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CETIRIZINE DIHYDROCHLORIDE 5MG/5ML ORAL SOLUTION
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIRTEK 5mg/5ml ORAL SOLUTION
5mg/5ml ORAL SOLUTION
This product is available using either of the above names but will be
referred to as Zirtek in this leaflet.
Read all of this leaflet carefully because it contains important
information for you.
Ask your doctor or pharmacist for advice before taking any
As with other drugs, use of Zirtek should be avoided in pregnant
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
Driving and using machines
Clinical studies have produced no evidence of impaired attention,
alertness and driving capabilities after taking Zirtek at the
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.
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.
Important information about some of the ingredients of Zirtek
You must contact a doctor if your symptoms worsen or do no
improve after 3 days.
Zirtek oral solution contains sorbitol; 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.
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.
In this leaflet:
Zirtek oral solution contain methyl (4-hydroxybenzoate) E 218,
(4-hydroxybenzoate) E 216 that may cause
allergic reactions (possibly delayed).
1. What Zirtek is and what it is used for
2. Before you take Zirtek
3. How to take Zirtek
3. HOW TO TAKE ZIRTEK
6. Further information.
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. The solution may be
swallowed as such.
1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR
Adults and adolescents above 12 years old:
4. Possible side effects
5. How to store Zirtek
Cetirizine dihydrochloride is the active ingredient of Zirtek.
Zirtek is an antiallergic medicine.
In adults and children aged 2 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).
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 1 mg/ml oral solution:
if you have rare hereditary problems of fructose intolerance.
Take special care with Zirtek
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 are an epileptic patient or a patient at risk of convulsions,
you should ask your doctor for advice.
10 mg once daily as 10 ml oral solution (2 full measuring spoons).
Children between 6 and 12 years old:
5 mg twice daily as 5 ml (one full measuring spoon) twice daily.
Children between 2 and 6 years old:
2.5 mg twice daily as 2.5 ml oral solution (a half measuring spoon)
Patients with moderate to severe kidney impairment
Patients with moderate kidney impairment are recommended to
take 5 mg or 5 ml 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 treatment depends on the type, duration and course
of your complaints. Please ask your pharmacist for advice.
If you take more Zirtek Allergy Solution than you should
If you think you have taken an overdose of Zirtek please inform your
Your doctor will then decide what measures, if any, should be
taken. 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 forget to take a dose
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
Do not take a double dose to make up for forgotten dose.
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.
Like all medicines Zirtek Allergy Solution can cause side effects,
although not everybody gets them.
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
Food does not affect absorption of Zirtek.
If you stop taking Zirtek
If you have any other questions about taking this medicine, ask your
4. POSSIBLE SIDE EFFECTS
The following side effect is very rare, but you must stop taking
the medicine and speak to your doctor straight away if you
Allergic reactions, including severe reactions and angioedema
(serious allergic reaction which cause swelling of the face and
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:
5. HOW TO STORE ZIRTEK
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Zirtek Oral Solution should be kept at a temperature below
Rare (affects 1 to 10 patients in 10,000)
Do not use after the expiry date printed on the carton or bottle.
Very rare (affects less than 1 patient in 10,000)
If your doctor tells you to stop taking the medicine, please take
it back to the pharmacist for safe disposal. Only keep it if the
doctor tells you to.
If the solution becomes discoloured or shows any other signs of
deterioration, you should speak to your pharmacist who will
advise you what to do.
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1000)
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
6. FURTHER INFORMATION
What Zirtek contains
Each 5ml of solution contains 5mg of the active ingredient
Cold-like symptoms of the nose (children only).
The solution also contains acetic acid, glycerol, methyl
parahydroxybenzoate, propyl parahydroxybenzoate, sodium
acetate, saccharin sodium, propylene glycol, sorbitol solution,
banana flavour and purified water.
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
Pain in the abdomen.
What Zirtek looks like and contents of the pack
Rare side effects (affects less than 1 in 1000 people)
Tachycardia (heart beating too fast)
Abnormal liver function test results (your doctor will know what
Zirtek is available in amber glass bottles containing 200ml.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Oedema (generalised swelling due to water retention)
Zirtek is a clear, colourless, banana-flavoured sugar-free solution
with a slightly sweet taste.
This product is manufactured by Aesica Pharmaceuticals S.r.l,
I-10044 Pianezza, Italy.
Aggression, confusion, depression, hallucination (hearing or
seeing things), sleeplessness
Leaflet revision date: 20 November 2012
Zirtek is a registered trade mark of UCB, Belgium.
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
A recurring rash.
Bad taste in the mouth
Abnormal elimination of urine (bedwetting, pain and/or difficulty
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.
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.
PL No: 08747/0456
456 LEAFLET Zirtek 20121120
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.