MEDICATION GUIDE Foradil [FOR-a-dil] Aerolizer (formoterol fumarate inhalation powder)

Transcription

1 MEDICATION GUIDE Fradil [FOR-a-dil] Aerlizer (frmterl fumarate inhalatin pwder) Imprtant: D nt swallw FORADIL capsules. FORADIL capsules are used nly with the Aerlizer inhaler that cmes with FORADIL AEROLIZER. Never place a capsule in the muthpiece f the AEROLIZER Inhaler. Read the Medicatin Guide that cmes with FORADIL AEROLIZER befre yu start using it and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking t yur health care prvider abut yur medical cnditin r treatment. What is the mst imprtant infrmatin I shuld knw abut FORADIL AEROLIZER? FORADIL AEROLIZER can cause serius side effects, including: 1. Peple with asthma wh take lng-acting beta 2 -adrenergic agnist (LABA) medicines, such as frmterl fumarate inhalatin pwder (FORADIL AEROLIZER), have an increased risk f death frm asthma prblems. Call yur healthcare prvider if breathing prblems wrsen ver time while using FORADIL AEROLIZER. Yu may need a different treatment. Get emergency medical care if: breathing prblems wrsen quickly, and yu use yur rescue inhaler medicine, but it des nt relieve yur breathing prblems. 2. D nt use FORADIL AEROLIZER as yur nly asthma medicine. FORADIL AEROLIZER must nly be used with a lng-term asthma cntrl medicine, such as an inhaled crticsterid. 3. When yur asthma is well cntrlled, yur healthcare prvider may tell yu t stp taking FORADIL AEROLIZER. Yur healthcare prvider will decide if yu can stp FORADIL AEROLIZER withut lss f asthma cntrl. Yu will cntinue taking yur lng-term asthma cntrl medicine, such as an inhaled crticsterid. 4. Children and adlescents wh take LABA medicines may have an increased risk f being hspitalized fr asthma prblems. What is FORADIL AEROLIZER? FORADIL AEROLIZER is a lng-acting beta 2 -agnist (LABA). LABA medicines help the muscles arund the airways in yur lungs stay relaxed t prevent asthma symptms, such as wheezing and shrtness f breath. These symptms can happen when the muscles arund the airways tighten. This makes it hard t breathe. In severe cases, wheezing can stp yur breathing and cause death if nt treated right away. FORADIL AEROLIZER is used fr asthma, exercise-induced brnchspasm (EIB) and chrnic bstructive pulmnary disease (COPD) as fllws: Asthma FORADIL AEROLIZER is used with a lng-term asthma cntrl medicine, such as an inhaled crticsterid, in adults and children ages 5 and lder: t cntrl symptms f asthma, and t prevent symptms such as wheezing

2 LABA medicines, such as FORADIL AEROLIZER, increase the risk f death frm asthma prblems. FORADIL AEROLIZER is nt fr adults and children with asthma wh are well cntrlled with lng-term asthma cntrl medicine, such as lw t medium dse f an inhaled crticsterid medicine. Exercise-Induced Brnchspasm (EIB) FORADIL AEROLIZER is used t prevent wheezing caused by exercise in adults and children 5 years f age and lder. If yu have EIB nly, yur healthcare prvider may prescribe nly FORADIL AEROLIZER fr yur cnditin If yu have EIB and asthma, yur healthcare prvider shuld als prescribe a lngterm asthma cntrl medicine, such as an inhaled crticsterid Chrnic Obstructive Pulmnary Disease (COPD) FORADIL AEROLIZER is used lng-term, 2 times each day (mrning and evening), t cntrl symptms f COPD and prevent wheezing in adults with COPD. It is nt knwn if FORADIL AEROLIZER is safe and effective in children under 5 years f age. Wh shuld nt use FORADIL AEROLIZER? D nt take FORADIL AEROLIZER: t treat yur asthma withut a lng-term asthma cntrl medicine, such as an inhaled crticsterid t treat sudden symptms f asthma r COPD if yu are allergic t frmterl fumarate r any f the ingredients in FORADIL AEROLIZER. Ask yur healthcare prvider if yu are nt sure. See the end f this Medicatin Guide fr a cmplete list f ingredients in FORADIL AEROLIZER. What shuld I tell my healthcare prvider befre using FORADIL AEROLIZER? Tell yur healthcare prvider abut all f yur health cnditins, including if yu: have heart prblems have high bld pressure have seizures have thyrid prblems have diabetes have an aneurysm (swelling f an artery) have a phechrmcytma (a tumr f the adrenal gland that can affect yur bld pressure) are scheduled t have surgery are pregnant r planning t becme pregnant. It is nt knwn if FORADIL AEROLIZER may harm yur unbrn baby. are breastfeeding. It is nt knwn if FORADIL AEROLIZER passes int yur milk and if it can harm yur baby. are allergic t FORADIL AEROLIZER, any ther medicines, r fd prducts. FORADIL AEROLIZER cntains lactse (milk sugar) and a small amunt f milk prteins. It is pssible that allergic reactins may happen in patients wh have a severe milk prtein allergy.

