Panangin tablets film-coated

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

magnesium aspartate (magnesium aspartate tetrahydrate), potassium aspartate (potassium aspartate hemihydrate)

Доступно од:

Gedeon Richter PLC

АТЦ код:

A12CC30

INN (Међународно име):

magnesium aspartate (magnesium aspartate tetrahydrate), potassium aspartate (potassium aspartate hemihydrate)

Дозирање:

140mg+ 158mg

Фармацеутски облик:

tablets film-coated

Јединице у пакету:

(50) in plastic container

Тип рецептора:

OTC

Статус ауторизације:

Registered

Датум одобрења:

2016-02-04

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panangin
®
158 mg/140 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 158 mg potassium aspartate anhydride
(in the form of 166.3 mg
potassium aspartate hemihydrate) and 140 mg magnesium aspartate
anhydride (in the form of 175 mg
magnesium aspartate tetrahydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White or almost white coloured, slightly polished, almost odourless,
biconvex, round, film-coated
tablets with a slightly uneven surface.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a supplement for treatment of potassium and magnesium deficiency.
According to the approval of the attending physician:
-
as a part of combination therapy of chronic heart disease (heart
failure in post-infarction
patients), cardiac arrhythmia (ventricular, primarily).
-
add-on to cardiac glycoside therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dose is 1 to 2 film-coated tablets three times daily.
The daily dose may be increased to 3 times 3 film-coated tablets.
_Paediatric population_
Children and adolescents
The safety and efficacy of Panangin film-coated tablets in children
and adolescents have not been
established. No data are available.
Method of administration
For oral administration.
Gastric acid may reduce the effectiveness of this preparation and
therefore, it is recommended to take
Panangin after meals.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
2
Acute or chronic renal failure.
Addison’s disease.
Grade III atrioventricular block.
Cardiogenic shock (BP <90 mmHg).
Children's age under 18 years.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Particular caution is necessary in patients suffering from disorders
associated with hyperkalaemia.
Regular monitoring of serum electrolytes is recommended.
This medicine contains 36.2 mg potassium in each f