INSTRUCTION FOR MEDICAL USE OF UNIENZYM® WITH MPS
Registration number П N012401/01
Commercial name: Unienzyme® with MPS
- PHARMACEUTICAL DOSAGE FORM
Coated tablets
- Each coated tablet contains: Active ingredients: fungal diastasis (1:800) - 20,000 mg, papain (6,000 U/mg) - 30,000 mg, simethicone - 50,000 mg, activated carbon - 75,000 mg, nicotinamide - 25,000 mg
Each coated tablet contains:
Active ingredients:
fungal diastasis (1:800) - 20,000 mg,
papain (6,000 U/mg) - 30,000 mg,
simethicone - 50,000 mg,
activated carbon - 75,000 mg,
nicotinamide - 25,000 mg- EXCIPIENTS:
microcrystalline cellulose - 293.150 mg,
lactose - 50,000 mg,
gum acacia - 15,000 mg,
sodium benzoate - 0.100 mg,
gelatine - 10,000 mg,
colloidal silicon dioxide - 20,000 mg,
talc - 15,000 mg
magnesium stearate - 5,000 mg,
carmellose sodium 20,000 mg- TABLET COATING:
castor oil - 0.00044 ml,
shellac - 12,500 mg
calcium carbonate - 3.330 mg,
charcoal - 0.833 mg,
colloidal silicon dioxide - 0,222 mg,
sucrose - 90.555 mg,
gum acacia - 6,666 mg,
gelatine - 1,666 mg,
sodium benzoate - 0,080 mg,
talc - 23,333 mg
carnauba wax - 0.075 mg,
beeswax - 0.075 mg.- DESCRIPTION:
Black, oval-shaped, film-coated tablets with white “UNICHEM” lettering on one side. Color inhomogeneity is allowed.
- PHARMACOTHERAPEUTIC GROUP:
digestive enzyme product
ATC Code: А09АА02- PHARMACOLOGICAL PROPERTIES
Papain and fungal diastase are digestive enzyme products that facilitate the digestion and absorption of proteins, fats and carbohydrates in the body.
Simethicone has a carminative effect: it hinders the gas bubble formation and breaks them down; it also facilitates the elimination of gases from the intestines, thereby reducing bloating, nausea, as well as pain and discomfort caused by the flatulence.
Activated carbon is an adsorbent. It absorbs gases and toxins from indigestion.
Nicotinamide (vitamin PP) has a regulating effect on digestion processes.- RECOMMENDED INDICATIONS
The pathological conditions accompanied by a violation of the exocrine function of the pancreas: chronic pancreatitis, pancreatectomy, condition after irradiation (as part of complex therapy).
Flatulence, incl. in the postoperative period.
Dyspepsia due to unaccustomed food or hyperalimentation.- CONTRAINDICATIONS
Hypersensitivity to the agent components, acute pancreatitis, exacerbation of chronic pancreatitis, children under 3 years of age.
- DOSAGE AND INTAKE METHODS
Peroral. 1 tablet OAD/BID after meals.
- SIDE EFFECTS
Allergic reactions, skin redness.
- SPECIAL WARNINGS
The agent should be used with caution under the doctor's supervision during the pregnancy and lactation period.
- PHARMACEUTICAL FORM
10 tablets in a strip of aluminum foil.
2 strips with instructions for use are placed in a cardboard pack.
Or 2 strips with instructions for use are placed in a cardboard pack.
5 packs are placed in a cardboard box.- RECOMMENDATIONS FOR STORAGE
At a temperature not exceeding 25°C in a dry, dark place.
Keep out of the reach of children.- EXPIRATION DATE
3 years. Do not use after the expiration date printed on the pack.
- DISPENSING RULES
Without recipes.
Name and address of the manufacturing site of the medicinу manufacturer:
Unicem Laboratories Ltd.
C-31, C-32 and D-10, Industrial Area, Meerut Road, Ghaziabad - 201 003, India.
Name and address of the location of the holder (owner) of the medicinal product registration certificate:
Unicem Laboratories Ltd.
Unichem Bhavan, Prabhat Estate, Off S.V. Road, Jogeshwari (West), Mumbai - 400 102, India.
Name, address of the organization authorized by the holder or owner of the product registration certificate for medical use to accept claims from the consumer/exclusive distributor:
ZAO TRANSATLANTIC INTERNATIONAL, Russia.
119590, Moscow, 1 Olof Palme st.
Tel.: (495) 775-39-38,
Fax: (495) 514-10-54/67.
