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PANCREX V POWDER

Active substance(s): PANCREATIN

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POSSIBLE SIDE EFFECTS

Like all medicines, Pancrex V Powder can cause side effects,
although not everybody gets them.
It is possible that some people may be allergic
(hypersensitive) to Pancrex V Powder. Allergic/asthmatic
reactions have occasionally occurred on handling the powder.
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 Powder, 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.

Patient Information Leaflet

Pancrex V Powder

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.

Some irritation of the skin of the mouth may occur if the
powder is kept in the mouth. Irritation of the anus may also
occur, which may be prevented by use of the 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.

5.

HOW TO STORE PANCREX V POWDER

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.
The expiry date for this medicine is on the packaging. Do not
take Pancrex V Powder after this date. The expiry date refers to
the last day of that month.

In this leaflet:
1.
What Pancrex V Powder is and what it is used for
2.
Before you take Pancrex V Powder
3.
How to take Pancrex V Powder
4.
Possible side effects
5.
How to store Pancrex V Powder
6.
Further information

1.

WHAT PANCREX V POWDER IS AND
WHAT IT IS USED FOR

The active ingredient in Pancrex V Powder 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 Powder
may also be used when the stomach has been removed, as an

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 Powder contains
The active substance is Pancreatin BP. BP is a British
standard measure of potency (expected biological effect) of a
pharmaceutical product.
Each gram of powder contains at least:
• 1400 BP units of free protease, an enzyme
that digests protein
• 25000 BP units of lipase, an enzyme that
digests fat
• 30000 BP units of amylase, an enzyme that
digests starch and sugars
The other ingredient in Pancrex V Powder is lactose. See end
of Section 2 for further information on lactose.

P

What Pancrex V Powder looks like and contents of the pack
Pancrex V Powder is a white or buff-coloured powder. Each
plastic container holds 300g of powder.
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 Powder is held by
Essential Pharmaceuticals Ltd, 7 Egham Business Village,
Crabtree Road, Egham, Surrey, TW20 8RB, UK.
The powder is manufactured by Dales Pharmaceuticals Ltd,
Snaygill Industrial Estate, Keighley Road, Skipton, North
Yorkshire, BD23 2RW, UK.
This leaflet was last revised in 10/2015.

aid to digestion.
The pancreatin in Pancrex V Powder is derived from
pancreases of pigs.

2.

Pancrex V
Powder

KEEP ALL MEDICINES OUT OF
CHILDREN’S REACH
CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION

EP00239
PL 41094/0004
E2076
Essential Pharmaceuticals Ltd
Egham, Surrey, TW20 8RB, UK.

BEFORE YOU TAKE PANCREX V POWDER

^V

Do not take Pancrex V Powder if you

are allergic (hypersensitive) to pancreatin
There are no known diseases that may prevent you from
taking Pancrex V Powder.
Taking other medicines
Pancrex V Powder is 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 Powder.
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.

EP00239

300g

PANCREATIN BP POWDER
Each gram contains not less than the following activity:
Free protease
1400 B.P. Units
Lipase
25000 B.P. Units
Amylase
30000 B.P. Units
Dose: Dosage should be adjusted according to the needs of the
individual patient and the amount and type of food consumed.
Pancreatin
The following dosage ranges provide a suitable basis for adjustment.
Pancreatin BP Oral Powder Adults, the elderly and children: 0.5 - 2 grams swallowed dry or
mixed with a little water or milk with each snack or meal.
Newborn infants: 0.25 - 0.5 grams with each feed.
If mixed with liquids use within one hour.
Store at a temperature not exceeding 15˚C.

PANCREX V
POWDER

^Pancrex
^Powder
EAN CODE

E2076

Driving and using machines
Pancrex V Powder does not interfere with your ability to drive
or operate machinery.
Important information about some of the ingredients of
Pancrex V Powder
• lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

3. HOW TO TAKE PANCREX V POWDER

Dosage
Your doctor or pharmacist will advise you on the amount of
Pancrex V Powder 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.
Always check with your pharmacist if you are not sure.
The following should provide a good starting point for
adjustment of the dose:



^V

KEEP ALL MEDICINES OUT OF
CHILDREN’S REACH
CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION

E2076
EP00239
PL 41094/0004
Essential Pharmaceuticals Ltd
Egham, Surrey, TW20 8RB, UK.

P

Tear here, but do not remove

4.

EAN CODE

^Pancrex
^Powder

b

Batch no.:
Manuf. date:
Expiry date:

PANCREATIN BP POWDER
Each gram contains not less than the following activity:
Free protease
1400 B.P. Units
Lipase
25000 B.P. Units
Amylase
30000 B.P. Units
Dose: Dosage should be adjusted according to the needs of the
individual patient and the amount and type of food consumed.
Pancreatin
The following dosage ranges provide a suitable basis for adjustment.
Pancreatin BP Oral Powder Adults, the elderly and children: 0.5 - 2 grams swallowed dry or
mixed with a little water or milk with each snack or meal.
Newborn infants: 0.25 - 0.5 grams with each feed.
If mixed with liquids use within one hour.
Store at a temperature not exceeding 15˚C.

b

300g
PANCREX V
POWDER

For adults, elderly, and children, 0.5g-2g swallowed dry
or mixed with a little water or milk before each meal or
snack.

For newborn infants, 0.25g-0.5g with each feed.
If the powder is mixed with liquids or feeds, use within one
hour.
Pancrex V Powder is taken by mouth.
Pancrex V Powder may be given via a tube direct into the
stomach.
If you take more Pancrex V Powder 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 Powder
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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