PANCREASE HL CAPSULES

Active substance: PANCREATIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2013

GB - AW_85759

Pancrease™ HL
Pancreatin equivalent to pancrelipase
Pancrease is a trademark

Read all of this leaflet carefully before you
start taking this medicine because 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 has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1 What Pancrease HL is and what it is used for
2 What you need to know before you take
Pancrease HL
3 How to take Pancrease HL
4 Possible side effects
5 How to store Pancrease HL
6 Contents of the pack and other information

1 What Pancrease HL is and what it is used for
Pancrease HL is a white capsule that contains light
brown coloured mini-tablets. It belongs to a group
of medicines called ‘pancreatic enzyme replacement
therapy’. Pancrease HL contains three medicines:
• Protease
• Amylase
• Lipase
They are proteins (called enzymes) that help you
to break down and digest food. Without them your body
will not receive the nourishment it needs.

It may be necessary to take Pancrease HL if you have
or have had any of the following:
• Cystic fibrosis (a problem with your digestive system
and lungs)
• Long-term inflammation of your pancreas (chronic
pancreatitis). The pancreas is a gland behind your
stomach
• Blockage of your pancreas or passage (duct) that
releases ‘bile’. Bile is a fluid made by the liver
• Surgery to remove your pancreas or bypass your stomach

2 What you need to know before you take Pancrease HL
Do not take Pancrease HL:

• If you are under 15 years old and have cystic fibrosis

Pancrease HL with food and drink

Check with your doctor or pharmacist before taking this
medicine:
• If you have had an allergic reaction to pork protein or
any of the other ingredients of this medicine (listed in
Section 6).
• If you have gout (a disease with painful, swollen joints
caused by uric acid crystals) or kidney problems as
Pancrease HL can increase the levels of uric acid

• You will need to drink plenty of water every day while
taking Pancrease HL
• If you have difficulty swallowing the capsules, you can
open them and mix the mini-tablets inside with drinks
or soft foods that don’t need to be chewed. It will not
affect the taste of the food
• If you need to mix the mini-tablets with food or drink,
please ask your doctor for advice on the best food or
drink to use. Pancrease HL will not work as well if they
are mixed with certain foods (such as milk, custard, ice
cream, and many other dairy products)

Other medicines and Pancrease HL

Pregnancy and breast-feeding

Warnings and precautions

Tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines. This
includes medicines that you buy without a prescription or
herbal medicines. You may still be able to take Pancrease
HL if you are taking other medicines.

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
You may still be able to use Pancrease HL if your doctor
thinks you need to.
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine is unlikely to affect you being able to drive
or use any tools or machines.

3 How to take Pancrease HL
Always use this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you are
not sure.

How many capsules to take

Your doctor will tell you how many capsules you should
take. The recommended dose is one or two at a time, but
may be more. The number of capsules you will need to
take will depend on:
• Your symptoms
• How well the medicine works for you
• What you eat

How to take Pancrease HL

• You will need to drink plenty of water every day while
taking Pancrease HL
• The capsules should be taken by mouth with each meal
or snack
• If you have difficulty swallowing the capsules, you can
open them and mix the mini-tablets inside with drinks
or soft foods that don’t need to be chewed. It will not
affect the taste of the food
• If you need to mix the mini-tablets with food or drink,
please ask your doctor for advice on the best food or
drink to use. Pancrease HL will not work as well if they
are mixed with certain foods (such as milk, custard, ice
cream, and many other dairy products)

It is important that you:

• Do not chew or crush the capsules as this will damage
the mini-tablets inside. This will stop the medicine
working properly
• Do not take the capsules (or mini-tablets inside)
on an empty stomach as they will not have any effect

If you take more Pancrease HL than you
should

If you take a lot of capsules by accident you might:
• Feel sick (nausea), be sick (vomit) or have stomach pain
• Have a sore or itchy bottom
If this happens, contact your doctor as soon as possible.

