Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amylase; Lipase; Protease
Essential Pharma Ltd
A09AA02
Amylase; Lipase; Protease
3300unit ; 2950unit ; 160unit
Oral capsule
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01090400; GTIN: 5015001142111
P P EAN CODE 5060312430051 EAN CODE 5060312430051 BN: EXP: Pan125mgCap-LPL-UK-4 Pan125mgCap-LPL-UK-4 Pan125mgCap-LPL-UK-4 Tear here, BUT DO NOT REMOVE _PACKAGE LEAFLET: INFORMATION FOR THE USER_ PANCREX V 125 MG HARD CAPSULES pancreatin The full name of this medicine is “Pancrex V 125 mg hard capsules”. The short form of the name “Pancrex V” is used throughout the remainder of the package leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Pancrex V is and what it is used for 2. What you need to know before you take Pancrex V 3. How to take Pancrex V 4. Possible side effects 5. How to store Pancrex V 6. Contents of the pack and other information 1. WHAT PANCREX V IS AND WHAT IT IS USED FOR Pancrex V contains the active substance pancreatin. Pancreatin is a combination of enzymes normally produced by the pancreas which help to digest protein, fat, starch and sugars in the food that you eat. Pancreatin is given to people who do not produce enough enzymes to digest their food properly, in conditions such as cystic fibrosis, persistent inflammation of the pancreas, and when the pancreas has been removed. Pancrex V may also be used when the stomach has been removed, as an aid to digestion. These low-dose capsules may be used when small amounts of pancreatin are required, such as in newborns. The pancreatin in Pancrex V is derived from pancreases of pigs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANCREX V DO NOT TAKE PANCREX V - If you are allergic to pancreat Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pancrex V 125 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 125 mg pancreatin to provide enzymatic activity per capsule not less than: Free protease 160 BP units Lipase 2950 BP units Amylase 3300 BP units For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule (capsule). A white or buff coloured powder in clear hard gelatin capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pancrex V is used to compensate for reduced intestinal enzyme activity in pancreatic deficiency states. It is indicated for the treatment of fibrocystic disease of the pancreas (cystic fibrosis), chronic pancreatitis and pancreatic steatorrhoea following pancreatectomy. It may also be indicated following gastrectomy as an aid to digestion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology These low dose capsules may be used when small amounts of Pancrex V are required, for example for neonates. Dosage should be adjusted according to the needs of the individual patient and the amount of food consumed. The following dosage scale provides a suitable basis for adjustment. _Paediatric population _ Neonates: The contents of 1-2 capsules mixed with feeds. Method of administration Oral use. The capsules should be taken with each feed or before a meal. If the capsule contents are mixed with liquids or feeds the resulting mixture should not be allowed to stand for more than one hour prior to use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE It is possible that some irritation of the skin of the mouth may occur if capsules are chewed or the contents retained in the mouth. Irritation of the anus may also occur. A barrier cream may prevent this local irritation. Allergic/asthmatic reactions have occasionally occurred on handling the capsule contents. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND Przeczytaj cały dokument