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CETIRIZINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS

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

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TEVA UK Ref:

231-30-50005-E LEA CETIRIZINE 10mg TAB EMP
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

3

Colours Used:

17 March 2017
BLACK
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

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.
- You must contact a doctor if your
symptoms worsen or do not improve.
- If you get any side effects talk to your
doctor or pharmacist. This includes any
side effects not listed in the leaflet. See
section 4.
What is in this leaflet

Pharma code 319

1. What EM Pharma Antihistamine Hayfever
Relief is and what it is used for
2. What you need to know before you take
EM Pharma Antihistamine Hayfever Relief
3. How to take EM Pharma Antihistamine
Hayfever Relief
4. Possible side effects
5. How to store EM Pharma Antihistamine
Hayfever Relief
6. Contents of the pack and other information

1

WHAT EM PHARMA
ANTIHISTAMINE HAYFEVER
RELIEF IS AND WHAT IT IS USED
FOR

• EM Pharma Antihistamine Hayfever Relief
contains the active substance cetirizine (as
cetirizine dihydrochloride, also known as
cetirizine hydrochloride)
• cetirizine is an antihistamine.
Antihistamines help to relieve the
symptoms of some allergies
• in adults and children 6 years and above,
this medicine is used:
• to relieve the nasal symptoms of hay
fever, seasonal rhinitis (runny and itchy
nose)
• to relieve the symptoms of other allergies
e.g. pet or house dust mite allergies
• for skin allergies such as rash, itching
and urticaria (hives).

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE EM PHARMA
ANTIHISTAMINE HAYFEVER
RELIEF

Do not take EM Pharma Antihistamine
Hayfever Relief if you:
• are allergic to cetirizine or similar
products e.g. hydroxyzine, cyclizine,
meclozine or to any of the other
ingredients of this medicine (listed in
section 6)
• are undergoing dialysis for kidney problems
• have a hereditary galactose intolerance,
Lapp lactase deficiency or
glucose-galactose malabsorption.
Warnings and precautions
Talk to your doctor or pharmacist before
taking EM Pharma Antihistamine Hayfever
Relief if you:
• have liver problems
• have kidney problems, as the dose may
need to be adjusted.
• are epileptic or at risk of convulsions
• have urinary retention problems.

REG0209757

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Approved

If you take this medicine for a long time, there
is an increased risk of tooth decay due to
mouth dryness. It is important to brush your
teeth regularly whilst taking this medicine.
Children and adolescents
Not recommended in children aged less
than 6 years of age.
Other medicines and EM Pharma
Antihistamine Hayfever Relief
Due to the profile of cetirizine, no
interactions with other drugs are expected.
Please tell your doctor or pharmacist if you
are taking, have recently taken or might take
any other medicines.

Top of page cut-off to middle of registration mark: 44 mm.

EM Pharma Antihistamine Hayfever Allergy tests: If you are going to have an
allergy skin test, stop taking this medicine
Relief 10mg Tablets
3 days before the test.
cetirizine hydrochloride

EM Pharma Antihistamine Hayfever Relief
with food, drink and alcohol
Do not take large amounts of alcohol whilst
taking this medicine, as it may increase the
effects of alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or are planning to
become pregnant or are breast-feeding, ask
your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines:
• when taken at the recommended dose,
this medicine is not expected to affect
your ability to drive or operate machinery.
However, there are exceptions and you
should take care when using this medicine
for the first time.
• if this product makes you feel drowsy, DO
NOT drive or operate machinery. This
effect will be worse if you are also taking
sedatives or drinking alcohol.
EM Pharma Antihistamine Hayfever Relief
contains lactose
Patients who are intolerant to lactose should
note that this medicine contains a small
amount of lactose. If your doctor has told
you that you have an intolerance to some
sugars, contact your doctor before taking
this medicinal product.

3

HOW TO TAKE EM PHARMA
ANTIHISTAMINE HAYFEVER
RELIEF

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.
This medicine should be swallowed with a
drink of water.
The recommended dosage is given below:
• Adults and adolescents aged 12 years and
over:
One tablet (10 mg) once daily.
• Children aged from 6 to 12 years:
Half a tablet (5 mg) twice daily.
• Children under 6 years of age:
This medicine is not recommended for
children under this age.
If you have kidney problems, you should
talk to your doctor or pharmacist for advice
before taking these tablets, as a lower dose
may be required.
If you take more EM Pharma Antihistamine
Hayfever Relief than you should
If you (or someone else) swallow a lot of the
tablets all together or if you think a child has
accidentally swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.

