Creon^® (Pancreatin)

Creon^® is indicated for the treatment of pancreatic exocrine insufficiency in adults, children and infants. It is orally administered and provides extra digestive enzymes needed to maintain a healthy digestion. Creon^® should be taken with all meals and snacks.¹

Pancreatic exocrine insufficiency (PEI) is a condition in which people are unable to adequately digest fats, carbohydrates and proteins due to a lack of digestive enzymes being produced from the pancreas. This results in nutrient malabsorption and malnutrition, which can have further consequences for patients.² The main treatment for PEI is PERT (pancreatic enzyme replacement therapy).

For more information on PEI, please click here

The data demonstrates that Creon^® treats the symptoms of PEI and improves the nutritional status of patients with PEI and:

• chronic pancreatitis¹
• pancreatic cancer¹
• cystic fibrosis²
• diabetes³
• coeliac disease¹

In all associated diseases, Creon^® has been shown to: ^1-3

• increase fat absorption and reduce steatorrhoea
• reduce stool frequency
• improve stool consistency
• be well tolerated

Creon^® can achieve such improvements in patients with PEI because it has been developed to mimic the physiological pattern of pancreatic exocrine secretion.⁴

Therapeutic indication¹

Creon is indicated for the treatment of pancreatic exocrine insufficiency.

Method of administration for Creon capsules¹

Adults (including the elderly) and children: Initially one or two capsules during or immediately after each meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing.

This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. If the granules are mixed with fluid or food, it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken to ensure that no product is retained in the mouth.

It is important to ensure adequate hydration of patients at all times whilst dosing Creon.

Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day.

Dosing

Creon^® offers a wide range of strengths to accommodate all patients, from Creon^® Micro (5,000) to Creon^® 25,000 lipase unit capsules.¹ 

Recommended initial doses of PERT in adults are:¹

The recommended starting dose for adults is 2 x Creon^® 25,000 per meal and 1 x Creon^® 25,000 per snack with subsequent titration depending on level of response.

While different patients may have the same or similar starting doses, the dose should be titrated according to the individual's response and experience. Initially one or two capsules with each meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.^1,2-4

The correct dose is that which successfully controls bowel symptoms and maintains good nutritional status in the individual patient which successfully controls.⁵

Creon^® should always be taken with food.¹ At the end of the first week of treatment, recheck adult patients’ dietary intake and ensure they have adequate acid suppression using proton pump inhibitors (PPIs). If an adequate response is not achieved, Creon^® can be titrated.

To download or order the Creon^® dosing card go to Viatris shop: click here

Recommended initial doses of PERT in children are:¹

Creon^® 10,000 and Creon^® Micro (5,000 lipase units per 100 mg scoop) allow you to prescribe a smaller dose to babies and younger children.

Dosing with Creon^® Micro:

• Initially 100 mg of Creon^® Micro (one measure equal to 5,000 lipase units) should be taken with each feed or meal¹
• Dose increases, if required, should be added slowly with careful monitoring of response and symptoms¹
• Titrate dose upwards as necessary to control symptoms and achieve adequate weight gain⁶
• Doses should not exceed 10,000 units of lipase/kg/day¹
  

Dosing with Creon^® 10,000:

• Initially one or two capsules with each meal.
• Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

As children grow they are likely to increase their Creon^® d ose and take more capsules per meal. To help improve compliance and efficacy and to minimise pill burden, consider moving children to Creon^® 25,000 capsules.

Pancreatic Enzyme Replacement Therapy (PERT) has the following demonstrated benefits:⁷

Higher titration of PERT doses has shown to improve several aspects of patients’ health from baseline, including:¹

• Fat and nitrogen absorption
• Clinical symptoms of pancreatic exocrine insufficiency (PEI)
• Quality of life

Creon^® is indicated for the treatment of pancreatic exocrine insufficiency 

PRESCRIBING INFORMATION

Creon Micro Pancreatin 60.12 mg Gastro-resistant Granules, Creon 10000 Capsules, Creon 25000 Capsules

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

Presentation:

Creon Micro: Gastro-resistant granules of pancreatin, containing in 100mg: 5,000 PhEur units of lipase; 3,600 PhEur units of amylase; 200 PhEur units of protease.

