INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PANKREASE HL® Capsules

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME
(and dosage form):

PANKREASE HL® Capsules

COMPOSITION
Each capsule contains
Pancreatin equivalent to:
Not less than:
25 000 BP units Lipase.
22 500 BP units Amylase
1 250 BP units Protease.

PHARMACOLOGICAL CLASSIFICATION
A.11.1. Medicines acting on the gastro-intestinal tract. Digestants.

PHARMACOLOGICAL ACTION
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.

INDICATIONS
PANKREASE HL is indicated for patients with exocrine pancreatic enzyme deficiency as in:
–cystic fibrosis
–chronic pancreatitis
–post-pancreatectomy.

CONTRA-INDICATIONS
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.
Acute pancreatitis.
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
Side-effects
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.
Precautions
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.

IDENTIFICATION
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.

PRESENTATION
High density polyethylene bottles with a low density polyethylene snap top lid in pack sizes of 100 or 500 capsules.

STORAGE INSTRUCTIONS
Keep container tightly closed. Store below 25°C in a dry place. Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
27/11.1/0397

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN
PHARMACEUTICA
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No 80/11122/07)
15TH ROAD
HALFWAY HOUSE
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
7 June 1993

©JANSSEN PHARMACEUTICA SOUTH AFRICA 1993
                                Code No.: 022777
                                94D
        Britepak

®TRADEMARK


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