MEDICATION GUIDE DEXILANT

Transcription

1 MEDICATION GUIDE DEXILANT (decks-i-launt) (dexlansprazle) delayed-release capsules and DEXILANT SluTab (decks-i-launt sl-u-tab) (dexlansprazle) delayed-release rally disintegrating tablets Read this Medicatin Guide befre yu start taking DEXILANT 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 yur treatment. What is the mst imprtant infrmatin that I shuld knw abut DEXILANT? DEXILANT may help yur acid-related symptms, but yu culd still have serius stmach prblems. Talk with yur dctr. DEXILANT can cause serius side effects, including: Diarrhea. DEXILANT may increase yur risk f getting severe diarrhea. This diarrhea may be caused by an infectin (Clstridium difficile) in yur intestines. Call yur dctr right away if yu have watery stl, stmach pain, and fever that des nt g away. Bne fractures. Peple wh take multiple daily dses f prtn pump inhibitr medicines fr a lng perid f time (a year r lnger) may have an increased risk f fractures f the hip, wrist r spine. Yu shuld take DEXILANT exactly as prescribed, at the lwest dse pssible fr yur treatment and fr the shrtest time needed. Talk t yur dctr abut yur risk f bne fracture if yu take DEXILANT. DEXILANT can have ther serius side effects. See What are the pssible side effects f DEXILANT? What is DEXILANT? DEXILANT is a prescriptin medicine called a prtn pump inhibitr (PPI). DEXILANT reduces the amunt f acid in yur stmach. DEXILANT delayed-release capsules (DEXILANT capsules) are used in peple 12 years f age and lder: fr up t 8 weeks t heal acid-related damage t the lining f the esphagus (called ersive esphagitis r EE) fr up t 6 mnths in adults and up t 16 weeks in children 12 t 17 years f age t cntinue healing f ersive esphagitis and relief f heartburn fr 4 weeks t treat heartburn related t gastresphageal reflux disease (GERD) DEXILANT SluTab delayed-release rally disintegrating tablets (DEXILANT SluTab) is used in peple 12 years f age and lder: fr up t 6 mnths in adults and up t 16 weeks in children 12 t 17 years f age t cntinue healing f EE and relief f heartburn fr 4 weeks t treat heartburn related t GERD GERD happens when acid frm yur stmach enters the tube (esphagus) that cnnects yur muth t yur stmach. This may cause a burning feeling in yur chest r thrat, sur taste r burping. It is nt knwn if DEXILANT is safe and effective in children under 12 years f age. DEXILANT is nt effective fr symptms f GERD in children under 1 year f age. Wh shuld nt take DEXILANT? D nt take DEXILANT if yu: are allergic t dexlansprazle r any f the ther ingredients in DEXILANT. See the end f this Medicatin Guide fr a cmplete list f ingredients in DEXILANT. are taking a medicine that cntains rilpivirine (EDURANT, COMPLERA) used t treat HIV-1 (Human Immundeficiency Virus)