Creon 10000: Each capsule contains pancreatin equivalent to: 10,000 PhEur units of lipase; 8,000 PhEur units of amylase; 600 PhEur units of protease.

Creon 25000: Each capsule contains pancreatin equivalent to: 25,000 PhEur units of lipase; 18,000 PhEur units of amylase; 1,000 PhEur units of protease.

Indication: Pancreatic exocrine insufficiency.

Dosage and Administration: Creon Micro: Initially 100mg (5000 lipase units) taken with each feed or meal or immediately after. The required quantity of granules should be dispensed using the measuring scoop provided which holds 100mg. In young infants, mix with a small amount of (undiluted) apple juice and give from a spoon directly before the feed. In weaned infants, mix with acidic liquids or soft foods (e.g. undiluted apple juice or apple puree) and take directly before the meal without chewing. Alternatively, mix the granules with a small amount of milk on a spoon and administer to the infant immediately. The granules should not be added to the baby’s bottle.

Creon 10000 and 25000: Initially one or two capsules during or immediately after meals, then adjust according to response. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing. This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice.

Creon Micro, 10000 and 25000: Dose increases, if required, should be added slowly with careful monitoring of response and symptomatology. Maximum daily dosage of Creon Micro should not exceed 10,000 units lipase/kg/day. Ensure adequate hydration. If the granules are mixed with fluid or food, it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken to ensure that no product is retained in the mouth. Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see below).

Contraindications, Warnings and Precautions: Hypersensitivity to pancreatin of porcine origin or any excipients. Fibrosing colonopathy has been reported in CF patients taking high dose pancreatin preparations. As a precaution, medically assess unusual or changes in abdominal symptoms, especially for doses above 10000 units of lipase/kg/day.

Pregnancy and Lactation: There is inadequate evidence of safety in use during pregnancy. Pancreatic enzymes can be used during breast-feeding.

Effects on Ability to Drive and Operate Machinery: No or negligible influence on ability.

Undesirable Effects: Most commonly, gastrointestinal disorders. Common: nausea, vomiting, constipation, diarrhoea and abdominal distension. Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain (very common, ≥1/10). Uncommon: rash. Frequency unknown: Hypersensitivity (anaphylaxis), pruritus and urticaria, strictures of the ileo-caecum and large bowel (fibrosing colonopathy). See SPC for further information.

Interactions: no studies performed.

Marketing Authorisation Holder: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL

Marketing Authorisation Number: Creon Micro: PL 46302/0031, Creon 10000: PL 46302/0028, Creon 25000: PL 46302/0029,

NHS price: Creon Micro (20g): £31.50, Creon 10000 (100 capsules): £12.93, Creon 25000 (100 capsules): £28.25

Legal Category: Creon Micro and Creon 10000: P, Creon 25000: POM

Date of Last Revision: 14/08/2020

The SmPC for this product, including adverse reactions, precautions, contra-indications, and method of use can be found at: http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs/index.htm and from Mylan Medical Information, Building 4, Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, phone no. 01707 853000, Email: info@mylan.co.uk

CRE-2022-0744 November 2022

Creon^® Contraindications¹

Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

Side Effects¹

The SPC for Creon lists abdominal pain, nausea, vomiting, constipation, abdominal distention and diarrhoea as very common or common adverse reactions.

For a full list of adverse reactions, precautions, contraindications, and method of use please consult the SPC.¹

https://www.medicines.org.uk/emc/search?q=creon

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. Any abdominal symptoms not usually experienced by the patient or changes in abdominal symptoms should be reviewed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking more than 10000 units of lipase/kg/day.¹

We have a range of patient support materials available to you that can be ordered via our Viatris Shop:

• Creon dosing card
• Creon information leaflet for patients
• PERT capsule holders
• PERT patient booklet

To download or order go to Viatris Shop: click here

CRE-2022-0744 November 2022