Nolpaza tablets gastro-resistant

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

pantoprazole (pantoprazole sodium sesquihydrate)

Доступна с:

KRKA d.d.

код АТС:

A02BC02

ИНН (Международная Имя):

pantoprazole (pantoprazole sodium sesquihydrate)

дозировка:

20mg

Фармацевтическая форма:

tablets gastro-resistant

Штук в упаковке:

(28/2x14/) in blister, (56/4x14/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-08-24

Характеристики продукта

PI_Text018839_1
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1.
NAME OF THE MEDICINAL PRODUCT
Nolpaza
®
20 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole as 22.55 mg
pantoprazole sodium
sesquihydrate.
Excipient:
Each gastro-resistant tablet contains 18 mg sorbitol (E420).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
Light yellowish brown, oval, slightly biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults and adolescents 12 years of age and above_
-
Symptomatic gastro-oesophageal reflux disease.
-
For long-term management and prevention of relapse in reflux
oesophagitis.
_ _
_Adults_
-
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory
drugs (NSAIDs) in patients at high risk with a need for continuous
NSAID treatment (see
section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE_
Symptomatic gastro-oesophageal reflux disease
The recommended oral dose is one Nolpaza 20 mg gastro-resistant tablet
per day. Symptom relief is
generally accomplished within 2–4 weeks. If this is not sufficient,
symptom relief will normally be
achieved within a further 4 weeks. When symptom relief has been
achieved, reoccurring symptoms
can be controlled using an on-demand regimen of 20 mg once daily, when
required. A switch to
continuous therapy may be considered in case satisfactory symptom
control cannot be maintained with
on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
PI_Text018839_1
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Page 2 of 10
For long-term management, a maintenance dose of one Nolpaza 20 mg
gastro-resistant tablet per day
is recommended, increasing to 40 mg pantoprazole per day if a relapse
occurs. Nolpaza 40 mg is
available for this case. After healing of the relapse, the dose can be
reduced again to 20 mg
pantoprazole.
_ADULTS_
Prevention of gastroduoden