Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fungal diastase (1:800), simeticone, papain (6000U/mg), activated charcoal, nicotinamide
Unichem Laboratories Ltd.
A09AA02
fungal diastase (1:800), simeticone, papain (6000U/mg), activated charcoal, nicotinamide
20mg+ 50mg+ 30mg+ 75mg+ 25mg
tablets coated
(20/2x10/) in strip
OTC
Registered
2020-08-04
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 Прочитать полный документ