Clarityn 10 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loratadine

Available from:

Bayer Limited

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:

Marketed

Authorization date:

1988-11-18

Patient Information leaflet

PACKAGE LEAFLET
BCH22023
2
September 2022
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 med

Summary of Product characteristics

Health Products Regulatory Authority
04 May 2023
CRN00DK45
Page 1 of 6
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: The quantity of lactose monohydrate in
the loratadine 10 mg tablet composition is 71.3mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
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
4.1 THERAPEUTIC INDICATIONS
Clarityn tablet is indicated for the symptomatic treatment of allergic
rhinitis and chronic idiopathic urticaria_. _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One tablet once daily.
_Paediatric population_
Children 6 years of age and older with a body weight greater than 30
kg: one tablet once daily. For appropriate dosing in
children younger than 6 years or with body weight of 30 kg or less,
there are other formulations more suitable.
Children under 2 years of age:
The safety and efficacy of Clarityn have not been established . No
data are available.
_Patients with hepatic impairment_
Patients with severe liver impairment should be administered a lower
initial dos ebecaus ethe ymay have reduced clearance of
loratadine. An initial dose of 10 m g e very other day is recommended
for adults and children weighing more than 30 kg .
_Patients with renal impairment_
No dosage adjustments are required in patients with renal
insufficiency.
_Elderly_
No dosage adjustments are required in the elderly.
M ethod of administration
Oral use. Th e table t ma y b e take n withou t regar d t o mealtime .
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Clarityn should be administered with caution in patients with severe