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 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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Nutrizym 22 is and what it is used for
2. What you need to know before you take Nutrizym 22
3. How to take Nutrizym 22
4. Possible side effects
5. How to store Nutrizym 22
6. Contents of the pack and other 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. What you need to know before you take Nutrizym 22
Do not take Nutrizym 22:
• 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)
• if you are allergic (hypersensitive) to pig (pork) products
• if you have cystic fibrosis and are 15 years old or younger
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking 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.
Other medicines and Nutrizym 22
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Nutrizym 22 with food and drink
Take the capsules with a meal or snack. Swallow the capsules whole with water. (See Section 3)
Pregnancy and breast-feeding
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.
Nutrizym 22 contains Castor Oil
Nutrizym 22 also contains Castor Oil which may cause stomach upset and diarrhoea

3. How to take Nutrizym 22
Always take this medicine exactly as your doctor or pharmacist has told you. 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.

Measure bar should be 150mm at 100% scale
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Wasdell Packaging Ltd

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Description

Nutrizym 22 capsules leaflet

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22

Recommended 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 medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5. How to store Nutrizym 22
Keep this medicine out of the sight and reach of children.
Do not store 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 use this medicine after the expiry date which is stated on the carton and bottle after 'EXP'. 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 enviroment.

6. Contents of the pack and other information
What Nutrizym 22 contains
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 looks 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 and Manufacturer
Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK.

MCKLT02-1

This leaflet was last revised in 10/2013.

TW627880

Measure bar should be 150mm at 100% scale
Customer

Wasdell Packaging Ltd

Colours Used

Description

Nutrizym 22 capsules leaflet

Process Black

Item Code

MCKLT02-1

Profile
Size

170 x 240mm
UK

Language

English

Proof By

elkie.bramall

Proof No.

3

Date

31/10/2013

Folded 170 x 30mm

Outlined

Market

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Keylines

N/A

Min. Point Size

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Non printable area

Artwork No.

461054-465030-466718

Pharma
Code

22

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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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