Skip to Content

UK Edition. Click here for US version.

CETIRIZINE 10 MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

TEVA UK Ref:

231-30-51069-B LEA CETIRIZINE 10MG FC TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
420 mm
148 mm
N/A
N/A

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

What Cetirizine is and what it
is used for

Cetirizine dihydrochloride is the active
ingredient of Cetirizine 10mg
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

1

Colours Used:

Cetirizine 10 mg Film-Coated
Tablets
cetirizine dihydrochloride

1

Version:

BLACK
PANTONE® GREEN C
Template

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
your doctor or pharmacist has told you.
What you need to know before Check with your doctor or pharmacist if
you are not sure.
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.

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.
Adults and adolescents above 12 years
old
10 mg once daily as 1 tablet.

If you have problems passing urine (like
Children between 6 and 12 years old
spinal cord problems or prostate or
5 mg twice daily as a half tablet twice
bladder problems), please ask your
daily.
doctor for advice.
Patients with moderate renal
If you are an epileptic patient or a
impairment
patient at risk of convulsions, you
Patients with moderate renal
should ask your doctor for advice.
impairment are recommended to take 5
If you are going to have an allergy skin mg once daily.
If you suffer from severe kidney disease,
test please tell your doctor that you
please contact your doctor or
currently take Cetirizine. Usually you
pharmacist who may adjust the dose
will need to stop taking any medicines
for a period of 3 days before the allergy accordingly.
If your child suffers from kidney disease,
skin test.
please contact your doctor or
No clinically significant interactions
pharmacist who may adjust the dose
have been observed between alcohol (at according to your child’s needs.
the blood level of 0.5 per mille (g/l)
corresponding to one glass of wine) and Method of administration
The tablet can be divided into equal
cetirizine used at the recommended
doses.
doses. However, there are no data
available on the safety when higher
Directions for use
doses of cetirizine and alcohol are taken If your treatment with Cetirizine
together. Therefore, as it is the case with stipulates that you have to split tablets,
all antihistamines, it is recommended to you should ideally do so as follows.
avoid taking Cetirizine with alcohol.
Place the tablet on a hard, flat surface
(such as a table top or plate) with the
score line facing upwards. Then press
Tell your doctor or pharmacist if you are with both of your index fingers (or
taking/using or have recently taken/used thumbs) at the same time briefly and
or might take/use any other medicines. firmly on the outer edges to the left and
Other medicines and Cetirizine

21 November 2016

TEVA UK Ref:

231-30-51069-B LEA CETIRIZINE 10MG FC TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
420 mm
148 mm
N/A
N/A

Version:

1

Colours Used:

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

BLACK
PANTONE® GREEN C
Template

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

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

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.

5

How to store Cetirizine

Keep this medicine out of the sight and
reach of children.
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.
This medicinal product does not require
any special storage conditions.

Do not throw away any medicines via
wastewater or household waste. Ask your
Serious side effects:
pharmacist how to throw away medicines
rare (may affect up to 1 in 1,000 people): you no longer use. These measures will
help protect the environment.
• allergic reactions (causing
symptoms such as wheezing,
difficulty breathing, rash, hives)
6 Contents of the pack and other
very rare (may affect up to 1 in 10,000
people):
• angioedema (serious allergic
reaction which causes swelling of
the face or throat)
At the first signs of a hypersensitivity
reaction, stop taking Cetirizine. Your
doctor will then assess the severity and
decide on any further measures that
may be necessary.

information

What CETIRIZINE contains
The active substance is cetirizine
dihydrochloride.
One film-coated tablet contains 10 mg
cetirizine dihydrochloride.
The other ingredients are lactose
monohydrate, microcrystalline
cellulose, colloidal silica, magnesium
stearate, titanium dioxide (E171),
hypromellose (E464) and macrogol.

Tell your doctor immediately if you get
any of these symptoms:
rare (may affect up to 1 in 1,000 people): What CETIRIZINE looks like and
• Convulsions
contents of the pack
very rare (may affect up to 1 in 10,000
people):
• thrombocytopenia (low levels of
blood platelets causing symptoms
such as bleeding, bruises, blotches
or red spots on the skin)
• dyskinesia (involuntary movements)
• dystonia (abnormal prolonged
muscular contractions)

The film-coated tablet is white to almost
white, round, biconvex with a score line
on one side and is approximately 6.5 mm
in diameter.
The tablet can be divided into equal
doses.
PVC//PVDC/alu blisters.
Blister with 7, 14, 15, 20, 28, 30, 50 and
100 tablets.
Not all pack sizes may be marketed.

not known (frequency cannot be
estimated from the available data):
• suicidal ideation (recurring thoughts
Marketing Authorisation Holder
of, or preoccupation with suicide).
Teva UK Limited, Eastbourne,
Other side effects:
common (may affect up to 1 in 10 people): BN22 9AG, UK






fatigue
dry mouth, nausea, diarrhoea
dizziness, headache
somnolence (sleepiness)
pharyngitis, rhinitis (in children).

uncommon (may affect up to 1 in 100
people):
• abdominal pain
• asthenia (extreme fatigue), malaise
• paresthesia (abnormal feelings of
the skin)
• agitation
• pruritus (itchy skin), rash.

21 November 2016

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse
3, D-89143 Blaubeuren, GERMANY
This leaflet was last revised in 11/2016
PL 00289/1523

51069-B

148 x 420

Expand Transcript

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.

Hide