Pancrease HL gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amylase; Lipase; Protease

Available from:

Janssen-Cilag Ltd

ATC code:

A09AA02

INN (International Name):

Amylase; Lipase; Protease

Dosage:

22500unit ; 25000unit ; 1250unit

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01090400; GTIN: 5012946351097

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PANCREASE™ HL
Pancreatin equivalent to pancrelipase
Pancrease is a trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or pharmacist
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
•
WHAT IS IN THIS LEAFLET
1.
What Pancrease HL is and what it is used for
2.
What you need to know before you take Pancrease HL
3.
How to take Pancrease HL
4.
Possible side effects
5.
How to store Pancrease HL
6.
Contents of the pack and other information
1. WHAT PANCREASE HL IS AND WHAT IT IS USED FOR
Pancrease HL is a white capsule that contains light brown coloured
mini-tablets. It
belongs to a group of medicines called ‘pancreatic enzyme
replacement therapy’.
Pancrease HL contains three medicines:
•
Protease
•
Amylase
•
Lipase
They are proteins (called enzymes) that help you to break down and
digest food.
Without them your body will not receive the nourishment it needs.
It may be necessary to take Pancrease HL if you have or have had any
of the
following:
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•
Cystic fibrosis (a problem with your digestive system and lungs)
•
Long-term inflammation of your pancreas (chronic pancreatitis). The
pancreas is a
gland behind your stomach
•
Blockage of your pancreas or passage (duct) that releases ‘bile’.
Bile is a fluid
made by the liver
•
Surgery to remove your pancreas or bypass your stomach
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKEPANCREASE HL
DO NOT TAKE PANCREASE HL:
•
If you are under 15 years old and have cystic fibrosis
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before taking this medicine:
•
I

Summary of Product characteristics

OBJECT 1
PANCREASE HL CAPSULES
Summary of Product Characteristics Updated 10-Aug-2015 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Pancrease™ HL Capsules
2. Qualitative and quantitative composition
Each capsule contains pancreatin, equivalent to 25000 units of lipase,
22500 units of amylase and 1250
units of protease.
3. Pharmaceutical form
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.
4. Clinical particulars
4.1 Therapeutic indications
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).
4.2 Posology and method of administration
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
inter-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, the fat content of the diet and
symptomatology. Further dose
increases, if required, should be added slowly, with careful
monitoring of response and symptomatology.
Patients should be instructed not to increase the dosage on their own.
Changes in dosage may require an
adjustment period of several days.
Where patients are already in receipt of lower unit dose enteric
coated pancreatin supplements, Pancrease
HL Capsules may be substituted at one-third of the number of capsules
of the previous