Pancrex V gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amylase; Lipase; Protease

Available from:

Essential Pharmaceuticals Ltd

ATC code:

A09AA02

INN (International Name):

Amylase; Lipase; Protease

Dosage:

1700unit ; 1900unit ; 110unit

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01090400; GTIN: 5015001143026

Patient Information leaflet

Tear here,
BUT DO NOT REMOVE
EAN CODE
EAN CODE
EAN CODE
P
P
Batch no.:
Manuf. date:
Expiry date:
EP00204
EP00204
EP00204
PANCREX V TABLETS
PANCREATIN
PANCREATIN TABLETS BP
300 TABLETS
PANCREATIN TABLETS B.P.
Each enteric coated tablet contains not less than the following
activity:
Free protease
110 B.P. Units
Lipase
1900 B.P. Units
Amylase
1700 B.P. Units
DOSE:
Adults, the elderly and children: 5-15 tablets taken whole before
meals.
Store at a temperature not exceeding 15
o
C.
KEEP ALL MEDICINES OUT OF CHILDREN’S REACH
CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION
PANCREX V TABLETS
PANCREATIN
PANCREATIN TABLETS BP
300 TABLETS
PANCREATIN TABLETS B.P.
Each enteric coated tablet contains not less than the following
activity:
Free protease
110 B.P. Units
Lipase
1900 B.P. Units
Amylase
1700 B.P. Units
DOSE:
Adults, the elderly and children: 5-15 tablets taken whole before
meals.
Store at a temperature not exceeding 15
o
C.
CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION
KEEP ALL MEDICINES OUT OF CHILDREN’S REACH
_PATIENT INFORMATION LEAFLET_
PANCREX V TABLETS
Pancreatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 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 is available without prescription. However, you still
need to take Pancrex
carefully to get the best results from it. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
You must contact a doctor if your symptoms worsen or do not improve.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Pancrex V Tablets are and what they are used for
2.
Before you take Pancrex V Tablets
3.
How to take Pancrex V Tablets
4.
Possible side effects
5.
How to store Pancrex V Tablets
6.
Further information
1.
WHAT PANCREX V TABLETS ARE AND WHAT THEY

Summary of Product characteristics

OBJECT 1
PANCREX V TABLETS
Summary of Product Characteristics Updated 16-Oct-2015 | Essential
Pharmaceuticals Ltd
1. Name of the medicinal product
Pancrex V Tablets.
2. Qualitative and quantitative composition
Pancreatin BP to provide enzymatic activity per tablet not less than:
Free protease
110 BP units
Lipase
1900 BP units
Amylase
1700 BP units
3. Pharmaceutical form
Tablet.
4. Clinical particulars
4.1 Therapeutic indications
Pancrex 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
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.
Adults, the Elderly, and Children
5 - 15 tablets before each snack or meal, swallowed whole.
4.3 Contraindications
Hypersensitivity to the active ingredient (porcine pancreatin) or any
of the excipients.
4.4 Special warnings and precautions for use
Unsuitable for people with lactase insufficiency, galactosaemia or
glucose/galactose malabsorption
syndrome.
Variations in response to treatment may be due to enteric coating. It
is possible that some irritation of the
skin of the mouth may occur if tablets are chewed or preparations
retained in the mouth. Irritation of the
anus may also occur. A barrier cream may prevent this local
irritation.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Fertility, pregnancy and lactation
Pancrex 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.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Rare cases of hyperuric