PANKREASE HL® Capsules
(and dosage form):
PANKREASE HL® Capsules
Each capsule contains Pancreatin equivalent to:
Not less than:
25 000 BP units Lipase.
22 500 BP units Amylase
1 250 BP units Protease.
A.11.1. Medicines acting on the gastro-intestinal tract. Digestants.
The enteric coated minitablets in PANKREASE HL resist gastric inactivation and deliver high levels of biologically active enzymes into the duodenum.
The enzymes catalyse the hydrolysis of fats into glycerol and fatty acids, protein into proteases and derived substances, and starch into dextrins and sugars.
PANKREASE HL is indicated for patients with exocrine pancreatic enzyme deficiency as in:
PANKREASE HL is contra-indicated in patients known to be sensitive to pork protein. Reports have been received of skin rashes probably related to the above.
Pregnancy: The safety of PANKREASE HL in pregnancy has not been established and such use is not recommended.
DOSAGE AND DIRECTIONS FOR USE
Adults and children:
1 or 2 capsules during each meal and 1 capsule with snacks. The individual 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. Where patients are already in receipt of lower unit dose enteric coated pancreatin supplements, PANKREASE HL may be commenced at a dose relative to the lipase enzyme content of capsules normally consumed with the previous preparation, but it is important that the individuals response is monitored during the first weeks of therapy and dosage adjusted if necessary. Dose increases, if required, should he be made slowly, with careful monitoring of response and symptomatology. It is important to ensure adequate hydration of patients at all times while dosing PANKREASE HL.
Where swallowing of capsules is difficult then they may be opened and the minitablets taken with liquids 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 foods having a pH greater than 5,5 can dissolve the protective enteric shell.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The most frequently reported adverse reactions to pancreatin supplements are gastrointestinal in nature such as abdominal discomfort, nausea, vomiting, perianal irritation or inflammation. Sensitivity reactions have also been observed, these may be sneezing, lacrymation or skin rashes.
It should be noted that extremely high doses of pancreatic enzymes have been associated with hyperuricosuria and hyperuricaemia. This was associated with pancreatin tablet or powder supplements and has been virtually eliminated with enteric coated preparations. The folic acid status of these patients may have to be monitored periodically.
Cases of fibrotic stricture formation in the ascending colon have been reported in cystic fibrosis patients with the use of high potency enzyme supplements in high doses (6 500 - 50 000 BP lipase units/kg/meal). If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment is symptomatic.
Elongated white opaque gelatin capsule with a red band and the letters "HL" in red on the body and cap. Capsules are filled with light brown, homogenous enterically coated minitablets.
High density polyethylene bottles with a low density polyethylene snap top lid in pack sizes of 100 or 500 capsules.
Keep container tightly closed. Store below 25°C in a dry place. Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No 80/11122/07)
DATE OF PUBLICATION OF THIS PACKAGE INSERT
7 June 1993
©JANSSEN PHARMACEUTICA SOUTH AFRICA 1993
Code No.: 022777
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