Indications: For the treatment of exocrine pancreatic insufficiency. Presentation: Crezanta 10,000: Each gastro-resistant capsule contains pancreatin (as pancreas powder) corresponding to: 8,000 Ph. Eur. Units of Amylase, 10,000 Ph. Eur. Units of Lipase, 600 Ph. Eur. units of Protease. Crezanta 25,000: Each gastro-resistant capsule contains pancreatin (as pancreas powder) corresponding to: 18,000 Ph. Eur. Units of Amylase, 25,000 Ph. Eur. Units of Lipase, 1,000 Ph. Eur. units of Protease. Dosage and Method of administration: 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 micro pellets 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 Crezanta. Contraindications: Hypersensitivity to the pancreatin of porcine origin or to any of the excipients. Special warnings and precautions for use: Fibrosing colonopathy: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. 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/per kilogram bodyweight per day. Anaphylactic reactions: Rarely, anaphylactic reactions have been reported with pancreatic enzyme products with different formulations of the same active ingredient (pancreas powder). If this reaction occurs, patients should be advised to discontinue treatment immediately and seek urgent medical assistance. To reduce the risk of adverse reactions due to hypersensitivity, caution is advised in patients with allergy to porcine proteins. Potential for irritation to oral mucosa: Care should be taken to ensure that no medicinal product is retained in the mouth. This medicine should not be crushed or chewed or kept too long in the mouth and/or mixed in foods having a pH greater than 5.5. These actions can disrupt the protective gastro-resistant coating resulting in early release of enzymes, oral pain, irritation of oral mucosa, bleeding, ulcer formation in the mouth and/or loss of enzyme activity.  Rinsing the mouth and drinking a glass of water may help if there are preliminary signs of mouth irritation. Alcohol: Use of this medicine concomitantly with heavy alcohol is not recommended for all the proposed strengths. Interactions: No studies performed. Effects on ability to drive/use machines: None/negligible. Fertility, pregnancy, and breastfeeding: Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of porcine pancreatic enzymes in pregnant women. There is no data from animal studies with respect to reproductive toxicity, but animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected. This medicinal product can be used during pregnancy if necessary, to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. Breastfeeding: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to porcine pancreatic enzymes is negligible. Pancreatic enzymes can be used during breastfeeding. Fertility: No effects on fertility are anticipated since pancreatic enzymes are not absorbed from the gastrointestinal tract. Side effects: Common and serious side effects included here. For full list of side effects consult SmPC.  Very common (≥1/10): Abdominal pain Common (≥1/100 to <1/10): Nausea, vomiting, constipation, abdominal distention, diarrhea. Very rare serious/unknown frequency serious: hypersensitivity, anaphylactic reactions, strictures of the ileo-caecum and large bowel (fibrosing colonopathy). MA number: PL 35533/0206, PL 35533/0207. Cost: 10,000 Ph. Eur. Units: (100 capsules) £12.90, 25,000 Ph. Eur. Units: (100 capsules) £28.20 MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Legal category: Crezanta 10,000: P, Crezanta 25,000: POM. Version Number: MAT-UK-PAN-0015-1 | July 2026