Active substance(s): PANCREATIN
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
For the full list of excipients, see section 6.1.
Hard gelatin red and yellow 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.
Posology and method of administration
Adults (including elderly) and Paediatric population
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
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.
Method of administration
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 with a small amount of acidic fluid or soft food, but without chewing.
This could be apple sauce or yoghurt or any fruit juice with acidic pH (a pH
less than 5.5), e.g. apple, orange or pineapple juice. If the minitablets 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 minitablets are not
crushed or chewed. Crushing and chewing of the minitablets or mixing with
food or fluid with alkaline pH can disrupt the protective enteric coating. This
can result in early release of enzymes in the oral cavity and may lead to reduced
efficacy and irritation of the mucous membranes. Care should be taken to
ensure that no product is retained in the mouth.
Adequate patient hydration should be ensured at all times whilst treating with
In children aged 15 years and under with cystic fibrosis. Hypersensitivity to the active
substance (porcine pancreatin) or to any of the excipients listed in section 6.1.
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.
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
For pancreatic enzymes no clinical data on exposed pregnancies are available.
Animal studies show no evidence for any absorption of porcine pancreatic
enzymes. Therefore, no reproductive or developmental toxicity is to be
expected. Caution should be exercised when prescribing to pregnant women.
No effects on the suckling child are anticipated since animal studies suggest no
systemic exposure of the breast-feeding woman to pancreatic enzymes.
Pancreatic enzymes can be used during breast-feeding.
If required during pregnancy or lactation, pancreatin should be used in doses
sufficient to provide adequate nutritional status.
Effects on ability to drive and use machines
In clinical trials, more than 900 patients were exposed to pancreatin. The most
commonly reported adverse reactions were gastrointestinal disorders and were
primarily mild or moderate in severity.
The following adverse reactions have been observed during clinical trials with
the below indicated frequencies:
to < 1/10
≥ 1/1000 to
strictures of the
and large bowel
*Gastrointestinal disorders are mainly associated with the underlying disease.
Similar or lower incidences compared to placebo were reported for abdominal
pain and diarrhoea.
Allergic reactions mainly, but not exclusively, limited to the skin have been
observed and identified as adverse reactions during post-approval use.
Because these reactions were reported spontaneously from a population of
uncertain size, it is not possible to reliably estimate their frequency.
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 (see section 4.4). 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
No specific adverse reactions were identified in the paediatric population.
Frequency, type and severity of adverse reactions were similar in children with
cystic fibrosis as compared to adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
Inappropriately large doses could result in abdominal discomfort, nausea,
vomiting and perianal irritation or inflammation. Extremely high doses of
pancreatin have been reported to be associated with hyperuricosuria and
hyperuricaemia. Refer to section 4.8 for the potential side-effects of high
doses of pancreatic enzymes in patients with cystic fibrosis.
Supportive measures including stopping enzyme therapy and ensuring
adequate rehydration are recommended.
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 safety data
Preclinical data are not available.
List of excipients
Castor Oil (hydrogenated)
Silicon dioxide, colloidal
Methacrylic acid copolymer, type C (Eudragit L30D)
Iron oxide, red
Iron oxide, yellow
Special precautions for storage
Store below 25 °C in tightly closed containers.
Nature and contents of container
Polyethylene or polypropylene containers with polyethylene tamper evident
closures containing 50, 100, 200 or 500 capsules.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Merck Serono Ltd
Bedfont Cross, Stanwell Road
TW14 8NX, UK
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
17 August 1992
DATE OF REVISION OF THE TEXT