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CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG

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

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Zirtek should be avoided in pregnant women.

273 Zirtek Tablets 10mg 20170130

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

ZIRTEK TABLETS 10mg/
CETIRIZINE DIHYDROCHLORIDE TABLETS 10mg
(cetirizine dihydrochloride)
Your medicine is known by either of the above name but will be
referred to as Zirtek throughout the remainder of the 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.
 If you get any side effects, talk to your doctor or pharmacist.
This includes 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 Zirtek is and what it is used for
2. What you need to know before you take Zirtek
3. How to take Zirtek
4. Possible side effects

Accidental use of the drug by a pregnant woman should not
produce any harmful effects on the foetus. Nevertheless,the
medicine should only be administered if necessary and after
medical advice.
Cetirizine passes into breast milk. Therefore, you should not take
Zirtek during breast-feeding unless you have contacted a doctor.
Driving and using machines
Clinical studies have produced no evidence of impaired attention,
alertness and driving capabilities after taking Zirtek at the
recommended dose.
You should closely observe your response to the drug after you
have taken Zirtek if you are intending to drive, engage in potentially
hazardous activities or operate machinery. You should not exceed
the recommended dose.
Zirtek film-coated tablets 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 ZIRTEK
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

5. How to store Zirtek

The tablets need to be swallowed with a glass of liquid. The tablet
can be divided into 2 equal doses.

6. Content of the pack and further information.

Adults and adolescents above 12 years old:
The recommended dose is 10 mg once daily as 1 tablet.

1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR

Use in children between 6 and 12 years old:

Cetirizine dihydrochloride is the active ingredient of Zirtek.

The recommended dose is 5 mg twice daily as a half tablet twice
daily.

Zirtek is an antiallergic medication.
In adults and children aged 6 years and above, Zirtek is indicated


for the relief of nasal and ocular symptoms of seasonal and
perennial allergic rhinitis.



for the relief of urticarial.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIRTEK
Do NOT take Zirtek:


if you have a severe kidney disease (severe renal failure with
creatinine clearance below 10 ml/min);



if you are allergic to cetirizine dihydrochloride, to any of the
other ingredients (listed in section 6), to hydroxyzine or to
piperazine derivatives (closely related active ingredients of
other medicines).

Patients with renal impairment
Patients with moderate renal impairment are recommended to take
5 mg once daily.
If you suffer from severe kidney disease, please contact your doctor
or pharmacist who may adjust the dose accordingly.
If your child suffers from kidney disease, please contact your doctor
or pharmacist who may adjust the dose according to your child’s
needs.
If you feel that the effect of Zirtek 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. Please ask your doctor or pharmacist for advice.

Warning and precautions

If you take more Zirtek than you should

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.

If you think you have taken an overdose of Zirtek please inform your
doctor. Your doctor will then decide what measures, if any, should
be taken.

If you have problems passing urine (like spinal cord problems or
prostate or bladder problems), please ask your doctor for advice.If
you are an epileptic patient or a patient at risk of convulsions, you
should ask your doctor for advice.

After an overdose, the side effects described below may occur with
increased intensity. Adverse effects such as confusion, diarrhoea,
dizziness, tiredness, headache, ailing, dilating of pupil, itching,
restlessness, sedation, somnolence, stupor, abnormal rapid heart
rate, tremors and urinary retention have been reported.

No clinically significant interactions have been observed between
alcohol (at the blood level of 0.5 per mille (g/l) corresponding to one
glass of wine) and cetirizine used at the recommended doses.
However, there are no data available on the safety when higher
doses of cetirizine and alcohol are taken together. Therefore, as it is
the case with all antihistamines, it is recommended to avoid taking
Zirtek with alcohol. If you are scheduled for allergy testing, ask your
doctor if you should stop taking Zirtek for several days before
testing. This medicine may affect your allergy test results.
Children
Do not give this medicine to children below the age of 6 years
because the tablet formulation does not allow the necessary dose
adjustments.

If you forget to take Zirtek
Do not take a double dose to make up for a forgotten dose.
If you stop taking Zirtek
Rarely, pruritus (intense itching) and/or urticaria may return if you
stop taking Zirtek.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Other medicines and Zirtek

4. POSSIBLE SIDE EFFECTS

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Zirtek with food and drink

The following side effects are rare or very rare, but you must
stop taking the medicine and speak to your doctor straight
away if you notice them:

Food does not affect absorption of Zirtek.
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 for advice before
taking this medicine.



Allergic reactions, including severe reactions and angioedema
(serious allergic reaction which causes swelling of the face or
throat). These reactions may start soon after you first take the
medicine, or it might start later.

Common side effects (may affect up to 1 in 10 patients)

6. CONTENT OF THE PACK AND FURTHER INFORMATION



Somnolence (sleepiness)

What Zirtek contains



Dizziness, headache





Pharyngitis, rhinitis (in children)

Each tablet contains 10mg of the active ingredient cetirizine
dihydrochloride



Diarrhea, nausea, dry mouth





Fatigue

The other ingredients are: colloidal silica, magnesium stearate,
microcrystalline cellulose, lactose, titanium dioxide (E171),
hypromellose, polyethylene glycol 400.

Uncommon side effects (may affect up to 1 in 100 patients)


Agitation



Paraesthesia (abnormal feelings of the skin)



Abdominal pain



Pruritus (itchy skin), rash



Asthenia (extreme fatigue), malaise

Rare side effects (may affect up to 1 in 1,000 patients)

What Zirtek looks like and contents of the pack
Zirtek is available as a white oblong film-coated tablet coded ‘Y’
either side of a score line on one face and plain on the reverse.
Zirtek is available as packs of 10, 20 or 30 tablets.
Product Licence holder



Allergic reactions, some severe (very rare)



Depression, hallucination, aggression, confusion, insomnia



Convulsions



Tachycardia (heart beating too fast)



Liver function abnormal

Manufacturer



Urticaria (hives)

Zirtek is manufactured by either:



Oedema (swelling)



UCB S.A., Agios Dimitrios Alimos, Greece or



Weight increased



Aesica Pharmaceuticals S.r.l., Italy.

Very rare side effects (may affect up to 1 in 10,000 patients)

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.

POM

PL 08747/0273



Thrombocytopenia (low levels of blood platelets)



Tics (habit spasm)

Leaflet revision date: 30 January 2017



Syncope, dyskinesia (involuntary movements), dystonia
(abnormal prolonged muscular contractions), tremor,
dysgeusia (altered taste)



Blurred vision, accommodation disorder (difficulty focusing),
oculogyration (eyes having uncontrolled circular movements)



Angioedema (serious allergic reaction which causes swelling
of the face or throat), fixed drug eruption



Abnormal elimination of urine (bed wetting, pain and/or
difficulty passing water)

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.

Not known frequency of side effects (frequency cannot be
estimated from the available data)


Increased appetite



Amnesia, memory impairment



Vertigo (sensation of rotation or movement)



Urinary retention (inability to completely empty the urinary
bladder)



Pruritus (intense itching) and/or urticaria upon discontinuation
In very rare cases people have thought about committing
suicide and if you feel this way then stop taking the tablets
and see your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
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 ZIRTEK


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Zirtek should be stored below 30°C.



Do not use after the expiry date printed on the carton, label or
blister strip.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if the doctor tells you to.



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will advise you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Zirtek® is a registered trade mark of UCB PHARMA S.A.
273 Zirtek Tablets 10mg 20170130

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.

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