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CARE HAYFEVER AND ALLERGY 1MG/ML SOLUTION

Active substance: CETIRIZINE HYDROCHLORIDE

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2.  efore you use this
B
Care Hayfever and Allergy
medicine

 not use the medicine if you or
Do
your child have­­­….

1 mg/ml Solution
(cetirizine hydrochloride)

FRONT FACE TOP

Hayfever and Allergy 1 mg/ml Solution should
not be used whilst breastfeeding.

Important information about Care Hayfever
and Allergy 1 mg/ml Solution
•  his medicine relieves the symptoms of
T
hayfever in adults and children over 2 years.
• t can also be used for other allergies in older
I
children and adults. See section 3.
Do not….
•  rink large amounts of alcohol whilst taking
D
this medicine.
Now read the rest of the leaflet before you use
this medicine. It includes other information
which might be especially important for you.
•  eep this leaflet. You may need to read it again.
K
•A
  sk your pharmacist if you need any more
information or advice.
• f any of the side effects gets serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

1. What the medicine is for
Hayfever and Allergy 1 mg/ml Solution contains
cetirizine, an antihistamine, to treat the
symptoms of allergies.
• t can be used for the symptoms of hayfever
I
in adults and children over 2 years.
• t can also be used for the symptoms of nonI
seasonal allergies which cause a runny, itchy
nose, and skin allergies such as rash, itching
and hives in adults and children over 6 years.
•  dults and children over 12 years may use it
A
for inflammation of the eyes caused by
allergic reactions (conjunctivitis).

•  n allergy to any of the ingredients listed in
A
section 6.
•  n allergy to hydroxyzine or to piperazine
A
derivatives.
•  n intolerance to some sugars e.g. fructose
A
as this medicine contains sorbitol.
• Moderate to severe kidney problems.
• Or your child is under 2 years old.

 
Children from 2 – 6 years (or weigh
less than 30kg)

Driving and using machines….

One 5ml spoonful once a day or half a spoonful
(2.5ml) twice a day in the morning and evening.

This medicine may slow down your reaction
time or cause drowsiness and you should not
drive or operate machinery until the effects
have worn off.

Children under 2 years
Do not give to children under 2 years unless
your doctor tells you to.


Important information about some
of the ingredients

• Poor kidney or liver function.
• Epilepsy or are at risk of convulsions.


Talk to your doctor if you or your
child are taking….

For non-seasonal allergies (runny, itchy

•  his medicine contains sorbitol. If you have
T
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
• t also contains methyl and propyl
I
parahydroxybenzoates (E218) which may
cause allergic reactions (possibly delayed).

3. How to use this medicine

 
Talk to your doctor if you or your
child have….

•  ranquillisers, sedatives (e.g. temazepam,
T
nitrazepam, diazepam, promethazine) or alcohol.
•  n allergy test. You should not take Hayfever
A
and Allergy 1 mg/ml Solution for 3 days
before the test, as it may effect the result.

Take special care….
If you take this medicine for long periods there
is an increased risk of tooth decay due to
mouth dryness. It is important to brush your
teeth regularly.

Pregnant or breastfeeding….

nose, and skin allergies such as rash, itching
and hives).

Adults and children over 12 years:
Two 5ml spoonfuls (10ml) once a day.
If drowsiness occurs, take the medicine in the
evening.

Children from 6 – 12 years

Take this medicine by mouth.

Two 5ml spoonfuls once a day or one 5ml
spoonful twice a day in the morning and
evening.

For relief from hayfever
Adults and children over 12 years:
Two 5ml spoonfuls (10ml) once a day.
If drowsiness occurs, take the medicine in the
evening.

If you forget a dose
Take the next dose as soon as you remember.
Do not take a double dose. You can then carry
on with the normal dose.

Children from 6 – 12 years Header Box For allergic conjunctivitis
MHRA
Two 5ml spoonfuls once a day or one 5ml
Product
spoonful twice a day in the morning and
Title
evening.

Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might
be pregnant or are breastfeeding.

Colours Used
Care Adults and children over 12 years:
Hayfever and Allergy 1mg/ml
Solution 5ml spoonfuls (10ml) once a day.
Two
Process Black

If drowsiness occurs, take the medicine in the
Keylines (non-printing)
evening.

Component
Pack Size

200ml
23814505

Helvetica

338 x 148mm flat (29 x 148mm folded)
1

Fonts Used

Leaflet

IG Code

Turn over
23814505
Date

02.02.2015

PCP Header Box

MHRA Header Box
Colours Used

Product
Title

Care Hayfever and Allergy 1mg/ml
Solution

Component

Leaflet

Pack Size
IG Code

23814505

Dimensions

338 x 148mm flat (29 x 148mm folded)

Proof No.

