Creon

PATIENT LEAFLET: INFORMATION FOR THE USER

CREON 10000 U.Ph.Eur modified-release hard capsules

pancrelipase
Please read all of this leaflet carefully before you start using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. What CREON is and what it is used for

• CREON is an oral medicinal product containing pancreatin, which consists of pancreatic enzymes (lipase, amylase, protease). Pancreatic enzymes are necessary for digestion, i.e. the breakdown of fats, proteins, and starch into simpler substances.
• CREON is indicated for the treatment of exocrine pancreatic insufficiency (reduced or inadequate pancreatic function) caused by cystic fibrosis (an inherited disease), chronic pancreatitis, pancreatectomy (total or partial removal of the pancreas), total gastrectomy and partial gastric resections (removal of the stomach), and ductal obstruction due to neoplasms (tumors of the pancreas or common bile duct). Pancreatic enzyme supplementation may also be beneficial in age-related exocrine pancreatic insufficiency.

2. What you need to know before using CREON

Do not use CREON

• if you are allergic to porcine pancreatic enzymes or to any of the other ingredients of this medicine (listed in section 6).
• if you have acute pancreatitis (acute inflammatory disease of the pancreas).

Warnings and precautions
Talk to your doctor or pharmacist before using Creon

• if unusual intestinal symptoms develop or intestinal symptoms change, especially if you are being treated with high enzyme doses (more than 10,000 lipase units per kg body weight per day). In such case, inform your doctor immediately.

Additional information on pancreatic enzymes
Creon, like other pancreatic enzyme products, is produced from pancreatic glands derived from pigs intended for human consumption. These pigs may carry viruses. During the manufacturing of Creon, numerous measures are taken to reduce the risk of virus transmission, including virus inactivation and testing for specific viruses. The risk of infection caused by these or other unknown or new viruses cannot be completely ruled out. However, no cases of patient infection have been reported so far.
Other medicines and Creon
No interaction studies have been conducted between Creon and other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Creon with food, drinks and alcohol
It is recommended to take Creon during or immediately after main meals, with an adequate amount of liquid (see How to use Creon).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
Creon may be used during breastfeeding.
Driving and using machines
Creon has no effect or negligible effect on the ability to drive vehicles and operate machinery.
Creon contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to use CREON

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage should be adjusted according to individual needs and depends on the severity of the disease and the composition of the diet. It is recommended to take the capsules during or immediately after main meals.
The capsules must be swallowed whole, without breaking or chewing them, during or immediately after each meal or snack, with an adequate amount of liquid. If swallowing the capsules is difficult (e.g. in young children or elderly patients), the capsules may be carefully opened and the minimicrospheres mixed with acidic semi-solid foods (pH < 5.5, i.e. acidic) that do not require chewing, or taken together with acidic liquids (pH < 5.5, i.e. acidic). Examples of acidic semi-solid foods include apple puree or yoghurt. Acidic liquids may include apple, orange or pineapple juice.
This method should be used in gastrectomized patients.
Any mixture of minimicrospheres with food or liquid must be used immediately and must not be stored.
Breaking or chewing the minimicrospheres, or mixing them with foods having a pH greater than 5.5 (i.e. alkaline), may destroy the gastro-protective membrane coating the minimicrospheres. This could result in premature release of the enzymes in the oral cavity, leading to reduced efficacy of the medicine and irritation of the mucous membranes. Care should be taken to ensure that no residue of the medicine remains in the mouth.
It is important to ensure adequate hydration of patients at all times, especially during periods of increased fluid loss. Inadequate hydration may worsen constipation.

Dosage in Cystic Fibrosis (adults and children)
In cystic fibrosis, the following dosage is recommended for pancreatic enzyme replacement therapy:

• Enzyme treatment should start with 1000 lipase units per kg of body weight per meal in children up to 4 years of age, and with 500 lipase units per kg of body weight per meal in children over 4 years of age.
• The dosage should be adjusted according to the severity of the disease to ensure control of steatorrhea and maintenance of good nutritional status.
• Most patients should not exceed 10,000 lipase units per kg of body weight or 4000 lipase units per gram of ingested fat.

Dosage in other conditions associated with exocrine pancreatic insufficiency
The dosage should be adjusted according to individual needs, depending on the degree of maldigestion and the fat content of the meal. The dose per meal ranges between 25,000 and 80,000 lipase units, while for snacks it should be half of that amount.

