XYZAL 5MG FILM-COATED TABLETS

Active substance: LEVOCETIRIZINE DIHYDROCHLORIDE

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Variation 6 - To update the manufacturers name.
This version replaces PIL dated 2/10/2009,
assessed against UK PIL dated 7/4/2009.
A Chohan. 18 October 2011
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Xyzal 5mg film-coated tablets are and what they are
used for
Before you take Xyzal 5mg film-coated tablets
How to take Xyzal 5mg film-coated tablets
Possible side effects
How to store Xyzal 5mg film-coated tablets
Further information

1. What Xyzal 5mg film-coated tablets are
and what they are used for
Antihistamine for systemic use.
For the treatment of signs of illness (symptoms) associated with:
allergic rhinitis (including persistent allergic rhinitis);
chronic nettle rash of unknown origin (chronic idiopathic
urticaria).

2. Before you take Xyzal 5mg film-coated
tablets
Do not take Xyzal 5mg film-coated tablets

if you are allergic (hypersensitive) to levocetirizine
dihydrochloride or to an antihistamine or any of the other
ingredients of Xyzal 5mg film-coated tablets (see ‘What Xyzal
5mg film-coated tablets contains’)
if you have a severe impairment of kidney function (severe
renal failure with creatinine clearance below 10ml/min).

Take special care with Xyzal 5mg film-coated
tablets

The use of Xyzal 5mg film-coated tablets is not recommended in
children less than 6 years since the film-coated tablets do not
allow for dose adaptation.

Taking Xyzal 5mg film-coated tablets with food and
drink

Caution is advised if Xyzal 5mg film-coated tablets 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

If you take more Xyzal 5mg film-coated tablets 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 5mg film-coated
tablets, please tell your doctor who will then decide what action
should be taken.

If you forget to take Xyzal 5mg film-coated tablets

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.

If you forget to take Xyzal 5mg film-coated tablets, 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.

Driving and using machines

If you stop taking Xyzal 5mg film-coated tablets

Some patients being treated with Xyzal 5mg film-coated tablets
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 5mg film-coated tablets

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 5mg film-coated tablets
Always take Xyzal 5mg film-coated tablets 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 5mg film-coated tablets is not recommended for children
under 6 years of age.

How and when should you take Xyzal 5mg filmcoated tablets?

The tablets should be swallowed whole with water and may be
taken with or without food.

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.
Page 1 of 2

Stopping the treatment with Xyzal 5mg film-coated tablets 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 5mg film-coated tablets.
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 5mg film-coated tablets 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, convulsions, visual disturbances,
oedema, pruritis (itchiness), rash, urticaria (swelling, redness and
itchiness of the skin), shortness of breath, weight increase,
muscular pain, aggressive or agitated behaviour, hepatitis,
abnormal liver function and nausea, have also been reported.
At the first signs of a hypersensitivity reaction, stop taking Xyzal
5mg film-coated tablets 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 (angiodema), sudden fall in blood
pressure leading to collapse or shock, which may be fatal.
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.

5. How to store Xyzal 5mg film-coated
tablets
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF
CHILDREN.

Expiry Date:

Do not use after the expiry date printed on the carton or blister
strip. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage
conditions.

Important:

If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to. If the tablets become
discoloured or show signs of deterioration, you should seek the
advice of your pharmacist.

6. Further information
What Xyzal 5mg film-coated tablets contain

Each tablet contains 5mg of levocetirizine dihydrochloride together
with microcrystalline cellulose, lactose monohydrate, colloidal
anhydrous silica, magnesium stearate, hypromellose (E464),
titanium dioxide (E171), and macrogol 400.

What Xyzal 5mg film-coated tablets look like and
the contents of the pack

The tablets are small, white, oval and film-coated with a Y logo on
one side. They are supplied in blister packs of 30 tablets. Your
medicine belongs to the antihistamine group of drugs.

