Skip to Content

ZIRTEK ALLERGY 10MG TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Zirtek® Allergy 10mg Tablets

1519
23.01.17[12]

(cetirizine dihydrochloride)
PATIENT INFORMATION LEAFLET
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.
Your medicine will be referred to as Zirtek throughout the following leaflet.
What is in this leaflet:
1. What Zirtek is and what it is used for
2. What you need to know before you take Zirtek
3. How to take Zirtek
4. Possible side effects
5. How to store Zirtek
6. Content of the pack and further information.
1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek. Zirtek is an
antiallergic medication.
In adults and children aged 6 years and above, Zirtek 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
Do NOT take Zirtek
- 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 with alcohol.
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.
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
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Zirtek with food and drink
Food does not affect absorption of Zirtek.
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 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
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 at the recommended dose. 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.
Zirtek 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
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 half a 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 is too weak or too strong, please consult
your doctor.
Duration of treatment
The duration of the treatment depends on the type, duration and course of
your complaints. Please ask your doctor or pharmacist for advice.
If you take more Zirtek than you should
If you think you have taken an overdose of Zirtek 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 a tablet
Do not take a double dose to make up for forgotten dose.
If you stop taking Zirtek
Rarely, pruritus (intense itching) and/or urticaria may return if you stop
taking Zirtek.
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
- Pruritis (itchy skin), rash
- Asthenia (extreme fatigue), malaise

Rare side effects (may affect upto 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 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
Keep out of the sight and reach of children.
Do not use Zirtek after the expiry date which is stated on the box and
blister.
Do not store above 30oC. Store in the original pack.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required.
These measures will help to protect the environment
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zirtek contains
Each film-coated tablet contains 10 mg cetirizine dihydrochloride as the
active ingredient.
Your medicine also contains microcrystalline cellulose, lactose, colloidal
anhydrous silica, magnesium stearate, hypromellose, macrogol and
titanium dioxide (E171).
What Zirtek looks like and contents of the pack
The tablets are white oblong film-coated tablets with the markings 'Y/Y' and
a scoreline on one side. Your medicine is supplied in blister packs of 20
and 30 tablets.
Manufacturer and Product Licence holder
Manufactured by Vedim Sp. z.o.o., ul. Kruczkowskiego 8, 00-380 Warsaw,
Poland and is procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
P

PL 20636/1519

Leaflet revision and issue date (Ref.) 23.01.17[12]
Zirtek is a trademark of UCB Pharma SA.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

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.

Hide