NUTRIZYM 22

Active substance: PANCREATIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nutrizym 22
Pancreatin
Read all of this leaflet carefully before you start taking 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Nutrizym 22 is and what it is used for
Before you take Nutrizym 22
How to take Nutrizym 22
Possible side effects
How to store Nutrizym 22
Further information

1. WHAT NUTRIZYM 22 IS AND WHAT IT IS USED FOR
This medicine is given to patients who have a disorder of their pancreas. The pancreas is an organ situated in your abdomen near to
your stomach.
The pancreas releases substances called enzymes into the small intestine (small bowel) to digest food. If you have a disorder such as
cystic fibrosis or pancreatitis and your pancreas is not working properly you may need to take extra enzymes, so that your food is
fully digested. Nutrizym 22 contains the active ingredient pancreatin, which includes the enzymes that you need.

2. BEFORE YOU TAKE NUTRIZYM 22
Do not take Nutrizym 22 and tell your doctor if you:
• have ever had an allergic reaction to pancreatin or any of the other ingredients of Nutrizym 22 (see list of ingredients in section 6)
• are allergic (hypersensitive) to pig (pork) products
• have cystic fibrosis and are 15 years old or younger

Take special care with Nutrizym 22:
Hyperuricaemia (high levels of uric acid in the blood) and hyperuricosuria (excessive amounts of uric acid in the urine) can occur in
cystic fibrosis patients. Pancreatin extracts contain small amounts of purine and if high doses of Nutrizym are given this may cause
hyperuricaemia and hyperuricosuria.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any medicines, including medicines obtained without a prescription.

Taking Nutrizym 22 with food and drink
Take the capsules with meal or snack. Swallow the capsules whole with water. (See Section 3)

Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, planning to become pregnant or breast-feeding, you should not take Nutrizym 22
unless clearly necessary. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.

Important information about some of the ingredients of Nutrizym 22
Nutrizym 22 also contains Castor Oil which may cause stomach upset and diarrhoea

3. HOW TO TAKE NUTRIZYM 22
Always take Nutrizym 22 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the capsules whole with water with meals and snacks.
If you find that swallowing the capsules is difficult, remove the minitablets from their capsule and swallow them with a drink. You
can also mix them with a small amount of soft food and swallow quickly. You should not chew the minitablets because this
damages the special coating on them. It is important that you drink plenty of fluid while you are on Nutrizym 22.

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Dose
Your doctor or dietician will tell you how many capsules you should take. The number taken will depend on your symptoms and on
how well you respond to Nutrizym 22. If your doctor tells you to increase the number of capsules you are taking, make sure you do it
gradually. Do not take more capsules than he has told you to.

If you take more Nutrizym 22 than you should
You may have an uncomfortable stomach, feel sick or vomit. If you do take a large overdose and feel unwell contact your doctor.

If you forget to take Nutrizym 22
It is important to take your capsules with snacks or meals. If you forget to do this, make sure you take your next dose with your next
snack or meal. Do not take any capsules other than at meal or snack time.

If you stop taking Nutrizym 22
If you stop taking this medicine your condition may worsen. Do not do this unless your doctor has told you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nutrizym 22 can cause side effects, although not everybody gets them.
If you experience any of the following side effects with Nutrizym 22, STOP taking the capsules and contact your doctor
immediately: A severe allergic reaction, such as itching, swelling of the face, lips, tongue, mouth, or throat, which may cause
shortness of breath, wheezing, or difficulty breathing.

Other side effects include:
• A narrowing of the bowel can occur in cystic fibrosis patients who take large doses of some types of pancreatin. This may
result in the need for an operation.
• Sometimes patients taking pancreatic enzymes develop a sore mouth or anus. If this happens to you and becomes a problem,
talk to your doctor.
• If you develop unusual stomach pains or a change in the regularity of your bowel habits you should see your doctor.
• Inflammation of the colon has been reported in children with cystic fibrosis taking pancreatic enzymes.
Some patients are allergic (hypersensitive) to this product so if you have any other side effects which persist whilst using Nutrizym
22 please tell your doctor or pharmacist straight away.
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. HOW TO STORE NUTRIZYM 22
Keep out of the sight and reach of children.
Do not store Nutrizym 22 above 25°C.
It should be kept in the original container given to you by the pharmacist. You should keep the container tightly closed.
Do not take any capsules after the expiry date on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no
longer needed. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Nutrizym 22 contain
The active substance is pancreatin. Each capsule contains 340mg of pancreatin as the active ingredient. This is equivalent to at least
22,000 units of lipase, 19,800 units of amylase and 1,100 units of protease.
The other ingredients are: castor oil, silicon dioxide, magnesium stearate, sodium carboxymethylcellulose, microcrystalline
cellulose, simethicone emulsion, a methacrylic copolymer, talc and triethyl citrate. The capsules are made from gelatin and are
coloured with Titanium dioxide (E171), as well as iron oxide red and iron oxide yellow (E172).

What Nutrizym 22 look like and contents of the pack
The active ingredient, pancreatin, is made into minitablets which have been put inside hard, red and yellow gelatine capsules.
The capsules are available in packs of 100.

Marketing Authorisation Holder
Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK.

Manufacturer
EURAND International SpA, Via Martin Luther King. 13, 20060 Pessano con Bornago. Milan, Italy
This leaflet was last approved in May 2010

41822A
TW203517

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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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