If you forget to take Pancrease HL

• If you forget to take your capsules, take them as soon
as you remember. However, if it is nearly time for the
next capsules, skip the missed capsules
• Do not take a double dose to make up for a forgotten
dose

If you stop taking Pancrease HL

• Keep taking Pancrease HL as long as your doctor tells
you to. Do not stop taking it without talking to your
doctor first.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop using Pancrease HL and tell your doctor
straight away if you notice the following. You may
need medical treatment.
• Severe irritation or reddening of your skin or other
signs of allergy during treatment. This only happens
in a small number of people taking other pancreatic
enzyme products. It has not been reported in patients
taking Pancrease HL.
Contact your doctor as soon as possible if:
• You get an obstruction of the intestine and severe or
long lasting stomach pains, unusual stomach pains
or a change in existing stomach pain (Fibrosing
colonopathy). Other signs include constipation,
diarrhoea, bloated stomach and being sick (vomiting).
Your doctor will check that no damage has been
caused to your gut (intestine).

AW_85759.pdf - Page 1 of 3 - June 19, 2013 - 06:50:12

Other side effects
Very common (can affect more than 1 in 10 people)
• Stomach pain
Common (affects less than 1 in 10 people)
• Rash
• Bloated stomach, diarrhoea, feeling sick (nausea) and
being sick (vomiting)
If you get any side effects, talk to your doctor or
pharmacist. 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.

© J-C 2013

GB - AW_85759

5 How to store Pancrease HL
Keep this medicine out of the sight and reach of children.
• Keep the bottle tightly closed
• Do not store above 25°C
• Do not refrigerate or freeze
Do not use Pancrease HL after the expiry date which
is stated on the label. The expiry date refers to the last
day of that month.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

6 Contents of the pack and other information
What Pancrease HL contains

The active substances are:
• Protease (not less than 1,250 units)
• Amylase (not less than 22,500 units)
• Lipase (not less than 25,000 units)
The other ingredients are:
Mini-tablet: hydrogenated castor oil, silica colloidal
anhydrous, magnesium stearate, croscarmellose sodium,
microcrystalline cellulose
Mini-tablet coating: simethicone emulsion, methacrylic
acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, water
Capsule (body and cap): titanium dioxide, gelatine
Ink: Shellac, red iron oxide (E172), dehydrated alcohol,
strong ammonia solution, propylene glycol, isopropyl
alcohol, butyl alcohol
OR
Ink: Shellac, red iron oxide (E172), dehydrated alcohol,
propylene glycol, isopropyl alcohol, butyl alcohol, strong
ammonia solution, potassium hydroxide, water

What Pancrease HL looks like and contents
of the pack
Pancrease HL is an opaque gelatine capsule, ringed
with a red band and the letters HL in red. Each capsule
contains a number of light brown mini-tablets.
Pancrease HL capsules come in a polyethylene bottle
containing 100 or 500 capsules.
Not all pack sizes may be marketed.

AW_85759.pdf - Page 2 of 3 - June 19, 2013 - 06:50:12

Marketing Authorisation Holder:
JANSSEN-CILAG LTD,
50-100 Holmers Farm Way, High Wycombe, Bucks,
HP12 4EG, UK
Manufacturer:
Lusomedicamenta Sociedade Técnica Farmacêutica SA,
Estrada Consiglieri Pedroso, 69B, Queluz de Baixo,
2730-055 Barcarena, Portugal
Or
McGregor Cory Ltd, Middleton Close, Banbury,
Oxfordshire, OX16 4RS, UK

For information in large print,
tape, CD or Braille, telephone
0800 7318450.
This leaflet was last revised in June 2013

AW_85759.pdf - Page 3 of 3 - June 19, 2013 - 06:50:12

INSERT PANCREASE HL
Article Number : AW_85759
Format Name: 3P_LUS/I/038/V2 (170x460)
Technical Info/Spec: NA
Pointsize : 8 pt
File Name: AW_85759.indd (CS5_PC)

Market: GB
Mat. ID Code: NA
Operator: Rajesh

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JANSSEN-CILAG

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Date: 1. 07-05-2013
2. 14-05-2013
3. 14-05-2013
4. 14-06-2013 (Soumen)
5. 19-06-2013

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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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