Skip to Content

PANCREX GRANULES

Active substance(s): PANCREATIN

View full screen / Print PDF » Download PDF ⇩
Transcript
300g
PANCREX
GRANULES
Pancreatin
Pancreatin BP Granules

Signs of an allergy to something include rash, wheezing, breathlessness, swollen
eyelids, face or lips, and in extreme cases collapse. In the unlikely event that you
should get any of these symptoms soon after taking Pancrex Granules, don’t take any
more. Tell a doctor straight away and take the packaging and this leaflet with you.
Rarely, high levels of uric acid in the blood and urine have been reported when
extremely high doses of pancreatin have been taken.
Narrowing of parts of the bowel, and inflammation of the colon, have been reported in
children with cystic fibrosis taking high doses of pancreatic enzyme supplements.
Some irritation of the skin of the mouth may occur if the capsules are chewed or kept in
the mouth. Irritation of the anus may also occur, which may be prevented by use of a
barrier cream.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.

Batch no.:
Manuf. date:
Expiry date:

Pancrex
Granules

5.

EAN CODE

HOW TO STORE PANCREX GRANULES

Store at, or below, 15˚C. This is best achieved by storing the container in the refrigerator.
Keep out of the reach and sight of children.
Do not use Pancrex Granules after the expiry date which is stated on the pack after
Expiry Date. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6.

FURTHER INFORMATION

What Pancrex Granules contain
The active substance is Pancreatin BP. BP is a British standard measure of potency
(expected biological effect) of a pharmaceutical product.
Each gram of granules contains at least:
300 BP units of free protease, an enzyme that digests protein
5000 BP units of lipase, an enzyme that digests fat
4000 BP units of amylase, an enzyme that digests starch and sugars
The other ingredients are lactose, acacia (E414), Opaseal P17-0200 containing IMS,

Patient Information Leaflet
Pancrex Granules
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 Granules carefully to get the best results from them. 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 Granules are and what they are used for
2.
Before you take Pancrex Granules
3.
How to take Pancrex Granules
4.
Possible side effects
5.
How to store Pancrex Granules
6.
Further information

1.

PANCREATIN GRANULES B.P.
Each gram contains not less than the following activity:
Free protease
300 B.P. Units
Lipase
5000 B.P. Units
Amylase
4000 B.P. Units
Dose: As directed by the physician, swallowed dry or
taken mixed in a little soft food or liquid just before or
with meals. Average dose for adults, the elderly and
children: 5-10 grams four times daily.
When mixed with liquid, use within one hour.
Store at a temperature not exceeding 15˚C.
KEEP ALL MEDICINES OUT OF
CHILDREN’S REACH
INCLUDES LACTOSE
see leaflet for further information
PL 41094/0003

P

300g

polyvinyl acetate phthalate and stearic acid (E570).
Pancrex Granules contain approximately 70g of lactose per 100g. When taken as
recommended (see section 3 ‘How to take Pancrex Granules’) each dose supplies up
to 7g of lactose.
What Pancrex Granules look like and contents of the pack
Pancrex Granules are light to dark buff-coloured coated granules. Each plastic
container holds 300g of granules.

PANCREX
GRANULES

Internet sites for patients with your condition
There are a number of websites available on your condition and its treatment, which
may provide you with further useful information. Contact the Pancreatic Society of
Great Britain and Ireland for assistance.

This leaflet was last approved in August 2015

WHAT PANCREX GRANULES ARE AND WHAT THEY ARE USED
FOR

Pancreatin is a combination of enzymes normally produced by the pancreas which help to
digest protein, fat, starch and sugars in the food that you eat.
Pancreatin is given to people who do not produce enough enzymes to digest their food
properly, in conditions such as cystic fibrosis, persistent inflammation of the pancreas,
and when the pancreas has been removed. Pancrex Granules may also be used when the
stomach has been removed, as an aid to digestion.
The pancreatin in Pancrex Granules is derived from pancreases of pigs.
BEFORE YOU TAKE PANCREX GRANULES

Do not take Pancrex Granules if you
are allergic (hypersensitive) to pancreatin or any of the other ingredients of
Pancrex Granules (see list in section 6 ‘Further Information’)
cannot easily digest or absorb milk sugars (lactose, galactose, glucose).
Contact your doctor or pharmacist before taking Pancrex Granules if you think this
might be the case.

Pancreatin
Pancreatin BP Granules

EAN CODE

Pregnancy and breast-feeding
If you are pregnant, thinking of becoming pregnant or breast-feeding, discuss this with
your doctor before taking your medicine as dose adjustments may be necessary.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pancrex Granules do not interfere with your ability to drive or operate machinery.
Important information about some of the ingredients of Pancrex Granules
This product contains lactose. If you are lactose intolerant, contact your doctor or
pharmacist before taking this product.
HOW TO TAKE PANCREX GRANULES

Dosage
Your doctor or pharmacist will advise you on the amount of Pancrex Granules to take
before each meal, although you may find with experience that you need to adjust the
dose according to the size and type of meal that you eat. If loose pale stools (faeces) occur

PL 41094/0003

EP00203

P

Essential Pharmaceuticals Ltd
Egham, Surrey, TW20 8RB, UK.

EP00203

Taking other medicines
Pancrex Granules are not known to interfere with any other medicines that you may be
taking. However, if you are prescribed another medicine, inform the doctor you are
taking Pancrex Granules.

3.

PANCREATIN GRANULES B.P.
Each gram contains not less than the following activity:
Free protease
300 B.P. Units
Lipase
5000 B.P. Units
Amylase
4000 B.P. Units
Dose: As directed by the physician, swallowed dry or
taken mixed in a little soft food or liquid just before or
with meals. Average dose for adults, the elderly and
children: 5-10 grams four times daily.
When mixed with liquid, use within one hour.
Store at a temperature not exceeding 15˚C.
KEEP ALL MEDICINES OUT OF
CHILDREN’S REACH
INCLUDES LACTOSE
see leaflet for further information

^pancrex
^Granules

Marketing authorisation holder and manufacturer
The Marketing Authorisation for Pancrex Granules is held by Essential
Pharmaceuticals Ltd, 7 Egham Business Village, Crabtree Road, Egham, Surrey,
TW20 8RB, UK.
The granules are manufactured by Penn Pharmaceuticals Ltd., Tredegar, Gwent,
NP2 3AA, South Wales, UK.

The active ingredient in Pancrex Granules is pancreatin.

2.

EP00203

Essential Pharmaceuticals Ltd
Egham, Surrey, TW20 8RB, UK.

Tear here, but do not remove

^pancrex
^Granules

you may need to increase the dose. Always check with your pharmacist if you are not
sure.
For adults, elderly, and children, 5g-10g of granules swallowed dry or mixed with a little
water or milk just before meals should provide a good starting point for adjustment of the
dose.
If the granules are mixed with liquids or food, use within one hour.
If you take more Pancrex Granules than you should
There are no special precautions to take, although the use of a barrier cream may help
prevent possible irritation of the anus.
If you forget to take Pancrex Granules
Simply skip that dose and take the next dose with your next meal.
If you have any further questions on the use of this product, ask your pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Pancrex Granules can cause side effects, although not everybody gets
them.
It is possible that some people may be allergic (hypersensitive) to Pancrex Granules.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide