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XITON 5 MG ORODISPERSIBLE TABLETS

Active substance(s): LEVOCETIRIZINE DIHYDROCHLORIDE

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Package leaflet: Information for the patient
XITON 5 mg Orodispersible Tablets
Levocetirizine Dihydrochloride
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. What XITON is and what it is used for
2. What you need to know before you take XITON
3. How to take XITON
4. Possible side effects
5. How to store XITON
6. Contents of the pack and other information
1. What XITON is and what it is used for
Levocetirizine Dihydrochloride is the active ingredient of XITON is an anti-allergic
medication.
For treatment of signs of illness (symptoms) associated with:
• Allergic rhinitis (including persistent allergic rhinitis);
• Nettle rash (urticaria).
2. What you need to know before you take XITON
Do not take XITON
• If you are allergic (hypersensitive) to levocetirizine dihydrochloride or to an antihistamine
or any of the other ingredients of this medicine (listed in section 6).>
• If you have a severe impairment of kidney function (severe kidney failure with creatinine
clearance below 10 ml/min).
Warnings and Precautions
Talk to your doctor or pharmacist before using XITON
If you are likely to be unable to empty your bladder (with conditions such as spinal cord
injury or enlarged prostate), please ask your doctor for advice.
If you are scheduled for allergy testing, ask your doctor if you should stop taking XITON for
several days before testing. This medicine may affect your allergy test results.

Children:
The use of XITON is not recommended in children less than 6 years since the orodispersible
tablet does not allow for dose adaptation
Other medicines and XITON
Tell your doctor or pharmacist if you are taking, have recently taken might take any other
medicines, including medicines obtained without a prescription.
XITON with food, drink and alcohol
Caution is advised if XITON 5 mg Orodispersible Tablets is taken at the same time as alcohol
or other centrally acting agents on the brain. In sensitive patients, the simultaneous use of
XITON and alcohol or otheragents acting on the brain may cause additional reductions in
alertness and impairment of performance.
Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some patients being treated with XITON may experience somnolence / drowsiness, tiredness
and exhaustion. Use caution when driving or operating machinery until you know how this
medicine affects you. However, special tests have revealed no impairment of mental
alertness, the ability to react or the ability to drive in healthy test persons after taking
levocetirizine in the recommended dosage.
Important information about some of the ingredients of XITON
These tablets contain lactose and sorbitol (E420), if you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicinal
product.
These tablets also contain aspartame (E951), which is a source of phenylalanine and may be
harmful for people with phenylketonuria.
These tablets also contain “sulphite” which can cause severe allergic reactions and difficulties
breathing.
This medicine contains potassium, less than 1 mmol (39 mg) per tablet, i.e. esentially
“potassium-free”
3. How to take XITON
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose for adults and children aged 6 years and over is one tablet daily.

Special dosage instructions for specific populations:
Renal and hepatic impairment






Patients with impaired kidney function may be given a lower dose according to the
severity of their kidney disease, and in children the dose will also be chosen on the
basis of body weight; the dose will be determined by your doctor.
Patients who have severe impairment of kidney function must not take XITON
Patients who only have impaired liver function should take the usual prescribed dose.
Patients who have both impaired liver and kidney function may be given a lower dose
depending on the severity of the kidney disease, and in children the dose will also be
chosen on the basis of body weight; the dose will be determined by your doctor.

Elderly patients aged 65 years and above
No adaptation of the dose is necessary in elderly patients, provided their renal function is
normal.
Use in children
XITON is not recommended for children under 6 years of age.
How and when should you take XITON
For oral use only.
The orodispersible tablet should be placed on the tongue and should be sucked, not chewed,
until complete disintegration. The resulting suspension has to be swallowed with saliva. The
orodispersible tablet can be taken with or without water and may be taken with or without
food.
How long should you take XITON
The duration of use depends on the type, duration and course of your complaints and is
determined by your physician.
If you take more XITON than you should
If you take more than XITON than you should, may cause somnolence in adults. Children may

initially show excitation and restlessness followed by somnolence.
If you think you have taken an overdose of XITON , please tell your doctor who will then
decide what action should be taken.
If you forget to take XITON
If you forget to take XITON, or if you take a dose lower than that prescribed by your doctor,
do not take a double dose to compensate; just wait for the scheduled time of the next dose,
and take a normal dose as prescribed by your doctor.

