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WOCKHARDT ALLERGY AND HAYFEVER RELIEF 10MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE

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Package leaflet: Information for the user
Wockhardt Allergy & Hayfever Relief 10mg 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 has 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 of the 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 your doctor if you do not feel better or if you feel worse after 3 days.
What is in this leaflet:
1. What Allergy & Hayfever Relief Tablets are and what they are used for
2. What you need to know before you take Allergy & Hayfever Relief Tablets
3. How to take Allergy & Hayfever Relief Tablets
4. Possible side effects
5. How to store Allergy & Hayfever Relief Tablets
6. Contents of pack and other information
1. What Allergy & Hayfever Relief Tablets are and what they are 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, cetirizine 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 cetirizine 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.

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2. What you need to know before you take Allergy
& Hayfever Relief Tablets
Do not take Allergy & Hayfever Relief Tablets if:
• you have severe kidney problems (severe renal failure
with creatinine clearance below 10 ml/min).
• you are allergic to cetirizine dihydrochloride, any of
the other ingredients of this medicine (listed in section
6), to hydroxyzine or piperazine derivatives (closely
related active ingredients of other medicines).
Warnings and precautions
Talk to your doctor or pharmacist before taking Allergy & Hayfever Relief Tablets:
• 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.
• If you are scheduled for allergy testing, ask your doctor if you should stop taking
Allergy & Hayfever Relief Tablets for several days before testing. This medicine may
affect your allergy test results.

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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 Allergy & Hayfever Relief Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

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Allergy & Hayfever Relief Tablets with food, drink and alcohol
Food does not affect absorption of cetirizine.
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 Allergy & Hayfever Relief Tablets with
alcohol.
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.
Allergy & Hayfever Relief Tablets 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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Cetirizine passes into breast milk. Therefore, you should not take Allergy & Hayfever Relief
Tablets 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 Allergy & Hayfever Relief Tablets at the recommended dose.

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

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Always take this medicine exactly as described in this leaflet or as the 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.
Use in children aged 6-12 years:
• The recommended dose is 5mg twice daily as a half tablet twice daily.
Adults and adolescents aged 12 years and over:
• The recommended dose is 10mg 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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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.

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Allergy & Hayfever Relief Tablets - Cetirizine Dihydrochloride
Wockhardt UK
FP4250
Daman (Bhimpore)
(w)128mm x (h)420mm
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223572
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Allergy & Hayfever Relief_Cetrizine_Lit_107821-2.ai
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R 1st PDF sent on - 1ST MARCH 2017

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Changes in detail: • New regulatory text

Non-Regulatory

If you forget to take Allergy & Hayfever Relief Tablets
Do not take a double dose to make up for a forgotten dose. 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 Cetirizine Tablets
Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Cetirizine
Tablets.

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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.

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If you take more Allergy & Hayfever Relief Tablets than you should
If you think you have taken an overdose of Allergy & Hayfever Relief Tablets please inform
your doctor. Your doctor will then decide what measures, if any, should be taken.

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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.

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If you feel that the effect of Cetirizine Tablets is too weak or too strong, please consult
your doctor.

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Common side effects (may affect up to 1 in 10 patients)
• Somnolence (sleepiness)
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhoea, nausea, dry mouth
• Fatigue

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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.
• Thrombocytopenia (low levels of blood platelets) – symptoms may include bruising or
bleeding more easily than normal.

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Like all medicines this medicine can cause side effects, although not everybody gets them.

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4. Possible side effects

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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor, 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: http://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 Allergy & Hayfever Relief Tablets

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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)
• Pruritus (intense itching) and/or urticaria upon discontinuation

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Very rare side effects (may affect up to 1 in 10,000 patients)
• 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)
• Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)

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Rare side effects (may affect up to 1 in 1,000 patients)
• Depression, hallucination, aggression, confusion, insomnia
• Convulsions
• Tachycardia (heart beating too fast)
• Liver function abnormal
• Urticaria (hives)
• Oedema (swelling)
• Weight increased

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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

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

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This medicinal product does not require any special storage conditions. Do not use after
the expiry date which is stated on the blister strip and carton.

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Keep medicine out of the sight and reach of children.

Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free
of charge: 0800 198 5000 (UK Only).

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What Allergy & Hayfever Relief Tablets look like and contents of the pack
Allergy & Hayfever Relief Tablets are white, or almost white, oval-shaped tablets with a
score line on one side. Allergy & Hayfever Relief Tablets are available from in packs of 7,
10, 14, 20 or 30 Tablets. Not all pack sizes may be marketed.

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What Allergy & Hayfever Relief Tablets contain
The active substance is cetirizine; each tablet contains 10 mg of cetirizine
dihydrochloride. The other ingredients are microcrystalline cellulose, lactose
monohydrate, crospovidone, anhydrous colloidal silica, magnesium stearate,
hypromellose (E464), titanium dioxide (E171) and polyethylene glycol (macrogol 400).

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6. Contents of the pack and other information

Reference number
PL 29831/0681

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Product name
Wockhardt Allergy & Hayfever Relief 10mg Tablets

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Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder:
Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, United Kingdom

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This leaflet was last revised in 02/2017.

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Manufacturer:
CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, United Kingdom

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Further information

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