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BELLS HEALTHCARE ALLERGY RELIEF 10MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE HYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE

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221216/2

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Relonchem_Bell's

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Description

Cetirizine 10mg Leaflet

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UK

Language

English

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150 x 360 mm

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9 pt

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Version No.

1

Date

22-12-16

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Coreldraw 12

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BELL'S HEALTHCARE ALLERGY &
HAYFEVER 10 MG TABLETS
(cetirizine hydrochloride)

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.

!
Oedema (swelling)
!
Weight increased

Very rare side effects (may affect up to 1 in
10,000 patients)
PATIENT INFORMATION LEAFLET
!
Thrombocytopenia (low levels of blood
platelets)
Children
The name of this medicine is Bell's Healthcare
!
Tics (habit spasm)
Do not give this medicine to children below
Allergy & Hayfever 10mg Tablets, which will
If you feel the effect of Cetirizine is too week or
!
Syncope, dyskinesia (involuntary
the
age
of
6
years
because
the
tablet
be referred to as Cetirizine Tablets throughout
too strong, please contact your doctor.
movements), dystonia (abnormal
formulation does not allow necessary dose
this leaflet.
prolonged muscular contractions),
adjustment.
Duration of treatment
tremor, dysgeusia (altered taste)
Read all of this leaflet carefully before you
The duration of treatment depends on the
!
Blurred vision, accommodation disorder
Taking
other
medicines
start taking this medicine.
type, duration and course of your complaints.
(difficulty focusing), oculogyration (eyes
Please tell your doctor if you are taking or
!
Keep this leaflet. You may need to read it
Please ask your doctor or pharmacist for
having uncontrolled circular movements)
have
recently
taken
any
of
the
following
again.
advice.
!
Angioedema (serious allergic reaction
medicines, as they may decrease or increase
!
If you have any further questions, ask your
which causes swelling of the face or
the
effect
of
Allergy
&
Hayfever
Tablets
and
doctor or your pharmacist.
If drowsiness occurs, your tablet can be taken
throat), fixed drug eruption
vice versa.
!
Do not pass this medicine on to others; it
in the evening
!
Abnormal elimination of urine (bed
!
medication
for
anxiety
or
stress
(CNS
may harm them, even if their symptoms
Method of administration: For oral use.
wetting, pain and/or difficulty passing
depressants)
are the same as yours.
water)
!
If any of the side effects gets serious, or if
If you take more Allergy & Hayfever
It may still be alright for you to take Allergy &
you notice any side effects not listed in the
Tablets than you should
Not known frequency of side effects
Hayfever
Tablets
and
your
doctor
will
be
able
leaflet, please tell your doctor or
If
you
have
accidentally
taken
more
than
the
(frequency
cannot be estimated from the
to decide what is suitable for you. Please tell
pharmacist.
recommended dose, contact your nearest
available data)
your
doctor
or
pharmacist
if
you
are
taking
or
!
you must talk to a doctor if you do not feel
!
Increased appetite
hospital casualty department or tell your
have recently taken any other medicines,
