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LEVOCETIRIZINE 5MG FILM-COATED TABLETS

Active substance(s): LEVOCETIRIZINE DIHYDROCHLORIDE

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SAME SIZE ARTWORK
SIZE: 170 mm x 320 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levocetirizine 5 mg 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. What Levocetirizine 5 mg film-coated tablets
are and what they are used for
2. Before you take Levocetirizine 5mg film-coated
tablets
3. How to take Levocetirizine 5 mg film-coated
tablets
4. Possible side effects
5. How to store Levocetirizine 5 mg film-coated
tablets
6. Further information

320 mm

1. WHAT LEVOCETIRIZINE 5 MG
FILM-COATED TABLETS ARE AND
WHAT THEY ARE USED FOR

Taking Levocetirizine 5 mg film-coated tablets
with food and drink
Levocetirizine should be swallowed with a drink
of water. It may be taken with or without food.
You should be careful if Levocetirizine is taken at
the same time as alcohol as the effects of alcohol
may be increased.
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
may experience drowsiness, tiredness and
exhaustion. If you are intending to drive, do some
potentially hazardous activity or use machines you
should not do so until you have found out how you
respond to the medication. However, tests have
shown no effects on mental alertness, the ability to
react or the ability to drive in healthy people after
taking levocetirizine in the recommended dosage.
Important information about some of the
ingredients of Levocetirizine 5 mg 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.

Levocetirizine is a type of medicine called a
non-sedating antihistamine. It is used to treat signs
of an allergic reaction such as:
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an itchy rash (similar to nettle rash) which lasts
3. HOW TO TAKE LEVOCETIRIZINE 5 MG
a long time (chronic idiopathic urticaria).
FILM-COATED TABLETS
2. BEFORE YOU TAKE LEVOCETIRIZINE
5 MG FILM-COATED TABLETS

Always take Levocetirizine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Do not take Levocetirizine 5 mg film-coated
The usual dose for adults and children aged 6 years
tablets
and over is one tablet daily (5mg). Children under
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if you are allergic (hypersensitive) to
6 years of age should not take this medicine.
levocetirizine dihydrochloride or to an
Patients whose kidneys do not work very well may
antihistamine or any of the other ingredients of
be given a lower dose according to the severity of
Levocetirizine (see 'What Levocetirizine 5 mg
their kidney disease.
film-coated tablets contains')
If your liver does not work very well you can still
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if your kidneys do not work well (severe renal
take the usual prescribed dose.
failure with creatinine clearance below
10 ml/min)
If both your liver and your kidneys do not
work very well, you may be given a lower dose
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if your doctor has told you that you have
depending on how well your kidneys work.
intolerance to some sugars. If this is the case,
contact your doctor before taking this medicine.
Levocetirizine is not recommended for infants and
toddlers under the age of 2 and should not be used
Take special care with Levocetirizine 5 mg
in children under 6 years of age.
film-coated tablets
For adults and children aged 6 years and over, the
The use of Levocetirizine is not recommended in
tablets should be swallowed with water.
infants and toddlers less than 2 years. The use of
Levocetirizine is not recommended in children
If you take more Levocetirizine 5 mg
aged less than 6 years since the currently available
film-coated tablets than you should
film-coated tablets do not allow appropriate dose
A large overdose may cause drowsiness in adults.
adaptation
Children may initially get excited and restless and
Taking other medicines
then become drowsy.
If you think you have taken an overdose of
Please tell your doctor or pharmacist if you
Levocetirizine, please tell your doctor who will
are taking or have recently taken any other
then decide what action should be taken.
medicines, including medicines obtained without a
prescription.

85 mm

Date: 11-04-2014
Version: 01 (UK)

SAME SIZE ARTWORK
SIZE: 170 mm x 320 mm

If you forget to take Levocetirizine 5 mg
film-coated tablets
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 it; just
wait for the time to take the next dose, and take a
normal dose as prescribed by your doctor.

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.

If you stop taking Levocetirizine 5 mg
film-coated tablets
Stopping the treatment with Levocetirizine earlier
than you thought should not have any harmful
effects, however, your illness may come back.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

6. FURTHER INFORMATION

320 mm

4. POSSIBLE SIDE EFFECTS

What Levocetirizine 5 mg film-coated tablets
contains
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The active substance is levocetirizine
dihydrochloride
Each film-coated tablet contains 5 mg
levocetirizine dihydrochloride.
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The other ingredients are microcrystalline
cellulose, lactose monohydrate, colloidal
anhydrous silica, magnesium stearate,
hypromellose (E464), titanium dioxide (E171),
and macrogol 400.

Like all medicines, Levocetirizine can cause side
effects, although not everybody gets them.
If you suffer from any of the following, stop
taking levocetirizine and tell your doctor
What Levocetirizine 5 mg film-coated tablets
immediately or go to your nearest hospital
looks like and contents of the pack
emergency department:
The 5mg film-coated tablets are white, oval, with
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Serious allergic reaction symptoms include
a G breakline G on one side and the other side is
swelling of the mouth, face and/or throat,
plain. The tablet can be divided into equal halves
breathing or swallowing difficulties, together
with hives, a sudden fall in blood pressure
The tablets are packed in either Aluminium/
leading to collapse or shock, which may be
Aluminium blisters or PVC / PVdC -Aluminium
fatal.
blisters
At the first signs of an allergic reaction, stop
Pack Sizes
taking levocetirizine and see your doctor
10, 20, 21, 28, 30, 50, 90 and 100*
straight away.
*Not all pack sizes may be marketed.
Common side effects (occur in less than 10 users
Marketing Authorisation Holder and
in 100)
Manufacturer
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dry mouth
headache
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited,
tiredness
Laxmi House, 2 B Draycott Avenue,
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drowsiness
Kenton, Middlesex HA3 0BU,
Uncommon side effects (occur in less than 10 users United Kingdom
in 1000)
Manufacturer
exhaustion
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Glenmark Pharmaceuticals s.r.o,
abdominal pain
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Fibíchova 143, 566 17 Vysoké Mýto,
Czech Republic
Very rare side effects (occur in less than 1 user in
l
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Tillomed Laboratories Ltd.
10,000):
3 Howard Road,Eaton Socon, St.Neots,
palpitations
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Cambridgeshire, PE19 8ET
convulsions
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United Kingdom
visual disturbances (such as blurred vision)
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oedema ( water retention causing swelling)
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Glenmark Pharmaceuticals Europe Limited.
Building 2, Croxley Green Business Park,
pruritus (itchiness)
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Croxley Green, Hertfordshire, WD18 8YA
rash and urticaria or eruption (swelling, or
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United Kingdom
outbreak, redness and itchiness of the skin)
shortness of breath
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This leaflet was last approved in 04/2014.
weight gain
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muscular pain
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aggressive or agitated behaviour
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hepatitis or liver problems (the skin or whites of
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the eyes may become yellow)
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nausea
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 LEVOCETIRIZINE
5 MG FILM-COATED TABLETS
Keep out of the reach and sight of children.
Do not use Levocetirizine after the expiry date
which is stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.

85 mm

Date: 11-04-2014
Version: 01 (UK)

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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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