CLARITYNE TABLET 10mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Loratadine

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

R06AX13

Dosage:

10mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Loratadine 10mg

Administration route:

ORAL

Prescription type:

General Sale List

Manufactured by:

Schering-Plough Labo NV

Authorization status:

ACTIVE

Authorization date:

2012-01-12

Patient Information leaflet

Brand of loratadine, a potent, long-acting & non-sedating
antihistamine
PACKAGE INSERT FOR MALAYSIA MARKET
1. NAME OF THE MEDICINAL PRODUCT
Clarityne® Tablet 10mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
CLARITYNE®
Tablet
contains
10
mg
micronized
loratadine.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
CLARITYNE® Tablet: White to off-white oval tablet with score on one
side, and plain on the
other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CLARITYNE® Products are indicated for the relief of symptoms
associated with allergic rhinitis,
such as sneezing, nasal discharge (rhinorrhea) and itching, as well as
ocular itching and
burning. Nasal and ocular signs and symptoms are relieved rapidly
after oral administration.
CLARITYNE® Products are also indicated for relief of symptoms and
signs of chronic urticaria
and other allergic dermatologic disorders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and Children 12 years of age and over: _
CLARITYNE® Tablet: One tablet (10 mg) once daily;
_Children 6 to 12 years of age: _
CLARITYNE® TABLET:
Body Weight >30 kg -- One tablet (10 mg) once daily
Safety and efficacy of CLARITYNE® has not been established in
children younger than 2 years
of age.
Patients with severe liver impairment should be administered a lower
initial dose because
they may have reduced clearance of loratadine; an initial dose of 5 mg
once daily, or 10 mg
every other day is recommended.
4.3 CONTRAINDICATIONS
CLARITYNE® Products are contraindicated in patients who are
hypersensitivity to the active
substance or to any of the excipients in these formulations.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
CLARITYNE® Products should be administered with caution in patients
with severe liver
impairment (see section 4.2).
CLARITYNE®
Tablet:
This
medicinal
product
contains
lactose;
thus
patients
with
rare
hereditary
problems
of
galactose
intolerance,
the
Lapp
lactase
deficiency
or
glucose-
galactose malabsorption should not take this medicine.
The administr