CREONIPE 20000 Enteric-coated hard capsules

Зміст інструкції

1. CREONIPE 20000 U.Ph.Eur. hard gastro-resistant capsules
   1. What is CREONIPE and what is it used for
   2. What you need to know before taking CREONIPE
   3. How to take CREONIPE
   4. Possible side effects
   5. How to store CREONIPE
   6. Content of the pack and other information

CREONIPE 20000 U.Ph.Eur. hard gastro-resistant capsules

pancrelipase

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What CREONIPE is and what it is used for
• 2. What you need to know before you take CREONIPE
• 3. How to take CREONIPE
• 4. Possible side effects
• 5. How to store CREONIPE
• 6. Contents of the pack and other information

1. What is CREONIPE and what is it used for

What is CREONIPE

• CREONIPE contains an enzymatic mixture called “pancrelipase”.
• Pancrelipase is also called pancreatin. It will help you digest food. These enzymes are extracted from the pancreas of pigs.
• The CREONIPE capsules contain small granules that slowly release the pancrelipase into the intestine (gastro-resistant granules, called minimicrospheres).

What is CREONIPE used for
CREONIPE is used for the treatment of “exocrine pancreatic insufficiency”, that is when the
pancreas gland does not produce enough enzymes to digest food. For example, people with:
are often affected by

• cystic fibrosis, a rare genetic disease
• chronic inflammation of the pancreas (chronic pancreatitis)
• removal of part or all of the pancreas (partial or total pancreatectomy)
• pancreatic cancer CREONIPE 20000 U.Ph.Eur. is indicated for use in children, adolescents and adults. The

CREONIPE”.
Treatment with CREONIPE improves the symptoms of exocrine pancreatic insufficiency, including the
consistency of stools (e.g. greasy stools), abdominal pain, flatulence and frequency of stools (diarrhea
or constipation), regardless of the underlying disease.

How does CREONIPE work
The enzymes in CREONIPE work by digesting food as it passes through the intestine. You must take
CREONIPE during or immediately after a meal or snack. This will allow the enzymes to
mix completely with the food.

2. What you need to know before taking CREONIPE

Do not take CREONIPE

• if you are allergic to pancrelipase or any of the other ingredients of CREONIPE (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking CREONIPE.
Patients with cystic fibrosis
In patients with cystic fibrosis treated with high doses of pancreatic enzymes, a rare intestinal
condition called “fibrosing colonopathy” has been observed, which causes narrowing of the intestine.
If you have cystic fibrosis and are taking pancreatic enzymes at a dose greater than 10,000
lipase units per kilogram of body weight per day and develop unusual abdominal symptoms or
changes in your abdominal symptoms, tell your doctor immediately.
CREONIPE”.
Severe allergic reaction
If you develop an allergic reaction, stop treatment and see a doctor. An allergic
reaction may manifest with symptoms such as itching, hives or rash. In rare cases, a
more severe allergic reaction may include a feeling of warmth, dizziness, fainting and difficulty
breathing; these symptoms are indicative of a severe allergic reaction, potentially fatal,
called “anaphylactic shock”. If this occurs, seek immediate medical attention.
Talk to your doctor if you are allergic to pork proteins before taking CREONIPE.
Mouth irritation
Pain in the oral cavity, irritation (stomatitis), bleeding and ulceration in the mouth may
occur if the capsules are chewed and/or kept in the mouth for too long.
Rinsing your mouth and drinking a glass of water may help if you notice the first signs of mouth
irritation.
CREONIPE can only be sprinkled on certain foods (see section 3 of this leaflet, “How to
take CREONIPE”).
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is
essentially “sodium-free”.

Other medicines and CREONIPE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The doctor will decide whether you can take CREONIPE during pregnancy.
CREONIPE can be used during breastfeeding.

Driving and operating machinery
CREONIPE does not affect the ability to drive or operate tools or machinery.

3. How to take CREONIPE

Take this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, ask your doctor or pharmacist.
The dose is measured in “lipase units”. Lipase is one of the enzymes in pancrelipase. Different dosages
of CREONIPE contain different amounts of lipase.
Always follow your doctor’s advice on how much CREONIPE you should take. Your doctor will adjust the
dose according to your needs.
This will depend on:

• the severity of your illness
• your weight
• your diet
• the amount of fat in your stools

If you still have fatty stools or other stomach or intestinal problems (gastrointestinal symptoms), talk to your
doctor as it may be necessary to adjust the dose.

How much CREONIPE to take
For patients with cystic fibrosis
Children:
This dosage of the medicine may not be suitable to start therapy in children, in
relation to the child's age and weight.
The dose needed for a child must be determined by the doctor with doses containing less units
of lipase (e.g. 10,000 or 5,000 lipase units).
Once the dose for a meal has been established, this dosage of the medicine can be used in children.

• The usual starting dose for children under 4 years of age is 1000 lipase units per kilogram of body weight per meal.
• The usual starting dose for children 4 years of age or older is 500 lipase units per kilogram of body weight per meal. Adolescents and adults The initial enzyme dose based on weight is 500 lipase units/kg of body weight per meal in adolescents and adults.