Page 1 of 3

TEVA UK Ref:

231-30-50005-E LEA CETIRIZINE 10mg TAB EMP
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

3

Colours Used:

17 March 2017
BLACK
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

The effects of an overdose may cause
confusion, diarrhoea, dizziness, tiredness,
headache, a general feeling of being unwell,
restlessness, feeling sleepy, a state of
semi-unconsciousness, faster heartbeat,
shaking or problems urinating.
Please take this leaflet, any remaining
tablets and the container with you to the
hospital or doctor so that they know which
tablets were consumed.
If you forget to take EM Pharma
Antihistamine Hayfever Relief
If you forget to take a tablet, take one as
soon as you remember, unless it is nearly
time to take the next one. Do not take a
double dose to make up for a forgotten
tablet or dose. Take the remaining doses at
the correct time.








fainting
decreased sense of taste
bed wetting
pain in passing water
inflammatory skin eruption
unusual movements or contractions in the
face
• abnormal muscle rigidity or movements
• shaking.
Not known (frequency cannot be estimated
from the available data):
• amnesia - partial or total loss of memory,
memory impairment
• increased appetite
• vertigo
• urinary retention.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
If you have any further questions on the use of
any possible side effects not listed in this
this medicine, ask your doctor or pharmacist.
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
4 POSSIBLE SIDE EFFECTS
www.mhra.gov.uk/yellowcard
Like all medicines, this medicine can have
By reporting side effects you can help
side effects, although not everybody gets
provide more information on the safety of
them.
this medicine.
Stop taking the tablets and tell your doctor
immediately or go to the casualty
department at your nearest hospital if the
following happens:
• a severe allergic reaction (swelling of the
face, lips, mouth or throat leading to
severe difficulty in breathing or
swallowing; skin rash or hives).
This is a very serious but rare side effect.
You may need urgent medical attention or
hospitalisation.

5

HOW TO STORE EM PHARMA
ANTIHISTAMINE HAYFEVER
RELIEF

Keep this medicine out of sight and reach of
children.
There are no special storage conditions. Do
not transfer to another container.
Do not take this medicine after the expiry
date which is stated on the outer packaging.
The expiry date refers to the last day of that
month.

In very rare cases people have thoughts
about committing suicide and if you feel this Do not take this medicine if you notice any
defects or signs of deterioration in the
way then stop taking these tablets and see
tablets such as broken tablets.
your doctor.
Do not throw away any medicines via
The following side effects have been
wastewater or household waste. Ask your
reported at the approximate frequencies
pharmacist how to throw away medicines
shown:
you no longer take. These measures will
Common (may affect up to 1 in 10 people):
help protect the environment.
• tiredness or sleepiness
• dizziness or headache
6 CONTENTS OF THE PACK AND
OTHER INFORMATION
• nausea or diarrhoea
• dry mouth or difficulty in swallowing
What EM Pharma Antihistamine Hayfever
accompanied by earache and swollen
Relief contains
glands, sore throat
• the active ingredient is cetirizine
• runny and itchy nose.
dihydrochloride 10 mg (also known as
cetirizine hydrochloride)
Uncommon (may affect up to 1 in 100 people):
• the other ingredients are microcrystalline
• agitation
cellulose, lactose monohydrate, colloidal
• abdominal pain
anhydrous silica, magnesium stearate
• lethargy or feeling weak and/or unwell
(E572), hypromellose (E464), macrogol,
• pins and needles
titanium dioxide (E171) and polydextrose
• skin itchiness or rashes.
Rare (may affect up to 1 in 1,000 people):
• rapid heartbeat
• water retention
• liver problems (diagnosed by blood
and/or urine tests)
• weight gain
• fits or unusual movements of your arms
and/or legs
• aggression or depression
• confusion
• hallucinations
• difficulty in sleeping
• red and/or blotchy skin rash.

What EM Pharma Antihistamine Hayfever
Relief looks like and contents of the pack
• EM Pharma Antihistamine Hayfever Relief
10 mg film-coated tablets are white to off
white, capsule-shaped tablets, debossed
with C10 on one side and a deep break
line on the other.
• the product is available in pack sizes of 7,
14, 15, 20, 28 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG, UK.

Very rare (may affect up to 1 in 10,000 people): This leaflet was last revised: January 2017
• bleeding and bruising easily (could
PL 00289/0388
indicate problems with your blood)
• sight problems including difficulty
focusing and blurred vision
• unusual movements of the eyeball

50005-E
160 x 323

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
uk-mockup-pil-pl00289-0388

APPROVALS
Signed by
Martina Tredget

REG0209757

Meaning of Signature
Regulatory Affairs Approval

Version 0.3

Approved

Server Date
21-Mar-2017 04:24:33 PM

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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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