3 Tell yur healthcare prvider abut all the medicines yu take including prescriptin and nnprescriptin medicines, vitamins, and herbal supplements. FORADIL AEROLIZER and certain ther medicines may interact with each ther. This may cause serius side effects. Knw the medicines yu take. Keep a list and shw it t yur healthcare prvider and pharmacist each time yu get a new medicine. Hw d I use FORADIL capsules with the Aerlizer inhaler? See the step-by-step instructins fr using FORADIL Capsules with the Aerlizer inhaler at the end f this Medicatin Guide. D nt use FORADIL unless yur healthcare prvider has taught yu and yu understand everything. Ask yur healthcare prvider r pharmacist if yu have any questins. Children shuld use FORADIL AEROLIZER with an adult s help, as instructed by the child s healthcare prvider. Use FORADIL AEROLIZER exactly as prescribed. D nt use FORADIL AEROLIZER mre ften than prescribed. Fr asthma and COPD, the usual dse is 1 FORADIL capsule inhaled thrugh the AEROLIZER inhaler 2 times each day (mrning and evening). The 2 dses shuld be abut 12 hurs apart. Fr preventing exercise-induced brnchspasm, the usual dse is 1 FORADIL capsule inhaled thrugh the AEROLIZER inhaler at least 15 minutes befre exercise, as needed. D nt use FORADIL AEROLIZER mre ften than every 12 hurs. D nt use extra FORADIL AEROLIZER befre exercise if yu already use it 2 times each day. If yu miss a dse f FORADIL AEROLIZER, just skip that dse. Take yur next dse at yur usual time. Never take 2 dses at ne time. D nt use a spacer device with FORADIL AEROLIZER. D nt breathe int FORADIL AEROLIZER. While yu are using FORADIL AEROLIZER 2 times each day, d nt use ther medicines that cntain a lng-acting beta 2 -agnist (LABA) fr any reasn. Ask yur healthcare prvider r pharmacist fr a list f these medicines. D nt stp using FORADIL AEROLIZER r any f yur asthma medicines unless tld t d s by yur healthcare prvider because yur symptms might get wrse. Yur healthcare prvider will change yur medicines as needed. FORADIL AEROLIZER des nt relieve sudden symptms. Always have a rescue inhaler medicine with yu t treat sudden symptms. If yu d nt have an inhaled, shrt-acting brnchdilatr, cntact yur healthcare prvider t have ne prescribed fr yu. Call yur healthcare prvider r get medical care right away if: yur breathing prblems wrsen with FORADIL AEROLIZER yu need t use yur rescue inhaler medicine mre ften than usual yur rescue inhaler medicine des nt wrk as well fr yu at relieving symptms yu need t use 4 r mre inhalatins f yur rescue inhaler medicine fr 2 r mre days in a rw yu use 1 whle canister f yur rescue inhaler medicine in 8 weeks time yur peak flw meter results decrease. Yur healthcare prvider will tell yu the numbers that are right fr yu. yu have asthma and yur symptms d nt imprve after using FORADIL AEROLIZER regularly fr 1 week. What are the pssible side effects with FORADIL AEROLIZER? FORADIL AEROLIZER may cause serius side effects, including:

