Clarityn Rapide Allergy 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:

Oral lyophilisate

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other antihistamines for systemic use; loratadine

Authorization status:

Not marketed

Authorization date:

1999-11-26

Patient Information leaflet

Clarityn
December 2017
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITYN RAPIDE ALLERGY 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 Rapide Allergy is and what it is used for
2.
What you need to know before you take Clarityn Rapide Allergy
3.
How to take Clarityn Rapide Allergy
4.
Possible side effects
5.
How to store Clarityn Rapide Allergy
6.
Contents of the pack and other information
1.
WHAT CLARITYN RAPIDE ALLERGY IS AND WHAT IT IS USED FOR
The full name of your medicine is Clarityn Rapide Allergy. Clarityn
Rapide Allergy are “oral
lyophilisates” which are tablets that dissolve in your mouth
instantly.
WHAT CLARITYN RAPIDE ALLERGY IS
Clarityn Rapide Allergy contains the active substance loratadine which
belongs to a class of medicines
called “antihistamines”.
HOW CLARITYN RAPIDE ALLERGY WORKS
Clarityn Rapide Allergy 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 RAPIDE ALLERGY 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 in adults and children
over the age of 2 years who
weigh more than 30 kg.
Clarityn Rapide Allergy may also be used to help relieve symptoms of
urticaria (itching, redness and
number and size of hives).
The effect of Cl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarityn Rapide Allergy 10 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oral lyophilisate contains 10 mg loratadine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral lyophilisate
White, round, tablet - shaped unit debossed with 'C10'.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarityn Rapide Allergy is indicated for the symptomatic treatment of
allergic rhinitis and chronic idiopathic urticaria
in adults and children over the age of 2 years with a body weight more
than 30 kg_._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age: 10 mg once daily (one oral
lyophilisate once daily).
_Paediatric population_
Children 2 to 12 years of age are dosed by weight:
Body weight more than 30 kg:
10 mg once daily (one oral lyophilisate once daily).
Body weight 30 kg or less:
The 10 mg strength oral lyophilisate is not appropriate in children
with a body weight less than 30 kg. There are other
formulations more suitable for children 2 to 12 years old with body
weight 30 kg or less.
The safety and efficacy of Clarityn Rapide Allergy in children under 2
years of age have not been established. No data
are available.
_Patients with hepatic impairment_
Patients with severe liver impairment should be administered a lower
initial dose because they may have reduced
clearance of loratadine. An initial dose of 10 mg every 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.
Method of administration
Oral use. The oral lyophilisate may be taken without regard to
mealtime. Water or other liquid is not needed to swallow the
tablet. Carefully peel open an individual blister. Place it in the
mouth and it will disperse instantly.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___