Pancrease^™ HL Capsules

Each capsule contains pancreatin, equivalent to 25000 units of lipase, 22500 units of amylase and 1250 units of protease.

Size 0, elongated hard gelatin capsule, with a white opaque body and a white opaque cap, each ringed with a red band and the letters HL in red, containing enterically coated minitablets.

Exocrine pancreatic enzyme deficiency as in cystic fibrosis, chronic pancreatitis, post pancreatectomy, post gastro-intestinal bypass surgery (eg Billroth II gastroenterostomy), and ductal obstruction from neoplasm (eg of the pancreas or common bile duct).

For oral administration.

Patients with pancreatic insufficiency should undergo regular nutritional assessments as a component of routine care and additionally, when dosing of pancreatic enzyme replacement is altered.

Dosage should be individualised to each patient, with therapy being initiated at the lowest possible dose and gradually increase until the desired control of steatorrhoea is obtained.

Adults and children

One or two capsules during each meal and one capsule with snacks. The interindividual response to pancreatin supplements is variable and the number of capsules may need to be titrated to the individual based upon parameters of steatorrhoea and symptomatology. Further dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

Where patients are already in receipt of lower unit dose enteric coated pancreatin supplements, then Pancrease HL Capsules may be substituted at one-third of the number of capsules of the previous preparation.

Where swallowing of capsules is difficult, then they may be opened and the minitablets taken with liquid or soft foods which do not require chewing. To protect the enteric coating, the minitablets should not be crushed or chewed.

Contact of the minitablets with food having a pH higher than 5.0 can dissolve the protective coating and will reduce the efficacy of the product.

It is important to ensure adequate hydration of patients at all times whilst dosing Pancrease HL Capsules.

Patients who are taking or have been given in excess of 10,000 units of lipase/kg/day are at risk of developing colon damage. The dose of Pancrease HL should usually not exceed this dose.

Pancrease HL Capsules are contra-indicated in patients known to be hypersensitive to pork protein or any other component of this product.

Children aged 15 or under with cystic fibrosis.

Contact of the minitablets with food or liquid having a pH higher than 5.0 can dissolve the protective coating and will reduce efficacy of the product.

Cases of fibrotic strictures in the colon have been reported primarily in cystic fibrosis patients with the use of enzyme supplements, generally at dosages above the recommended range. If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered. In some cases surgery including resection of the bowel is required and the need for this should also be considered.

Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should be made cautiously and only under medical supervision.

None stated.

No adequate, well-controlled studies have been conducted in pregnant women. Pancrease HL capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Pancrease HL 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 (see warnings about high dose sections 4.2 & 4.8)

The possibility of protein constituents appearing in the breast milk cannot be excluded; therefore caution should be exercised when prescribing Pancrease HL capsules to lactating women.

None stated.

Postmarketing Experience

Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Pancrelipase Capsules that meet threshold criteria are included in Table 1. The adverse drug reactions are ranked by frequency, using the following convention:

Very common 1/10

Common 1/100 and < 1/10

Uncommon 1/1,000 and <1/100

Rare 1/10,000 and <1/1,000

Very rare <1/10,000, including isolated reports

The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates that might be obtained in clinical trials or epidemiological studies.

The most frequently reported adverse events were of gastrointestinal origin i.e. nausea, vomiting and diarrhoea.

Overdosage is unlikely and has not been experienced to date with Pancrease HL. Inappropriately large doses could result in symptoms such as abdominal discomfort, nausea, vomiting, perianal irritation or inflammation.

The enzymes catalyse the hydrolysis of fats into glycerol and fatty acids, protein into proteoses and derived substances, and starch into dextrins and sugars.

Pancreatin is not systemically absorbed from the gastro-intestinal tract.

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Castor oil, hydrogenated

Silica Colloidal Anhydrous

Magnesium stearate

Croscarmellose Sodium

Cellulose microcrystalline

Coat composition:

Simethicone emulsion

Methacryllic acid-ethyl acrylate copolymer (1:1)

Talc

Triethyl citrate

Purified water

Capsule composition (body and cap):

Titanium dioxide

Gelatin

Ink composition:

Shellac

Red iron oxide (E172)

Industrial methylated spirits

Purified Water

Propylene Glycol

Isopropyl Alcohol

n-Butyl Alcohol

OR

Shellac

Red Iron Oxide (E172)

Dehydrated Alcohol

Propylene Glycol

Isopropyl Alcohol

Butyl Alcohol

Strong Ammonia Solution

Potassium Hydroxide

Purified Water.

None stated.

2 years.

Do not store above 25°C . Keep bottle tightly closed. Do not refrigerate or freeze.

High density polyethylene bottles with a low density polyethylene snap top lid, containing 100 or 500 capsules.

Not applicable.

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Bucks

HP12 4EG

UK

PL 0242/0255

1 October 1995/26 March 2008

August 2008

Legal category POM