MEDICATION GUIDE. PANCREAZE (pan-kre-aze) (pancrelipase) Delayed-Release Capsules

Transcription

1 MEDICATION GUIDE PANCREAZE (pan-kre-aze) (pancrelipase) Delayed-Release Capsules Read this Medicatin Guide befre yu start taking PANCREAZE and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur dctr abut yur medical cnditin r treatment. What is the mst imprtant infrmatin I shuld knw abut PANCREAZE? PANCREAZE may increase yur chance f having a rare bwel disrder called fibrsing clnpathy. This cnditin is serius and may require surgery. The risk f having this cnditin may be reduced by fllwing the dsing instructins that yur dctr gave yu. Call yur dctr right away if yu have any unusual r severe: stmach area (abdminal) pain blating truble passing stl (having bwel mvements) nausea, vmiting, r diarrhea Take PANCREAZE exactly as prescribed by yur dctr. D nt take mre r less PANCREAZE than directed by yur dctr. What is PANCREAZE? PANCREAZE is a prescriptin medicine used t treat peple wh cannt digest fd nrmally because their pancreas des nt make enugh enzymes due t cystic fibrsis r ther cnditins. PANCREAZE may help yur bdy use fats, prteins, and sugars frm fd. PANCREAZE cntains a mixture f digestive enzymes including lipases, prteases, and amylases frm pig pancreas. PANCREAZE is safe and effective in children when taken as prescribed by yur dctr. 16

2 What shuld I tell my dctr befre taking PANCREAZE? Befre taking PANCREAZE, tell yur dctr cnditins, including if yu: abut all yur medical are allergic t prk (pig) prducts. have a histry f blckage f yur intestines, r scarring r thickening f yur bwel wall (fibrsing clnpathy) have gut, kidney disease, r high bld uric acid (hyperuricemia) have truble swallwing capsules have any ther medical cnditin are pregnant r plan t becme pregnant. It is nt knwn if PANCREAZE will harm yur unbrn baby. are breast-feeding r plan t breast-feed. It is nt knwn if PANCREAZE passes int yur breast milk. Yu and yur dctr shuld decide if yu will take PANCREAZE r breast-feed. Tell yur dctr abut all the medicines yu take, including prescriptin and nnprescriptin medicines, vitamins, r herbal supplements. Knw the medicines yu take. Keep a list f them and shw it t yur dctr and pharmacist when yu get a new medicine. Hw shuld I take PANCREAZE? Take PANCREAZE exactly as yur dctr tells yu. D nt take mre capsules in a day than the number yur dctr tells yu t take (ttal daily dse). Always take PANCREAZE with a meal r snack and plenty f fluid. If yu eat a lt f meals r snacks in a day, be careful nt t g ver yur ttal daily dse. Yur dctr may change yur dse based n the amunt f fatty fds yu eat r based n yur weight. 17

3 D nt crush r chew the PANCREAZE capsules r their cntents, and d nt hld the capsule r cntents in yur muth. Crushing, chewing r hlding the PANCREAZE Capsules in yur muth may cause irritatin in yur muth r change the way PANCREAZE wrks in yur bdy. Giving PANCREAZE t infants (children up t 12 mnths): 1. Give PANCREAZE right befre each feeding f frmula r breast milk. 2. D nt mix PANCREAZE capsule cntents directly int frmula r breast milk. 3. Open the capsules and sprinkle the cntents directly int yur infant s muth r mix the cntents in a small amunt f sft fd such as applesauce. These fds shuld be the kind fund in baby fd jars that yu buy at the stre, r ther fd recmmended by yur dctr. 4. If yu sprinkle the PANCREAZE n fd, give the PANCREAZE and fd mixture t yur child right away. D nt stre PANCREAZE that is mixed with fd. 5. Give yur child enugh liquid t cmpletely swallw the PANCREAZE cntents r the PANCREAZE and fd mixture. 6. Lk int yur child s muth t make sure that all f the medicine has been swallwed. Giving PANCREAZE t children and adults 1. Swallw PANCREAZE capsules whle and take them with enugh liquid t swallw them right away. 2. If yu have truble swallwing capsules, pen the capsules and sprinkle the cntents n a small amunt f acidic fd such as applesauce. Ask yur dctr abut ther fds yu can mix with PANCREAZE. 3. If yu sprinkle PANCREAZE n fd, swallw it right after yu mix it and drink plenty f water r juice t make sure the medicine is swallwed cmpletely. D nt stre PANCREAZE that is mixed with fd. 18

4 4. If yu frget t take PANCREAZE, call yur healthcare prvider r wait until yur next meal and take yur usual number f capsules. Take yur next dse at yur usual time. D nt make up fr missed dses. What are the pssible side effects f PANCREAZE? PANCREAZE may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut PANCREAZE? Irritatin f the inside f yur muth. This can happen if PANCREAZE is nt swallwed cmpletely. Increase in bld uric acid levels. This may cause wrsening f swllen, painful jints (gut) caused by an increase in yur bld uric acid levels Allergic reactins including truble with breathing, skin rashes, r swllen lips. Call yur dctr right away if yu have any f these symptms. The mst cmmn side effects f PANCREAZE include: Pain in yur stmach (abdminal area) Gas Other Pssible Side Effects PANCREAZE and ther pancreatic enzyme prducts are made frm the pancreas f pigs, the same pigs peple eat as prk. These pigs may carry viruses. Althugh it has never been reprted, it may be pssible fr a persn t get a viral infectin frm taking pancreatic enzyme prducts that cme frm pigs. Tell yur dctr if yu have any side effect that bthers yu r des nt g away. These are nt all the pssible side effects f PANCREAZE. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Yu may als reprt side effects t Janssen Pharmaceuticals, Inc. at

5 Hw d I stre PANCREAZE? Stre PANCREAZE at rm temperature belw 77 F (25 C). Avid heat. Keep PANCREAZE in a dry place and in the riginal cntainer. After pening the bttle, keep it clsed tightly between uses. The PANCREAZE 4200 USP Units f lipase bttle cntains a desiccant packet. DO NOT eat r thrw away the packet (desiccant) in yur medicine bttle. This packet will prtect yur medicine frm misture. Stre PANCREAZE in a dry place. Keep PANCREAZE and all medicines ut f reach f children. General infrmatin abut PANCREAZE Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use PANCREAZE fr a cnditin fr which it was nt prescribed. D nt give PANCREAZE t ther peple t take, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut PANCREAZE. If yu wuld like mre infrmatin, talk t yur dctr. Yu can ask yur pharmacist r dctr fr infrmatin abut PANCREAZE that is written fr healthcare prviders. Fr mre infrmatin g t r call (Mnday - Friday 9am t 5pm EST). What are the ingredients in PANCREAZE? Active Ingredient: lipase, prtease, amylase Inactive Ingredients: cellulse, cllidal anhydrus silica, crspvidne, magnesium stearate, methacrylic acid ethyl acrylate cplymer, mntan glycl wax, simethicne emulsin, talc and triethyl citrate. The capsule shell cntains gelatin, titanium dixide, sdium lauryl sulfate, srbitan mnlaurate, and gelatin capsule imprint ink. PANCREAZE 4,200, 10,500, and 16,800 USP Units f lipase als cntain irn xide. 20

6 Prduct f Germany Finished Prduct Manufactured by: Nrdmark Arzneimittel GmbH & C. KG Uetersen, Germany. Manufactured fr: Janssen Pharmaceuticals, Inc. Titusville, NJ Revised: September 2011 Janssen Pharmaceuticals, Inc