NUTRIZYM 10,000 155 Milligram Capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PANCREATIN

Available from:

E. Merck Ltd

INN (International Name):

PANCREATIN

Dosage:

155 Milligram

Pharmaceutical form:

Capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Withdrawn

Authorization date:

2010-11-26

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutrizym 10, 000 Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Pancreas Powder 154mg with not less than the following
activities: Lipase 10,000 FIP Units, Protease 500 FIP Units and Amylase FIP 9,000 Units.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule.
Hard gelatin capsule, with a yellow body and red cap, containing uniform white enteric coated pancreas powder
minitablets.
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
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 at the discretion of the physician. Capsules should be swallowed
whole with water. Where the swallowing is difficult, the capsule may be opened, the minitablets removed and
swallowed with fluid or mixed with soft food which does not require chewing. In the latter case the food should be
swallowed unchewed and it should be used straight away.
The suggested starting dose is as follows:
Adults (including elderly) and children: 1 - 2 capsules with meals
Further dose increases, if required, should be added slowly with careful monitoring of response and symptomatology.
If food is taken without Nutrizym 10000 inadvertently, the next meal should be taken with the capsules at the
recommended dose.
Colonic damage has been reported in children with cystic fibrosis taking in excess of 10,000 units of lipase per kg day.
The daily dose of pancreatic enzymes for most patients should remain below 2500 un