Ilaxten 20 mg tablets

• 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.

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

if you are allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before using Ilaxten if you have moderate or severe renal impairment, low blood levels of potassium, magnesium, calcium, if you have or had heart rhythm problems or if your heart rate is very low, if you are taking medicines that may affect the heart rhythm, if you have or had a certain abnormal pattern to your heart beat (known as prolongation of the QTC interval on the Electrocardiogram) which can occur in some forms of heart disease and in addition you are taking other medicines (see “Other medicines and Ilaxten”).

Do not give this medicine to children under 12 years of age.

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

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 HIV)
• Rifampicin (an antibiotic)

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.

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 your doctor for advice before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

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 you, before driving or operating machinery.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

Other forms of this medicine - orodispersible tablets or oral solution - may be more suitable for children 6 to 11 years of age with a body weight of at least 20 kg ask your doctor or pharmacist.

Do not give bilastine to children under 6 years of age with a body weight below 20 kg since no sufficient data are available.

If you, or anyone else, have taken too many ILAXTEN tablets, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take this medicine pack or this leaflet with you.

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.

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

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

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: https://yellowcard.mhra.gov.uk/ 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.

• 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.

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.

Marketed by:

A. Menarini Farmaceutica Internazionale SRL.