Clarityn 10 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loratadine

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

R06AX; R06AX13

INN (International Name):

Loratadine

Pharmaceutical form:

Tablet

Therapeutic area:

Other antihistamines for systemic use; loratadine

Authorization date:

2023-05-12

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, 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 or if you feel
worse. See
section 4.
WHAT IS IN THIS LEAFLET:
What Clarityn is and what it is used for
What you need to know before you take Clarityn
How to take Clarityn
Possible side effects
How to store Clarityn
Contents of the pack and other information WHAT CLARITYN IS AND WHAT IT IS USED FOR
The full name of your medicine is Clarityn tablets.
WHAT CLARITYN IS
Clarityn tablets contain the active substance loratadine which belongs
to a
class of medicines called “antihistamines”.
HOW CLARITYN WORKS
Clarityn helps 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 SHOULD BE TAKEN
Clarityn relieves symptoms associated with allergic rhinitis (for
example, hay
fever), such as sneezing, runny or itchy nose, and burning or itchy
eyes.
Clarityn may also be used to help relieve symptoms of urticaria
(itching,
redness and number and size of hives).
The effect of Clarityn 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITYN
DO NOT TAKE CLARITYN IF:
*
you are allergic (hypersensitive) to loratadine or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Clarityn if:
*
you have liver diseas

Summary of Product characteristics

Health Products Regulatory Authority
12 May 2023
CRN00DHNK
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarityn 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg loratadine.
Excipients with known effect: contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Greece_
White to off-white, oval tablet with a score on one side and plain on
the other side.
The score line of the tablet is only to facilitate breaking for ease
of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA1410/075/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/075/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Maize starch
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container
1
and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Clarityn tablets are blister packs consisting of aluminium foil with
vinyl heat coating and a clear PVC film. with ten tablets per
blister. Each pack contains 30 tablets on 3 blister strips.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Health Products Regulatory Authority
12 May 2023
CRN00DHNK
Page 2 of 2
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3,
Harcourt Centre,
Harcourt Road,
Dublin 2,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/060/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12
th
May 2023
10 DATE OF REVISION OF THE TEXT