2 What shuld I tell my dctr befre taking DEXILANT? Befre yu take DEXILANT, tell yur dctr if yu: have been tld that yu have lw magnesium levels in yur bld have liver prblems have any ther medical cnditins are pregnant r plan t becme pregnant. It is nt knwn if DEXILANT will harm yur unbrn baby. are breastfeeding r plan t breastfeed. It is nt knwn if DEXILANT passes int yur breast milk r if it will affect yur baby r yur breast milk. Talk t yur dctr abut the best way t feed yur baby if yu take DEXILANT. Tell yur dctr abut all the medicines yu take, including prescriptin and ver-the-cunter medicines, vitamins, and herbal supplements. DEXILANT may affect hw ther medicines wrk, and ther medicines may affect hw DEXILANT wrks. Especially tell yur dctr if yu take methtrexate (Otrexup, Rasuv, Trexall). Knw the medicines that yu take. Keep a list f them t shw yur dctr and pharmacist when yu get a new medicine. Hw shuld I take DEXILANT? Take DEXILANT exactly as prescribed by yur dctr. D nt change yur dse r stp taking DEXILANT withut talking t yur dctr first. DEXILANT capsules: Take DEXILANT capsules with r withut fd. Swallw DEXILANT capsules whle. D nt chew DEXILANT capsules r the granules that are in the capsules. If yu have truble swallwing a whle capsule, yu can pen the capsule and take the cntents in applesauce. See the Instructins fr Use at the end f this Medicatin Guide fr instructins n hw t take DEXILANT capsules with applesauce. See the Instructins fr Use at the end f this Medicatin Guide fr instructins n hw t mix and give DEXILANT capsules with water using an ral syringe r thrugh a nasgastric tube. DEXILANT SluTab DEXILANT SluTab is a tablet that melts in yur muth withut water. Take DEXILANT SluTab at least 30 minutes befre a meal. D nt break r cut DEXILANT SluTab. Place DEXILANT SluTab n yur tngue until it melts. Withut using water, swallw after the tablet melts. D nt chew the granules after the tablet melts. DEXILANT SluTab may als be swallwed whle with water. See the Instructins fr Use at the end f this Medicatin Guide fr instructins abut hw t mix and give DEXILANT SluTab with water using an ral syringe r thrugh a nasgastric tube. If yu miss a dse f DEXILANT, take it as sn as yu remember. If it is almst time fr yur next dse, d nt take the missed dse. Take yur next dse at yur regular time. D nt take 2 dses at the same time t make up fr the missed dse. If yu take t much DEXILANT, call yur dctr r yur pisn cntrl center at right away r g t the nearest hspital emergency rm. What shuld I avid while taking DEXILANT SluTab? Avid taking DEXILANT SluTab with alchl. Taking DEXILANT SluTab with alchl may affect hw DEXILANT SluTab wrks. What are the pssible side effects f DEXILANT? DEXILANT may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut DEXILANT? Vitamin B-12 deficiency. DEXILANT reduces the amunt f acid in yur stmach. Stmach acid is needed t absrb Vitamin B-12 prperly. Talk with yur dctr abut the pssibility f Vitamin B-12 deficiency if yu have been n DEXILANT fr a lng time (mre than 3 years). Lw magnesium levels in yur bdy. This prblem can be serius. Lw magnesium can happen in sme

3 peple wh take a prtn pump inhibitr medicine fr at least 3 mnths. If lw magnesium levels happen, it is usually after a year f treatment. Yu may r may nt have symptms f lw magnesium. Tell yur dctr right away if yu develp any f these symptms: seizures dizziness abnrmal r fast heartbeat jitteriness jerking mvements r shaking (tremrs) muscle weakness spasms f the hands and feet cramps r muscle aches spasm f the vice bx Yur dctr may check the level f magnesium in yur bdy befre yu start taking DEXILANT, r during treatment, if yu will be taking DEXILANT fr a lng perid f time. The mst cmmn side effects f DEXILANT in adults include: diarrhea stmach pain nausea cmmn cld vmiting gas The mst cmmn side effects in children 12 t 17 years f age include: headache stmach pain diarrhea pain r swelling (inflammatin) in yur muth, nse r thrat Other side effects: Serius allergic reactins. Tell yur dctr if yu get any f the fllwing symptms with DEXILANT: rash face swelling thrat tightness difficulty breathing Yur dctr may stp DEXILANT if these symptms happen. Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f DEXILANT. 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 Hw shuld I stre DEXILANT? Stre DEXILANT at rm temperature between 68 F t 77 F (20 C t 25 C). Keep DEXILANT and all medicines ut f the reach f children.

4 General infrmatin abut the safe and effective use f DEXILANT Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use DEXILANT fr a cnditin fr which it was nt prescribed. D nt give DEXILANT t ther peple, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut DEXILANT. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut DEXILANT that is written fr health prfessinals. Fr mre infrmatin, g t r call What are the ingredients in DEXILANT capsules and DEXILANT SluTab? Active ingredient: dexlansprazle. DEXILANT capsules: Inactive ingredients: sugar spheres, magnesium carbnate, sucrse, lw-substituted hydrxyprpyl cellulse, titanium dixide, hydrxyprpyl cellulse, hyprmellse 2910, talc, methacrylic acid cplymers, plyethylene glycl 8000, triethyl citrate, plysrbate 80, and cllidal silicn dixide. The capsule shell is made f hyprmellse, carrageenan and ptassium chlride. Based n the capsule shell clr, blue cntains FD&C Blue N. 2 aluminum lake; gray cntains black ferric xide; and bth cntain titanium dixide. DEXILANT SluTab: Inactive ingredients: lactse mnhydrate-micrcrystalline cellulse spheres, magnesium carbnate, lw-substituted hydrxyprpyl cellulse, hydrxyprpyl cellulse, hyprmellse, talc, titanium dixide, mannitl, methacrylic acid cplymer, ethyl acrylate methyl methacrylate cplymer, plysrbate 80, glyceryl mnstearate, triethyl citrate, anhydrus citric acid, ferric xide, red; ferric xide, yellw; plyethylene glycl 8000, methylacrylate methylmethacrylate methacrylic acid cplymer, micrcrystalline cellulse, crspvidne, sucralse, strawberry durarme, and magnesium stearate.

