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ILAXTEN 20MG TABLETS

Active substance(s): BILASTINE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ILAXTEN 20 MG TABLETS
bilastine

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.



If you get 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.

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

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).

2.

What you need to know before you take Ilaxten 20 mg tablets
Do not take Ilaxten:
if you are 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 you have moderate or severe renal

impairment and in addition you are taking other medicines (see ”Other medicines and
Ilaxten”).
Children
Do not give this medicine to children under 12 years of age
Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and Ilaxten
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.
In particular, please discuss with your doctor if you are taking any of the following
medicines:


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 tablets 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:


take the tablet and wait for one hour before taking food or fruit juice or



if you have taken food or fruit juice, wait for two hours before taking the tablet.

Bilastine, at the recommended dose (20 mg), does not increase the drowsiness produced
by alcohol.
Pregnancy, breast-feeding and fertility
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask you doctor for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
A study performed to establish the effect of bilastine on the ability to drive demonstrated
that treatment with 20 mg bilastine does not affect the driving performance. However
very rarely some people experience drowsiness, which may affect their ability to drive or
use machines.
3.

How to take Ilaxten
Always take this medicine exactly as your doctor or pharmacist have told you. Check
with your doctor or pharmacist if you are not sure.
The recommended dose in adults, including the elderly and adolescents aged 12 years and
over, is 1 tablet (20 mg) a day.


The tablet is for oral use.



The tablet must be taken on an empty stomach, for example in the morning prior to
breakfast. You must not eat for 1 hour after taking bilastine (see section 2, Ilaxten
with food, drink and alcohol”).



Swallow your tablet with a glass of water.



The score line is only here to help you break the tablet if you have difficulty
swallowing it whole

Regarding the duration of treatment, your physician will determine the type of disease
you are suffering from and will determine for how long you should take ILAXTEN.
Use in children
Do not give this medicine to children under 12 years of age.
If you take more ILAXTEN than you should
If you, or anyone else, have taken too many ILAXTEN tablets, contact your doctor or
pharmacist immediately.
If you forget to take ILAXTEN
Do not take a double dose to make up for a forgotten dose.
If you forget to take your dose on time, take it as soon as possible, and then go back to
your regular dosing schedule.
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 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 you get 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. Website: 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
blisters 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 or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help to
protect the environment.

6.

Contents of the pack and other information
What ILAXTEN contains
-

The active substance is bilastine. Each tablet contains 20 mg of bilastine.

-

The other ingredients are cellulose microcrystalline, sodium starch glycolate type
A (derived from potato), colloidal anhydrous silica, magnesium stearate.

What ILAXTEN looks like and contents of the pack
ILAXTEN tablets are white, oval, biconvex and scored (length 10 mm, width 5 mm.
The tablets are supplied in blisters of 10, 20 , 30, 40 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
A.Menarini Manufacturing Logistics and Services S.r.l.
Campo di Pile
L’Aquila
Italy
Marketed by:
A. Menarini Farmaceutica Internazionale SRL.
This leaflet was last revised in 01/2018.

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