Patient leaflet - ILAXTEN 20 MG TABLETS
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.'
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1. What ILAXTEN is and what it is used for
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2. What you need to know before you take ILAXTEN
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3. How to take ILAXTEN
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4. Possible side effects
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5. How to store ILAXTEN
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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 tabletsdo not take ilaxtenif 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 your 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 you, before driving or operating machinery.
Ilaxten contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.
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 one hour before or two hours after intake of food or fruit juice (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
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 this medicine to children under 6 years of age with a body weight below 20 kg since no sufficient data are available.
If you take more ILAXTEN than you should
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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.
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. If you experience symptoms of an allergic reaction 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, stop taking the medicine and seek urgent medical advice straight away.
Other 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
- 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
- headache
- stomach pain (abdominal /upper abdominal pain)
- lip swelling
- eczema
- urticaria (hives)
- fatigue
- 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)
Frequency not known: cannot be estimated from the available data
- palpitations (feeling your heart beat)
- tachycardia (fast heart beat)
- vomiting
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)
Uncommon: may affect up to 1 in 100 people
- eye irritation
- dizziness
- loss of consciousness
- diarrhoea
- nausea (the feeling of being sick)
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: 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.
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 informationwhat ilaxten contains- the active substance is bilastine. each tablet contains 20 mg of bilastine.
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– 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
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 12/2020.
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________________________________________________________________________________ P PDF 1.5 ^Product: Pil Ilaxten 20mg format/dimention: 003F 150×254 mm
Part code: 109R9A Font Type: Helvetica Lt Std Cond.
Country of destination: UK Font Size: 8 Spacing: 8
Production site: MMLS L’Aquila Pharmacode: XIIXIIXXX
Pantone colours: black
| DATE 30/11/2020 | OPERATOR RI016 | DRAFT 01 | cc 2 |
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