5 Instructins fr Use DEXILANT (decks-i-launt) (dexlansprazle) delayed-release capsules and DEXILANT SluTab (decks-i-launt sl-u-tab) (dexlansprazle) delayed-release rally disintegrating tablets DEXILANT delayed-release capsules (DEXILANT capsules) Taking DEXILANT capsules with applesauce: 1. Place 1 tablespn f applesauce int a clean cntainer. 2. Carefully pen the capsule and sprinkle the granules nt the applesauce. 3. Swallw the applesauce and granules right away. D nt chew the granules. D nt save the applesauce and granules fr later use. Giving DEXILANT capsules with water using an ral syringe: 1. Place 20 ml f water int a clean cntainer. 2. Carefully pen the capsule and empty the granules int the cntainer f water. 3. Use an ral syringe t draw up the water and granule mixture. 4. Gently swirl the ral syringe t keep the granules frm settling. 5. Place the tip f the ral syringe in yur muth. Give the medicine right away. D nt save the water and granule mixture fr later use. 6. Refill the syringe with 10 ml f water and swirl gently. Place the tip f the ral syringe in yur muth and give the medicine that is left in the syringe. 7. Repeat step 6. Giving DEXILANT capsules with water thrugh a nasgastric tube (NG tube): Fr peple wh have an NG tube that is size 16 French r larger, DEXILANT may be given as fllws: 1. Place 20 ml f water int a clean cntainer. 2. Carefully pen the capsule and empty the granules int the cntainer f water. 3. Use a 60 ml catheter-tip syringe t draw up the water and granule mixture. 4. Gently swirl the catheter-tip syringe t keep the granules frm settling. 5. Cnnect the catheter-tip syringe t the NG tube. 6. Give the mixture right away thrugh the NG tube that ges int the stmach. D nt save the water and granule mixture fr later use. 7. Refill the catheter-tip syringe with 10 ml f water and swirl gently. Flush the NG tube with the water. 8. Repeat step 7. DEXILANT SluTab delayed-release rally disintegrating tablets (DEXILANT SluTab) Giving DEXILANT SluTab with water using an ral syringe: 1. Put 1 tablet in an ral syringe and draw up 20 ml f water int the ral syringe. 2. Gently swirl the ral syringe t mix the tablet and the water. 3. After the tablet is mixed in the water, place the tip f the ral syringe in yur muth. Give the medicine right away. D nt save the tablet and water mixture fr later use. 4. Refill the syringe with abut 10 ml f water and swirl gently. Place the tip f the ral syringe in yur muth and give the medicine that is left in the syringe. 5. Repeat step 4.

6 Giving DEXILANT SluTab with water thrugh a nasgastric tube (NG tube): Fr peple wh have an NG tube that is size 8 French r larger, DEXILANT SluTab may be given as fllws: 1. Put 1 tablet in a catheter-tip syringe and draw up 20 ml f water. 2. Gently swirl the catheter-tip syringe t mix the tablet and the water. 3. After the tablet is mixed in the water, swirl the catheter-tip syringe gently in rder t keep the particles frm settling. 4. Cnnect the catheter-tip syringe t the NG tube. 5. Give the mixture right away thrugh the NG tube that ges int the stmach. D nt save the tablet and water mixture fr later use. 6. Refill the catheter-tip syringe with abut 10 ml f water and swirl gently. Flush the NG tube with water. 7. Repeat step 6. Hw shuld I stre DEXILANT? Stre DEXILANT at rm temperature between 68 F t 77 F (20 C t 25 C). Keep DEXILANT and all medicines ut f the reach f children. This Medicatin Guide and Instructins fr Use have been apprved by the U.S. Fd and Drug Administratin. Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL Revised: July 2016 DEXILANT is a trademark f Takeda Pharmaceuticals U.S.A., Inc. registered with the U.S. Patent and Trademark Office and DEXILANT SluTab is a trademark f Takeda Pharmaceuticals U.S.A., Inc. used under license by Takeda Pharmaceuticals America, Inc. All ther trademark names are the prperty f their respective wners Takeda Pharmaceuticals America, Inc. DEX006 R26