Creonipe

PACKAGE LEAFLET

Package leaflet: information for the patient

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

pancreatin
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 CREONIPE is and what it is used for

What CREONIPE is

• CREONIPE contains an enzyme mixture called "pancrelipase".
• Pancrelipase is also known as pancreatin. It will help you digest food. These enzymes are extracted from the pancreas of pigs.
• CREONIPE capsules contain small granules that slowly release pancrelipase in the intestine (enteric-coated granules, called minimicrospheres).

What CREONIPE is used for
CREONIPE is used to treat “exocrine pancreatic insufficiency”, which is when the pancreas gland does not produce enough enzymes to digest food. This condition commonly affects people with:

• 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 tumour

CREONIPE 20000 U.Ph.Eur. is indicated for use in children, adolescents and adults. Dosage by age group is described in section 3 of this leaflet, “How to take CREONIPE”.

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

How CREONIPE works
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 ensures that the enzymes mix thoroughly with the food.

2. What you need to know before taking CREONIPE

Do not take CREONIPE

• if you are allergic to pancrelipase or to 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
A rare intestinal condition called "fibrosing colonopathy," which causes intestinal narrowing, has been observed in patients with cystic fibrosis treated with high doses of pancreatic enzymes.
If you have cystic fibrosis and are taking pancreatic enzymes at a dose exceeding 10,000 lipase units per kilogram of body weight per day, and you develop unusual abdominal symptoms or changes in your usual abdominal symptoms, inform your doctor immediately.
The dosage in lipase units is indicated in section 3 of this leaflet, "How to take CREONIPE."
Severe allergic reaction
If you develop an allergic reaction, stop treatment and contact your doctor. An allergic reaction may present with symptoms such as itching, hives, or skin rash. In rare cases, a more severe allergic reaction may include a sensation of warmth, dizziness, fainting, and difficulty breathing; these symptoms may indicate a serious, potentially fatal allergic reaction called "anaphylactic shock." If this occurs, seek immediate medical help.
Talk to your doctor if you are allergic to porcine proteins before taking CREONIPE.
Mouth irritation
Pain in the oral cavity, irritation (stomatitis), bleeding, and formation of mouth ulcers may occur if the capsules are chewed and/or held in the mouth for too long.
Rinsing the mouth and drinking a glass of water may help if you notice early signs of mouth irritation.
CREONIPE may 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, which means it is essentially "sodium-free."
Other medicines and CREONIPE
Inform 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, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take CREONIPE during pregnancy.
CREONIPE may be used during breastfeeding.
Driving and using machines
CREONIPE does not affect the ability to drive or operate tools or machinery.

3. How to take CREONIPE

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The dose is measured in “lipase units”. Lipase is one of the enzymes in pancrelipase. Different strengths
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 individual needs.
This will depend on:

• the severity of your condition
• your body weight
• your diet
• the amount of fat in your stools

If you still have fatty stools or other stomach or intestinal problems (gastrointestinal symptoms), speak with your
doctor, as your dose may need to be adjusted.
How much CREONIPE to take
For patients with cystic fibrosis
Children:
This strength of the medicine may not be suitable for initiating therapy in children, depending on the child's
age and weight.
The dose required for a child must be determined by the doctor using lower-strength formulations containing fewer lipase units (e.g. 10,000 or 5,000 lipase units).
Once the mealtime dose has been established, this strength of the medicine may be used in children.

• The usual initial dose for children under 4 years of age is 1,000 lipase units per kilogram of body weight per meal.
• The usual initial dose for children aged 4 years and older is 500 lipase units per kilogram of body weight per meal. Adolescents and adults The initial enzyme dose based on body weight is 500 lipase units/kg of body weight per meal for adolescents and adults.

For all age groups
The dose must 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.
For patients 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 allows the
enzymes to mix thoroughly with food and digest it as it passes through the intestine.
How to take CREONIPE

• CREONIPE must always be taken during a meal or snack.

• The capsules must be swallowed whole 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 alter the way CREONIPE works in your body.

• If you have difficulty swallowing the capsules, carefully open them and mix the minimspheres with a small amount of soft acidic food or acidic liquid. Acidic soft foods may include, for example, yoghurt or apple sauce. Acidic liquids may include apple, orange, or pineapple juice. Do not mix the minimspheres with water, milk (including flavoured milk),
  breast milk, or infant formula, or with hot foods. Swallow the mixture immediately, without
  crushing or chewing it, followed by water or juice.

• Mixing with non-acidic foods or liquids, crushing, or chewing the minimspheres may cause irritation inside the mouth or alter the way CREONIPE works in your body.

• Do not keep CREONIPE capsules or their contents in the mouth. Ensure that the mixture of medicine and food is completely swallowed, without leaving any minimspheres in the mouth.

• Do not store the mixture.

If you take more CREONIPE than you should
If you take more CREONIPE than prescribed, drink plenty of water and contact a doctor or pharmacist.
Very high doses of pancrelipase have occasionally caused excess 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 the next meal. Do not take a double
dose to make up for the missed dose.
If you stop taking CREONIPE
Do not stop treatment with CREONIPE without consulting your doctor. Many patients need to take CREONIPE for the rest of their lives.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CREONIPE may cause side effects, although not everyone experiences 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 adverse reactions have occurred in a small number of people, but their exact frequency is unknown.

Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can develop rapidly. If you notice any of the following symptoms, seek immediate medical assistance:

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

Repeated high doses of pancreatic enzyme replacement medicines may also cause scarring or thickening of the intestine, which could lead to intestinal blockage, a condition called fibrosing colonopathy. If you experience severe stomach pain, difficulty passing stools (constipation), nausea, or vomiting, inform your doctor immediately.

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

• stomach pain (abdominal pain)

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

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

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

• skin rash

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You can also report side effects directly via 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 stated on the packaging. The expiry date refers to the last day of that month.
Store below 25 °C.
After opening, do not store above 25 °C and use within 6 months. Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CREONIPE contains
The active substance in CREONIPE is pancrelipase.

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

Description of the appearance of CREONIPE and contents of the pack
CREONIPE 20000 U.Ph.Eur. is presented as size 0 elongated capsules, brown and transparent, containing brownish gastro-resistant granules (mini-microspheres).
CREONIPE 20000 U.Ph.Eur. is available in HDPE bottles with PP screw cap 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

Manufacturers:
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 European Economic Area countries under the
following names: