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CLARITYN ALLERGY 10MG TABLETS

Active substance(s): LORATADINE

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CH–8293
BAYER
Clarityn Allergy
Tablets
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OTH 002879
84292729/84292737/84292745/
84293067
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Illustrator CS6
PIL-OTH002879
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155 x 297 mm
October 12th 2015
9 pt (x-height=1,76mm)

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Pantone 287 C

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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, pharmacist, or nurse
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 side effects, talk to your doctor,
pharmacist, or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel
better, if you feel worse or if your symptoms
change. See section 4.
What is in this leaflet:
1. What Clarityn Allergy Tablets are and what they
are used for
2. What you need to know before you take
Clarityn Allergy Tablets
3. How to take Clarityn Allergy Tablets
4. Possible side effects
5. How to store Clarityn Allergy Tablets
6. Contents of the pack and other information
1. WHAT CLARITYN ALLERGY TABLETS
ARE AND WHAT THEY ARE USED FOR
The full name of your medicine is Clarityn
Allergy 10 mg Tablets.

What Clarityn Allergy Tablets are
Clarityn Allergy tablets contain the active substance
loratadine which belongs to a class of medicines
called “antihistamines”.
13,3 mm
13,3 mm
Dennis Prochota
prochota@packpool.ch
+41 61 201 10 23

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version

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version

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How Clarityn Allergy Tablets work
Clarityn Allergy tablets help to reduce your allergy
symptoms by stopping the effects of a substance
called “histamine”, which is produced in the body
when you are allergic to something.
When Clarityn Allergy Tablets should be
taken
Clarityn Allergy Tablets relieves symptoms
associated with allergic rhinitis (for example, hay
fever), such as sneezing, runny or itchy nose, and
burning or itchy eyes in adults and children over
the age of 2 years who weigh more than 30 kg.
Clarityn Allergy Tablets may also be used to help
relieve symptoms of urticaria (itching and redness)
which is often known as hives or nettle rash.
The effect of Clarityn Allergy Tablets will last a
whole day and should help you to continue your
normal daily activities and sleep.
You must talk to a doctor if you do not feel better
or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CLARITYN ALLERGY
TABLETS
Do not take Clarityn Allergy Tablets if:
• You are allergic (hypersensitive) to loratadine or
any of the other ingredients of this medicine
(listed in section 6).
• You are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Clarityn Allergy Tablets if:
• You have liver disease.
• You are scheduled to have any skin tests for
allergies. Do not take Clarityn Allergy Tablets for
two days before having these tests. This is
because it may affect the test results.
If any of the above apply to you (or you are not
sure), talk to your doctor, pharmacist or nurse
before taking Clarityn Allergy Tablets.
Children
Do not give Clarityn Allergy Tablets to children
younger than 2 years old or to children 2 to 12
years old who weigh less than 30 kg. There are
other formulations more suitable for children 2 to
12 years old who weigh less than 30 kg.
Other medicines and Clarityn Allergy Tablets
The side effects of Clarityn Allergy Tablets may
increase when used together with medicines that
alter the performance of some enzymes
responsible for drug-metabolism in the liver.
However, in clinical studies, no increase in side
effects of loratadine was seen with products that
altered the performance of these enzymes.
Tell your doctor, pharmacist or nurse if you are
taking, have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription.
Clarityn Allergy Tablets with alcohol
Clarityn Allergy Tablets have not been shown to
add to the effects of an alcoholic drink.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
As a precautionary measure, it is preferable to
avoid the use of Clarityn Allergy Tablets during
pregnancy.
Do not take Clarityn Allergy Tablets if you are
breast-feeding. Loratadine is excreted in breast milk.
Driving and using machines
In clinical trials that assessed driving ability, no
impairment was observed in patients receiving
loratadine. At the recommended dose, Clarityn
Allergy Tablets are not expected to cause you to be
drowsy or less alert. However, very rarely some
people experience drowsiness, which may affect
their ability to drive or use machines.
Clarityn Allergy Tablets contains lactose
Clarityn Allergy Tablets contains lactose; thus if you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.
3. HOW TO TAKE CLARITYN ALLERGY
TABLETS
Always take this medicine exactly as described in
this leaflet or as your doctor, pharmacist or nurse
has told you. Check with your doctor, pharmacist
or nurse if you are not sure.

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CH–8293
BAYER
Clarityn Allergy
Tablets
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The score line of the tablet is only there to help you
break the tablet if you have difficulty swallowing it
whole.
Giving this medicine to children
Clarityn Allergy syrup may be preferable for
children. It is important to know how much your
child weighs to make sure that you give the correct
amount of medicine. For example, a 9 year old child
weighs about 30kg (4st 7lb). If in doubt weigh your
child and then follow the instructions in the table.

84292729/84292737/84292745/
84293067
Leaflet
XXXXXXXXXXX
triptyque code

-

barcode

Illustrator CS6

Do not give to children under 2 years or who weigh
30 kg (4st 7lb) or less.

PIL-OTH002879
3

How much to take:

155 x 297 mm

Age

October 12th 2015
9 pt (x-height=1,76mm)

Offset
2
Pantone 287 C

Dieline

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Helvetica, U001, Myriad Pro

Children of 2 to 12
years who weigh more
than 30kg (4st 7lb)

How much How often
to take
to take
1 x tablet Once daily

1 x tablet Once daily
Adults and children
over 12 years
If you have severe liver problems your doctor
or pharmacist may advise you to take the
recommended amount every other day. If this
applies to you follow their instructions.

If you take more Clarityn Allergy Tablets
than you should
If you take more Clarityn Allergy Tablets than you
should, talk to your doctor or pharmacist straight
away. No serious problems are expected however,
you may get a headache, have a rapid heartbeat or
feel sleepy.
If you forget to take Clarityn Allergy Tablets
• If you forget to take your dose, take it as soon
as you remember, then continue to take it as
usual.
• Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this
product, ask your doctor, pharmacist or nurse.

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13,3 mm
Dennis Strauss
strauss@packpool.ch
+41 61 201 10 23

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version

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4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The most commonly reported side effects in adults
and children over 12 years of age are:
• drowsiness
• headache
• increased appetite
• difficulty sleeping.
The most commonly reported side effects in
children aged 2 to 12 years are:
• headache
• nervousness
• tiredness
The following very rare side effects (may affect up
to 1 in 10,000 people) have also been seen during
the marketing of loratadine:
• severe allergic reaction (including swelling)
• dizziness
• convulsion
• fast or irregular heartbeat
• nausea (feeling sick)
• dry mouth
• upset stomach
• liver problems
• hair loss
• rash
• tiredness

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 (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom: Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
Malta: ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3, Rue
D'Argens, GŻR-1368 Gżira Website:
www.medicinesauthority.gov.mt,e-mail:
postlicensing.medicinesauthority@gov.mt
5. HOW TO STORE CLARITYN ALLERGY
TABLETS
• This medicinal product does not require any
special storage conditions.
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which is stated on the blister after Exp. The
expiry date refers to the last day of the month.
• Do not use this medicine if you notice any
change in the appearance of the tablet.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Clarityn Allergy Tablets contain
• The active substance is loratadine. Each tablet
contains 10 mg loratadine.
• The other ingredients are lactose monohydrate,
maize starch, magnesium stearate.
What Clarityn Allergy Tablets looks like and
contents of the pack
Clarityn Allergy Tablets are white, to off-white, oval
tablets with flask and bowl, scoreline and the
number “10” on one side.
Clarityn Allergy tablets are available in pack sizes of
5, 7, 10, 14, 15, 20, 21, 28, 30, or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Bayer plc, Consumer Care Division
Bayer House, Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom

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OTH 002879

Manufacturer:
Schering-Plough Labo NV,
Industriepark, 30
B-2220 Heist-op-den-Berg,
Belgium
Schering-Plough
Rue Louis Pasteur, 2
F-14200 Herouville Saint Clair
France
This leaflet was last revised in
October 2015.

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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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