Claritine tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

loratadine

Available from:

Schering-Plough Labo N.V Industriepark 30

ATC code:

R06AX13

INN (International Name):

loratadine

Dosage:

10mg

Pharmaceutical form:

tablets

Units in package:

(10/1x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-12-27

Summary of Product characteristics

Page 1 of 5
Summary of Product Characteristics
Claritine

tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Claritine tablets 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 10 mg of loratadine.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Indicated for
the
symptomatic
treatment
of
allergic
rhinitis
(characterized
by
sneezing, rhinorrhea and nasal congestion, accompany with itching of
conjunctiva
or throat, lacrimation) and chronic idiopathic urticaria
(characterized by cutaneous
eruption which may be accompanied by itching or/and swelling) 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 _
_Method of administration _
Oral use. The tablet may be taken without regard to mealtime.
_Posology _
Adults and children over 12 years of age: 10 mg once daily (one tablet
once daily).
_Pediatric population_
Children 2 to 12 years of age are dosed by weight.
Body weight more than 30 kg: 10 mg once daily (one tablet once daily).
Body weight 30 kg or less: The 10 mg strength tablet 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 Claritine
®
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, and for children weighing 30 kg or less, 5 ml (5 mg) every other
day is
recommended.
_Patients with renal impairment _
No dosage adjustments are required in patients with renal
insufficiency.
_Elderly_
No dosage adjustments are required in the elderly.
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Summar