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CETIRIZINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE HYDROCHLORIDE

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TEVA UK Ref:

Version:

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

3

17 November 2015

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.
- Keep this leaflet. You may need to read it
again.
- Ask your pharmacist if you need more
information or advice.
- You must contact a doctor if your
symptoms worsen or do not improve.
- If you get any side effects talk to your
doctor or pharmacist. This includes any
side effects not listed in the leaflet. See
section 4.

Children and adolescents
• Not recommended in children aged less
than 6 years of age.
Other medicines and Cetirizine
Due to the profile of cetirizine, no
interactions with other drugs are expected.
Please tell your doctor or pharmacist if you
are taking, have recently taken or might take
any other medicines.
Cetirizine with food, drink and alcohol
• Do not take large amounts of alcohol
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 or are breast-feeding, ask
your doctor or pharmacist for advice before
taking this medicine.

Pharma code 319

Driving and using machines:
• When taken at the recommended dose,
The name of this medicine is Cetirizine
Cetirizine is not expected to affect your
Hydrochloride 10 mg Film-coated Tablets but
ability to drive or operate machinery.
will be referred to as Cetirizine in the rest of
However, there are exceptions and you
the leaflet.
should take care when using this
medicine for the first time.
What is in this leaflet
• If this product makes you feel drowsy,
1. What Cetirizine is and what it is used for
DO NOT drive or operate machinery. This
2. What you need to know before you take
effect will be worse if you are also taking
Cetirizine
sedatives or drinking alcohol.
3. How to take Cetirizine
Cetirizine contains lactose
4. Possible side effects
Patients who are intolerant to lactose should
5. How to store Cetirizine
note that Cetirizine contains a small amount
6. Contents of the pack and other
of lactose. If your doctor has told you that
information
you have an intolerance to some sugars,
contact your doctor before taking this
1 WHAT CETIRIZINE IS AND WHAT IT medicinal product.

IS USED FOR

• Cetirizine is an antihistamine.
Antihistamines help to relieve the
symptoms of some allergies.
• In adults and children 6 years and above,
Cetirizine is used
• to relieve the nasal symptoms of hay
fever, seasonal rhinitis (runny and itchy
nose)
• to relieve the symptoms of other
allergies e.g. pet or house dust mite
allergies.
• for skin allergies such as rash, itching
and urticaria (hives).

2

3

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 with a drink
of water.
The recommended dosage is given below:
• Adults and adolescents aged
12 years and over:
One tablet (10 mg) once daily.
• Children aged from 6 to 12 years:

Half a tablet (5 mg) twice daily.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CETIRIZINE
• Children under 6 years of age:

Do not take Cetirizine if you:
• Are allergic to cetirizine or similar products
e.g. hydroxyzine, cyclizine, meclozine or to
any of the other ingredients of this
medicine (listed in section 6).
• Are undergoing dialysis for kidney
problems
• Have a hereditary galactose intolerance,
Lapp lactase deficiency or
glucose-galactose malabsorption
Warnings and precautions
Talk to your doctor or pharmacist before
taking Cetirizine if you:
• Have liver problems
• Have kidney problems, as the dose may
need to be adjusted.
• Are epileptic or at risk of convulsions
• Have urinary retention problems.
Allergy tests: If you are going to have an
allergy skin test, stop taking this medicine
3 days before the test.

Cetirizine is not recommended for
children under this age.
If you have kidney problems, you should
talk to your doctor or pharmacist for advice
before taking these tablets, as a lower dose
may be required.
If you take more Cetirizine than you should
If you (or someone else) swallow a lot of the
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,
restlessness, feeling sleepy, a state of
semi-unconsciousness, faster heartbeat,
shaking or problems urinating.

Please take this leaflet, any remaining
tablets and the container with you to the
hospital or doctor so that they know which
If you take Cetirizine for a long time, there is
tablets were consumed.
an increased risk of tooth decay due to
mouth dryness. It is important to brush your
teeth regularly whilst taking Cetirizine.

