PANCREASE HL CAPSULES

Active substance: PANCREATIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2011

GB - AW_73248

Pancrease™ HL
Pancreatin equivalent to pancrelipase
Pancrease is a trademark

Read all of this leaflet carefully before you
start using this medicine.

• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours
• If you get side effects and they become serious
or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist

In this leaflet
1 What Pancrease HL is and what it is used for
2 Before you use Pancrease HL
3 How to use Pancrease HL
4 Possible side effects
5 How to store Pancrease HL
6 Further 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 Before you use Pancrease HL
Do not use Pancrease HL if:

• You are allergic to pork protein or anything
in Pancrease HL (listed in section 6 below)
• You are under 15 years old and have cystic fibrosis
Do not use this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist
before using Pancrease HL.

Taking other medicines

You can take Pancrease HL if you are taking other
medicines. However, please tell your doctor or pharmacist
if you are taking or have recently taken any other medicines.
This includes medicines that you buy without a prescription
or herbal medicines.

Pregnancy and breast-feeding

Talk to your doctor before using Pancrease HL if you are
pregnant, think you may be pregnant or might become
pregnant.
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.

Using Pancrease HL with food and drink

• 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 foods or drinks that are ‘alkaline’
(this means they have a pH higher than 5.0)

3 How to use Pancrease HL
Always use this medicine exactly as your doctor has told
you. You should 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. It is usually 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

© J-C 2011

GB - AW_73248

3 How to use Pancrease HL (continued)
How to use 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 foods or drinks that are ‘alkaline’
(this means they have a pH higher than 5.0)

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

When to stop using 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 take too much Pancrease HL

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 have any further questions on the use of this product,
ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Pancrease HL 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
Contact your doctor as soon as possible if:
• You get unusual stomach pains or a change in existing
stomach pain. Your doctor will check that no damage
has been caused to your gut (intestine)

Other side effects
Very rare (affects less than 1 in 10,000 people)
• Feeling sick (nausea), being sick (vomiting), indigestion
and stomach pain
• Blood in stools, constipation, diarrhoea, wind
• High levels of uric acid in the blood and urine if you
take very high doses of Pancrease HL. These effects
can be confirmed by medical tests
• Narrowing or inflammation of the bowel in children with
cystic fibrosis
• Decrease in weight
If you get side effects and they become serious or if you
notice any other side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5 How to store Pancrease HL
Keep 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.

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 protect the environment.

6 Further information
The active substances in Pancrease HL 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.

The product licence is held by:
JANSSEN-CILAG LTD,
50-100 Holmers Farm Way, High Wycombe, Bucks,
HP12 4EG, UK
Pancrease HL is made by:
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 approved in 03/2012

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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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