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ILAXTEN 10MG ORODISPERSIBLE TABLETS

Active substance(s): BILASTINE

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PACKAGE LEAFLET
Package leaflet: Information for the patient
Ilaxten 10 mg orodispersible tablets
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).
Ilaxten10 mg orodispersible tablets are indicated in children aged 6 to 11 years with a body weight of at least
20 kg.

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
These orodispersible tablet 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 orodispersible tablet 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 orodispersible
tablet.

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,
the 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
2.

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 (1 orodispersible tablet) 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 suitable dosage form – tablet - is available, ask your
doctor or pharmacist.



The orodispersible tablet is for oral use.
Please place the orodispersible tablet in the mouth of your child. It will disperse rapidly in saliva and
can then be easily swallowed.
Alternatively, you may disperse the orodispersible tablet in a tea-spoon of water before giving it to
your child. It has to be ensured that no rest of sediment remains in the spoon.
You should use exclusively water for dispersion, do not use grapefruit juice or any other fruit
juices.
You should give the orodispersible tablet 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 or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly 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 blister after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater . 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. Each orodispersible tablet contains 10 mg of bilastine.
The other ingredients are mannitol, croscarmellose sodium, sodium stearyl fumarate, sucralose, red
grape flavour (major components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, dlimonene, linalool)

What Ilaxten looks like and contents of the pack
Ilaxten orodispersible tablets are round, slightly biconvex, white, of 8 mm diameter.
The orodispersible tablets are supplied in blisters of 10, 20, 30 or 50 tablets.
Not all pack sizes may be marketed.

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
A. Menarini Manufacturing Logistics and Services S.r.L.,
Via Campo di Pile 67100, L’Aquila,
Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Nasitop 10 mg Schmelztabletten
Belgium: Bellozal 10 mg orodispersible tablets
Bulgaria: Фортекал за деца 10 mg диспергиращи се в устата таблетки
Cyprus: Bilaz
Czech Republic: Xados
Denmark: Revitelle
Estonia: Opexa
Finland: Revitelle
France: Bilaska
Germany: Bilaxten 10 mg Schmelztabletten
Greece: Bilaz
Hungary: Lendin
Iceland: Bilaxten
Ireland: Drynol
Latvia: Opexa 10 mg mutē disperģējamās tabletes
Lithuania: Opexa
Luxembourg: Bellozal 10 mg orodispersible tablets
Malta: Gosall
Norway: Zilas
Poland: Clatra
Portugal: Lergonix
Romania: Borenar 10 mg comprimate orodispersabile
Slovak Republic: Omarit
Slovenia: Bilador 10 mg orodispersibilne tablete
Spain: Ibis
Sweden: Bilaxten
United Kingdom: Ilaxten

This leaflet was last revised in 01/2018.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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