If you take more CREON than you should:
If you accidentally take too much CREON, contact your doctor immediately or go to the nearest hospital.
Overdosing on this medicine may lead to increased uric acid excretion in the urine (hyperuricosuria) and elevated levels of uric acid in the blood (hyperuricemia).

If you forget to take CREON:
Do not take a double dose to make up for the forgotten dose.

If you stop taking CREON:
Caution: Do not stop taking CREON without consulting your doctor. Symptoms of your condition may worsen.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported adverse reactions have been gastrointestinal disorders,
mostly of mild or moderate severity. Gastrointestinal disorders are mostly related to the
underlying disease. The following adverse effects were reported during clinical studies:

Very common (affects more than 1 in 10 people):

• abdominal pain

Common (affects less than 1 in 10 people):

• nausea
• vomiting
• constipation
• abdominal distension
• diarrhoea

Uncommon (affects less than 1 in 100 people):

• skin rash (erythema)

Not known (frequency cannot be estimated from available data):

• pruritus and urticaria
• other severe allergic reactions (hypersensitivity) which may include breathing difficulties or swelling of the lips.
• intestinal strictures in the ileocaecal region and large intestine (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system: www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CREON

CREON should be stored at a temperature not exceeding 25°C and kept in a tightly closed container.
After opening, use within 6 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Creon 10000 U.Ph.Eur contains
The active substance is pancrelipase. One capsule contains 150 mg of pancrelipase (equivalent to: amylase 8,000 U.Ph.Eur., lipase 10,000 U.Ph.Eur., protease 600 U.Ph.Eur).
The other components are: macrogol 4000, hypromellose phthalate, simethicone 1000, cetyl alcohol, triethyl citrate, gelatin, anhydrous iron (III) oxide E172, hydrated iron (III) oxide E172, iron (II, III) oxide E172, sodium lauryl sulfate.
Description of the appearance of Creon 10000 U.Ph.Eur and package contents
CREON 10000 U.Ph.Eur is presented as two-colored capsules (opaque brown cap and transparent body) for oral use, containing gastro-resistant granules, packaged in high-density polyethylene (HDPE) containers with polypropylene cap containing 50, 100 or 200 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milan, Italy
Manufacturer:
Abbott Laboratories GmbH, Neustadt - Germany.

PACKAGE LEAFLET: INFORMATION FOR THE USER

CREON 25000 U.Ph.Eur. modified-release hard capsules

pancreatin
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

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

1. What CREON is and what it is used for

• CREON is an oral product containing pancrelipase, which consists of pancreatic enzymes (lipase, amylase, protease). Pancreatic enzymes are necessary for digestion, i.e. breaking down fats, proteins, and starch into simpler substances.
• CREON is indicated for the treatment of exocrine pancreatic insufficiency (reduced or inadequate pancreatic function) caused by cystic fibrosis (a hereditary disease), chronic pancreatitis, pancreatectomy (total or partial surgical removal of the pancreas), total gastrectomy and partial gastric resections (resections of the stomach), and ductal obstruction due to neoplasms (tumors of the pancreas or common bile duct). Pancreatic enzyme supplementation may also be beneficial in age-related exocrine pancreatic insufficiency.

2. What you need to know before taking CREON

Do not take CREON

• if you are allergic to porcine pancreatic enzymes or to any of the other ingredients of this medicine (listed in section 6).
• if you have acute pancreatitis (acute inflammatory disease of the pancreas).

Warnings and precautions
Talk to your doctor or pharmacist before taking Creon

• if unusual intestinal symptoms develop or if there are changes in intestinal symptoms, especially if you are being treated with high enzyme doses (more than 10,000 lipase units per kg body weight per day). In such case, inform your doctor immediately.

Additional information on pancreatic enzymes
Creon, like other pancreatic enzyme products, is produced from pancreatic glands derived from pigs intended for food consumption. These pigs may carry viruses. During the manufacturing of Creon, numerous measures are taken to reduce the risk of viral transmission, including viral inactivation and specific virus testing. The risk of infections caused by these or other unknown or new viruses cannot be completely ruled out. However, no cases have been reported in which patients have developed an infection.

