Unienzyme cMPS tablets tablets coated

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

fungal diastase (1:800), simeticone, papain (6000U/mg), activated charcoal, nicotinamide

Mevcut itibaren:

Unichem Laboratories Ltd.

ATC kodu:

A09AA02

INN (International Adı):

fungal diastase (1:800), simeticone, papain (6000U/mg), activated charcoal, nicotinamide

Doz:

20mg+ 50mg+ 30mg+ 75mg+ 25mg

Farmasötik formu:

tablets coated

Paketteki üniteler:

(20/2x10/) in strip

Reçete türü:

OTC

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2020-08-04

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
UNIENZYME cMPS TABLET
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INGREDIENTS
QTY/TABLET (MG)
FUNCTION
ACTIVE INGREDIENTS
Fungal Diastase (1:800) O. Sp.
20.000
Active
Simethicone USP
50.000
Active
Papain (6000 units/mg) USP
30.000
Active
Activated Charcoal BP
75.000
Active
Nicotinamide BP
25.000
Active
EXCIPIENTS
Colloidal Anhydrous Silica BP
20.222
Excipients
Microcrystalline Cellulose BP
40.000
Excipients
Lactose BP
50.000
Excipients
Acacia BP
21.666
Excipients
Sodium Benzoate BP
0.180
Excipients
Gelatin BP
11.666
Excipients
Purified Talc BP
38.333
Excipients
Magnesium Stearate BP
5.000
Excipients
Carboxymethylcellulose Sodium BP
20.000
Excipients
Microcrystalline Cellulose BP
(Directly compressible)
253.150
Excipients
Dichloromethane BP
---
Excipients
Castor Oil BP
0.00044 ml
Excipients
Calcium Carbonate BP
3.333
Excipients
Vegetable Charcoal O. Sp.
0.833
Excipients
Shellac BP
12.500
Excipients
Sugar M30 O. Sp.
90.555
Excipients
Carnauba Wax BP
0.075
Excipients
White Bees Wax BP
0.075
Excipients
Carbon Tetrachloride USP-NF
---
Excipients
Industrial Methylated Spirit BP
---
Excipients
Titanium Dioxide
---
Сolorant of the
printing on the
tablets
3.
PHARMACEUTICAL FORM
Coated tablets
Description : Black coloured, oval shaped, coated tablets having
“UNICHEM” printed
in white along one side. Allowed non-uniformity of colour of tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief in digestive disorders manifested by dyspepsia,
bloating, belching,
flatulence, abdominal discomfort or feeling of abdominal fullness,
i.e. indigestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Via the oral route.
In adults.
Take 1 tablet once or twice a day after meal.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Acute pancreatitis.
Exacerbation of chronic pancreatitis.
Activated charcoal is contraindicated when specific oral antidotes
such as methionine
are used.
Nicotinic acid is contraindicated in hepatic dysfunction