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CETIRIZINE 10 MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE

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TEVA UK Ref:

231-30-51069-A.LEA CETIRIZINE 10mg FC TAB TUK
Cetirizine 10 mg Film-coated
Tablets
cetirizine dihydrochloride
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 has 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. See section 4.
• You must talk to a doctor if you do not
feel better or if you feel worse after 3
days.
What is in this leaflet:

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

Cetirizine dihydrochloride is the active
ingredient of Cetirizine 10 mg
Film-coated Tablets. Cetirizine is an
antiallergic medication.
In adults and children aged 6 years and
above, Cetirizine is indicated
• for the relief of nasal and ocular
symptoms of seasonal and perennial
allergic rhinitis
• for the relief of urticaria.
You must talk to a doctor if you do not
feel better or if you feel worse after 3
days.

2

Version:

5

12 December 2014

Due to the profile of cetirizine, no
interactions with other drugs are
expected.
Taking Cetirizine with food
Food does not noticeably affect the
absorption of cetirizine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.
As with other drugs, use of Cetirizine
should be avoided in pregnant women.
Accidental use of the drug by a
pregnant woman should not produce
any harmful effects on the foetus.
Nevertheless, the administration of the
medicine should be discontinued.
You should not take Cetirizine during
breast-feeding because cetirizine passes
into breast milk.
Driving and using machines
Clinical studies have produced no
evidence of impaired attention,
alertness and driving capabilities after
taking Cetirizine at the recommended
dose.
If you are intending to drive, engage in
potentially hazardous activities or
operate machinery, you should not
exceed the recommended dose. You
should closely observe your response to
the drug.
If you are a sensitive patient, you may
find that the simultaneous use of
alcohol or other nervous depressant
agents may additionally affect your
attention and ability to react.
Cetirizine contains lactose
If you have been told by your doctor
that you have an intolerance to some
sugars, please contact your doctor
before taking this medicinal product.

3

How to take Cetirizine

Always take this medicine exactly as

What you need to know before your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you take Cetirizine

Do not take CETIRIZINE
• if you are allergic (hypersensitive) to
the active substance of Cetirizine or
any of the other ingredients of
Cetirizine (listed in section 6), to
hydroxyzine or to piperazine
derivatives (closely related active
substances of other medicines)
• if you have a severe kidney disease
(severe renal failure with creatinine
clearance below 10 ml/min).
Warnings and precautions
If you are a patient with renal
insufficiency, please ask your doctor for
advice; if necessary, you will take a
lower dose. The new dose will be
determined by your doctor.

you are not sure.

How and when should you 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.
These guidelines apply unless your
doctor has given you different
instructions on how to use Cetirizine.
Please follow these instructions;
otherwise Cetirizine may not be fully
effective.
Tablets need to be swallowed with a
glass of liquid.

If you have problems passing urine (like Adults and adolescents above 12 years
spinal cord problems or prostate or
old
bladder problems), please ask your
10 mg once daily as 1 tablet.
doctor for advice.
Children between 6 and 12 years old
If you are an epileptic patient or a
5 mg twice daily as a half tablet twice
patient at risk of convulsions, you
daily.
should ask your doctor for advice.
Patients with moderate renal
If you are going to have an allergy skin impairment
test please tell your doctor that you
Patients with moderate renal
currently take Cetirizine. Usually you
impairment are recommended to take
will need to stop taking any medicines
5 mg once daily.
for a period of 3 days before the allergy
skin test.
If you suffer from severe kidney disease,
please contact your doctor or
No clinically significant interactions
pharmacist who may adjust the dose
have been observed between alcohol (at accordingly.
the blood level of 0.5 per mille (g/l)
corresponding to one glass of wine) and If your child suffers from kidney disease,
cetirizine used at the recommended
please contact your doctor or
doses. However, there are no data
pharmacist who may adjust the dose
available on the safety when higher
according to your child’s needs.
doses of cetirizine and alcohol are taken
together. Therefore, as it is the case with The tablet can be divided into equal
all antihistamines, it is recommended to doses.
avoid taking Cetirizine with alcohol.
Other medicines and Cetirizine
Tell your doctor or pharmacist if you are
taking/using or have recently taken/used
or might take/use any other medicines.

TEVA UK Ref:

231-30-51069-A.LEA CETIRIZINE 10mg FC TAB TUK
Directions for use
If your treatment with Cetirizine
stipulates that you have to split tablets,
you should ideally do so as follows.
Place the tablet on a hard, flat surface
(such as a table top or plate) with the
score line facing upwards. Then press
with both of your index fingers (or
thumbs) at the same time briefly and
firmly on the outer edges to the left and
right of the score line as shown in the
graphical representation below.