If you stop taking XITON
Stopping treatment should have no negative effects. However, rarely pruritus (intense
itching) may occur if you stop taking XITON, even if those symptoms were not present
before treatment initiation. The symptoms may resolve spontaneously. In some cases, the
symptoms may be intense and may require treatment to be restarted. The symptoms should
resolve when the treatment is restarted.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
Dry mouth, headache, tiredness and somnolence/drowsiness
Uncommon: may affect up to 1 in 100 people
Exhaustion and abdominal pain
Not known: frequency cannot be estimated from the available data
Other side effects such as palpitations, increased heart rate, fits, pins and needles, dizziness,
syncope, tremor, dysgeusia (distortion of the sense of taste), sensation of rotation or
movement, visual disturbances, blurred vision, painful or difficult urination, inability to
completely empty the bladder, oedema, pruritus (itchiness), rash, urticaria (swelling, redness
and itchiness of the skin), skin eruption, shortness of breath, weight increase, muscular pain,
joint pain, aggressive or agitated behaviour, hallucination, depression, insomnia, recurring
thoughts of or preoccupation with suicide, hepatitis, abnormal liver function, vomiting,
increased appetite, nausea and diarrhoea have also been reported.
Pruritus (intense itching) upon discontinuation.
At the first signs of a hypersensitivity reaction, stop taking XITON and see your doctor
immediately. Hypersensitivity reaction symptoms may include: swelling of the mouth,
tongue, face and/or throat, breathing or swallowing difficulties together with hives
(angioedema), sudden fall in blood pressure leading to collapse or shock, which may be fatal.
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 at:
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 XITON
Keep this medicine out of the sight and reach of children.
Do not use XITON after the expiry date which is stated on the carton after Exp. The expiry
date refers to the last day of that month.
This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What XITON contains
- The active substance is Levocetirizine Dihydrochloride
Each orodispersible tablet contains 5 mg Levocetirizine Dihydrochloride
- The other ingredients are polacrilin potassium, lactose monohydrate, aspartame (E951),
silica, colloidal anhydrous, magnesium stearate, flavour black current (contains 10.09 percent
of flav ouring substances, 0.07 percent of flavouring preparations,0.03 percent of natural
flavouring substances, 79.17 percent of Maize maltodextrin, 5.43 percent of E1518 Glyceryl
triacetate, 0.16 percent of E1505 Triethyl citrate, 0.0009 percent of E150d Sulphite ammonia
caramel and 5 percent moisture), and Pharmaburst B2 (Pharmaburst B2 consists of 85 percent
mannitol (E421), 10 percent polyplasdone, 5 percent sorbitol (E420), and less than 1 percent
syloid).
What XITON looks like and contents of the pack
The orodispersible tablets are round, white to off-white, flat, bevelled edged tablets plain on
both sides.
They are supplied in Alu-Alu blister packs of 1, 2, 4, 5, 7, 10, 2 x 10, 10 x 10, 14, 15, 20, 21,
28, 30, 40, 50, 60, 70, 90 or 100 tablets. All the pack sizes will not be marketed
Marketing Authorisation Holder and Manufacturer
SUBSTIPHARM DEVELOPPEMENT
24 RUE ERLANGER
75016 PARIS
FRANCE

This medicinal product is authorised in the Member States of the EEA under the
following names:
Spain: LORITOZIN 5 mg, comprimidos bucodispersables
This leaflet was last revised in 04/2017

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