Other medicines and Creon
No interaction studies between Creon and other medicines have been conducted.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Creon with food, drinks and alcohol
It is recommended to take Creon during or immediately after main meals, with an adequate amount of liquid (see How to take Creon).

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.
Breastfeeding
Creon may be used during breastfeeding.

Driving and use of machines
Creon has no effect or negligible effect on the ability to drive vehicles and operate machinery.

Creon contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to use CREON

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage should be adjusted according to individual needs and depends on the severity of the disease and the composition of the diet. It is recommended to take the capsules during or immediately after main meals.
The capsules must be swallowed whole, without breaking or chewing them, during or immediately after each meal or snack, with an adequate amount of liquid. If swallowing the capsules is difficult (e.g. in young children or elderly patients), the capsules may be carefully opened and the minimicrospheres mixed with semi-solid acidic foods (pH < 5.5, i.e. acidic) that do not require chewing, or taken together with acidic liquids (pH < 5.5, i.e. acidic). For example, suitable semi-solid acidic foods include apple puree or yoghurt. Acidic liquids may include apple, orange or pineapple juice.
This method should be used in gastrectomized patients.
Any mixture of minimicrospheres with food or liquid must be used immediately and must not be stored.
Breaking or chewing the minimicrospheres, or mixing them with foods having a pH greater than 5.5 (i.e. basic), may destroy the gastro-protective membrane coating the minimicrospheres. This may result in premature release of enzymes in the oral cavity, leading to reduced efficacy of the medicine and possible irritation of mucous membranes. Care must be taken to ensure that no residual medicine remains in the mouth.
It is important to ensure adequate hydration of patients at all times, especially during periods of increased fluid loss. Inadequate hydration may worsen constipation.

Dosage in Cystic Fibrosis (adults and children)
In cystic fibrosis, the following dosage is recommended for pancreatic enzyme replacement therapy:

• Enzyme treatment should start with 1000 lipase units per kg of body weight per meal in children up to 4 years of age, and with 500 lipase units per kg of body weight per meal in children over 4 years of age;
• Dosage should be adjusted according to disease severity to ensure control of steatorrhea and maintenance of good nutritional status;
• Most patients should not exceed 10000 lipase units per kg of body weight or 4000 lipase units per gram of ingested fat.

Dosage in other conditions associated with exocrine pancreatic insufficiency
Dosage should be adjusted according to individual needs, depending on the degree of maldigestion and the fat content of the meal. The dose per meal ranges between 25000 and 80000 lipase units, while half this dose is recommended for snacks.

If you take more CREON than you should:
If you have taken or ingested too much CREON, contact your doctor immediately or go to the nearest hospital.
Overdose may lead to increased urinary excretion of uric acid (hyperuricosuria) and elevated blood levels of uric acid (hyperuricemia).

If you forget to take CREON:
Do not take a double dose to make up for the missed dose.

If you stop taking CREON:
Caution: do not stop taking CREON without consulting your doctor. Symptoms of your condition may worsen.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most commonly reported adverse reactions have been gastrointestinal disorders,
mostly of mild or moderate severity. Gastrointestinal disorders are mostly associated
with the underlying disease. The following undesirable effects have been reported during clinical studies:
Very common (affects more than 1 in 10 people) :

• abdominal pain

Common (affects less than 1 in 10 people) :

• nausea
• vomiting
• constipation
• abdominal distension
• diarrhoea

Uncommon (affects less than 1 in 100 people):

• skin rash

Not known (frequency cannot be estimated from the available data)

• pruritus and urticaria
• other severe allergic reactions (hypersensitivity) which may include breathing difficulties or swelling of the lips.
• intestinal strictures at the ileocaecal region and in the large intestine (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CREON

CREON should be stored at a temperature not exceeding 25°C, keeping the container tightly closed.
After opening, use within 6 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Creon 25000 U.Ph.Eur contains
The active substance is pancreatin. One capsule contains 300 mg of pancreatin (equivalent to: amylase 18,000 U. Ph. Eur., lipase 25,000 U. Ph. Eur., protease 1,000 U. Ph. Eur.).
The other components are: macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate, gelatin, anhydrous iron (III) oxide E172, hydrated iron (III) oxide E172, sodium lauryl sulfate.
Description of the appearance of Creon 25000 U.Ph.Eur and the contents of the pack
CREON 25000 U.Ph.Eur is presented as two-coloured capsules (orange cap and transparent body) for oral use, containing gastro-resistant granules, packaged in high-density polyethylene (HDPE) containers with polypropylene caps containing 50 or 100 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milan
Manufacturer:
Abbott Laboratories GmbH, Neustadt – Germany

