CREON Capsule containing gastro-resistant granules Ref.[8466] Active ingredients: Pancreatin

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 (see section 4.4).

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.

2 years.

Once opened, use within 3 months.

Do not store above 25°C. Keep container tightly closed.

HDPE container with tamper-evident PP cap. Containers hold 100, 250 or 300 capsules.

No special instructions.