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ZIRTEK ALLERGY RELIEF FOR CHILDREN 1MG/ML ORAL SOLUTION

Active substance(s): CETIRIZINE DIHYDROCHLORIDE

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CIA70970E_MU2

Package leaflet: Information for the user

Zirtek

®

Allergy Relief for Children 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 Relief for Children is and what it is used for
2. What you need to know before you take Zirtek Allergy Relief for Children
3. How to take Zirtek Allergy Relief for Children
4. Possible side effects
5. How to store Zirtek Allergy Relief for Children
6. Contents of the pack and other information.
1. What Zirtek Allergy Relief for Children is and what it is used for
Cetirizine dihydrochloride, the active ingredient of the solution is an antihistamine. It blocks the effects of a substance called histamine
which occurs naturally in the body. Histamine is involved in allergic reactions.
Zirtek Allergy Relief for Children is used to treat adults and children aged 6 years and over who have hay fever (seasonal allergic rhinitis),
year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).
Antihistamines like Zirtek Allergy Relief for Children relieve the unpleasant symptoms and discomfort associated with these conditions,
such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.
2. What you need to know before you take Zirtek Allergy Relief for Children
Do not take Zirtek Allergy Relief for Children
• 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).
Warning 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 Relief for Children with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop taking Zirtek Allergy Relief for Children for several days
before testing. This medicine may affect your allergy test results.
Other medicines and Zirtek Oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Zirtek Allergy Relief for Children with food and drink
Food does not affect absorption of Zirtek Allergy Relief for Children.
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 Relief for Children 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.
Cetirizine passes into breast milk. Therefore, you should not take Zirtek Allergy Relief for Children 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 Allergy Relief
for Children at the recommended dose.
You should closely observe your response to the drug after you have taken Zirtek Allergy Relief for Children if you are intending to drive,
engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
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.
Zirtek oral solution contains methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216) that may cause allergic reactions
(possibly delayed).
3. How to take Zirtek Allergy Relief for Children
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
Children aged 6 to 12 years:
The recommended dose is 5 mg twice daily as 5 ml (one full measuring spoon) twice daily.
Adults and adolescents over 12 years of age:
The recommended dose is 10 mg once daily as 10 ml oral solution (2 full measuring spoons).
Zirtek Allergy Relief for Children is not suitable for children under 6 years of age.
Patients with renal impairment
Patients with moderate renal impairment are recommended to take 5 mg once daily.
If you feel that the effect of Zirtek Allergy Relief for Children is too weak or too strong, please consult your doctor.

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany

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

Zirtek Allergy

Print Colours

Techn. Colours

Artwork Studio

Aesica Id.-No.

UCB00605

black

techn. info

PT Approval

external Id.-No.

CIA70970E_MU2/GB

Dimensions

305 x 148 mm

Operator

Nagler

Creation Date

24.09.2015

Amended by

PH

Modific. Date

15.08.2016

Edition No.

05

Product Name

Date

Operator

Approver

PIA

Manufacturing Site

PIA

Fontsize Bodytext

8 Pt

Linespacing

8,5 Pt

Technical Changes

TI006PIL-028-02

Dispatched to
Artwork Information

Laetus code: TBC

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

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 Relief for Children 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 Relief for Children
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, you should take one as soon as you remember, but wait at least 24 hours before taking the next dose.
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)
• Diarrhoea, nausea, dry mouth
• Dizziness, headache
• Fatigue
• Pharyngitis, rhinitis (in children)
Uncommon side effects (may affect up to 1 in 100 patients)
• Agitation
• Abdominal pain
• Paraesthesia (abnormal feelings
• Pruritus (itchy skin), rash
of the skin)
• Asthenia (extreme fatigue), malaise
Rare side effects (may affect up to 1 in 1,000 patients)
• Allergic reactions, some
• Tachycardia (heart beating too fast)
severe (very rare)
• Liver function abnormal
• Depression, hallucination,
• Urticaria (hives)
aggression, confusion, insomnia
• Oedema (swelling)
• Convulsions
• 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
• Suicidal ideation (recurring thoughts of or preoccupation with suicide)
• Amnesia, memory impairment
• Vertigo (sensation of rotation or movement)
• Urinary retention (inability to completely empty the urinary bladder)
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor or 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zirtek Allergy Relief for Children
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 carton. The expiry date refers to the last day of that month. Do
not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.
6. Contents of the pack and other information
What Zirtek Allergy Relief for Children contains
The solution contains 1 mg/ml of the active substance, cetirizine dihydrochloride.
The other ingredients are sorbitol (E 420), glycerol, propylene glycol, saccharin sodium, methylparahydroxybenzoate (E 218),
propylparahydroxybenzoate (E216), banana flavour 54.330/A (Firmenich), sodium acetate, glacial acetic acid and purified water.
10 ml Zirtek Allergy Relief for Children (=2 measuring spoons) contain: 3.15 g glucose equivalents (sorbitol).
What Zirtek Allergy Relief for Children looks like and contents of the pack
It is a clear, colourless solution with slightly sweet taste and a banana flavour. It is supplied in amber glass bottles containing 70 ml.
Marketing Authorisation Holder and Manufacturer
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
This leaflet was last revised in August 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
CIA70970E_MU2

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany

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

Zirtek Allergy

Print Colours

Techn. Colours

Artwork Studio

Aesica Id.-No.

UCB00605

black

techn. info

PT Approval

external Id.-No.

CIA70970E_MU2/GB

Dimensions

305 x 148 mm

Operator

Nagler

Creation Date

24.09.2015

Amended by

PH

Modific. Date

15.08.2016

Edition No.

05

Product Name

Date

Operator

Approver

PIA

Manufacturing Site

PIA

Fontsize Bodytext

8 Pt

Linespacing

8,5 Pt

Technical Changes

TI006PIL-028-02

Dispatched to
Artwork Information

Laetus code: TBC

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

Expand view ⇕

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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