देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
A09AA02
PANCREATIN 300 mg
GASTRO-RESISTANT HARD CAPSULE
PANCREATIN 300 mg
POM
DIGESTIVES, INCL. ENZYMES
Authorised
2018-11-15
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CREON 20 000 GASTRO-RESISTANT CASPULES, HARD 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 Creon is and what it is used for 2. What you need to know before you take Creon 3. How to take Creon 4. Possible side effects 5. How to store Creon 6. Contents of the pack and other information 1. WHAT CREON IS AND WHAT IT IS USED FOR WHAT CREON IS • Creon contains an enzyme mixture called “pancreas powder”. • Pancreas powder is also called pancreatin. It helps you digest food. The enzymes are taken from pig pancreas glands. • Creon capsules contain small pellets which slowly release the pancreas powder in your gut (gastro-resistant pellets, called minimicrospheres). WHAT CREON IS USED FOR Creon is used for the treatment of “pancreatic exocrine insufficiency”. This is when the pancreas gland does not make enough enzymes to digest food. It is for example often found in people who have: • cystic fibrosis, a rare genetic disorder • chronic inflammation of the pancreas (chronic pancreatitis) • had a part or the whole of their pancreas removed (partial or total pancreatectomy) • cancer of the pancreas Creon 20 000 can be used by children, adolescents and adults. The dosing in age groups is explained in section 3 of this leaflet, “How to take Creon” Treatment with Creon improves the symptoms of pancreatic exocrine insufficiency including stool consistency (e.g. fatty stools), abdominal pain, flatulence and stoo पूरा दस्तावेज़ पढ़ें
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 8 1. NAME OF THE MEDICINAL PRODUCT Creon 20 000 gastro-resistant capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION *produced from porcine pancreatic tissue For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard Bicoloured hard gelatin capsule (size 0 elongated) with brown opaque cap and transparent body filled with brownish gastro-resistant pellets (minimicrospheres). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pancreatic enzyme replacement treatment in pancreatic excocrine insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, pancreatectomy or pancreatic cancer). Creon gastro-resistant capsules are indicated in children, adolescents and adults. Creon 20000: One capsule contains 300 mg pancreas powder* corresponding to Lipase 20,000 Ph.Eur. units Amylase 16,000 Ph. Eur. units Protease 1,200 Ph.Eur. units Page 3 of 8 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The posology aims at individual needs and depends on the severity of the disease and the composition of food. Therapy should be initiated at the lowest recommended dose and gradually increased with careful monitoring of the patient’s response, symptoms and nutritional status. Patients should be instructed not to increase the dosage on their own. Changes in dosage may require an adjustment period of several days. DOSING IN CYSTIC FIBROSIS Children: The strengths of 20,000 and 35,000 Ph. Eur. lipase units may not be suitable for the initiation of therapy in patients under a certain body weight, depending on the age. In the paediatric age group, dosing is recommended to be started with 1,000 Ph. Eur. units of lipase units per kilogram body weight per meal in children less than four years of age, and with 500 Ph.Eur. units of lipase per kilogram bodyweight per meal in children at the age of four and older. The dose needed in this population may therefore need to be established with dosage forms contain पूरा दस्तावेज़ पढ़ें