Pancrex V capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amylase; Lipase; Protease

Available from:

Essential Pharma Ltd

ATC code:

A09AA02

INN (International Name):

Amylase; Lipase; Protease

Dosage:

9000unit ; 8000unit ; 430unit

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01090400; GTIN: 5015001142029

Patient Information leaflet

Pan340mgCap-LPL-UK-4
Pan340mgCap-LPL-UK-4
Pan340mgCap-LPL-UK-4
P
P
EAN CODE
5060312430068
EAN CODE
5060312430068
BN:
EXP: 300
CAPSULES 300
CA
P
SU
LES
Ea
ch capsule contains 340 mg pancreatin to provide
enzymatic activity per capsule n
ot less than:
Free protease
430 BP Units
Lipase
8000 BP Units
Amylase
9000 BP Units
Pancreatic enzymes for digestive support.
Oral use. Read the package leaflet before use.
DOSE:
I
nfants: The contents of 1-2 capsules
mixed tho
roughly with feeds.
Older
Children and Adults: 2-6 ca
psules 4 times
daily
swallowed
whole with meals.
When mixed with liquids
use within one hour.
Store in a refrigerator.
Ea
ch capsule contains 340 mg pancreatin to provide
enzymatic activity per capsule n
ot less than:
Fre
e protease
43
0 BP Units
Li
pase
80
00 BP Units
Am
ylase
90
00 BP Units
Pancreatic enzymes for digestive support. Oral use. Read
the package leaflet before use.
DO
SE:
Infants: The contents of 1-2 capsules
m
ixed
thoroughly
with feeds.
Older
Children and Adults: 2-6 ca
psules 4 times
daily
swallowed
whole with meals.
When mixed with liquids use
within one hour.
Store in a refrigerator.
_PACKAGE LEAFLET: INFORMATION FOR THE USER_
PANCREX V 340 MG HARD CAPSULES
pancreatin
The full name of this medicine is “Pancrex V 340 mg hard
capsules”. The short
form of the name “Pancrex V” is used throughout the remainder of
the package leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Pancrex V is and what it is used for
2.
What you need to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pancrex V 340 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 340 mg pancreatin to provide enzymatic
activity per
capsule not less than:
Free protease
430 BP units
Lipase
8000 BP units
Amylase
9000 BP units
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule (capsule).
A white or buff coloured powder in ivory coloured opaque hard gelatin
capsules
imprinted Pancrex V and the company logo.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pancrex V is used to compensate for reduced intestinal enzyme activity
in pancreatic
deficiency states.
It is indicated for the treatment of fibrocystic disease of the
pancreas (cystic fibrosis),
chronic pancreatitis and pancreatic steatorrhoea following
pancreatectomy. It may
also be indicated following gastrectomy as an aid to digestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage should be adjusted according to the needs of the individual
patient and the
amount and type of food consumed.
The following dosage ranges provide a suitable basis for adjustment.
Infants: the contents of 1 - 2 capsules mixed with feeds.
Older Children and Adults: the contents of 2 - 6 capsules with each
snack or meal.
The capsules may be swallowed.
The capsules may provide a suitable alternative to the enteric coated
presentations in
cases where the pH of the duodenum is not sufficiently alkaline to
dissolve the enteric
coat.
_Paediatric population _
Capsules provide a simple and convenient method of dose measurement of
pancreatin
for administration to younger children requiring a low dose.
Method of administration
Oral use.
The capsules should be taken with each feed or meal or snack.
If the capsule contents are mixed with liquids or feeds the resulting
mixture should
not be allowed to stand for more than one hour prior to use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIA