Claritine tablets

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

loratadine

Prieinama:

Bayer Bitterfeld GmbH

ATC kodas:

R06AX13

INN (Tarptautinis Pavadinimas):

loratadine

Dozė:

10mg

Vaisto forma:

tablets

Vienetai pakuotėje:

(10/1x10/) in blister

Recepto tipas:

OTC

Autorizacija statusas:

Registered

Leidimo data:

2022-12-08

Prekės savybės

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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 _
For the symptomatic treatment of allergic rhinitis and chronic
idiopathic urticaria.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
_Method of administration _
Oral use. The tablet may be taken without regard to mealtime.
_Posology _
Adults: one tablet (10 mg) once daily.
_Pediatric population_
Children 6 years of age and over with a body weight greater than 30
kg: one tablet
(10 mg) once daily.
Children below 6 years of age and 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 more suitable formulations.
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.
_4.3 _
_CONTRAINDICATIONS _
Hypersensitivity to the active substance, to any of the excipients.
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
Claritine
®
should
be
administered
with
caution
in
patients
with
severe
liver
impairment.
This
medicinal
product
contains
lactose;
thus
patients
with
rare
hereditary
problems
of
galactose
intolerance,
the
Lapp
lactase
deficiency
or
glucose-
galactose malabsorption sh