Consumer Medicine Information

PANCREASE™ Capsules

pancrelipase

What is in this leaflet

This leaflet answers some of the common questions about PANCREASE capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking PANCREASE, ask your doctor or pharmacist. Your doctor and pharmacist have more information.

Keep this leaflet with your PANCREASE. You may need to read it again.

What PANCREASE is used for

PANCREASE is used to help digestion in certain conditions in which the pancreas is not working properly. These conditions may include:

• Cystic fibrosis
• Chronic pancreatitis
• After certain types of gastro-intestinal surgery
• After certain types of gastro-intestinal cancer.

PANCREASE contains the enzymes needed for the digestion of proteins, starches and fats.

Your doctor may have prescribed PANCREASE for another reason. Ask you doctor if you have any questions about why this medicine has been prescribed for you.

PANCREASE is not addictive.

Before you take PANCREASE

When you must not take it

Do not use PANCREASE if:

• you have an allergy to PANCREASE, other pancreatic enzyme supplements or any of the ingredients (See the last section of this leaflet for a list of ingredients). Signs of allergy include a skin rash, itching, shortness of breath and/or a swollen face.
• you are allergic to pork or pork products.
• you have a condition called "acute pancreatitis".

Do not use PANCREASE if the packaging shows signs of tampering. Do not use PANCREASE beyond the expiry date (month and year) printed on the pack.

Before you start to take it

Certain people must use PANCREASE with caution. Ask your doctor for advice.

Driving and Operating Machinery

Using PANCREASE should not affect your ability to drive a motor vehicle or to operate machinery.

You must tell your doctor if:

• you are pregnant or planning to become pregnant
• you are breast feeding or wish to breastfeed
• you are allergic to any other medicines
• you are allergic to any other substances, such as foods, preservatives or dyes.
• If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given PANCREASE.

Your doctor will advise you whether or not to take PANCREASE or if you need to adjust the dose, or adapt your treatment.

Other medicines and food

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy from a pharmacy, supermarket or health food shop.

In particular, tell your doctor or pharmacist if you are taking antacids. If antacids are taken at the same time as PANCREASE, PANCREASE will not work as effectively as it should.

Your doctor or pharmacist can tell you what to do if you need to take antacids.

PANCREASE should not be taken with alkaline foods.

Taking PANCREASE

How much to take

PANCREASE should be taken as directed by your doctor. The dose of PANCREASE will be different for different patients. The following information includes only the average doses of PANCREASE.

Adults and children over 12 months

One or two capsules should be taken with each meal. Some people need to take more capsules.

Usually half the meal-time dose is given with each snack.

Infants up to 12 months

Empty the contents of one or two capsules onto soft food that does not need chewing.

How to take it

PANCREASE should be taken immediately before meals or snacks.

PANCREASE should be swallowed whole with a whole glass of water.

If you have difficulty swallowing capsules, the capsule can be opened and the micropheres sprinkled onto a small quantity of soft food on a teaspoon or tablespoon and swallowed immediately without chewing.

DO NOT CHEW OR CRUSH THE MICROSPHERES. The microspheres have a special coating to stop them dissolving until they have gone through the stomach. Without this enteric coating, the pancrelipase may irritate your mouth and throat.

If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.

If you forget to take it

• Take your dose (the dose you missed) as soon as you remember, and then continue taking it as you would normally.
• If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
• Do not take a double dose to make up for the one you missed.

If you have missed more than one dose, or are not sure what to do, check with your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you have taken too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre [phone (03) 474 700], or go to the Accident and Emergency at your nearest hospital immediately if you think you or anybody else has taken too much PANCREASE.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep the telephone numbers handy.

While you are taking PANCREASE

Things you must do

• Always follow your doctor's instructions carefully.
• Tell your doctor if you become pregnant while taking PANCREASE.
• If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking PANCREASE.

Things you must not do

Do not use PANCREASE to treat any other complaint unless your doctor says so.

• Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side Effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you experience any of the following and they worry you:

• Diarrhoea
• Abdominal pain
• Nausea or vomiting
• Stomach gas or passing wind
• Constipation
• Gout pain (pain in joints).

Tell your doctor immediately if you notice any of the following as you may need urgent medical care:

• Severe stomach pain
• Blood in bowel motions.

STOP taking PANCREASE and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:

• Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
• Hives
• Fainting.
• These are very serious side effects. If you have them you may have had a serious allergic reaction to PANCREASE. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.

Other side effects not listed above may also occur in some people. Do not hesitate to report any other side effects to your doctor or pharmacist.

After taking PANCREASE

Storage

• Keep PANCREASE capsules in the bottle until it is time to take them.
• Keep PANCREASE capsules in a cool dry place where the temperature is below 25°C.
• Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5m) above the ground is a good place to store medicines.
• Do not store PANCREASE, or any medicine, in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking PANCREASE capsules, or your medicine has passed its expiry date, ask your pharmacist what to do with any medicine which may be left over.

Product Description

What it looks like

• PANCREASE capsules are white gelatin capsules containing microspheres of enteric-coated pancrelipase. Capsules are printed with "0095" in red.
• PANCREASE capsules are available in pack size of 250 capsules.

Ingredients

Each PANCREASE capsule contains the active ingredient pancrelipase which provides the following enzyme quantities:

• 5,600 BP Units of lipase
• 350 BP Units of protease
• 3,200 BP Units of amylase.

PANCREASE capsules also contain povidone, sodium starch glycollate, sugar, cellulose acetate phthalate, diethyl phthalate, talc, maize starch, titanium dioxide, sodium chloride and gelatin.

Each capsule contains not more than 19 mg sodium chloride, equivalent to not more than 7.5 mg (0.32 mmol) sodium.

The capsules do not contain lactose or gluten.

Sponsor

Janssen-Cilag Pty Ltd
PO Box 9222
Newmarket
Auckland 
New Zealand

Telephone: (09) 524 5012

This leaflet was prepared in March 2001.

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