POM: Prescription only medicine
This information is intended for use by health professionals
Adults (including elderly) and Paediatric population1-2 capsules with meals and 1 capsule with snacks.Since the individual response to pancreatin supplements is variable, the number of capsules taken may need to be titrated to the individual according to symptoms and at the discretion of the physician. Dose increase, if required should be added slowly with careful monitoring of response and symptomatology.Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day. The dose of Nutrizym 22 should usually not exceed this dose.Where a patient is already receiving a lower unit dose enteric coated pancreatic supplement, then Nutrizym 22 may be substituted at 1/2 of the number of capsules normally consumed with the previous preparation.
Method of administrationCapsules should be swallowed whole with water. Where swallowing of capsules proves to be difficult, the minitablets may be removed and taken with water or with a small amount of acidic fluid or soft food, but without chewing. This could be apple sauce or yoghurt or any fruit juice with acidic pH (a pH less than 5.5), e.g. apple, orange or pineapple juice. If the minitablets 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 minitablets are not crushed or chewed. Crushing and chewing of the minitablets or mixing with food or fluid with alkaline pH 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.Adequate patient hydration should be ensured at all times whilst treating with Nutrizym 22.
PregnancyFor 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.
LactationNo 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, pancreatin should be used in doses sufficient to provide adequate nutritional status.
|Organ system||Very common ≥ 1/10||Common ≥ 1/100 to < 1/10||Uncommon ≥ 1/1000 to < 1/100||Frequency not known|
|gastrointestinal disorders||abdominal pain*||nausea, vomiting, constipation, abdominal distention, diarrhea||strictures of the ileo-caecum and large bowel (fibrosing colonopathy)|
|skin and subcutaneous tissue disorders||rash||pruritus, urticaria|
|immune system disorders||hypersensitivity (anaphylactic reactions)|
Paediatric populationNo 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.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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