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ZIRTEK ALLERGY SOLUTION 1MG/ML ORAL SOLUTION

Active substance(s): CETIRIZINE DIHYDROCHLORIDE

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Package leaflet: Information for the user

CIA79732B

Zirtek Allergy Solution

1 mg/ml oral solution

Cetirizine dihydrochloride
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 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 Zirtek Allergy Solution is and what it is used for
2. What you need to know before you take Zirtek Allergy Solution
3. How to take Zirtek Allergy Solution
4. Possible side effects
5. How to store Zirtek Allergy Solution
6. Contents of the pack and other information

1. What Zirtek Allergy Solution is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Zirtek Allergy
Solution.
Zirtek Allergy Solution is an antiallergic medication.
In adults and children aged 2 years and above, Zirtek Allergy 1 mg/ml oral
solution is indicated
• for the relief of nasal and ocular symptoms of seasonal and perennial
allergic rhinitis.
• for the relief of urticaria.

2. What you need to know before you take Zirtek Allergy
Solution

Do not take Zirtek Allergy Solution
• 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 any piperazine
derivatives (closely related active ingredients of other medicines).

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.
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.
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 Allergy Solution with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop
taking Zirtek Allergy Solution for several days before testing. This
medicine may affect your allergy test results.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness
and driving capabilities after taking Zirtek Allergy Solution at the
recommended dose.
You should closely observe your response to the drug after you have taken
Zirtek Allergy Solution if you are intending to drive, engage in potentially
hazardous activities or operate machinery. You should not exceed the
recommended dose.
Zirtek Allergy 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.
Zirtek Allergy Solution contains methylparahydroxybenzoate (E 218),
propylparahydroxybenzoate (E 216) that may cause allergic reactions
(possibly delayed).

3. How to take Zirtek Allergy Solution

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.
The solution can be swallowed as such

Adults and adolescents above 12 years old:

Other medicines and Zirtek Allergy Solution

The recommended dose is 10 mg once daily as 10 ml oral solution (2 full
measuring spoons)

Zirtek Allergy Solution with food and drink

The recommended dose is 5 mg twice daily as 5 ml (one full measuring
spoon) twice daily.

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Food does not affect absorption of Zirtek Allergy Solution.

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.
Zirtek Allergy Solution 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.

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Use in children between 6 and 12 years old:
Use in children between 2 and 6 years old

The recommended dose is 2.5 mg twice daily as 2.5 ml oral solution (a
half-measuring spoon) twice daily

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

01/07/2016 08:27

Aesica Queenborough Ltd.
North Road, Queenborough,
Kent ME11 5EL UK

NOTE: Artwork studio checks pre-press suitability of this artwork
only. Ensure the artwork has been thoroughly checked for textual
accuracy and has been approved as such!

Product name: Zirtek 1MG GB
Creation date: 07/04/2016
DCMF No: N/A
Operator: LS
Commodity: UCB01179
Ref no: CIA79732B
Core spec size: TI006PIL-028-02 305x148
Revision: GARF 2016_FEB_0036_1 GB
Amended by: LS
Page no: 1 of 2

Cetirizine passes into breast milk. Therefore, you should not take Zirtek
Allergy Solution during breast-feeding unless you have contacted a doctor.

Modification date: 01/07/2016

Font size body text: 8.5pt
Pharma code: 3735
Colours:
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pharmacist who may adjust the dose according to your child’s needs.
If you feel that the effect of Zirtek Allergy Solution 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.

If you take more Zirtek Allergy Solution than you should

If you think you have taken an overdose of Zirtek Allergy Solution please
inform your doctor.
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 Zirtek Allergy Solution

Do not take a double dose to make up for a forgotten dose.

If you stop taking Zirtek Allergy Solution

Rarely, pruritus (intense itching) and/or urticaria may return if you stop
taking Zirtek Allergy Solution.
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 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:
• 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)
• Somnolence (sleepiness)
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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)
• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Convulsions
• Tachycardia (heart beating too fast)
• Liver function abnormal
• Urticaria (hives)
• Oedema (swelling)
• Weight increased
Very rare side effects (may affect up to 1 in 10,000 patients)
• Thrombocytopenia (low levels of blood platelets)
• Tics (habit spasm)
• 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)
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 oral solution 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 national reporting system listed below:

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5. How to store Zirtek Allergy Solution

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 bottle. The expiry date refers to the last day of that month.
Do not use after 3 months of first opening the bottle.
This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Zirtek Allergy Solution contains
• The active substance is cetirizine. 10 ml (equals to 2 measuring spoons)
contain 10 mg of cetirizine dihydrochloride.

• The other ingredients are sorbitol (E 420), glycerol, propylene glycol,
saccharin sodium, methylparahydroxybenzoate (E 218),
propylparahydroxybenzoate (E 216), banana flavor 54.330/A
(Firmenich), sodium acetate, glacial acetic acid, purified water.
• 10 ml Zirtek Allergy Solution (=2 measuring spoons) contain: 3.15 g
glucose equivalents (sorbitol).

What Zirtek Allergy Solution looks like and contents of the pack
Clear and colorless liquid with slightly sweet taste and a banana flavor.
Pack with a bottle containing volumes of 60, 75, 100, 150, or 200 ml
solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
UCB Pharma Ltd
208 Bath Road
Slough
Berkshire
SL1 3WE

This leaflet was last revised in 06/2016.
If this leaflet is difficult to see or read or you would like it in a
different format, please contact UCB Pharma Ltd, UK
CIA79732B

01/07/2016 08:27

Aesica Queenborough Ltd.
North Road, Queenborough,
Kent ME11 5EL UK

NOTE: Artwork studio checks pre-press suitability of this artwork
only. Ensure the artwork has been thoroughly checked for textual
accuracy and has been approved as such!

Product name: Zirtek 1MG GB
Creation date: 07/04/2016
DCMF No: N/A
Operator: LS
Commodity: UCB01179
Ref no: CIA79732B
Core spec size: TI006PIL-028-02 305x148
Revision: GARF 2016_FEB_0036_1 GB
Amended by: LS
Page no: 2 of 2

The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the
safety of this medicine.

Modification date: 01/07/2016

Font size body text: 8.5pt
Pharma code: 3735
Colours:
Black
Technical info

Proof no: 05

V

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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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