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

CREON 5000 U.Ph.Eur. gastro-resistant granules

pancreatin
Please read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

1. What CREON 5000 U.Ph.Eur. is and what it is used for
2. What you need to know before taking CREON 5000 U.Ph.Eur.
3. How to take CREON 5000 U.Ph.Eur.
4. Possible side effects
5. How to store CREON 5000 U.Ph.Eur.
6. Contents of the pack and other information

1. What CREON 5000 U.Ph.Eur. is and what it is used for

• CREON 5000 U.Ph.Eur. is an oral medicinal product containing pancreatin, which consists of pancreatic enzymes (lipase, amylase, protease). Pancreatic enzymes are necessary for digestion, i.e. the breakdown of fats, proteins and starch into simpler substances.
• CREON 5000 U.Ph.Eur. is indicated for the treatment of exocrine pancreatic insufficiency (reduced or inadequate pancreatic function) caused by cystic fibrosis (hereditary disease), chronic pancreatitis, pancreatectomy (total or partial removal of the pancreas), total gastrectomy and partial gastric resections (removal of the stomach), and ductal obstruction due to neoplasms (tumors of the pancreas or common bile duct). Pancreatic enzyme supplementation may also be beneficial in exocrine pancreatic insufficiency in the elderly.

2. WHAT YOU SHOULD KNOW BEFORE USING CREON 5000 U.Ph.Eur.

Do not use CREON 5000 U.Ph.Eur.

• if you are allergic to porcine pancreatin or to any of the other ingredients of this medicine (listed in section 6).
• if you have acute pancreatitis (acute inflammatory disease of the pancreas).

Warnings and precautions
Consult your doctor or pharmacist before using Creon 5000 U.Ph.Eur.

• if unusual intestinal symptoms occur or changes in intestinal symptoms arise, especially if you are being treated with high doses of enzymes (more than 10,000 lipase units per kg of body weight per day). In such case, inform your doctor immediately.

Additional information on pancreatic enzymes
Creon 5000 U.Ph.Eur., like other pancreatic enzyme products, is produced from pancreatic glands derived from pigs intended for food consumption. These pigs may carry viruses. During the manufacturing of Creon 5000 U.Ph.Eur., numerous measures are taken to reduce the risk of virus transmission, including virus inactivation and specific virus testing.
The risk of infection due to these or other unknown or new viruses cannot be completely ruled out. However, no cases of patient infection have been reported to date.
Other medicines and Creon 5000 U.Ph.Eur.
No interaction studies between Creon 5000 U.Ph.Eur. and other medicines have been conducted.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Creon 5000 U.Ph.Eur. with food, drinks and alcohol
It is recommended to take Creon 5000 U.Ph.Eur. during or immediately after main meals, with a sufficient amount of liquid (see How to use Creon 5000 U.Ph.Eur.).
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Breast-feeding
Creon 5000 U.Ph.Eur. can be used during breast-feeding.
Driving and using machines
Creon 5000 U.Ph.Eur. has no effect or negligible effect on the ability to drive vehicles and operate machinery.

3. HOW TO USE CREON 5000 U.Ph.Eur.

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Always use the dosing spoon provided in the package. The spoon contains 5000 lipase units.
The dosage should be adjusted according to individual needs and depends on the severity of the disease and the composition of the diet. It is recommended to take the enzymes during or immediately after main meals.
Creon 5000 U.Ph.Eur. is a dosage form consisting of small minimicrospheres, particularly suitable for neonates and children. Creon 5000 U.Ph.Eur. allows for better individual dosing in cases where low doses of lipase are required for the adequate treatment of young children.
The minimicrospheres can be added to small amounts of acidic semi-solid foods (pH < 5.5, i.e. acidic) that do not require chewing, such as apple puree or yoghurt, or taken together with acidic liquids (pH < 5.5, i.e. acidic), such as apple, orange, or pineapple juice. This mixture must not be stored.
Alternatively, the minimicrospheres can be mixed with a small amount of milk in a spoon (weaning spoon) and administered immediately to the child. Do not add the minimicrospheres to a feeding bottle.
The mixture of Creon 5000 U.Ph.Eur. with semi-solid foods must be taken immediately, without crushing or chewing, followed by drinking water or juice to ensure complete ingestion.
Breaking or chewing the minimicrospheres, or adding them to foods with a pH greater than 5.5 (i.e. basic), may destroy the gastro-protective membrane coating the minimicrospheres. This may lead to premature release of the enzymes in the oral cavity and result in reduced drug efficacy and irritation of the mucous membranes. Care must be taken to ensure that no medication remains in the mouth.
It is important to ensure adequate hydration of patients at all times, especially during periods of increased fluid loss. Inadequate hydration may worsen constipation.

