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LEVOCETIRIZINE DIHYDROCHLORIDE 5MG FILM-COATED TABLETS

Active substance(s): LEVOCETIRIZINE DIHYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

XYZAL® 5MG FILM-COATED TABLETS
(levocetirizine dihydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
®

The name of your medicine is Xyzal 5mg Film-Coated Tablets but will be referred to
as Xyzal throughout this leaflet.
In this leaflet:
1. What Xyzal is and what it is used for
2. Before you take Xyzal
3. How to take Xyzal
4. Possible side effects
5. How to store Xyzal
6. Further information
1. WHAT XYZAL IS AND WHAT IT IS USED FOR
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).
2. BEFORE YOU TAKE XYZAL
Do not take Xyzal
if you are allergic (hypersensitive) to levocetirizine dihydrochloride or to an
antihistamine or any of the other ingredients of Xyzal (see ‘What Xyzal contains’)
if you have a severe impairment of kidney function (severe renal failure with
creatinine clearance below 10 ml/min).
Take special care with Xyzal
The use of Xyzal is not recommended in children less than 6 years since the
film-coated tablets do not allow for dose adaptation.

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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Taking Xyzal with food and drink
Caution is advised if Xyzal is taken at the same time as alcohol.
In sensitive patients, the simultaneous use of cetirizine or levocetirizine and alcohol
or other centrally acting agents may have effects on the central nervous system,
although the racemate cetirizine has been shown not to increase the effect of alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant, trying to get pregnant or breast-feeding.
Driving and using machines
Some patients being treated with Xyzal may experience somnolence / drowsiness,
tiredness and exhaustion. If you are intending to drive, engage in potentially
hazardous activities or use machines you are therefore advised first to wait and
observe your response to the medication. 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 Xyzal
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.

3. HOW TO TAKE XYZAL
Always take Xyzal exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual dose for adults and children aged 6 years and over is one tablet daily.
Patients with impaired kidney function may be given a lower dose according to the
severity of their kidney disease.
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.
Xyzal is not recommended for children under 6 years of age.

How and when should you take Xyzal?
The tablets should be swallowed whole with water and may be taken with or without
food.
If you take more Xyzal than you should
A substantial overdose may cause somnolence 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 compensate; just wait for the foreseen time for
intake of the next dose, and take a normal dose as prescribed by your doctor.
If you stop taking Xyzal
Stopping the treatment with Xyzal earlier than foreseen should have no detrimental
effects, in the sense that the symptoms of the disease should just progressively
reappear with a severity not higher than the one experienced prior to treatment with
Xyzal.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Xyzal can cause side effects, although not everybody gets them.
Commonly (1% to 10%), mainly mild to moderate side effects such as dry mouth,
headache, tiredness and somnolence/drowsiness have been reported. Uncommon
(0.1% to 1%), side effects such as exhaustion and abdominal pain have been
observed. Other side effects such as palpitations, 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, aggressive or agitated behaviour, insomnia, recurring
thoughts of or preoccupation with suicide, hepatitis, abnormal liver function,
increased appetite and nausea, have also been reported.
At the first signs of a hypersensitivity reaction, stop taking Xyzal 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 side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 XYZAL
Keep your tablets out of the reach and sight of children.
Do not use 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.
If the tablets become discoloured or show any signs of deterioration, you should seek
the advice of your pharmacist.
If your doctor tells you to stop taking this medicine, take any unused tablets back to
your pharmacist for safe disposal, only keep them if your doctor tells you to.

6. FURTHER INFORMATION
What Xyzal contains
Each film-coated tablet contains 5mg of levocetirizine dihydrochloride as the active
ingredient. It also contains microcrystalline cellulose, lactose monohydrate, colloidal
anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171),
and macrogol 400.
The tablets are white to off-white, oval and film-coated with a Y logo on one side.
They are supplied in blister packs of 30 tablets.
Manufactured by: UCB Pharma S.A., Via Praglia 15, 10044 Pianezza (TO), Italy.
Procured from within the EU and repackaged by the Product Licence Holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.
®

XYZAL 5MG FILM-COATED TABLETS
PL No: 18799/1824
Leaflet Revised: 06.07.2015
Xyzal is a registered trademark of UCB Pharma Limited

POM

PATIENT INFORMATION LEAFLET

LEVOCETIRIZINE DIHYDROCHLORIDE
5MG FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is levocetirizine dihydrochloride 5mg Film-Coated Tablets
but will be referred to as levocetirizine dihydrochloride tablets throughout this leaflet.
In this leaflet:
1. What Levocetirizine dihydrochloride is and what it is used for
2. Before you take Levocetirizine dihydrochloride
3. How to take Levocetirizine dihydrochloride
4. Possible side effects
5. How to store Levocetirizine dihydrochloride
6. Further information
1. WHAT LEVOCETIRIZINE DIHYDROCHLORIDE IS AND WHAT IT IS USED

FOR
Levocetirizine dihydrochloride is the active ingredient of Levocetirizine
dihydrochloride.
Levocetirizine dihydrochloride is an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
allergic rhinitis (including persistent allergic rhinitis);
nettle rash (urticaria).

