Clarityn 10 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loratadine

Available from:

PCO Manufacturing Ltd.

ATC code:

R06AX; R06AX13

INN (International Name):

Loratadine

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other antihistamines for systemic use; loratadine

Authorization status:

Authorised

Authorization date:

2014-08-08

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITYN
® 10 MG TABLETS
loratadine
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:
1.
What Clarityn is and what it is used for
2.
What you need to know before you take Clarityn
3.
How to take Clarityn
4.
Possible side effects
5.
How to store Clarityn
6.
Contents of the pack and other information
1.
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.
2.
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).

Summary of Product characteristics

Health Products Regulatory Authority
16 September 2019
CRN008WK5
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: 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 flask and bowl, score and '10' on
one side and plain on the other side.
The scoreline 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 shall be the date shown on
the container and outer package of the product on the
market 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
Blister strip of 7 tablets in a cardboard carton.
Health Products Regulatory Authority
16 September 2019
CRN008WK5
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/336/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8
th
August 2014
10 DATE OF REVISION OF THE TEXT
September 2019