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POLLENSHIELD HAYFEVER

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

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Package leaflet: Information for the patient

Cetirizine hydrochloride
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.

What is in this leaflet
1  What Pollenshield Hayfever is and what
it is used for
2 What you need to know before you take
Pollenshield Hayfever
3 How to take Pollenshield Hayfever
4 Possible side effects
5 How to store Pollenshield
Hayfever
6 Contents of the pack and other
information

1  What Pollenshield Hayfever is and what it
is used for

Pollenshield Hayfever contains cetirizine hydrochloride
which belongs to a group of medicines called
antihistamines.
Pollenshield Hayfever may be used to relieve:
• 
long-term runny nose and watery eyes
• 
hayfever (runny and blocked-up nose, sneezing, watery
eyes)
• 
a skin reaction with pale or red irregular raised patches
and severe itching.

2  What you need to know before you take
Pollenshield Hayfever

Do not take Pollenshield Hayfever if you:
• 
are allergic to cetirizine, hydroxyzine, any piperazine
derivatives or any of the other ingredients of this
medicine (listed in section 6).
• have severe kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pollenshield
Hayfever if you:
• 
have epilepsy.
• 
have difficulty in passing water or any risk factors
associated with this.
If you are scheduled for allergy testing, ask your doctor if
you should stop taking Pollenshield Hayfever for several
days before testing. This medicine may affect your allergy
test results.
Children
Not recommended for children under 6 years old.
Other medicines and Pollenshield Hayfever
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pollenshield Hayfever and alcohol
Speak to your doctor before drinking alcohol with
Pollenshield Hayfever. Alcohol may impair your
performance and cause you to become less alert.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking any medicine.
Driving and using machines
Drinking alcohol or taking other medicines which slow
down the nervous system (CNS depressants) may impair
your performance and cause you to become less alert.
Make sure you are not affected before you drive or operate
machinery.
Pollenshield Hayfever contains lactose
If you have been told you have an intolerance to some
sugars, contact your doctor before taking this medicine, as
it contains a type of sugar called lactose.

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148x210 Leaflet Reel Fed Profile (BST)

Cetirizine Tablets 10mg x 30’s (UK)

Cetirizine (Pollenshield) 10mg 30 Tablets PIL - UK
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JDE No.:

Item no:

BBBA0149

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
20/10/16
09.11.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
148x210
Min Body Text Size: 8pt
Supplier:
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Colours

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2. Special Orange

2.

3. pms 7405 C

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* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50912551

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4194
Date Sent:
12/10/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
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3 How to take Pollenshield Hayfever

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.
Swallow the tablets with water.
The recommended dose is:
Adults (including the elderly) and children aged 12
years old and over: One 10mg tablet a day.
Children aged 6 to 12 years old: Half a tablet (5mg)
twice a day.
Children aged under 6 years old: Not recommended.
Patients with impaired kidney function or having
dialysis
If you have impaired kidney function or you are having
dialysis, your doctor will give you a lower dose.
If you take more Pollenshield Hayfever than you
should
If you (or someone else) swallow a lot of tablets at the
same time, or you think a child may have swallowed any
contact your nearest hospital casualty department or tell
your doctor immediately. Signs of an overdose include
confusion, diarrhoea, dizziness, tiredness, headache, a
feeling of general discomfort or illness, abnormal dilation
of the pupil of the eye, itching, restlessness, sedation,
sleepiness or drowsiness, near unconsciousness with no
apparent mental activity and reduced ability to respond
(stupor), fast heart beat, involuntary shakiness (tremor),
difficulty in passing water.
If you forget to take Pollenshield Hayfever
Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose take it as soon as you
remember it and then take the next dose at the right time.

4 Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact your doctor immediately if you notice signs of:
• an allergic reaction: swelling of the face, lips, tongue
or throat, narrowing of the airways causing difficulty
breathing or swallowing (anaphylactic shock), rash,
itching.
Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
• Uncommon (may affect up to 1 in 100 people):
diarrhoea, ‘pins and needles’ or tingling, agitation,
itching, rash, weakness or loss of strength, feeling of
general discomfort or illness.
• Rare (may affect up to 1 in 1000 people): fast heart
beat, fluid retention causing swelling, weight increase,
abnormal liver function (seen in tests), fits or seizures,
movement disorders, aggression, confusion, depression,
hallucination, difficulty sleeping, pale or red irregular
raised patches with severe itching (hives).
• Very rare (may affect up to 1 in 10,000 people):
reduction in platelets in the blood, impaired ability of the
eye to focus, blurred vision, abnormal eye movements,

taste disturbance, fainting or passing out, painful or
involuntary urination, involuntary movements, tremors,
muscle spasm.
• Not
 Known (frequency cannot be estimated from the
available data): increased appetite, loss of memory,
memory impairment, feeling of dizziness or spinning
(vertigo), difficulty passing water (urinary retention),
somnolence (sleepiness), tiredness, dizziness,
headache, unexpected stimulation of the nervous
system (unexpected excitation), dry mouth, sore throat,
nausea, abdominal pain, runny nose (rhinitis).
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.
If you notice any side effects, they get worse, or if you
notice any not listed, please tell 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: 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 Pollenshield Hayfever

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Do not use this medicine after the expiry date which is
stated on the label/carton/bottle. The expiry date refers to
the last day of that month.
Do not throw away 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 Pollenshield Hayfever contains
• The
 active substance (the ingredient that makes the
tablets work) is cetirizine hydrochloride. Each tablet
contains 10mg of the active substance.
• The
 other ingredients are microcrystalline cellulose
(E460), lactose monohydrate, crospovidone, colloidal
anhydrous silica, magnesium stearate, hypromellose
(E464), macrogol stearate, propylene glycol, titanium
dioxide (E171).
What Pollenshield Hayfever look like and contents of
the pack
Pollenshield Hayfever are film-coated, white or almost
white convex, elliptical tablets.
Pack size is 30.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in November 2016.

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

50912551

BBBA0149

148x210 Leaflet Reel Fed Profile (BST)

Cetirizine Tablets 10mg x 30’s (UK)

Cetirizine (Pollenshield) 10mg 30 Tablets PIL - UK
approved for print/date

Proof Round

03

UK-Eire-Artwork-Support@Actavis.com

JDE No.:

Item no:

BBBA0149

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
20/10/16
09.11.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
148x210
Min Body Text Size: 8pt
Supplier:
UK

Colours

Non Printing Colours

1. Black

1. Profile

2. Special Orange

2.

3. pms 7405 C

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50912551

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4194
Date Sent:
12/10/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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