Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
pancreas powder
Allergan Pharmaceuticals International Ltd
A09AA02
pancreas powder
Digestives, incl. enzymes
Exocrine Pancreatic Insufficiency
Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).Enzepi is indicated in infants, children, adolescents and adults.
Revision: 1
Withdrawn
2016-06-29
32 PACKAGE LEAFLET Medicinal product no longer authorised 33 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ENZEPI 5,000 UNITS GASTRO-RESISTANT HARD CAPSULES ENZEPI 10,000 UNITS GASTRO-RESISTANT HARD CAPSULES ENZEPI 25,000 UNITS GASTRO-RESISTANT HARD CAPSULES ENZEPI 40,000 UNITS GASTRO-RESISTANT HARD CAPSULES Pancreas powder READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Enzepi is and what it is used for 2. What you need to know before you take Enzepi 3. How to take Enzepi 4. Possible side effects 5. How to store Enzepi 6. Contents of the pack and other information 1. WHAT ENZEPI IS AND WHAT IT IS USED FOR Enzepi is a pancreatic enzyme replacement medicine for people whose bodies do not make enough of enzymes to digest food. Enzepi contains a mixture of natural digestive enzymes which are used to digest food. These include lipases for digesting fat, proteases for digesting protein and amylases for digestions carbohydrates. The enzymes are taken from pig pancreas glands. Enzepi is for use by adults, adolescents, children and infants with ‘exocrine pancreatic insufficiency’, a condition that makes the body less able to break down and digest food. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENZEPI DO NOT TAKE ENZEPI - if you are allergic to the active subtance or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Enzepi if you have ever had gout, kidney disease, or high uric acid levels in your blood (hyperur Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Enzepi 5,000 units gastro-resistant hard capsules Enzepi 10,000 units gastro-resistant hard capsules Enzepi 25,000 units gastro-resistant hard capsules Enzepi 40,000 units gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Enzepi 5,000 units gastro-resistant hard capsules One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity: 5,000 units*, amylolytic activity: not less than 1,600 units*, proteolytic activity: not less than 130 units*. Enzepi 10,000 units gastro-resistant hard capsules One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity: 10,000 units*, amylolytic activity: not less than 3,200 units*, proteolytic activity: not less than 270 units*. Enzepi 25,000 units gastro-resistant hard capsules One capsule contains 209.3 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity: 25,000 units*, amylolytic activity: not less than 4,800 units*, proteolytic activity: not less than 410 units*. Enzepi 40,000 units gastro-resistant hard capsules One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity: 40,000 units*, amylolytic activity: not less than 7,800 units*, proteolytic activity: not less than 650 units*. * Ph. Eur. units For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant hard capsule. Enzepi 5,000 units gastro-resistant hard capsules Hard capsules with a white opaque cap and a white opaque body, printed with “Enzepi 5” and containing light-brown gastro-resistant granules. Medicinal product no longer authorised 3 Enzepi 10,000 units gastro-resistant hard capsules Hard capsule with a yellow opaque cap and a white opaque body, printed with “Enzepi 10” an Lestu allt skjalið