4 See What is the mst imprtant infrmatin I shuld knw abut FORADIL AEROLIZER? Sudden breathing prblems immediately after inhaling yur medicine (wheezing r cughing and difficulty breathing) Fast r irregular heart beat (palpitatins) Serius allergic reactins including rash, hives, swelling f the face, muth, and tngue, and breathing prblems. Call yur healthcare prvider r get emergency medical care if yu get any symptms f a serius allergic reactin. Lw bld ptassium (which may cause symptms f muscle spasm, muscle weakness r abnrmal heart rhythm) Increases in bld sugar levels (hyperglycemia) Using t much f a LABA medicine may cause: chest pain increased bld pressure a fast r irregular heart beat headache tremr nervusness dizziness weakness truble sleeping electrcardigram (ECG) changes seizures Cmmn side effects with FORADIL AEROLIZER include: Asthma in Adults and Adlescents: headache tremr chest infectin chest pain truble sleeping Asthma in Children 5-12 Years f Age: viral infectins runny nse tnsillitis gastrenteritis abdminal pain nausea dyspepsia COPD: respiratry infectin thrat infectin chest pain sinus infectin fever leg cramps muscle cramps

5 Tell yur healthcare prvider abut any side effect that bthers yu r that des nt g away. These are nt all the side effects with FORADIL AEROLIZER. Ask yur healthcare prvider r pharmacist fr mre infrmatin. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw d I stre FORADIL AEROLIZER? Stre FORADIL AEROLIZER at rm temperature between 68 F and 77 F (20 C t 25 C). Prtect FORADIL AEROLIZER frm heat and misture. D nt remve FORADIL capsules frm their fil blister package until just befre use. Always discard the ld AEROLIZER inhaler by the Use by date and use the new ne prvided with each new prescriptin. Safely discard FORADIL capsules and the Aerlizer inhaler if n lnger needed r is ut-fdate. Keep FORADIL AEROLIZER and all medicines ut f the reach f children. General Infrmatin abut FORADIL AEROLIZER Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use FORADIL AEROLIZER fr a cnditin fr which it was nt prescribed. D nt give FORADIL AEROLIZER t ther peple, even if they have the same cnditin. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut FORADIL AEROLIZER. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut FORADIL AEROLIZER that was written fr healthcare prfessinals. If yu have any questins abut the use f FORADIL AEROLIZER, call (tll-free) r g t What are the ingredients in FORADIL AEROLIZER? Active ingredient: frmterl fumarate Inactive ingredients: lactse (cntains milk prteins), gelatin (capsule shell) T /T Nvember 2012/Nvember 2012

6 D nt swallw FORADIL capsules. INSTRUCTIONS FOR USE Fllw the instructins belw fr using yur FORADIL AEROLIZER. Yu will breathe-in (inhale) the medicine in the FORADIL capsules frm the FORADIL AEROLIZER. If yu have any questins, ask yur healthcare prvider r pharmacist. FORADIL AEROLIZER FORADIL AEROLIZER cnsists f FORADIL capsules and a AEROLIZER Inhaler. FORADIL capsules cme n blister cards. Keep yur FORADIL and AEROLIZER Inhaler dry. Handle with DRY hands. Fil blister card The Aerlizer cnsists f the fllwing parts: 1. A cap t prtect the muthpiece f the base 2. A base that allws the prper release f medicine frm the capsule. The base cnsists f: 3. A muth piece 4. A capsule chamber 5. A buttn with winglets (prjecting side pieces) and pins n each side 6. An air inlet channel. With each new prescriptin f FORADIL AEROLIZER r refill, yur pharmacist shuld have written the Use by date n the sticker n the utside f the FORADIL AEROLIZER bx. Remve the Use by sticker n the bx and place it n the AEROLIZER Inhaler cver that cmes with FORADIL. If the sticker is blank, cunt 4 mnths frm the date yu gt yur FORADIL AEROLIZER frm the pharmacy and write this date n the sticker. Als, check the expiratin date stamped n the bx. If this date is less than 4 mnths frm yur purchase date, write this date n the sticker. D nt use FORADIL capsules with any ther capsule inhaler, and d nt use the AEROLIZER inhaler t take any ther capsule medicine. Taking a dse f FORADIL AEROLIZER requires the fllwing steps: 1. D nt remve a FORADIL capsule frm the blister card until yu are ready fr a dse. 2. Pull ff the AEROLIZER Inhaler cver. (Figure A)

