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ZIRTEK ALLERGY 10MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE

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Package leaflet: Information for the user

Zirtek Allergy

10 mg film-coated tablets
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 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 is and what it is used for
2. What you need to know before you take Zirtek Allergy
3. How to take Zirtek Allergy
4. Possible side effects
5. How to store Zirtek Allergy
6. Content of the pack and further information.

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

Cetirizine dihydrochloride is the active ingredient of Zirtek Allergy.
Zirtek Allergy is an antiallergic medication.
In adults and children aged 6 years and above, Zirtek Allergy 10 mg filmcoated tablets are 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

Do NOT take Zirtek Allergy
• 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).

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 with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop
taking Zirtek Allergy 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.

Other medicines and Zirtek Allergy

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

Zirtek Allergy with food and drink

Food does not affect absorption of Zirtek Allergy.

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 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 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 at the recommended dose.

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Zirtek Allergy 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 Allergy

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

Adults and adolescents above 12 years old:

The recommended dose is 10 mg once daily as 1 tablet.

Use in children between 6 and 12 years old:

The recommended dose is 5 mg twice daily as a half tablet 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
pharmacist who may adjust the dose according to your child’s needs.
If you feel that the effect of Zirtek Allergy 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 than you should

If you think you have taken an overdose of Zirtek Allergy 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.

01/07/2016 08:03

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 10MG GB
Creation date: 07/04/2016
DCMF No: N/A
Operator: LS
Commodity: UCB01178
Ref no: CIA79731B
Core spec size: TI006PIL-024-03 305x148
Revision: GARF 2016_FEB_0036_1 GB
Amended by: LS
Page no: 1 of 2

You should closely observe your response to the drug after you have taken
Zirtek Allergy if you are intending to drive, engage in potentially hazardous
activities or operate machinery. You should not exceed the recommended
dose.

Modification date: 01/07/2016

Font size body text: 8.5pt
Pharma code: 3736
Colours:
Black
Technical info

Proof no: 05

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If you forget to take Zirtek Allergy

Do not take a double dose to make up for a forgotten dose.
If you stop taking Zirtek Allergy
Rarely, pruritus (intense itching) and/or urticaria may return if you stop
taking Zirtek Allergy.
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 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 national reporting system listed below:
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.

What Zirtek Allergy looks like and contents of the pack

White, oblong, film-coated tablet, with breakline and Y-Y logo.
Pack with 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100, or
100 (10x10) tablets.
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

5. How to store Zirtek Allergy

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 blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Zirtek Allergy contains
• The active substance is cetirizine dihydrochloride. One film-coated tablet
contains 10 mg cetirizine dihydrochloride.

• The other ingredients are microcrystalline cellulose, lactose-monohydrate,

CIA79731B.indd 2

CIA79731B

01/07/2016 08:03

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 10MG GB
Creation date: 07/04/2016
DCMF No: N/A
Operator: LS
Commodity: UCB01178
Ref no: CIA79731B
Core spec size: TI006PIL-024-03 305x148
Revision: GARF 2016_FEB_0036_1 GB
Amended by: LS
Page no: 2 of 2

colloidal anhydrous silica, magnesium stearate, Opadry Y-1-7000
(hydroxypropylmethylcellulose (E 464), titanium dioxide (E171),
macrogol 400).

Modification date: 01/07/2016

Font size body text: 8.5pt
Pharma code: 3736
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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