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ZIRTEK ALLERGY RELIEF 10MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE

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Package leaflet: Information for the user

Zirtek

®

Allergy Relief 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 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 is and what it is used for
2. What you need to know before you take Zirtek Allergy Relief
3. How to take Zirtek Allergy Relief
4. Possible side effects
5. How to store Zirtek Allergy Relief
6. Content of the pack and other information.
1. What Zirtek Allergy Relief is and what it is used for
Cetirizine dihydrochloride, the active ingredient of the tablets is an antihistamine. It blocks the effects of a substance called histamine
which occurs naturally in the body. Histamine is involved in allergic reactions.
In adults and children aged 6 years and above, Zirtek Allergy Relief is used to treat people 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 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
Do NOT take Zirtek Allergy Relief
• 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.

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

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 with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop taking Zirtek Allergy Relief 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 Relief
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Zirtek Allergy Relief with food and drink
Food does not affect absorption of Zirtek Allergy Relief.
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 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 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 at
the recommended dose.
You should closely observe your response to the drug after you have taken Zirtek Allergy Relief if you are intending to drive, engage in
potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
Zirtek Allergy Relief contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking these tablets.
3. How to take Zirtek Allergy Relief
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 equal doses. Do not take more than one tablet
each day.
Children aged 6 to 12:
The recommended dose is 5 mg twice daily as half a tablet twice a day.
Adults and adolescents aged 12 years and over:
The recommended dose is 10 mg once daily as one tablet daily. If the tablets make you feel drowsy or dizzy, taking half a tablet twice a day
may be better than taking one tablet once a day.
Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.

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Product name: ZIRTEK ALLERGY 10MG 7TAB - GB
Creation date: 12/10/2016
DCMF No: N/A
Operator: PH
Commodity: UCB02666
Ref no: CIA70971E_MU3
Core spec size: TI006PIL-024-03 - 305x148
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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 Relief 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 Relief than you should
If you think you have taken an overdose of Zirtek Allergy Relief 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
Do not take a double dose to make up for a forgotten tablet. If you forget to take a tablet, you should take one as soon as you remember,
but wait at least 24 hours before taking your next tablet.
If you stop taking Zirtek Allergy Relief
Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Zirtek Allergy Relief.
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 tablets 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
• Pruritus (itchy skin), rash
feelings 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

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

• 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
• Amnesia, memory impairment
• Suicidal ideation (recurring thoughts • Vertigo (sensation of rotation or movement)
of or preoccupation with suicide)
• Urinary retention (inability to completely empty the urinary bladder)
• Pruritus (intense itching) and/or
urticaria upon discontinuation
Reporting of side effects
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
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. This medicine does not require any special storage conditions. 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. Content of the pack and other information
What Zirtek Allergy Relief contains
The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg cetirizine dihydrochloride.
The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, Opadry Y-17000 (hydroxypropylmethylcellulose (E 464), titanium dioxide (E 171), Macrogol 400).
What Zirtek Allergy Relief looks like and content of the pack
White, oblong, film-coated tablet, with breakline and Y-Y logo. Your medicine is supplied in a blister packs of 7, 30 tablets. Not all pack
sizes are marketed.
Marketing Authorisation Holder and Manufacturer
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
This leaflet was last revised October 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
CIA70971E_MU3

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 ALLERGY 10MG 7TAB - GB
Creation date: 12/10/2016
DCMF No: N/A
Operator: PH
Commodity: UCB02666
Ref no: CIA70971E_MU3
Core spec size: TI006PIL-024-03 - 305x148
Revision: GARF 2016_SEP_0073_1
Amended by: N/A
Page no: 2 of 2

Modification date: N/A

Proof no: 01

Font size body text: 8pt
Pharma code: N/A
Colours:
Colours:
Black
TECHNICAL (do not print)

Expand Transcript

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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