Dyspa-East 360 mg 20 capsules

Trade Name:

Dyspa-East

Pancreatin 360 mg

20 Delayed release capsules containing enteric coated pellets.

Composition:

Each capsule contains:

Pancreatin 300 mg equivalent to:

Lipase 25,000 Ph Eur units

Amylase 18,000 Ph Eur units

Protease 1,000 Ph Eur units.

Inactive ingredients:

Povidone k30, Isopropyl alcohol, HPMC ES, Sprapol L30D55, Diethyl phthalate, Talcum, Titanium Dioxide, Purified water, Gelatin, Titanium dioxide,Quinoline yellow, Sunset yellow, Brilliant blue.

Properties:

Pancreatin digests carbohydrates, proteins and fats.  It contains mainly the enzymes amylase, protease and lipase. They turn starch into dextrins and simple sugars, proteins into peptones and oligopeptides, lipids into fatty acids and glycerol, respectively.

Delayed release capsules containing enteric coating ensures complete delivery of enzyme content of tablets in the intestines without changes in the stomach, providing a long-lasting effect and proper digestion.

Indications:

For the treatment of pancreatic exocrine insufficiency.

Dosage and administration:

-Adults (including the elderly) and children:

One or two capsųles during or immediately after each meal. 

-Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

-The capsules can be whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing. This could be applesauce or yogurt or any fruit juice with.

-If the granules are mixed with fluid or food, it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed.

-It is important to ensure adequate hydration of patients at all times whilst dosing Dyspa-east Capsule.

Side effects:

Possible: allergic reactions, diarrhea or constipation, nausea, discomfort in the epigastric region.

With prolonged use in high doses, hyperuricosuria may develop, an increase in the level of uric acid in the blood plasma.

In some cases, in patients suffering from cystic fibrosis, the formation of strictures in the ileocecal region is observed after taking high doses.

Contraindications:

-Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

Warnings and precautions:

• Pregnancy and lactation

Caution should be exercised when prescribing to Pregnant women.

• Lactation expected.

Pancreatic enzymes can be used during breast-feeding.

If required during pregnancy or lactation Dyspa-cas Should be used in doses sufficient to provide adequate

nutritional status.

• Effects on ability to drive and use machines:

Dyspa-east has no or negligible influence on the ability to drive or use machines.

• Keep out of reach of children.

Storage:

Store at a temperature not exceeding 30°C

Package:

Carton box holds 2 strips each of 10 capsules and an insert leaflet.