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Panzytrat 25,000

Pancrelipase, Enteric-Coated Mini-tablets, in capsules.


Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about Panzytrat 25,000. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

Please read this leaflet before you start taking Panzytrat 25,000.

If you are helping someone else take Panzytrat 25,000, please read this leaflet before you give the first dose.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Panzytrat 25,000 against the benefits expected for you.

If you have any concerns about taking Panzytrat 25,000, ask your doctor or pharmacist. Your doctor and pharmacist have more information.

Keep this leaflet with your Panzytrat 25,000. You may need to read it again.

What Panzytrat 25,000 is used for

Panzytrat 25,000 are pancreatic enzyme supplements that are used by people whose bodies do not make enough enzymes to digest their food such as patients with cystic fibrosis or chronic pancreatitis; or patients who have had their pancreas removed or who have had gastrointestinal bypass surgery or suffer from ductal obstruction. The enzymes are extracted from pig pancreas.

Panzytrat 25,000 is approved for the uses listed above. However, your doctor may prescribe this medicine for another use. If you would like more information, ask your doctor.

Panzytrat 25,000 cannot be obtained without a doctor's prescription.

There is no evidence Panzytrat 25,000 is addictive.

Before you take Panzytrat 25,000

When you must not take it

Do not take Panzytrat 25,000 if your doctor has told you that you have acute pancreatitis.

Do not take Panzytrat 25,000 if you are allergic to pork, other pig products or any of the ingredients listed at the end of this leaflet.

Do not use Panzytrat 25,000 after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well.

Do not use Panzytrat 25,000 if the packaging is torn or shows signs of tampering, or if the capsules do not look quite right.

Before you start to take it

You must tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

You must tell your doctor if you are pregnant, planning to become pregnant, are breast feeding or intend to breast feed. Your doctor will discuss whether you should take these products.

If you have not told your doctor about any of the above, tell them before you use Panzytrat 25,000

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

You should avoid taking antacids, which are medicines that are used to treat heartburn and indigestion, when taking Panzytrat 25,000. Antacids may affect how well Panzytrat 25,000 work by breaking down the special coating used to protect the pancreatic enzymes. If it is necessary to take an antacid, then it should be taken at least one hour before you take your Panzytrat 25,000.

How to take Panzytrat 25,000

Follow all directions given to you by your doctor carefully.

These directions may differ from the information in this leaflet.

How much to take

Your doctor will tell you how many capsules to take to suit your particular needs. Do not increase the number of capsules yourself without informing your doctor.

The usual starting dose Panzytrat 25,000 in adults (including the elderly) and children is one capsule with every meal and snack. Your doctor will probably adjust the number of capsules you are taking until the medicine is effective.

If the doctor advises you to increase the dosage, you should increase the number of capsules gradually (for example, by one at a time). A very rapid increase in dosage may lead to constipation. If you are unsure how to increase the dose, ask your doctor or pharmacist to explain it to you.

The maximum recommended dose of lipase in infants and children with cystic fibrosis is 20,000 units per kilogram body weight in 24 hours. Patients who use more than 10,000 units per kilogram per day, will probably be monitored closely by their doctor.

When to take it

Take Panzytrat 25,000 with every meal or snack.

How to take it

Swallow the capsules whole with a full glass of water or, if you prefer, open the capsules and mix the granules with soft food.

If you mix the granules with food, it is important to swallow the mixture straight away, without chewing.

Neither the capsules nor the granules inside should be chewed as they have a special coating to stop them dissolving until they have gone through the stomach and into the intestines where they work.

When you are taking Panzytrat 25,000, it is important to make sure that you drink plenty of liquid every day.

If you forget to take it

Wait until your next meal or snack and take your usual number of capsules.

Do not take a double dose to make up for the dose that you missed.

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

If you take too much (overdose)

If you, or anybody else, have taken too much Panzytrat 25,000, drink plenty of water and contact your doctor, pharmacist or the Poisons Information Centre (13 11 26), or go to the casualty department of the hospital nearest to you. Do this even if there are no signs of discomfort or poisoning.