1

Process Black

Approved by
Date

Fonts Used

200ml

Helvetica

Operator

gill.kennedy

Artwork No 555383

Keylines (non-printing)

Suf fix

CRN

Date

11913

Reason for
Change

Addition of reporting of side
effects statement

A

02.02.2015
Issued by
Date

MHRA/IMB
submission N/A
required

PCP Header Box
Approved by
Date

gill.kennedy

Artwork No 555383

11913

If you take too much
If you accidentally take too much, contact a
doctor straight away. Take the pack with you to
show which medicine you have swallowed.

Do not give to children under 6 years unless
your doctor tells you to.

Proof No.

CRN

Do not give to children under 12 years unless
your doctor tells you to.
If you have kidney problems your dose may
have to be changed on the advice of a doctor,
depending on how much your kidneys are
affected.
DO NOT EXCEED THE STATED DOSE.
If your symptoms persist you should ask your
doctor for advice.

Children under 6 years

Dimensions

Operator

Children under 12 years

Suf fix

A

Data Matrix: 23814505 VERIFIED

Data Matrix: 23814505 VERIFIED

REVERSE FACE TOP

4. Possible side effects
Like all medicines, Hayfever and Allergy
1 mg/ml Solution can have side effects,
although these don’t affect everyone.
Important side effects:
If you think you have any of the following side
effects or symptoms, stop using this medicine
immediately and see a doctor as soon as
possible.
•  llergic reactions which may cause difficulty
A
in breathing, fever, swelling of the mouth, lips
or skin, severe rashes, itching or hives.
•  onvulsions (fits).
C
• Confusion.
•  allucinations.
H
•  bnormal liver function tests.
A
•  apid heartbeat.
R
Other possible side effects are:
• Mouth dryness.
• Headache or dizziness.
• Drowsiness or feeling unusually tired.
• Sleepiness in children.
• Restlessness in adults.
• Stomach upsets or nausea.
• Diarrhoea or constipation.
• Sore throat or runny nose.
• Dry eyes.
Uncommon or rare side effects are:
• Agitation.
• Fainting, feeling weak or generally unwell.
• Insomnia.
• Skin itching, tingling or burning sensations.
• Rashes e.g. hives.
• Aggression, depression.
• Tremors, tics, muscle spasm.
• Swelling.

• Weight gain.
• Unpleasant taste in the mouth.
• Low blood platelet count.
• Blurred vision or eye movement disorder.
• Problems with passing water.
If you notice these or any other side effect not
included above, stop use and tell your doctor or
pharmacist. They will tell you what to do.
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. Storing this medicine

• Keep it out of the sight and reach of children.
•  o not use after the expiry date shown on the
D
carton. The expiry date refers to the last day
of that month.
•  edicine should not be disposed of via
M
wastewater or household waste. Ask your
pharmacist how to dispose of any unused
medicine. These measures will help to protect
the environment.

6. Further information
What the medicine contains

The active ingredient per 5ml is: cetirizine
5mg.
The other ingredients are: glycerol (E422),
propylene glycol, sorbitol (E420), methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate, sodium acetate, acetic
acid, saccharin sodium, banana flavour, and
purified water.

What the medicine looks like
Hayfever and Allergy 1 mg/ml­­­Solution is a
clear colourless liquid which smells of banana.
It is supplied in a 200ml bottle.

Marketing authorisation holder and
manufacturer
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
This leaflet was last revised in February 2015

MHRA Header Box
Colours Used

Product
Title

Care Hayfever and Allergy 1mg/ml
Solution

Component

Leaflet

Pack Size

200ml

IG Code

23814505

Dimensions

338 x 148mm flat (29 x 148mm folded)

Proof No.

1

Process Black

Colours Used

Product
Title

Care Hayfever and Allergy 1mg/ml
Solution

Component

Leaflet

Pack Size

23814505
Date

02.02.2015

IG Code

23814505

Dimensions

338 x 148mm flat (29 x 148mm folded)

Proof No.

1

Process Black

Approved by
Date

Fonts Used

200ml

Helvetica

Operator

gill.kennedy

Artwork No 555383

Keylines (non-printing)

Suf fix

CRN

Date

11913

Reason for
Change

Addition of reporting of side
effects statement

A

02.02.2015
Issued by
Date

MHRA/IMB
submission N/A
required

PCP Header Box
Approved by
Date

gill.kennedy

Artwork No 555383
CRN

11913

Helvetica

Keylines (non-printing)

PCP Header Box

MHRA Header Box

Operator

Fonts Used

Suf fix

A

Data Matrix: 23814505 VERIFIED

Data Matrix: 23814505 VERIFIED

Expand view ⇕

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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