better or if you feel worse after 3 days.
!
Amnesia, memory impairment
doctor or pharmacist immediately.
including medicines obtained without a
!
Vertigo (sensation of rotation or
Remember to take the pack and any
prescription.
In this leaflet
movement)
remaining tablets with you.
1. What Allergy & Hayfever Tablets are and
!
Urinary retention (inability to completely
Taking your medicine with food and drink
what they are used for
empty the urinary bladder)
After an overdose, the side effects described
Allergy
&
Hayfever
Tablets
can
be
taken
with
2. Before you take Allergy & Hayfever
!
Pruritus (intense itching) and/or urticaria
below may occur with increased intensity.
or
without
food.
Tablets
upon discontinuation
Adverse effects such as confusion,
3. How to take Allergy & Hayfever Tablets
diarrhoea, dizziness, tiredness, headache,
Pregnancy
and
breast-feeding
4. Possible side effects
In very rare cases people have thought about
ailing, dilating of pupil, itching, restlessness,
Tell your doctor if you are pregnant, think you
5. How to store Allergy & Hayfever Tablets
committing suicide and if you feel this way
sedation, somnolence, stupor, abnormal
might
be
pregnant,
or
are
planning
to
become
6. Contents of the pack and further
then stop taking the tablets and see your
rapid heart rate, tremors and urinary retention
pregnant. As with other drugs, the use of
information
doctor.
have been reported.
Allergy & Hayfever Tablets should be avoided
in pregnant women. Accidental use of the
1. WHAT ALLERGY & HAYFEVER
If you forget to take Allergy & Hayfever
Reporting of side effects
drug
by a pregnant woman should not
TABLETS ARE AND WHAT THEY ARE
Tablets
If you get any side effects, talk to your doctor,
produce
any
harmful
effects
on
the
foetus.
USED FOR
If you have forgotten to take your tablet, take it
pharmacist or nurse. This includes any
Nevertheless, the administration of the
possible side effects not listed in this leaflet.
as soon as you remember and then wait 24
medicine
should
be
discontinued.
The active ingredient in your tablets is
You can also report side effects directly via
hours before taking your next dose.
cetirizine hydrochloride, which belongs to a
the Yellow Card Scheme at:
If you have any further questions on the use of
You
should
not
take
Allergy
&
Hayfever
group of medicines called antihistamines.
www.mhra.gov.uk/yellowcard
this product, ask your doctor or pharmacist.
Tablets during breast-feeding because
These are used to relieve the symptoms of
By
reporting side effects you can help provide
cetirizine passes into breast milk.
seasonal allergic rhinitis (e.g. hay fever),
more information on the safety of this
If you stop taking Cetirizine
Ask
your
doctor
or
pharmacist
for
advice
perennial allergic rhinitis (e.g. year round
medicine.
Rarely, pruritus (intense itching) and/or
before taking any medicine.
allergies often due to house dust mites or
urticaria may return if you stop taking
animal allergies) and urticaria (itchy, red,
5. H O W TO S TO R E A L L E R G Y &
Cetrizine.
Driving and using machines
swollen skin). These symptoms include itchy
HAYFEVER TABLETS
If you have any further questions on the use of
Clinical
studies
have
produced
no
evidence
skin rashes; sneezing; itchy, runny or blocked
this
medicine,
ask
your
doctor
or
pharmacist.
of impaired attention, alertness and driving
nose; red, itchy and watering eyes.
Keep out of the sight and reach of
capabilities after taking Allergy & Hayfever
4.
POSSIBLE
SIDE
EFFECTS
children.
Tablets at the recommended dose.
2. BEFORE YOU TAKE ALLERGY &
HAYFEVER TABLETS

