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LEVOCETIRIZINE DIHYDROCHLORIDE 5MG FILM-COATED TABLETS

Active substance(s): LEVOCETIRIZINE DIHYDROCHLORIDE

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Package leaflet: Information for the patients

Xyzal® 5mg film-coated 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.
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. 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
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).

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 Xyzal and alcohol or other agents
acting on the brain may cause additional reductions in alertness and impairment of
performance.
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 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.
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.
3. HOW TO TAKE XYZAL
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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL
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
10ml/min)

Patients who have severe impairment of kidney function must not take Xyzal.

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

Elderly patients aged 65 years and above
No adaptation of the dose is necessary in elderly patients, provided their renal function is
normal.

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.
Children
The use of Xyzal is not recommended in children less than 6 years since the filmcoated tablets do not allow for dose adaptation.
Other medicines and Xyzal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines

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.

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
food.

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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets
them.

5. HOW TO STORE XYZAL
Keep out of the sight and reach of children.
Do not take the tablets after the expiry date which is stated on the carton and blister
labels 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, seek the advice
of your pharmacist.
Remember if your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor
tells you to.
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 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.
What Xyzal looks like and contents of the pack
The tablets are white to off-white, oval and film-coated with a Y logo on one side.

Common: may affect up to 1 in 10 people
Dry mouth, headache, tiredness and somnolence/drowsiness

They are supplied in blister packs of 30 tablets.

Uncommon: may affect up to 1 in 100 people
Exhaustion and abdominal pain

Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,UK.

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.

Xyzal 5mg film-coated tablets; PL 18799/1824

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, 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.

Manufactured by: UCB Pharma S.A., Via Praglia 15, 10044 Pianezza (TO), Italy.

®

Leaflet date: 21.09.2016
Xyzal is a registered trademark of UCB Pharma Limited.

POM

Package leaflet: Information for the patients

Levocetirizine dihydrochloride
5mg film-coated tablets
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.
The name of your medicine is Levocetirizine dihydrochloride 5mg film-coated tablets but
will be referred to as Levocetirizine throughout this leaflet.
In this leaflet:
1. What Levocetirizine is and what it is used for
2. What you need to know before you take Levocetirizine
3. How to take Levocetirizine
4. Possible side effects
5. How to store Levocetirizine
6. Contents of the pack and other information
1. WHAT LEVOCETIRIZINE IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of Levocetirizine.
Levocetirizine is an antiallergic medication.
For the 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 LEVOCETIRIZINE
Do not take Levocetirizine
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
10ml/min)
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine.
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.
Children
The use of Levocetirizine is not recommended in children less than 6 years since the
film-coated tablets do not allow for dose adaptation.
Other medicines and Levocetirizine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines

Levocetirizine with food, drink and alcohol
Caution is advised if Levocetirizine is taken at the same time as alcohol or other agents
acting on the brain.
In sensitive patients, the concurrent administration of Levocetirizine and alcohol or other
agents acting on the brain may cause additional reductions in alertness and impairment
of performance.
Levocetirizine 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 Levocetirizine may experience somnolence /
drowsiness, tiredness and exhaustion. Use caution when driving or operating machinary
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.
Levocetirizine 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.
3. HOW TO TAKE LEVOCETIRIZINE
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 Levocetirizine.
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
Levocetirizine is not recommended for children under 6 years of age.
How and when should you take Levocetirizine?
For oral use only.
Levocetirizine tablets should be swallowed whole with water and may be taken with or
without food.

How long should you take Levocetirizine?
The duration of use depends on the type, duration and course of your complaints and is
determined by your physician.
If you take more Levocetirizine than you should
If you take more Levocetirizine 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 Levocetirizine, please tell your doctor who
will then decide what action should be taken.
If you forget to take Levocetirizine
If you forget to take Levocetirizine, 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 Levocetirizine
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets
them.

5. HOW TO STORE LEVOCETIRIZINE
Keep out of the sight and reach of children.
Do not take the tablets after the expiry date which is stated on the carton and blister
labels 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, seek the advice
of your pharmacist.
Remember if your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor
tells you to.
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 Levocetirizine 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.
What Levocetirizine looks like and contents of the pack
The tablets are white to off-white, oval and film-coated with a Y logo on one side.

Common: may affect up to 1 in 10 people
Dry mouth, headache, tiredness and somnolence/drowsiness

They are supplied in blister packs of 30 tablets.

Uncommon: may affect up to 1 in 100 people
Exhaustion and abdominal pain

Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

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.

Levocetirizine dihydrochloride 5mg film-coated tablets; PL 18799/1824

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

Manufactured by: UCB Pharma S.A., Via Praglia 15, 10044 Pianezza (TO), Italy.

Leaflet date: 21.09.2016

POM

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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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