Unienzyme cMPS tablets tablets coated

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

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

Dostupno od:

Unichem Laboratories Ltd.

ATC koda:

A09AA02

INN (International ime):

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

Doziranje:

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

Farmaceutski oblik:

tablets coated

Jedinice u paketu:

(20/2x10/) in strip

Tip recepta:

OTC

Status autorizacije:

Registered

Datum autorizacije:

2020-08-04

Svojstava lijeka

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