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:

2023-11-07

제품 특성 요약

SUMMARY PRODUCT CHARACTERISTIC (SPC)
LORATADINE
10 MG TABLETS
1. NAME OF THE MEDICAL PRODUCT – 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:one tablet once daily
Paediatric population
Children 6 years of age and older with a body weight greater than 30
kg: One tablet once daily
For appropriate dosing in children younger than 6 years or with body
weight of 30 kg or less, there
are other formulations more suitable.
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 10 mg Tablets should be administered with caution in
patients with severe liver
impairment (see section 4.2).
The administration of Loratadine 10 mg Tablets should be discontinued
at least 48 hours before skin
tests since antihistamines may prevent or reduce otherwise positive
reactions to dermal reactivity
index.
This medicinal product contains lactose monohydrate. Patie