Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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Creon for Children 5000 Gastro-resistant Granules
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Each 100 mg of gastro-resistant granules (equivalent to one measuring spoonful) contains 60.12 mg Pancreatin, containing the following pancreatic enzymes:
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Lipase
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5,000 PhEur units
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Amylase
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3,600 PhEur units
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Protease
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200 PhEur units
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For excipients, see 6.1.
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Gastro-resistant granules.
Round, light brown gastro-resistant granules.
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For the treatment of pancreatic exocrine insufficiency.
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Initially 100 mg (5000 lipase units) of gastro-resistant granules (one measure) should be taken with each feed or meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The required quantity of gastro-resistant granules should be dispensed using the measuring spoon contained in the pack which holds 100 mg.
In young infants, Creon for Children 5000 granules should be mixed with a small amount of infant formula, expressed breast milk or fruit puree and given from a spoon directly before the feed. In weaned infants, granules should be taken with acidic liquids or soft foods (e.g. mixed with fruit juices or apple puree), but without chewing, directly before the meal.
It is important to ensure adequate hydration of patients at all times whilst dosing with Creon.
The daily dose of pancreatic enzymes for most patients should remain below 2500 units of lipase per kilogram per meal (10,000 units per kilogram per day), and higher doses should be used with caution and only if quantitative measures demonstrate substantially improved absorption with such treatment. This applies particularly to young children.
If the granules are mixed with food, it is important that they are taken immediately, 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.
Colonic damage has been reported in patients with cystic fibrosis taking high doses of pancreatic enzyme supplements (see 4.8 Undesirable effects).
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Patients with known hypersensitivity to porcine proteins or to any of the excipients.
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The product is of porcine origin.
Oral medications should not be administered during the early stages of acute pancreatitis.
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There are no adequate data from the use of Creon in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonal/foetal development, parturition and postnatal development. The potential risk to humans is unknown. Creon should not be used during pregnancy or lactation unless clearly necessary, but if required should be used in doses providing adequate nutritional status (see warnings about high dose sections 4.2 & 4.8.).
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Creon has no influence on the ability to drive or use machines.
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In pooled data from clinical trials, the overall incidence of adverse drug events reported with Creon was the same as with placebo. The incidence tended to reflect the general symptomatology of the underlying disease.
Very common (Frequency >10%):
Gastrointestinal disorders: abdominal pain
Common (Frequency 1-10%):
Gastrointestinal disorders: diarrhoea, constipation, abnormal stool, nausea and vomiting.
Skin and subcutaneous tissue: allergic or hypersensitivity reactions.
Rarely (Frequency 0.1-1%):
Cases of hyper-uricosuria and hyper-uricaemia have been reported with very high doses of pancreatin.
Stricture of the ileo-caecum and large bowel and colitis has been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. To date, Creon 10000 and 25000 have not been implicated in the development of colonic damage. Experience with Creon 40000 and Creon for Children 5000 in clinical use is limited. Unusual abdominal symptoms or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage especially if the patient is taking in excess of 10,000 units lipase/kg/day.
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Most cases respond to supportive measures including stopping enzyme therapy, ensuring adequate rehydration. Rarely cases of hyperuricosuria and hyperuricaemia have been reported with very high doses of pancreatin.
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The ATC code is A09A A (Enzyme preparations).
Replacement therapy in pancreatic enzyme deficiency states. The enzymes have hydrolytic activity on fat, carbohydrates and proteins.
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Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After exerting their action, the enzymes are digested themselves in the intestine.
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Hypromellose phthalate
Macrogol 4000
Triethyl citrate
Cetyl alcohol
Dimeticone
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3 years.
12 weeks after first opening.
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Do not store above 30°C.
Keep the container tightly closed in order to protect from moisture.
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Glass container with LDPE cap.
Containers hold 20 g of gastro-resistant granules.
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Abbott Healthcare Products Limited
Mansbridge Road
West End
Southampton
SO18 3JD/
UK
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Date of First Authorisation: 23 June 2006
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