2. BEFORE YOU TAKE LEVOCETIRIZINE DIHYDROCHLORIDE
Do not take Levocetirizine dihydrochloride
if you are allergic (hypersensitive) to levocetirizine dihydrochloride or to an
antihistamine or any of the other ingredients of Levocetirizine dihydrochloride (see
‘What Levocetirizine dihydrochloride contains’)
if you have a severe impairment of kidney function (severe renal failure with creatinine
clearance below 10 ml/min).

Take special care with Levocetirizine dihydrochloride
The use of Levocetirizine dihydrochloride is not recommended in children less than 6
years since the film-coated tablets do not allow for dose adaptation.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Taking Levocetirizine dihydrochloride with food and drink
Caution is advised if Levocetirizine dihydrochloride is taken at the same time as
alcohol.
In sensitive patients, the simultaneous use of cetirizine or levocetirizine and alcohol
or other centrally acting agents may have effects on the central nervous system,
although the racemate cetirizine has been shown not to increase the effect of alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant, trying to get pregnant or breast-feeding.
Driving and using machines
Some patients being treated with Levocetirizine dihydrochloride may experience
somnolence / drowsiness, tiredness and exhaustion. If you are intending to drive,
engage in potentially hazardous activities or use machines you are therefore advised
first to wait and observe your response to the medication. 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 Levocetirizine
dihydrochloride
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.

3. HOW TO TAKE LEVOCETIRIZINE DIHYDROCHLORIDE
Always take Levocetirizine dihydrochloride exactly as your doctor has told you. You
should check with your
doctor or pharmacist if you are not sure.
The usual dose for adults and children aged 6 years and over is one tablet daily.
Patients with impaired kidney function may be given a lower dose according to the
severity of their kidney disease.
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.
Levocetirizine dihydrochloride is not recommended for children under 6 years of age.

thoughts of or preoccupation with suicide, hepatitis, abnormal liver function,
increased appetite and nausea, have also been reported.

How and when should you take Levocetirizine dihydrochloride?
The tablets should be swallowed whole with water and may be taken with or without
food.

At the first signs of a hypersensitivity reaction, stop taking Levocetirizine
dihydrochloride 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.

If you take more Levocetirizine dihydrochloride than you should
A substantial overdose may cause somnolence in adults. Children may initially show
excitation and restlessness followed by somnolence.
If you think you have taken an overdose of Levocetirizine dihydrochloride, please tell
your doctor who will
then decide what action should be taken.

Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

If you forget to take Levocetirizine dihydrochloride
If you forget to take Levocetirizine dihydrochloride, 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 foreseen time for
intake of the next dose, and take a normal dose as prescribed by your doctor.
If you stop taking Levocetirizine dihydrochloride
Stopping the treatment with Levocetirizine dihydrochloride earlier than foreseen
should have no detrimental
effects, in the sense that the symptoms of the disease should just progressively
reappear with a severity not higher than the one experienced prior to treatment with
Levocetirizine dihydrochloride.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Levocetirizine dihydrochloride can cause side effects, although
not everybody gets them.
Commonly (1% to 10%), mainly mild to moderate side effects such as dry mouth,
headache, tiredness and somnolence/drowsiness have been reported. Uncommon
(0.1% to 1%), side effects such as exhaustion and abdominal pain have been
observed. Other side effects such as palpitations, 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, aggressive or agitated behaviour, insomnia, recurring

5. HOW TO STORE LEVOCETIRIZINE DIHYDROCHLORIDE
Keep your tablets out of the reach and sight of children.
Do not use 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.
If the tablets become discoloured or show any signs of deterioration, you should seek
the advice of your pharmacist.
If your doctor tells you to stop taking this medicine, take any unused tablets back to
your pharmacist for safe disposal, only keep them if your doctor tells you to.

6. FURTHER INFORMATION
What Levocetirizine dihydrochloride contains
Each film-coated tablet contains 5mg of levocetirizine dihydrochloride as the active
ingredient. It also contains microcrystalline cellulose, lactose monohydrate, colloidal
anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171),
and macrogol 400.
The tablets are white to off-white, oval and film-coated with a Y logo on one side.
They are supplied in blister packs of 30 tablets.
Manufactured by: UCB Pharma S.A., Via Praglia 15, 10044 Pianezza (TO), Italy.
Procured from within the EU and repackaged by the Product Licence Holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.
LEVOCETIRIZINE DIHYDROCHLORIDE 5MG FILM-COATED TABLETS
POM
PL No: 18799/1824
Leaflet Revised: 06.07.2015

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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.

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