If you feel that the effect of Cetirizine is
too weak or too strong, please consult
your doctor.
Duration of treatment
The duration of treatment depends on
the type, duration and course of your
complaints and is determined by your
doctor.
If you take more CETIRIZINE than you
should
If you think you have taken an overdose
of Cetirizine please inform your doctor.

Version:

5

12 December 2014

• paresthesia (abnormal feelings of the
skin)
• agitation
• pruritus (itchy skin), rash.
rare (may affect up to 1 in 1,000 people):
• tachycardia (heart beating too fast)
• oedema (swelling)
• liver function abnormal
• weight increased
• aggression, confusion, depression,
hallucination, insomnia
• urticaria (hives).
very rare (may affect up to 1 in 10,000
people):
• accommodation disorder (difficulty
focusing), blurred vision,
oculogyration (eyes having
uncontrolled circular movements)
• syncope, tremor, dysgeusia (altered
taste)
• tic (habit spasm)
• abnormal elimination of urine (bed
wetting, pain and/or difficulty passing
water)
• fixed drug eruption.
not known (frequency cannot be
estimated from the available data):
• amnesia, memory impairment
• increased appetite
• vertigo (sensation of rotation or
movement)
• urinary retention (inability to
completely empty the urinary
bladder).

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
After an overdose, the side effects
listed in this leaflet. You can also report
described below may occur with
side effects directly via the Yellow Card
increased intensity. Adverse effects such Scheme at:
as confusion, diarrhoea, dizziness,
www.mhra.gov.uk/yellowcard.
tiredness, headache, ailing, dilating of
By reporting side effects you can help
pupils, itching, restlessness, sedation,
provide more information on the safety
somnolence, stupor, abnormal rapid
of this medicine.
heart rate, tremors and urinary retention
have been reported.
How to store Cetirizine
Your doctor will then decide what
measures, if any, should be taken.

5

If you forget to take CETIRIZINE
Do not take a double dose to make up
for a forgotten dose.

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

If you stop taking Cetirizine
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Do not use this medicine after the expiry
date which is stated on the box and
blister after EXP. The expiry date refers
to the last day of that month.

4

Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
The side effects listed in this section
have been reported in post marketing
experience.

This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

Contents of the pack and other

6 information
• angioedema (serious allergic reaction
which causes swelling of the face or
throat)
What CETIRIZINE contains
• allergic reactions (causing symptoms The active substance is cetirizine
such as wheezing, difficulty breathing, dihydrochloride.
rash, hives).
One film-coated tablet contains 10 mg
At the first signs of a hypersensitive
cetirizine dihydrochloride.
reaction, stop taking Cetirizine. Your
doctor will then assess the severity and The other ingredients are lactose
decide on any further measures that
monohydrate, microcrystalline
may be necessary.
cellulose, colloidal silica, magnesium
stearate, titanium dioxide (E171),
Tell your doctor immediately if you get
hypromellose (E464) and macrogol.
any of these symptoms:
• thrombocytopenia (low levels of
What CETIRIZINE looks like and
blood platelets causing symptoms
contents of the pack
such as bleeding, bruises, blotches or The film-coated tablet is white to almost
red spots on the skin)
white, round, biconvex with a break-line
• dyskinesia (involuntary movements)
on one side and is approximately 6.5 mm
• dystonia (abnormal prolonged
in diameter.
muscular contractions
The tablet can be divided into equal
• convulsions
doses.
• suicidal ideation (recurring thoughts
PVC//PVDC/alu blisters.
of, or preoccupation with suicide).
Blister with 7, 14, 15, 20, 28, 30, 50 and
100 tablets.
Other side effects:
Not all pack sizes may be marketed.
common (may affect up to 1 in 10
people):
• fatigue
• dry mouth, nausea, diarrhoea
• dizziness, headache
• somnolence (sleepiness)
• pharyngitis, rhinitis (in children).

Marketing Authorisation Holder
Teva UK Limited, Eastbourne,
BN22 9AG, UK

uncommon (may affect up to 1 in 100
people):
• abdominal pain
• asthenia (extreme fatigue), malaise

This leaflet was last revised in 12/2014
PL 00289/1523

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse
3, D-89143 Blaubeuren, GERMANY

51069-A

148 x 420

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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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