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ZIRTEK TABLETS 10MG

Active substance(s): CETIRIZINE DIHYDROCHLORIDE

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273 Zirtek Tablets 10mg 20150421

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZIRTEK TABLETS 10mg/
CETIRIZINE DIHYDROCHLORIDE TABLETS 10mg
(cetirizine dihydrochloride)

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking Zirtek with food and drink

Your medicine is known by either of the above name but will be
referred to as Zirtek throughout the remainder of the leaflet.

Food does not affect absorption of Zirtek.

Read all of this leaflet carefully because it contains important
information for you.

Pregnancy



This medicine is available without prescription. However, you
still need to take it carefully to get the best results from it.



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 after 3 days.



If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Avoid alcoholic drink while you are taking this medicine.

Ask your doctor or pharmacist for advice before taking any
medicine. As with other drugs, use of Zirtek 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 medicine should only be administered if necessary and after
medical advice.
Driving and using machines

In this leaflet:

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.

1. What Zirtek is and what it is used for

You should not exceed the recommended dose.

2. Before you take Zirtek
3. How to take Zirtek

This medicine contains lactose

4. Possible side effects

This medicine contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking these tablets.

5. How to store Zirtek
6. Further information.
1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek.
Zirtek is an antiallergic medicine.
In adults and children aged 6 years and above, Zirtek is used




for the relief of nasal and ocular symptoms of seasonal and
perennial allergic rhinitis (hayfever and year-round allergies
affecting the nose and eyes).
for the relief of chronic nettle rash (chronic idiopathic urticaria).

3. HOW TO TAKE ZIRTEK
These guidelines apply unless your doctor has given you different
instructions on how to use Zirtek. Please follow these instructions,
otherwise Zirtek may not be fully effective.
Tablets need to be swallowed with a glass of liquid.
Adults and adolescents aged 12 years and over:
10 mg once daily as 1 tablet.
Children aged 6 to 12 years:
5 mg twice daily as half a tablet twice daily.

2. 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 known to be hypersensitive to the active substance of
Zirtek, to any of its excipients (other constituents), to
hydroxyzine or to any piperazine derivatives (closely related
active substances of other medicines).

You should not take Zirtek 10 mg tablets:


if you have rare hereditary problems of galactose intolerance,
the Lapp lactase deficiency or glucose-galactose
malabsorption.

If any of the above applies to you talk to your pharmacist.

Patients with moderate to severe kidney impairment
Patients with moderate kidney impairment are recommended to
take 5 mg once daily.
If you feel that the effect of Zirtek is too weak or too strong, please
consult your doctor.
Duration of treatment
The duration of the treatment depends on the type, duration and
course of your complaints. Please ask your pharmacist for advice.
If you take more Zirtek than you should
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 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.

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.



If you are an epileptic patient or a patient at risk of convulsions,
you should ask your doctor for advice.

If you forget to take a tablet

Take special care with Zirtek

No clinically significant interactions have been observed between
alcohol (at the blood level of 0.5 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.

Do not take a double dose to make up for forgotten dose.
If you stop taking Zirtek
If you have any other questions about taking this medicine, ask your
pharmacist.

4. POSSIBLE SIDE EFFECTS

Reporting of side effects:

Like all medicines Zirtek can cause side effects, although not
everybody gets them.
The following side effect is very rare, but you must stop taking
the tablets and speak to your doctor straight away if you notice
them

If you get any side effects, talk to your doctor, pharmacist or nurse.
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.



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

The frequency of possible side effects listed below is defined using
the following convention:
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1000)
Rare (affects 1 to 10 patients in 10,000)

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.

Very rare (affects less than 1 patient in 10,000)
Not known (frequency cannot be estimated from available data)
The following side effects have also been reported.
Common side effects (affects less than 1 in 10 people)


Tiredness, feeling sleepy



Headache



Dry mouth



Nausea



Diarrhoea

6. FURTHER INFORMATION



Dizziness

What Zirtek contains



Sore throat





Cold-like symptoms of the nose (children only).

Each tablet contains 10mg of the active ingredient cetirizine
dihydrochloride



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

Uncommon side effects (affects less than 1 in 100 people)


Itching and rash



Asthenia (extreme fatigue) or generally unwell



Tingling in the hands and feet

What Zirtek looks like and contents of the pack



Feeling agitated

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.

 Pain in the abdomen.
Rare side effects (affects less than 1 in 1000 people)

Zirtek is available as packs of 10, 20 or 30 tablets.



Tachycardia (heart beating too fast)



Oedema (generalised swelling due to water retention)



Abnormal liver function test results (your doctor will know what
to do)



Convulsions



Weight increased



Manufacturer

Aggression, confusion, depression, hallucination (hearing or
seeing things), sleeplessness

Zirtek is manufactured by either:

 Urticaria (hives).
Very rare side effects (affects less than 1 in 10,000 people)


Blurred vision, difficulty focussing



Oculogyration (eyes having uncontrolled circular movements)



Low level of blood platelets causing unusual bleeding or
bruising



Bad taste in the mouth



Tremor, tics (habit spasm)



Involuntary movements and/or jerking of the limbs



Muscle spasms in the neck and shoulders



Swelling of the skin particularly around the face or throat



Fainting



A recurring rash



Abnormal elimination of urine (bedwetting, pain and/or difficulty
passing water).

Not known frequency of side effects
 Memory loss and forgetfulness.
If you develop one of the side effects described above, please
inform your doctor or pharmacist. At the first signs of a
hypersensitivity reaction, stop taking Zirtek. Your doctor will
then assess the severity and decide on any further measures
that may be necessary. If you think you have any side effects
not mentioned in this leaflet, please inform your doctor or
pharmacist.

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



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



Aesica Pharmaceuticals S.r.l., Italy.

POM

PL No. 08747/0273

Leaflet revision date: 21 April 2015
273 Zirtek Tablets 10mg 20150421

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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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