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PANCREX V TABLETS

Active substance(s): PANCREATIN

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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.
5.
HOW TO STORE PANCREX V TABLETS
Store at, or below, 15˚C. This is best achieved by storing the container in the fridge.
Keep out of the reach and sight of children.

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.

-

The expiry date for this medicine is on the packaging. Do not take Pancrex V Tablets after this
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 V Tablets contain
The active substance is Pancreatin BP. BP is a British standard measure of potency (expected
biological effect) of a pharmaceutical product.
Each tablet contains at least:
110 BP units of free protease, an enzyme that digests protein
1900 BP units of lipase, an enzyme that digests fat

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

Pancrex V
Tablets

CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION

PL 41094/0007

EP00204

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

1700 BP units of amylase, an enzyme that digests starch and sugars
Each tablet also contains: lactose, povidone, stearic acid, Opaseal P17-28901 (containing IMS,
titanium dioxide (E171), polyvinyl acetate phthalate, and stearic acid (E570)), talc, sucrose, acacia,
calcium carbonate, titanium dioxide, Opalux AS 7000B (containing sucrose, sodium benzoate
(E211), titanium dioxide (E171), and indigo carmine aluminium lake (E132)), syrup, Opagloss
6000P (containing ethanol, shellac (E904), white weeswax (E901), yellow carnuba wax (E903)).
Pancrex V Tablets contain approximately 0.055g of lactose. When taken as recommended (see
section 3 ‘How to take Pancrex V Tablets’) each dose supplies up to 0.83g of lactose.
What Pancrex V Tablets look like and contents of the pack
Pancrex V Tablets are small, white, enteric- and sugar-coated tablets. Each plastic container holds 300 tablets.

1.
WHAT PANCREX V TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Pancrex V Tablets is pancreatin.
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 V Tablets may also be used when the stomach has been removed, as
an aid to digestion.
The pancreatin in Pancrex V Tablets is derived from pancreases of pigs.
2.
BEFORE YOU TAKE PANCREX V TABLETS
Do not take Pancrex V Tablets if you

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.
Marketing authorisation holder and manufacturer
The Marketing Authorisation for Pancrex V Tablets is held by Essential Pharmaceuticals Ltd,
7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, UK.
The tablets are manufactured by Penn Pharmaceuticals Ltd., Tredegar, Gwent, NP2 3AA, South
Wales, UK.
This leaflet was last approved in August 2015
EP00204

are allergic (hypersensitive) to pancreatin or any of the other ingredients of Pancrex V
Tablets (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 V Tablets if you think this might be the case.
Taking other medicines
Pancrex V Tablets 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 V
Tablets.
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 V Tablets do not interfere with your ability to drive or operate machinery.
Important information about some of the ingredients of Pancrex V Tablets
This product contains lactose and sucrose. If you are lactose or sucrose intolerant, contact your
doctor of pharmacist before taking this product.
3.
HOW TO TAKE PANCREX V TABLETS
Dosage
Your doctor or pharmacist will advise you on the amount of Pancrex V Tablets 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 you may need to increase the dose.

PANCREX V TABLETS
Pancreatin
Pancreatin Tablets BP

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 15oC.
P
KEEP ALL MEDICINES OUT OF CHILDREN’S REACH

^Pancrex
^Tablets

300 TABLETS

EAN CODE

^V

CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION

PL 41094/0007

EP00204

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

Tear here, but do not remove

Batch no.:
Manuf. date:
Expiry date:
in the mouth. Irritation of the anus may also occur, which may be prevented by use of the barrier
cream.

EAN CODE

^V

b

4.
POSSIBLE SIDE EFFECTS
Like all medicines, Pancrex V Tablets can cause side effects, although not everybody gets them.
It is possible that some people may be allergic (hypersensitive) to Pancrex V Tablets. 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 V Tablets, 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 tablets are chewed or the contents kept

300 TABLETS

^Pancrex
^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 15oC.
P
KEEP ALL MEDICINES OUT OF CHILDREN’S REACH

b

PANCREX V TABLETS
Pancreatin
Pancreatin Tablets BP

Always check with your pharmacist if you are not sure.
You may notice variations in response to Pancrex V Tablets, which can be due to the special coating
of the tablets.
For adults, elderly, and children, 5-15 tablets before each meal or snack should provide a good
starting point for adjustment of the dose. Each tablet should be swallowed whole and not chewed.
If you take more Pancrex V Tablets 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 V Tablets
Simply skip that dose and take the next dose before your next meal or snack.
If you have any further questions on the use of this product, ask your pharmacist.

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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.

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