Posology : מינונים

4.2 Posology and method of administration
The posology aims at individual needs and depends on the severity of the disease and the composition of food.
It is recommended to take the enzymes during or immediately after each meal or snack.
Adults (including the elderly) and children:
Initially one capsule with meals. Dose increases, if required, should be added slowly with careful monitoring of response and symptomatology.

For infants and children a median lipase intake of 10,000 Ph.Eur. units per kg body weight a day is recommended. A daily lipase intake of 15,000 - 20,000 Ph.Eur. units per kg body weight should not be exceeded.

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 25000, especially during periods of increased loss of fluids. Inadequate hydration may aggravate constipation. Any mixture of the minimicrospheres with food or liquids should be used immediately and should not be stored.


Dosing in paediatric and adult patients with cystic fibrosis
Based upon a recommendation of the Cystic Fibrosis Consensus Conference, the US CF Foundation case-control study, and the UK case-control study, the following general dosage recommendation for pancreatic enzyme replacement therapy can be proposed: • Weight-based enzyme dosing should begin with 1000 lipase units/kg/meal for children less than four years of age and with 500 lipase units/kg/meal for those over age four.
• Dosage should be adjusted according to the severity of the disease, control of steatorrhea and maintenance of good nutritional status.
• Most patients should remain below or should not exceed 10000 U/kg body weight per day or 4000 lipase unite/gram fat intake.



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).

Dosing in other conditions associated with exocrine pancreatic insufficiency Dosage should be individualized by patient according to the degree of maldigestion and the fat content of the meal. The required dose for a main meal (breakfast, lunch or dinner) ranges from about 25000 to 80000 Ph. Eur. U of lipase and half of the individual dose for snacks.