects your child, before you let your child ride bicycles or drive other vehicles or operate machinery.
Ilaxten contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which
may cause allergic reactions (possibly delayed).
3.

How to take Ilaxten

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Use in children
The recommended dose in children 6 to 11 years of age with a body weight of at least 20 kg is 10 mg
bilastine (4 ml of oral solution) once daily for the relief of symptoms of allergic rhinoconjunctivitis and
urticaria.
Do not give this medicine to children under 6 years of age with a body weight below 20 kg since no
sufficient data are available
For adults, including elderly and adolescents aged 12 years and over, the recommended dose is 20 mg
bilastine once daily. For this patient population a more appropriate dosage form - tablet- is available, ask
your doctor or pharmacist.



The oral solution is for oral use
The oral solution is accompanied by a cup for dosage with a mark of 4 ml (= 10 mg bilastine per
dosing), which will help you to dose the oral solution correctly
Fill the cup with 4 ml of oral solution
Administer directly from the cup
Wash the cup after use






You should give the oral solution to your child one hour before or two hours after your child has
taken any food or fruit juice.

As the duration of treatment depends on your child’s underlying disease, your physician will determine for
how long your child should take Ilaxten.
If you use more Ilaxten than you should
If your child, or anyone else, use too much of this medicine, tell your doctor immediately or go to the
emergency department of your nearest hospital. Please remember to take this medicine pack or this leaflet
with you.
If you forget to use Ilaxten
If you forget to give your child the daily dose on time, give it on the same day as soon as you remember.
Then, give the next dose on the next day at the usual time as prescribed by the doctor.
In any case, do not give a double dose to make up for a forgotten one.
If you stop using Ilaxten
Generally there will be no after-effects when treatment with Ilaxten is stopped.
If you have any further questions on 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.
Side effects that may be experienced in children are:
Common: may affect up to 1 in 10 people





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

Uncommon: may affect up to 1 in 100 people


eye irritation










dizziness
loss of consciousness
diarrhoea
nausea (the feeling of being sick)
lip swelling
eczema
urticaria (hives)
fatigue

Side effects that may be experienced 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


abnormal ECG heart tracing



blood tests which show changes in the way the liver is working



dizziness



stomach pain



tiredness



increased appetite



irregular heartbeat



increased weight



nausea (the feeling of being sick)



anxiety



dry or uncomfortable nose



belly pain



diarrhoea



gastritis (inflammation of the stomach wall)



vertigo (a feeling of dizziness or spinning)



feeling of weakness



thirst



dyspnoea (difficulty in breathing )



dry mouth



indigestion



itching



cold sores (oral herpes)



fever



tinnitus (ringing in the ears)



difficulty in sleeping



blood tests which show changes in the way kidney is working



blood fats increased

Frequency not known: cannot be estimated from the available data


palpitations (feeling your heart beat)



tachycardia (fast heart beat)



allergic reactions the signs of which may include difficulty in breathing, dizziness, collapsing or
losing consciousness, swelling of your face, lips, tongue or throat, and/or swelling and redness
of the skin. If you notice any of these serious side effects, stop taking the medicine and seek
urgent medical advice straight away.

Reporting of side effects
If your child gets any side effects, talk to your doctor. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

5.

How to store Ilaxten

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 carton and the bottle after EXP. The
expiry date refers to the last day of that month.
Do not store above 30 °C
The shelf life after first opening is 6 months.
Do not use this medicine if you notice any visible signs of particles.
Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Ilaxten contains
The active substance is bilastine. One milliliter of the oral solution contains 2.5 mg of bilastine.
The other ingredients are Betadex, Hydroxyethylcellulose, Methyl parahydroxybenzoate (E218),
Propyl parahydroxybenzoate (E216), Sucralose, Raspberry flavour (major components: ethanol,
triacetin, water, ethyl butyrate, linalyl acetate), Hydrochloric acid 37% or 10% (for pH-adjustment),
Sodium hydroxide (for pH-adjustment), Water, purified
What Ilaxten looks like and contents of the pack
Ilaxten oral solution is a clear, colourless, slightly viscous aqueous solution of pH 3.0-4.0, without
precipitate.
Ilaxten 2.5 mg/ml oral solution is packaged in an amber glass bottle, sealed with an aluminium screw cap,
including a 15 ml cup for dosage with a mark of 4 ml. Each bottle contains 120 ml of oral solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611, Luxembourg
Manufacturer
FAES FARMA, S.A.
Máximo Aguirre, 14. 48.940 – Leioa (Vizcaya)
Spain
Berlin Chemie AG,
Glienicker Weg 125, 12489 Berlin,
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Nasitop 2,5 mg/ml Lösung zum Einnehmen
Belgium: Bellozal 2,5 mg oral solution
Bulgaria: Фортекал за деца 2.5 mg/ml перорален разтвор
Cyprus: Bilaz
Czech Republic: Xados
Denmark: Revitelle
Estonia: Opexa
Finland: Revitelle
France: Bilaska
Germany: Bilaxten 2,5 mg/ml Lösung zum Einnehmen
Greece: Bilaz
Hungary: Lendin
Iceland: Bilaxten
Ireland: Drynol
Latvia: Opexa 2,5 mg/ml šķīdums iekšķīgai lietošanai
Lithuania: Opexa
Luxembourg: Bellozal 2,5 mg oral solution
Malta: Gosall
Norway: Zilas
Poland: Clatra
Portugal: Lergonix
Romania: Borenar 2,5 mg/ml soluţie orală
Slovak Republic: Omarit
Slovenia: Bilador 2,5 mg peroralna raztopina
Spain: Ibis
Sweden: Bilaxten

United Kingdom: Ilaxten
This leaflet was last revised in 01/2018.