Dosage in Cystic Fibrosis (adult and pediatric patients)
In cystic fibrosis, the following dosage is recommended for pancreatic enzyme replacement therapy:

• In neonates and children under 2 years of age, the dosage should start at 2000 to 5000 lipase units per meal, adjusted up to a maximum of 2500 lipase units per meal per kg of body weight, with a maximum daily dose of 10,000 lipase units per kg of body weight per day.
• Enzyme therapy should begin with 1000 lipase units per kg of body weight per meal in children up to 4 years of age, and with 500 lipase units per kg of body weight per meal in children over 4 years of age.
• The dosage should be adjusted according to the severity of the disease to ensure control of steatorrhea and maintenance of good nutritional status.
• Most patients should not exceed 10,000 lipase units per kg of body weight per day or 4000 lipase units per gram of fat ingested.

Dosage in other conditions associated with exocrine pancreatic insufficiency
The dosage should be adjusted according to individual needs, depending on the degree of maldigestion and the fat content of the meal. The dosage per meal ranges between 25,000 and 80,000 lipase units, and half that amount for snacks.

If you take more CREON 5000 U.Ph.Eur. than you should:
If you have taken or ingested too much CREON 5000 U.Ph.Eur., contact your doctor immediately or go to the nearest hospital.
In case of overdose, an increased amount of uric acid may be excreted in the urine (hyperuricosuria) and an increase in blood uric acid levels (hyperuricemia) may occur.

If you forget to take CREON 5000 U.Ph.Eur.:
Do not take a double dose to make up for the missed dose.

If you stop taking CREON 5000 U.Ph.Eur.:
Warning: Do not discontinue CREON 5000 U.Ph.Eur. without consulting your doctor. Your disease symptoms may worsen.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most commonly reported adverse reactions have been gastrointestinal disorders,
mostly of mild or moderate severity. Gastrointestinal disorders are mostly associated with the
underlying disease. The following adverse reactions were reported during clinical studies:
Very common (affects more than 1 in 10 people) :

• abdominal pain

Common (affects less than 1 in 10 people) :

• nausea
• vomiting
• constipation
• abdominal distension
• diarrhoea

Uncommon (affects less than 1 in 100 people) :

• skin rash

Not known (frequency cannot be estimated from available data) :

• Pruritus and urticaria
• other severe allergic reactions (hypersensitivity) which may include breathing difficulties or swelling of the lips.
• intestinal strictures in the ileo-caecal region and large intestine (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly
via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, you
can help provide more information on the safety of this medicine.

5. HOW TO STORE CREON 5000 U.Ph.Eur.

CREON 5000 U.Ph.Eur. should be stored keeping the container tightly closed.
After opening, store at a temperature not exceeding 25°C and use within 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACK CONTENT AND OTHER INFORMATION

What Creon 5000 U.Ph.Eur. contains
The active substance is pancrelipase. 100 mg of granules (equivalent to one dosing spoon) contain 60.12 mg of pancrelipase (corresponding to: amylase 3600 U.Ph.Eur., lipase 5000 U.Ph.Eur., protease 200 U.Ph.Eur.).
Excipients in the granule core: macrogol 4000
Excipients in the granule coating: hypromellose phthalate, simethicone 1000, cetostearyl alcohol, triethyl citrate.

Description of the appearance of Creon 5000 U.Ph.Eur. and pack contents
CREON 5000 U.Ph.Eur. is a gastro-resistant oral granule formulation consisting of round, light brown granules (mini-microspheres), packed in a 20 g glass bottle with a low-density polyethylene (LDPE) closure. The package includes a dosing spoon.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer:
Abbott Laboratories GmbH, Neustadt - Germany.