ASLT514

Do not take this medicine after the expiry date
Like all medicines, this medicine can cause
If you are intending to drive, engage in
(Exp.) stated. The expiry date refers to the
side effects, although not everybody gets
potentially
hazardous
activities
or
operate
Do not take Allergy & Hayfever Tablets if
last day of that month. This medicinal product
them.
machinery, you should not exceed the
you:
does not require any special storage
The following side effects are rare or very
recommended
dose.
You
should
closely
!
are allergic to cetirizine hydochloride,
conditions.
rare, but you must stop taking the
observe your response to the drug. If you are
hydroxyzine, piperazine derivatives or
medicine and speak to your doctor
a
sensitive
patient,
you
may
find
that
the
any of the other ingredients in Allergy &
Do not throw away any medicines via waste
straight away if you notice them:
simultaneous use of alcohol or other nervous
Hayfever Tablets (these are listed in
water or household waste. Ask pharmacist
!
Allergic reactions, including severe
depressant
agents
may
additionally
affect
section 6, Further Information)
reactions and angioedema (serious
how to throw away medicines no longer use.
your attention and ability to react.
!
have a severe kidney disease (severe
allergic reaction which causes swelling of
These measures will help to protect the
renal failure with creatine clearance below
the face or throat).
environment.
Important information about some of the
10/ml/min)
ingredients of Allergy & Hayfever Tablets
6. CONTENTS OF THE PACK AND
These reactions may start soon after you first
This product contains lactose. If you have
Warnings and precautions
FURTHER INFORMATION
take the medicine, or it might start later.
been
told
by
your
doctor
that
you
have
an
If you are a patient with renal insufficiency,
Common side effects (may affect up to 1 in
intolerance
to
some
sugars,
contact
your
please ask your doctor for advice; if
10 patients)
What Allergy & Hayfever Tablets contain:
doctor before taking this medicinal product.
necessary, you will take a lower dose. The
!
Somnolence (sleepiness)
The active ingredient is cetirizine
Methyl
parahydroxybenzoate
and
propyl
new dose will be determined by your doctor.
!
Dizziness, headache
hydrochloride. Each tablet contains 10 mg of
parahydroxybenzoate may cause allergic
!
Pharyngitis, rhinitis (in children)
cetirizine hydrochloride.
reactions
(possibly
delayed).
If you have problems of urinary retention,
!
Diarrhea, nausea, dry mouth
The other ingredients are: lactose
please ask your doctor for advice.
!
Fatigue
monohydrate, microcrystalline cellulose,
3. H O W T O TA K E A L L E R G Y &
colloidal anhydrous silica, maize starch, talc,
HAYFEVER TABLETS
If you are an epileptic patient or a patient at
Uncommon side effects (may affect up to 1
magnesium stearate, titanium dioxide
risk of convulsions, you should ask your
in 100 patients)
(E171), hypromellose, macrogol, sodium
Always
take
Allergy
&
Hayfever
Tablets
doctor for advice
!
Agitation
citrate.
exactly as your doctor or pharmacist has told
No interactions susceptible to have a
!
Paresthesia
(abnormal
feelings
of
the
you to do so. You should check with your
noticeable impact have been observed
skin)
What Allergy & Hayfever Tablets look like
doctor or pharmacist if you are not sure.
between alcohol (at the blood level of 0.5 per
!
Abdominal pain
and the contents of the pack:
ml corresponding to one glass of wine) and
!
Pruritus (itchy skin), rash
Allergy & Hayfever Tablets are white
Dosage
cetirizine used at the normal doses.
!
Asthenia
(extreme
fatigue),
malaise
coloured,
circular, biconvex film coated
The usual dosage is:
However, as is the case with all
tabletswith a break line .
Adults,
elderly
and
children
over
12
years:
antihistamines, it is recommended to avoid
Rare side effects (may affect up to 1 in 1,000
Your medicine is available in packs containing
Take one tablet (10 mg) once daily.
concurrent consumption of alcohol.
patients)
7, 10, 14, 28, 30, 60 and 100 tablets.
Children aged 6 - 12 years: Take half a tablet
!
Allergic reactions, some severe (very
(5 mg) twice daily (morning and evening).
Allergy & Hayfever Tablets can affect the
rare)
Not all pack sizes may be marketed.
Children
weighing
less
than
30
kg:
Half
a
results of allergy skin tests. If you require an
!
Depression,
hallucination,
aggression,
tablet (5 mg) should be taken once
allergy test you should stop taking Allergy &
confusion, insomnia
Marketing Authorisation Holder /
daily.Patients with renal impairment
Hayfever Tablets three days before you have
!
Convulsions
Manufacturer:
Patients with moderate renal impairment are
the tests.
!
Tachycardia (heart beating too fast)
Relonchem Limited, Cheshire House, Gorsey
recommended to take 5mg once daily.
!
Liver function abnormal
Lane, Widnes, Cheshire, WA8 0RP, UK.
!
Urticaria (hives)
Date Leaflet Approved December 2016

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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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