REG0064246

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CETIRIZINE HYDROCHLORIDE
10 mg FILM-COATED TABLETS

TEVA UK Ref:

Version:

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

3

17 November 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.

Not known (frequency cannot be estimated
from the available data):
• Amnesia – partial or total loss of memory,
memory impairment
• Increased appetite
• Vertigo
• Urinary retention.

If you have any further questions on the use Reporting of side effects
If you get any side effects, talk to your
of this medicine, ask your doctor or
doctor, pharmacist or nurse. This includes
pharmacist.
any possible side effects not listed in this
leaflet. You can also report side effects
4 POSSIBLE SIDE EFFECTS
directly via the Yellow Card Scheme at:
Like all medicines, this medicine can have
www.mhra.gov.uk/yellowcard
side effects, although not everybody gets
By reporting side effects you can help
them.
provide more information on the safety of
Stop taking the tablets and tell your doctor this medicine.
immediately or go to the casualty
department at your nearest hospital if the
5 HOW TO STORE CETIRIZINE
following happens:
Keep this medicine out of sight and reach of
• a severe allergic reaction (swelling of the
children.
face, lips, mouth or throat leading to
There are no special storage conditions.
severe difficulty in breathing or
Do not transfer to another container.
swallowing; skin rash or hives).
This is a very serious but rare side effect.
You may need urgent medical attention or
hospitalisation.

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.

In very rare cases people have thoughts
about committing suicide and if you feel this Do not take this medicine if you notice any
defects or signs of deterioration in the
way then stop taking these tablets and see
tablets such as broken tablets.
your doctor.
Do not throw away any medicines via
The following side effects have been
wastewater or household waste. Ask your
reported at the approximate frequencies
pharmacist how to throw away medicines
shown:
you no longer take. These measures will
Common (may affect up to 1 in 10 people):
help protect the environment.
• tiredness or sleepiness
• dizziness or headache
OF THE PACK AND
• nausea or diarrhoea
6 CONTENTS
OTHER INFORMATION
• dry mouth or difficulty in swallowing
accompanied by earache and swollen
What Cetirizine contain
glands, sore throat
• The active ingredient is cetirizine
• runny and itchy nose.
dihydrochloride 10 mg (also known as
cetirizine hydrochloride).
Uncommon (may affect up to 1 in 100
• The other ingredients are microcrystalline
people):
cellulose, lactose monohydrate, colloidal
• agitation
anhydrous silica, magnesium stearate
• abdominal pain
(E572), hypromellose (E464), macrogol,
• lethargy or feeling weak and/or unwell
titanium dioxide (E171) and polydextrose.
• pins and needles
• skin itchiness or rashes.
What Cetirizine look like and contents of the
pack
Rare (may affect up to 1 in 1,000 people):
• Cetirizine Tablets are white to off white,
• rapid heartbeat
capsule-shaped tablets, debossed with
• water retention
C10 on one side and a deep breakline on
• liver problems (diagnosed by blood
the other.
and/or urine tests)
• The product is available in pack sizes of 7,
• weight gain
14, 15, 20, 28 and 30 tablets.
• fits or unusual movements of your arms
Not all pack sizes may be marketed.
and/or legs
• aggression or depression
Marketing Authorisation Holder and
• confusion
Manufacturer
• hallucinations
TEVA UK Limited, Eastbourne, BN22 9AG.
• difficulty in sleeping
This leaflet was last revised:
• red and/or blotchy skin rash.
November 2015
Very rare (may affect up to 1 in 10,000
PL 00289/0388
people):
• bleeding and bruising easily (could
indicate problems with your blood)
• sight problems including difficulty
focusing and blurred vision
• unusual movements of the eyeball
• fainting
• decreased sense of taste
• bed wetting
• pain in passing water
• inflammatory skin eruption
• unusual movements or contractions in
the face
• abnormal muscle rigidity or movements
• shaking.

50005-D
160 x 323

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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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