Manufacturer:

Manufactured by: UCB Pharma S.p.A., Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX
PL No: 21828/0112

POM

XYZAL® is a registered trademark of UCB FARCHIM S.A. Z.I.
Planchy Chemin de Croix-Blanche, 10 C. P. 411, Bulle,
Switzerland, 1630
Leaflet revision date: 17.10.11

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Xyzal 5mg film-coated tablets are and what they are
used for
Before you take Xyzal 5mg film-coated tablets
How to take Xyzal 5mg film-coated tablets
Possible side effects
How to store Xyzal 5mg film-coated tablets
Further information

1. What Xyzal 5mg film-coated tablets are
and what they are used for
Antihistamine for systemic use.
For the treatment of signs of illness (symptoms) associated with:
allergic rhinitis (including persistent allergic rhinitis);
chronic nettle rash of unknown origin (chronic idiopathic
urticaria).

2. Before you take Xyzal 5mg film-coated
tablets
Do not take Xyzal 5mg film-coated tablets

if you are allergic (hypersensitive) to levocetirizine
dihydrochloride or to an antihistamine or any of the other
ingredients of Xyzal 5mg film-coated tablets (see ‘What Xyzal
5mg film-coated tablets contains’)
if you have a severe impairment of kidney function (severe
renal failure with creatinine clearance below 10ml/min).

Take special care with Xyzal 5mg film-coated
tablets

The use of Xyzal 5mg film-coated tablets is not recommended in
children less than 6 years since the film-coated tablets do not
allow for dose adaptation.

Taking Xyzal 5mg film-coated tablets with food and
drink

Caution is advised if Xyzal 5mg film-coated tablets 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

If you take more Xyzal 5mg film-coated tablets 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 5mg film-coated
tablets, please tell your doctor who will then decide what action
should be taken.

If you forget to take Xyzal 5mg film-coated tablets

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.

If you forget to take Xyzal 5mg film-coated tablets, 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.

Driving and using machines

If you stop taking Xyzal 5mg film-coated tablets

Some patients being treated with Xyzal 5mg film-coated tablets
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 5mg film-coated tablets

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 5mg film-coated tablets
Always take Xyzal 5mg film-coated tablets 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 5mg film-coated tablets is not recommended for children
under 6 years of age.

How and when should you take Xyzal 5mg filmcoated tablets?

The tablets should be swallowed whole with water and may be
taken with or without food.

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.
Page 1 of 2

Stopping the treatment with Xyzal 5mg film-coated tablets 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 5mg film-coated tablets.
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 5mg film-coated tablets 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, convulsions, visual disturbances,
oedema, pruritis (itchiness), rash, urticaria (swelling, redness and
itchiness of the skin), shortness of breath, weight increase,
muscular pain, aggressive or agitated behaviour, hepatitis,
abnormal liver function and nausea, have also been reported.
At the first signs of a hypersensitivity reaction, stop taking Xyzal
5mg film-coated tablets 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 (angiodema), sudden fall in blood
pressure leading to collapse or shock, which may be fatal.
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.

5. How to store Xyzal 5mg film-coated
tablets
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF
CHILDREN.

Expiry Date:

Do not use after the expiry date printed on the carton or blister
strip. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage
conditions.

Important:

If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to. If the tablets become
discoloured or show signs of deterioration, you should seek the
advice of your pharmacist.

6. Further information
What Xyzal 5mg film-coated tablets contain

Each tablet contains 5mg of levocetirizine dihydrochloride together
with microcrystalline cellulose, lactose monohydrate, colloidal
anhydrous silica, magnesium stearate, hypromellose (E464),
titanium dioxide (E171), and macrogol 400.

What Xyzal 5mg film-coated tablets look like and
the contents of the pack

The tablets are small, white, oval and film-coated with a Y logo on
one side. They are supplied in blister packs of 30 tablets. Your
medicine belongs to the antihistamine group of drugs.

Manufacturer:

Manufactured by: UCB Pharma S.p.A., Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX
PL No: 21828/0112

POM

XYZAL® is a registered trademark of UCB FARCHIM S.A. Z.I.
Planchy Chemin de Croix-Blanche, 10 C. P. 411, Bulle,
Switzerland, 1630
Leaflet revision date: 17.10.11

Page 2 of 2

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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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