Nutrizym 10

1. Name Of The Medicinal Product

Nutrizym 10

2. Qualitative And Quantitative Composition

Each capsule contains Pancreatin BP 155mg with not less than the following activities.

Lipase 10,000 BP Units, Protease 500 BP Units and Amylase 9000 BP Units.

3. Pharmaceutical Form

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

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

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 10 should usually not exceed this dose.

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 10.

4.3 Contraindications

Known hypersensitivity to the active ingredient (porcine pancreatin) or any of the excipients.

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety has not been established and animal toxicological studies are lacking, therefore Nutrizym 10 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.

4.7 Effects On Ability To Drive And Use Machines

Not known.

4.8 Undesirable Effects

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 pancreatic enzymes. 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.

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

The active ingredient of Nutrizym 10 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.

5.3 Preclinical Safety Data

Preclinical data are not available.

6. Pharmaceutical Particulars

6.1 List Of Excipients

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

6.2 Incompatibilities

Not known.

6.3 Shelf Life

18 months

6.4 Special Precautions For Storage

Store below 25°C in tightly closed containers.

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

Not relevant.

7. Marketing Authorisation Holder

Merck Serono Ltd

Bedfont Cross, Stanwell Road

Feltham, Middlesex,

TW14 8NX, UK

8. Marketing Authorisation Number(S)

PL 11648/0077

9. Date Of First Authorisation/Renewal Of The Authorisation

17 August 1992

10. Date Of Revision Of The Text

17^th April 2010

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