For all age groups
The dose should not exceed 2,500 lipase units/kg of body weight per meal or 10,000 lipase
units/kg of body weight per day or 4,000 lipase units per gram of fat ingested.

Forpatients with other pancreatic problems
Adolescents and adults:
The usual dose for a meal is between 25,000 and 80,000 lipase units.
The usual dose for a snack is half the dose for a meal.

When to take CREONIPE
Always take CREONIPE during or immediately after a meal or snack. This will allow the
enzymes to mix completely with the food and digest it as it passes through the intestine.

How to take CREONIPE

• CREONIPE should always be taken during a meal or snack.
• The capsules must be swallowed whole and taken with a glass of water or juice.
• Do not crush or chew the capsules or their contents as this may cause irritation inside the mouth or change the way CREONIPE works in your body.
• If you have difficulty swallowing the capsules, carefully open them and add the microgranules to a small amount of soft acidic food or acidic liquids. Soft acidic foods could for example be yogurt or applesauce. Acidic liquids can be apple, orange or pineapple juice. Do not mix the microgranules with water, milk including flavored milk,

breast milk and infant formula or with hot food. Immediately swallow the mixture, without
crushing or chewing it, with water or juice.

• Mixing with non-acidic foods or liquids, crushing or chewing the microgranules may cause irritation inside the mouth or alter the way CREONIPE works in your body.
• Do not hold the CREONIPE capsules or their contents in your mouth. Make sure the medicine and food mixture is swallowed completely without leaving any microgranules remaining in your mouth.
• Do not store the mixture.

If you take more CREONIPE than you should
If you take more CREONIPE than you should, drink plenty of water and contact a doctor or pharmacist.
Very high doses of pancrelipase have sometimes caused an excess of uric acid in the urine
(hyperuricosuria) and in the blood (hyperuricemia).

If you forget to take CREONIPE
If you forget a dose, take the next dose at the usual time, with your next meal. Do not take
a double dose to make up for a missed dose.

If you stop taking CREONIPE
Do not stop taking CREONIPE without consulting your doctor. Many patients
need to take CREONIPE for the rest of their lives.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, CREONIPE can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine.
The most important serious side effects observed with other pancreatic enzyme replacement therapies are “anaphylactic shock” and fibrosing colonopathy. These two side effects have occurred in a small number of people, but their exact frequency is unknown.
Anaphylactic shock is a severe allergic reaction, potentially life-threatening, that can develop
rapidly. If you notice any of the following symptoms, seek immediate medical attention:

• itching, hives or skin rash
• swelling of eyes, lips, hands or feet
• feeling dizzy or fainting
• difficulty breathing or swallowing
• palpitations
• dizziness, collapse or loss of consciousness.

Repeated high doses of medicines for pancreatic enzyme replacement therapy can
also cause scarring or thickening of the intestine which can lead to bowel obstruction, a
condition called fibrosing colonopathy. If you have severe stomach pain, difficulty with bowel
movements (constipation), nausea or vomiting, tell your doctor immediately.

Very common side effects(may affect more than 1 in 10 people)

• stomach pain (abdomen).

Common side effects(may affect up to 1 in 10 people)

• feeling sick (nausea)
• feeling unwell (vomiting)
• constipation
• bloating (abdominal distension)
• diarrhoea These may be due to the condition you are taking CREONIPE for.

Uncommon side effects(may affect up to 1 in 100 people)

• skin rashes

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system http://www.aifa.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store CREONIPE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ºC.
After opening, do not store at a temperature above 25 °C and use within 6 months. Keep the
bottle tightly closed to protect the medicine from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What CREONIPE contains
The active ingredient of CREONIPE is pancrelipase.

• Each capsule of CREONIPE 20000 U.Ph.Eur. contains 300 mg of pancrelipase corresponding to (Ph.Eur. units):
• Lipase 20,000
• Amylase 16,000
• Protease 1,200
• The other components are Capsule content:
• Hypromellose phthalate
• Macrogol 4000
• Triethyl citrate
• Dimethicone 1000
• Cetyl alcohol Capsule shell:
• Gelatin
• Iron oxides red, yellow and black (E 172)
• Sodium lauryl sulfate

Description of the appearance of CREONIPE and content of the pack
CREONIPE 20000 U.Ph.Eur. is presented as elongated size 0 capsules, of
brown color and transparent. They contain gastro-resistant granules of brownish color (minimicrospheres).
CREONIPE 20000 U.Ph.Eur. is available in HDPE bottles with PP screw caps containing 50 capsules, 60
capsules, 100 capsules, 120 capsules, 200 capsules, 250 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
Manufacturer:
Abbott Laboratories GmbH
Justus-von-Liebig-Str. 33
31535 Neustadt
Germany
Mylan Germany GmbH
Lütticher Straße 5
53842 Troisdorf
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: