Ilaxten 10 mg orodispersible tablets

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

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.

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.

Other 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)
• vomiting

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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, d-limonene, 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

Manufacturer