While you are taking Panzytrat 25,000

Things you must do

Make sure you tell your doctor if you are still having problems with fatty stools or abdominal pain while you are taking Panzytrat 25,000

Drink plenty of water every day when you are taking Panzytrat 25,000

Follow your doctor's instructions carefully and do not stop taking the capsules unless told to do so by your doctor.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking Panzytrat 25,000

Things you must not do

Do not give Panzytrat 25,000 to anyone else, even if they have the same condition as you.

Do not use this medicine for any purpose other than for the purpose it has been recommended for you.

Do not use more than the recommended amount.

Do not stop taking your medicine until your doctor tells you to do so.

Do not let yourself run out of medicine unless told to do so by your doctor.

Things that may help your condition

Diet should be considered as part of your overall management plan. Your doctor may advise you to watch the amount of fat in your diet.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Panzytrat 25,000

Panzytrat 25,000 helps most people whose bodies do not make enough enzymes to digest their food, but it may have unwanted side effects in a few people. 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 of the side effects.

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

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

  • stomach or bowel problems, including:
    - diarrhoea
    - constipation
    - abnormal stools
    - abdominal discomfort
    - nausea
  • skin reactions

Tell your doctor immediately if you have severe or prolonged abdominal pain. Several children with cystic fibrosis who were taking high doses of pancreatic enzyme supplements have suffered from narrowing of the bowel and required an operation.

Tell your doctor if you notice any other symptom while you are taking Panzytrat 25,000.

In rare cases, people taking very high doses have had a tendency to develop high levels of uric acid in their blood and urine.

If you take too much Panzytrat 25,000 you may get irritation or inflammation in the anal region.

Do not be alarmed by this list of possible side effects You may not experience any of them.

The active ingredient in Panzytrat 25,000 is an extract of pancreatic powder of porcine origin (pigs), therefore the presence of porcine parvovirus or other porcine viruses cannot be totally excluded. However, there is no evidence of transmission of these viruses to humans or of porcine pancreatic powder extracts causing illness in humans.

After taking Panzytrat 25,000

Storage

Keep your capsules in the bottle until it is time to take them. If you take the capsules out of the bottle they may not keep well.

Keep your Panzytrat 25,000 in a dry place where the temperature stays below 25 degrees C. Please note that in warmer climates it may be necessary to store Panzytrat 25,000 in the refrigerator.

Do not store it, or any other medicine, in the bathroom or near a sink.

Do not leave it in the car or on a window sill on hot days. Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least one-and-half meters above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Panzytrat 25,000, or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Panzytrat 25,000 capsules are red- brown/colourless capsules containing small off-white/ beige coloured mini- tablets that have a special coating. Available in bottles of 100 capsules.

Ingredients

Each microtablet in the capsules is identical with nominal enzyme activity of:
Lipase 400 BP units, Amylase 360 BP units & Protease 20 PH Eur units.

Each Panzytrat 25,000 capsule contains Pancrelipase equivalent to not less than lipase 25,000 BP units, amylase 22,500 BP units and protease 1,250 Ph. Eur. units.

Inactive ingredients include

  • lactose,
  • microcrystalline cellulose,
  • crospovidone,
  • colloidal anhydrous silica,
  • magnesium stearate,
  • methacrylic acid copolymer,
  • triethyl citrate,
  • talc,
  • simethicone,
  • gelatin,
  • erythrosine CI45430,
  • iron oxide red CI7749 1,
  • iron oxide yellow CI77492 and
  • montan wax.

Sponsor

Panzytrat 25,000 is manufactured in Germany by Nordmark GmbH for:
Technipro-Pulmomed Pty Ltd.,
Unit 10, 13 Berry Street, CLYDE.
NSW, 2142 Australia.

Postal: P.O. Box 6390
Parramatta B.C., NSW 2150.

Tele: (02) 9897 5899
Fax: (02) 9897 5799
e-mail: service@technipro.com.au

This leaflet was last updated: 26th February 2014.

Australian Registration Numbers:
Panzytrat 25,000: AUST R 55941

Published by MIMS September 2014

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