Nutrizym 22

Each capsule contains Pancreatin BP 340mg with not less than the following activities.

Lipase 22,000 BP Units, Protease 1,100 BP Units and Amylase 19,800 BP Units.

Hard gelatin capsule containing enteric coated pancreatin minitablets for oral administration.

For the symptomatic relief of pancreatic exocrine insufficiency such as in fibrocystic disease of the pancreas and chronic pancreatitis.

Adults (including the elderly) and children:

1-2 capsules with meals and 1 capsule with snacks.

Since the individual response to pancreatin supplements is variable, the number of capsules taken may need to be titrated to the individual according to symptoms and at the discretion of the physician. Dose increase, if required should be added slowly with careful monitoring of response and symptomatology.

Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day. The dose of Nutrizym 22 should usually not exceed this dose.

Where a patient is already receiving a lower unit dose enteric coated pancreatic supplement, then Nutrizym 22 may be substituted at 1/2 of the number of capsules normally consumed with the previous preparation.

Capsules should be swallowed whole with water. Where swallowing of capsules proves to be difficult, the minitablets may be removed and taken with water or mixed with a small amount of soft food and swallowed immediately without chewing.

Adequate patient hydration should be ensured at all times whilst treating with Nutrizym 22.

In children aged 15 years and under with cystic fibrosis. Known hypersensitivity to the active ingredient (porcine pancreatin) or any of the excipients.

Hyperuricaemia and hyperuricosuria have been reported to occur in cystic fibrosis patients; pancreatin extracts contain a small amount of purine which might, in high doses, contribute to this condition.

None known.

Safety has not been established and animal toxicological studies are lacking, therefore Nutrizym 22 should not be used in pregnancy and lactation unless clearly necessary, but if required should be used in doses sufficient to provide adequate nutritional status.

Refer to section 4.8 for the potential side - effects of high doses of pancreatic enzymes in patients with cystic fibrosis.

Not known.

Hypersensitivity reactions may occur. As with any pancreatin extract, high doses may cause buccal and perianal irritation, in some cases resulting in inflammation.

Stricture of the ileo-caecum and large bowel, and colitis have been reported in children with cystic fibrosis taking Nutrizym 22. Abdominal symptoms (those not usually experienced by the patient) or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10,000 units of lipase/kg/day.

Inappropriately large doses could result in abdominal discomfort, nausea, vomiting and perianal irritation or inflammation.

The active ingredient is a preparation of porcine pancreas with lipase, amylase and protease activity. Lipase enzymes hydrolyse fats to glycerol and fatty acids. Amylase converts starch into dextrins and sugars and protease enzymes change proteins into proteoses and derived substances.

The active ingredient of Nutrizym 22 is pancreatin which is a substance involved in the digestive process. During the enzymatic degradation of food substances the enzymes themselves are degraded. Any breakdown products are those that would be expected to appear following normal digestion.

Preclinical data are not available.

Uncoated minitablets:

Castor Oil (hydrogenated)

Silicon dioxide, colloidal

Magnesium stearate

Sodium carboxymethylcellulose

Microcrystalline cellulose

Minitablet coating:

Simethicone emulsion

Methacrylic acid copolymer, type C (Eudragit L30D)

Talc

Triethyl citrate

Gelatin capsules:

Titanium dioxide

Iron oxide, red

Iron oxide, yellow

Gelatin

Not known.

18 months

Store below 25 degree C in tightly closed containers.

Polyethylene or polypropylene containers with polyethylene tamper evident closures containing 50, 100, 200 or 500 capsules.

Not relevant.

Merck Serono Ltd

Bedfont Cross, Stanwell Road

Feltham, Middlesex,

TW14 8NX, UK

PL 11648/0078

14 October 2002

17^th April 2010

POM