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PANCREX V FORTE TABLETS

Active substance(s): PANCREATIN

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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 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 FORTE TABLETS

Store at, or below, 15˚C. This is best achieved by storing the container in the fridge.

EAN CODE

PL 41094/0008

EP00205

P

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

Keep out of the reach and sight of children.

ethanol, shellac (E904), white beeswax (E901), yellow carnuba wax (E903)).

The expiry date for this medicine is on the packaging. Do not take Pancrex V Forte 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.

Pancrex V Forte Tablets contain approximately 0.13g of lactose. When taken as recommended (see
section 3 ‘How to take Pancrex V Forte Tablets’) each dose supplies up to 1.3g of lactose.

6.

FURTHER INFORMATION

What Pancrex V Forte 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:
330 BP units of free protease, an enzyme that digests protein
5600 BP units of lipase, an enzyme that digests fat
5000 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

Patient Information Leaflet
Pancrex V Forte 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 Forte Tablets are and what they are used for
2.
Before you take Pancrex V Forte Tablets
3.
How to take Pancrex V Forte Tablets
4.
Possible side effects
5.
How to store Pancrex V Forte Tablets
6.
Further information

Pancrex V
Forte Tablets

CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION

1.

What Pancrex V Forte Tablets look like and contents of the pack
Pancrex V Forte Tablets are white, enteric- and sugar-coated tablets. Each plastic container holds 300
tablets.
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 V FORTE TABLETS 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 V Forte Tablets may also be used when the stomach has been removed, as an
aid to digestion.
The pancreatin in Pancrex V Forte Tablets is derived from pancreases of pigs.
BEFORE YOU TAKE PANCREX V FORTE TABLETS

Do not take Pancrex V Forte Tablets if you
are allergic (hypersensitive) to pancreatin or any of the other ingredients of Pancrex V Forte
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 Forte Tablets if you think this might be the case.
Taking other medicines
Pancrex V Forte Tablets are not known to interfere with any other medicines that you may be taking.

PANCREATIN TABLETS B.P.
Each enteric coated tablet contains not less
than the following activity:
Free protease
330 B.P. Units
Lipase
5600 B.P. Units
Amylase
5000 B.P. Units
DOSE: Adults, the elderly and children: 6-10
tablets taken whole before meals.
o
Store at a temperature not exceeding 15 C.
KEEP ALL MEDICINES OUT OF
CHILDREN’S REACH

^Pancrex ^V
^Forte ^Tablets

Pancreatin
Pancreatin Tablets BP

Marketing authorisation holder and manufacturer
The Marketing Authorisation for Pancrex V Forte 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

The active ingredient in Pancrex V Forte Tablets is pancreatin.

2.

PANCREX V
FORTE
TABLETS

EP00205

300 TABLETS

CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION

EAN CODE

PL 41094/0008

EP00205

P

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

Tear here, but do not remove

Batch no.:
Manuf. date:
Expiry date:

300 TABLETS

^Pancrex ^V
^Forte ^Tablets

b

Pancreatin
Pancreatin Tablets BP

PANCREATIN TABLETS B.P.
Each enteric coated tablet contains not less
than the following activity:
Free protease
330 B.P. Units
Lipase
5600 B.P. Units
Amylase
5000 B.P. Units
DOSE: Adults, the elderly and children: 6-10
tablets taken whole before meals.
o
Store at a temperature not exceeding 15 C.
KEEP ALL MEDICINES OUT OF
CHILDREN’S REACH

b

PANCREX V
FORTE
TABLETS

However, if you are prescribed another medicine, inform the doctor you are taking Pancrex V Forte
Tablets.

You may notice variations in response to Pancrex V Forte Tablets, which can be due to the special
coating of the 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.

For adults, elderly, and children, 6-10 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.

Driving and using machines
Pancrex V Forte Tablets do not interfere with your ability to drive or operate machinery.
Important information about some of the ingredients of Pancrex V Forte 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 FORTE TABLETS

Dosage
Your doctor or pharmacist will advise you on the amount of Pancrex V Forte 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. Always
check with your pharmacist if you are not sure.

If you take more Pancrex V Forte 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 Forte 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.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Pancrex V Forte Tablets can cause side effects, although not everybody gets them.
It is possible that some people may be allergic (hypersensitive) to Pancrex V Forte 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 Forte Tablets, don’t take any more. Tell a doctor straight away and take the
packaging and this leaflet with you.

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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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