Amrase is a prescription medicine used to treat the symptoms of lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts (Exocrine Pancreatic Insufficiency). Amrase may be used alone or with other medications.

• Trade Name: Amrase Enteric Coated Tablets.
• Generic Name: Pancreatin 8 X, Papain 5 X, Ox bile extract.

Composition

Each Enteric Coated Tablet contains: Active ingredients:

• Pancreatin 8 X …… 37.5 mg (Equivalent in activity to 300 mg Pancreatin USP).
• Papain 5 X ……. 10 mg (Equivalent in activity to 50 mg Papain USP).
• Ox-bile extract ……. 30 mg (Contains not less than 45% of cholic acid).

Inactive ingredients: Croscarmellose sodium, anhydrous lactose, Magnesium stearate, microcrystalline cellulose (type 101).

Pharmaceutical form: Enteric coated tablets.

Pharmacological action

• Pancreatin hydrolyses fats to glycerol and fatty acids, break down protein into peptides, proteoses and derived substances. and convert starch into dextrins and sugars.
• Papain consists chiefly of a mixture of papain and chymopapain, proteolytic enzymes that hydrolyse polypeptides, amides, and esters, especially at bonds involving basic amino acids, or leucine or glycine, yielding peptides of lower molecular weight.
• Ox bile extract have a choleretic action, increasing the secretion of bile, when given by mouth.

Indications

• For treatment of dyspepsia, has choleretic action.
• In conditions of pancreatic exocrine deficiency such as pancreatitis and cystic fibrosis.

Dosage and administration

One tablet three times daily with meals to be swallowed as a whole or as prescribed by the physician.

Contraindications

• Hypersensitivity to active ingredients or against any of the excipients.
• Use of high doses in patients with cystic fibrosis should be avoided.

Side effects

• Hypersensitivity reactions.
• gastrointestinal side effects such as abdominal discomfort, nausea and vomiting.
• Buccal and perianal irritation particularly in infants.

Package and Storage conditions

• Store at temperature not exceeding 25°C. In dry place.
• Package Carton box containing 3 (Al / Transparent Colorless PVC) strips, each of 10 enteric coated tablets + an inner leaflet.
• Manufactured By: Amriya for Pharmaceutical Industries Alexandria — Egypt.

Amrase – Information Leaflet

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