7 Figure A 3. Hld the base f the AEROLIZER Inhaler firmly and twist the muthpiece in the directin f the arrw t pen. (Figure B) Push the buttns in n each side t make sure that yu can see 4 pins in the capsule well f the AEROLIZER Inhaler. Figure B 4. Separate ne FORADIL capsule blister by tearing at the precut lines. (Figure C) Figure C 5. Peel the paper backing that cvers ne FORADIL capsule n the blister card. Push the FORADIL capsule thrugh the fil. (Figure D) Figure D

8 6. Place the FORADIL capsule in the capsule-chamber in the base f the AEROLIZER Inhaler. Never place a capsule directly int the muthpiece. (Figure E) Figure E 7. Twist the muthpiece back t the clsed psitin. (Figure F) Figure F 8. Hld the muthpiece f the AEROLIZER Inhaler upright and press bth buttns at the same time. Only press the buttns ONCE. Yu shuld hear a click as the FORADIL capsule is being pierced. (Figure G) Figure G

9 9. Release the buttns. If the buttns stay stuck, grasp the wings n the buttns and pull them ut f the stuck psitin befre the next step. D nt push the buttns a secnd time. This may cause the FORADIL capsule t break int small pieces. There is a screen built int the AEROLIZER Inhaler t hld these small pieces. It is pssible that tiny pieces f a FORADIL capsule might reach yur muth r thrat when yu inhale the medicine. This will nt harm yu, but t avid this, nly pierce the capsule nce. The FORADIL capsules are als less likely t break int small pieces if yu stre them the right way (See Hw d I stre FORADIL AEROLIZER? ). 10. Breathe ut (exhale) fully. D nt exhale int the AEROLIZER muthpiece. (Figure H) Figure H 11. Tilt yur head back slightly. Keep the AEROLIZER Inhaler level, with the blue buttns t the left and right (nt up and dwn). Place the muthpiece in yur muth and clse yur lips arund the muthpiece. (Figures I and J) 12. Breathe in quickly and deeply (Figure K). This will cause the FORADIL capsule t spin arund in the chamber and deliver yur dse f medicine. Yu shuld hear a whirring nise and experience a sweet taste in yur muth. If yu d nt hear the whirring nise, the capsule may be stuck. If this ccurs, pen the AEROLIZER Inhaler and lsen the capsule allwing it t spin freely. D nt try t lsen the capsule by pressing the buttns again. (Yu will have t repeat steps 10 t 12 again t get yur dse.) Figure K

10 13. Remve the AEROLIZER Inhaler frm yur muth. Cntinue t hld yur breath as lng as yu can and then exhale. 14. Open the AEROLIZER Inhaler t see if any pwder is still in the capsule. If any pwder remains in the capsule repeat steps 10 t 13. Mst peple are able t empty the capsule in ne r tw inhalatins. 15. After use, pen the AEROLIZER Inhaler, remve and discard the empty capsule. D nt leave a used capsule in the chamber. 16. Clse the muthpiece and replace the cver. Remember: Never breathe int the AEROLIZER Inhaler. Never take the AEROLIZER Inhaler apart. Never place a FORADIL capsule directly int the muthpiece f the AEROLIZER Inhaler. Never leave a used FORADIL capsule in the AEROLIZER Inhaler chamber. Always use the AEROLIZER Inhaler in a level psitin. Never wash the AEROLIZER Inhaler. Keep it dry. Always keep the AEROLIZER Inhaler and FORADIL capsules in a dry place. Always use the new AEROLIZER Inhaler that cmes with yur refill. This Medicatin Guide and Instructins fr Use has been apprved by the U.S. Fd and Drug Administratin. FORADIL is a registered trademark f Astellas Pharma Inc. AEROLIZER is a registered trademark f Nvartis AG. Manufactured by: Nvartis Pharma AG, Basle, Switzerland Cpyright 2010 Merck Sharp & Dhme Crpratin., a subsidiary f Merck & C., Inc. All rights reserved. T /T /T Nvember 2012/Nvember 2012/Nvember 2012