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Package leaflet: Information
for the patients


Xyzal 5 mg film-coated tablets

For adults and children aged 6 years and above

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.

In this leaflet:
1. What Xyzal is and what it is used for
2. What you need to know before you take Xyzal
3. How to take Xyzal
4. Possible side effects
5. How to store Xyzal
6. Contents of the pack and other information
Levocetirizine dihydrochloride is the active ingredient of Xyzal.
Xyzal is an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
• allergic rhinitis (including persistent allergic rhinitis);
• nettle rash (urticaria).

Other medicines and Xyzal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines
Xyzal with food, drink and alcohol
Caution is advised if Xyzal is taken at the same time as alcohol or other agents acting on
the brain.
In sensitive patients, the concurrent administration of Xusal and alcohol or other agents
acting on the brain may cause additional reductions in alertness and impairment of
Xyzal can be taken with or without food.
Pregnancy and breast-feeding
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 Xyzal may experience somnolence / drowsiness, tiredness and exhaustion. Use caution when driving or operating machinary untill 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.
Xyzal contains lactose
These tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars you should contact your doctor before taking them.
Always take this medicine exactly as your doctor r 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.

Do not take Xyzal
if you are allergic to levocetirizine dihydrochloride to cetirizine, to hydroxyzine or any of
the other ingredients of this medicine (listed in section 6)if you have a severe impairment of
kidney function (severe renal failure with creatinine clearance below 10 ml/min)

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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Xyzal.

Patients who have severe impairment of kidney function must not take Xyzal.
Patients who only have impaired liver function should take the usual prescribed dose.

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.

Patients who have both impaired liver and kidney function may be given a lower dose depending on the se-verity 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.

The use of Xyzal is not recommended in children less than 6 years since the film-coated
tablets do not allow for dose adaptation.

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
Xyzal is not recommended for children under 6 years of age.
How and when should you take Xyzal?
For oral use only.
Xyzal tablets should be swallowed whole with water and may be taken with or without
How long should you take Xyzal?
The duration of use depends on the type, duration and course of your complaints and is
determined by your physician.
If you take more Xyzal than you should
If you take more Xyzal than you should, somnolence can occur in adults. Children may
initially show excitation and restlessness followed by somnolence.
If you think you have taken an overdose of Xyzal, please tell your doctor who will then
decide what action should be taken.
If you forget to take Xyzal
If you forget to take Xyzal, or if you take a dose lower than that prescribed by your doctor,
do not take a double dose to make up for a forgotten dose. Take your next dose at your
normal time.
If you stop taking Xyzal
Stopping treatment should have no negative effects. Symptoms may return, but they should
not be any worse than they were prior to the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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, 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.

At the first signs of a hypersensitivity reaction, stop taking Xyzal and tell your doctor.
Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/
or throat, breathing or swallowing difficulties (chest tightness or wheezing) hives, 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 Yellow Card
Scheme, Website:
By reporting side effects you can help provide more information on the safety of this
Keep this medicine out of the sight and reach of children.
Do not use Xyzal after the expiry date which is stated on the label and carton after Exp.
The expiry date refers to the last day of that month.
This medicinal product 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 protect the
What Xyzal contains
- The active substance is 5 mg levocetirizine dihydrochloride
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal
anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171),
and macrogol 400.
What Xyzal looks like and contents of the pack
The film-coated tablets are white to off-white, oval, with a Y logo on one side.
They are supplied in 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 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
UCB Pharma Ltd,
208 Bath Road
Berkshire, SL1 3WE
United Kingdom
This leaflet was last approved in September 2015.



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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.