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CETIRIZINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance: CETIRIZINE HYDROCHLORIDE

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TEVA UK Ref:

Version:

231-30-50005-C LEA CETIRIZINE 10mg TAB TUK (GSL)

1

02 October 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

Patient Information Leaflet

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
Always take this medicine exactly as
described in this leaflet or as your doctor or
pharmacist have told you.
again.
information or advice.

Children and adolescents
than 12 years of age.
Other medicines and Cetirizine
Talk to your doctor if you are taking any of
the following
may be increased by Cetirizine.
Due to the profile of cetirizine, no
interactions with other drugs are expected.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Cetirizine with food, drink and alcohol

symptoms worsen or do not improve.
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist. This includes any side effects

whilst taking Cetirizine, as this medicine
may increase the effects of alcohol.

Pregnancy, breast-feeding and fertility
If you are pregnant or are planning to
become pregnant, ask your doctor or
pharmacist for advice before taking this
The name of this medicine is Cetirizine
Hydrochloride 10 mg Film-coated Tablets but medicine.
will be referred to as Cetirizine in the rest of
breast-feeding.
the leaflet.
Driving and using machines:
1. What Cetirizine is and what it is used for
2. What you need to know before you take
Cetirizine
3. How to take Cetirizine
4. Possible side effects
5. How to store Cetirizine
6. Contents of the pack and other
information

1

WHAT CETIRIZINE IS AND WHAT IT
IS USED FOR

Antihistamines help to relieve the
symptoms of some allergies.
above, Cetirizine is used

DO NOT drive or operate machinery. This
effect will be worse if you are also taking
sedatives or drinking alcohol.
Cetirizine contains lactose
Patients who are intolerant to lactose should
note that Cetirizine contains a small amount
of lactose. If your doctor has told you that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3

nose)
allergies e.g. pet or house dust mite
allergies

2

Cetirizine is not expected to affect your
ability to drive or operate machinery.
However, there are exceptions and you
should take care when using this
medicine for the first time.

HOW TO TAKE CETIRIZINE

Always take this medicine exactly as
described in this leaflet or as your doctor or
pharmacist have told you. Check with your
doctor or pharmacist if you are not sure.
Cetirizine should be swallowed whole with a
drink of water.

WHAT YOU NEED TO KNOW BEFORE
The recommended dosage is given below:
YOU TAKE CETIRIZINE
Adults and children 12 years and
over:

Do not take Cetirizine if you:
e.g. hydroxyzine, cyclizine, meclozine or to
any of the other ingredients of this
problems

Children under 12 years of age:
Cetirizine is not recommended for
children under this age.
Patients with moderate kidney problems

Lapp lactase deficiency or
glucose-galactose malabsorption.

once daily.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Cetirizine if you:

Patients with severe kidney problems
once every two days.
If you take more Cetirizine than you should

need to be adjusted

Allergy tests: If you are going to have an
allergy skin test, stop taking this medicine

tablets all together or if you think a child has
accidentally swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.

The effects of an overdose may cause
confusion, diarrhoea, dizziness, tiredness,
headache, a general feeling of being unwell,
If you take Cetirizine for a long time, there is
restlessness, feeling sleepy, a state of
an increased risk of tooth decay due to
semi-unconsciousness, faster heartbeat,
mouth dryness. It is important to brush your
shaking or problems urinating.
teeth regularly whilst taking Cetirizine.

REG0064246

Version 1.5

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CETIRIZINE HYDROCHLORIDE
10 mg FILM-COATED TABLETS

TEVA UK Ref:

Version:

231-30-50005-C LEA CETIRIZINE 10mg TAB TUK (GSL)

1

02 October 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Please take this leaflet, any remaining
tablets and the container with you to the
hospital or doctor so that they know which
tablets were consumed.
If you forget to take Cetirizine
If you forget to take a tablet, take one as
soon as you remember, unless it is nearly
time to take the next one. Do not take a
double dose to make up for a forgotten
tablet or dose. Take the remaining doses at
the correct time.

the face

Side effects with frequency not known
memory impairment

If you have any further questions on the use
In very rare cases people have thoughts
of this medicine, ask your doctor or
about committing suicide and if you feel this
pharmacist.
way then stop taking these tablets and see
your doctor.
4 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can have
side effects, although not everybody gets
them.

If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

Stop taking the tablets and tell your doctor
immediately or go to the casualty
department at your nearest hospital if the
following happens:

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

face, lips, mouth or throat leading to
severe difficulty in breathing or
swallowing; skin rash or hives).
This is a very serious but rare side effect.
You may need urgent medical attention or
hospitalisation.

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 CETIRIZINE

The below side effect has been reported
Keep this medicine out of sight and reach of
with Cetirizine. Tell your doctor if you notice
children.
the following:
There are no special storage conditions.
Do not transfer to another container.
by blood and/or urine tests).
The following side effects have been
reported at the approximate frequencies
shown:
Common
in 10 but more than one person in 100):

accompanied by earache and swollen
glands, sore throat
Uncommon
in 100 but more than one person in 1,000):

Do not take Cetirizine after the expiry date
which is stated on the outer packaging. The
expiry date refers to the last day of that
month.
Do not take this medicine if you notice any
defects or signs of deterioration in the
tablets such as broken tablets.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer take. These measures will
help protect the environment.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Cetirizine contains
dihydrochloride 10 mg.
Rare
but more than one person in 10,000):

cellulose, lactose monohydrate, colloidal
anhydrous silica, magnesium stearate

What Cetirizine looks like and contents of
the pack
and/or legs

Very rare
10,000):

capsule-shaped tablets, debossed with
C10 on one side and a deep breakline on
the other.

Marketing Authorisation Holder and
Manufacturer

indicate problems with your blood)
focusing and blurred vision

This leaflet was last revised: 08/2014

50005-C

REG0064246

Version 1.5

Approved

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
m
-tablets-GSL-status

APPROVALS
Signed by
Divya Jain

REG0064246

Meaning of Signature
Regulatory Affairs Approval

Version 1.5

Approved

Server Date
30-Oct-2014 12:03:48 PM

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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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