Nolpaza tablets gastro-resistant

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

pantoprazole (pantoprazole sodium sesquihydrate)

可用日期:

KRKA d.d.

ATC代码:

A02BC02

INN（国际名称）:

pantoprazole (pantoprazole sodium sesquihydrate)

剂量:

20mg

药物剂型:

tablets gastro-resistant

每包单位数:

(7/1x7) in blister, (14/2x7) in blister, (14/1x14/) in blister

处方类型:

OTC

授权状态:

Registered

授权日期:

2018-11-27

产品特点

1.3.1
Pantoprazole sodium sesquihydrate
SPC, Labeling and Package Leaflet
SmPCPIL112083_1
24.04.2018 – Updated: 24.04.2018
Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Nolpaza
®
20 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
gastro-resistant
tablets
contains
20
mg
pantoprazole
as
22.55
mg
pantoprazole
sodium
sesquihydrate.
Excipient with known effect:
-
sorbitol (E420): 18 mg/tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Gastro-resistant tablets are light yellowish brown, oval, slightly
biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of reflux symptoms (e.g. heartburn, acid
regurgitation) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 20 mg pantoprazole (one tablet) per day.
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of
symptoms. Once complete relief of symptoms has occurred, treatment
should be discontinued. The
treatment should not exceed 4 weeks without consulting a doctor.
If no symptom relief is obtained within 2 weeks of continuous
treatment, the patient should be
instructed to consult a doctor.
_Special populations_
No dose adjustment is necessary in elderly patients or in those with
impaired renal or liver function.
_Paediatric population_
Nolpaza is not recommended for use in children and adolescents below
18 years of age due to
insufficient data on safety and efficacy.
Method of administration
Nolpaza 20 mg gastro-resistant tablets should not be chewed or
crushed, and should be swallowed
whole with liquid before a meal.
1.3.1
Pantoprazole sodium sesquihydrate
SPC, Labeling and Package Leaflet
SmPCPIL112083_1
24.04.2018 – Updated: 24.04.2018
Page 2 of 10
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Co-administration of pantoprazole is not recommended with HIV protease
inhibitors for which
absorption is