PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 109G5M 0001/16

ILAXTEN 20 MG TABLETS

bilastine

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).

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 older people 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)

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/vellowcard. 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

Marketed by:

A. Menarini Farmaceutica Internazionale SRL.

This leaflet was last revised in 10/2015.

1753-T A/B

109G5M Ilaxten 20 mg UK leaflet.indd 2 20/05/16 09:16