Loratadine tablets

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

loratadine

제공처:

Arpimed LLC

ATC 코드:

R06AX13

INN (국제 이름):

loratadine

복용량:

10mg

약제 형태:

tablets

패키지 단위:

(10/1x10/) in blister

처방전 유형:

OTC

승인 상태:

Registered

승인 날짜:

2018-08-07

제품 특성 요약

SUMMARY PRODUCT CHARACTERISTIC (SPC)
LORATADINE
10 MG TABLETS
1.1 BRAND NAME – LORATADINE
1.2 INTERNATIONAL NON-PROPERTY NAME - LORATADINE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
_ACTIVE INGREDIENT:_ loratadine - 10 mg;
_For a full list of excipients, see section 6.1. _
3. PHARMACEUTICAL FORM
Tablet. White scored cylindrical tablets, the end surface of which are
flat.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Loratadine are 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
ADULTS
Posology
_Adults and children over 12 years of age:_
10mg once daily (one tablet once daily).
Paediatric population
C_hildren 2 to 12 years of age are dosed by weight:_
Bodyweight more than 30kg: 10mg once daily (one tablet once daily).
Bodyweight 30kg or less: The 10mg strength tablet is not appropriate
in children with a bodyweight
less than 30kg. 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 Loratadine in children under 2 years of age
has 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 10mg every
other day is recommended for
adults and children weighing more than 30kg.
_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 tablet may be taken without regard to 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
Loratadine should be administered with caution in patients with severe
liver impairment (