CETIRIZINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance: CETIRIZINE HYDROCHLORIDE

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CETIRIZINE HYDROCHLORIDE
10 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER

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.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
You must talk to a doctor if you do not feel
better or if you feel worse.

Other medicines and Cetirizine
Talk to your doctor if you are taking any of
the following
• Sedatives e.g. nitrazepam, as their effects
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
• Do not take large amounts of alcohol
whilst taking Cetirizine, as this medicine
may increase the effects of alcohol.
Pregnancy and breast-feeding
If you are pregnant or are planning to
become pregnant, ask your doctor or
pharmacist for advice before taking this
medicine.
• Do not take Cetirizine, if you are
breast-feeding.

The name of this medicine is Cetirizine
Hydrochloride 10 mg Film-coated Tablets but
will be referred to as Cetirizine in the rest of Driving and using machines:
• When taken at the recommended dose,
the leaflet.
Cetirizine is not expected to affect your
IN THIS LEAFLET:
ability to drive or operate machinery.
However, there are exceptions and you
1. What Cetirizine is and what it is used for
should take care when using this
2. What you need to know before you take
medicine for the first time.
Cetirizine
• If this product makes you feel drowsy,
3. How to take Cetirizine
DO NOT drive or operate machinery. This
4. Possible side effects
effect will be worse if you are also taking
5. How to store Cetirizine
sedatives or drinking alcohol.
6. Contents of the pack and other
information
Cetirizine contains lactose
Patients who are intolerant to lactose should
1 WHAT CETIRIZINE IS AND WHAT IT note that Cetirizine contains a small amount
IS USED FOR
of lactose. If your doctor has told you that
you have an intolerance to some sugars,
• Cetirizine is an antihistamine.
contact your doctor before taking this
Antihistamines help to relieve the
medicinal product.
symptoms of some allergies.
• In adults and children 12 years and
3 HOW TO TAKE CETIRIZINE
above, Cetirizine is used
• to relieve the nasal symptoms of hay
Always take this medicine exactly as
fever, seasonal rhinitis (runny and itchy described in this leaflet or as your doctor or
nose)
pharmacist have told you. Check with your
• for skin allergies such as rash, itching
doctor or pharmacist if you are not sure.
and urticaria (hives).
Cetirizine should be swallowed whole with a
WHAT YOU NEED TO KNOW BEFORE drink of water.

2

YOU TAKE CETIRIZINE

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.
Allergy tests: If you are going to have an
allergy skin test, stop taking this medicine
3 days before the test.

The recommended dosage is given below:
• Adults and children 12 years and
over:
One tablet (10 mg) once daily.
• Children under 12 years of age:
Cetirizine is not recommended for
children under this age.

Patients with moderate kidney problems
should only take 5 mg (half a 10 mg tablet)
once daily.
Patients with severe kidney problems
should only take 5 mg (half a 10 mg tablet)
once every two days.
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,
If you take Cetirizine for a long time, there is headache, a general feeling of being unwell,
an increased risk of tooth decay due to
restlessness, feeling sleepy, a state of
mouth dryness. It is important to brush your semi-unconsciousness, faster heartbeat,
teeth regularly whilst taking Cetirizine.
shaking or problems urinating.
Children and adolescents
Please take this leaflet, any remaining
• Not recommended in children aged less
tablets and the container with you to the
than 12 years of age.
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.

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

5

HOW TO STORE CETIRIZINE

Keep this medicine out of the sight and
reach of children.

If you have any further questions on the use There are no special storage conditions.
of this medicine, ask your doctor or
Do not transfer to another container.
pharmacist.
Do not take Cetirizine after the expiry date
which is stated on the outer packaging. The
4 POSSIBLE SIDE EFFECTS
expiry date refers to the last day of that
month.
Like all medicines, this medicine can have
side effects, although not everybody gets
Do not take this medicine if you notice any
them.
defects or signs of deterioration in the
Stop taking the tablets and tell your doctor tablets such as broken tablets.
immediately or go to the casualty
Do not throw away any medicines via
department at your nearest hospital if the
wastewater or household waste. Ask your
following happens:
pharmacist how to throw away medicines
• a severe allergic reaction (swelling of the you no longer take. These measures will
face, lips, mouth or throat leading to
help protect the environment.
severe difficulty in breathing or
swallowing; skin rash or hives).
6 CONTENTS OF THE PACK AND
This is a very serious but rare side effect.
OTHER INFORMATION
You may need urgent medical attention or
What Cetirizine contains
hospitalisation.
• The active ingredient is cetirizine
The following side effects have been
dihydrochloride 10 mg.
reported at the approximate frequencies
• The other ingredients are microcrystalline
shown:
cellulose, lactose monohydrate, colloidal
Common (affecting fewer than one person
anhydrous silica, magnesium stearate
in 10 but more than one person in 100):
(E572), hypromellose (E464), macrogol,
• tiredness or sleepiness
titanium dioxide (E171) and polydextrose.
• dizziness or headache
What Cetirizine looks like and contents of
• nausea or diarrhoea
the pack
• dry mouth or difficulty in swallowing
• Cetirizine Tablets are white to off white,
accompanied by earache and swollen
capsule-shaped tablets, debossed with
glands, sore throat
C10 on one side and a deep breakline on
• runny and itchy nose.
the other.
Uncommon (affecting less than one person • The product is available in pack sizes of 7
in 100 but more than one person in 1,000):
and 14 tablets.
• agitation
Not all pack sizes may be marketed.
• abdominal pain
Marketing Authorisation Holder and
• lethargy or feeling weak and/or unwell
Manufacturer
• pins and needles
TEVA UK Limited, Eastbourne, BN22 9AG.
• skin itchiness or rashes.
Rare (affecting less than one person in 1,000 This leaflet was last revised: April 2012
but more than one person in 10,000):
PL 00289/0388 – GSL category
• rapid heartbeat
• water retention
• liver problems
• weight gain
• fits or unusual movements of your arms
and/or legs
• aggression or depression
• confusion
• hallucinations
• difficulty in sleeping
• red and/or blotchy skin rash
• abnormal liver function tests (diagnosed
by blood and/or urine tests).
Very rare (affecting less than one person in
10,000):
• 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.
Side effects with frequency not known
• Partial or total loss of memory.
50005-B
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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