1. Name Of The Medicinal Product
Creon® 40000 Capsules
2. Qualitative And Quantitative Composition
Each capsule contains pancreatin PhEur 400 mg equivalent to:
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3. Pharmaceutical Form
Capsules.
Brown/clear size 00 capsules containing light brown, gastro-resistant granules.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of pancreatic exocrine insufficiency.
4.2 Posology And Method Of Administration
Adults (including the elderly) and children:
Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack. Creon 40000 should only be used in patients in whom the minimum effective dose has already been determined using lower strength pancreatic enzyme products.
Initially one or two capsules with each meal. The capsules should 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 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.
Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.
It is important to ensure adequate hydration of patients at all times whilst dosing Creon 40000.
Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see section 4.4).
4.3 Contraindications
Hypersensitivity to pancreatin of porcine origin or to any of the excipients
4.4 Special Warnings And Precautions For Use
Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. Case control studies did not reveal evidence for an association between Creon and the appearance of fibrosing colonopathy. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units of lipase/kg/day.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interaction studies have been performed.
4.6 Pregnancy And Lactation
Pregnancy
For pancreatic enzymes no clinical data on exposed pregnancies are available.
Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected.
Caution should be exercised when prescribing to pregnant women.
Lactation
No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breast-feeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breast-feeding.
If required during pregnancy or lactation Creon should be used in doses sufficient to provide adequate nutritional status.
4.7 Effects On Ability To Drive And Use Machines
Creon has no or negligible influence on the ability to drive or use machines.
4.8 Undesirable Effects
In clinical trials, more than 600 patients with pancreatic exocrine insufficiency, due to cystic fibrosis, chronic pancreatitis, and pancreatic surgery were exposed to Creon. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity.
The following adverse reactions have been observed during placebo-controlled clinical trials with the below indicated frequencies;
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
Skin and subcutaneous tissue disorders
Uncommon ( rash
Pruritus and urticaria have been additionally identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.
Multiple clinical trials were conducted in other patient populations: HIV, acute pancreatitis, diabetes mellitus. No additional adverse drug reactions were identified compared to the above three patient groups.
Paediatric population
No specific adverse reactions were identified in the paediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.
4.9 Overdose
Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia.
Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic Properties
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.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Granules:
Macrogol 4000
Hypromellose phthalate
Dimeticone
Cetyl alcohol
Triethyl citrate
Capsules:
Gelatin
Anhydrous iron (III) oxide (E172)
Hydrated iron (III) oxide (E172)
Iron (II, III) oxide (E172)
Titanium dioxide E171
Sodium lauryl sulphate
6.2 Incompatibilities
None known.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Do not store above 25°C. Keep container tightly closed.
6.5 Nature And Contents Of Container
HDPE container with tamper-evident PP cap. Each container contains 100 capsules.
6.6 Special Precautions For Disposal And Other Handling
No special instructions.
7. Marketing Authorisation Holder
Abbott Healthcare Products Limited
Mansbridge Road
West End
Southampton
SO18 3JD
United Kingdom
8. Marketing Authorisation Number(S)
PL 00512/0177
9. Date Of First Authorisation/Renewal Of The Authorisation
25/02/2009
10. Date Of Revision Of The Text
30/06/2011
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