Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64 Page 65 Page 66 Page 67 Page 68Patient Information COPAXONE (co-PAX-own) (glatiramer acetate injection) for subcutaneous use Read this Patient Information before you start using COPAXONE and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is COPAXONE? COPAXONE is prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS). It is not known if COPAXONE is safe and effective in children under 18 years of age. Who should not use COPAXONE? UÊ œÊ˜œÌÊÕÃiÊ "*8" ʈvÊޜÕÊ>ÀiÊ>iÀ}ˆVÊ̜Ê}>̈À>“iÀÊ>ViÌ>Ìi]Ê mannitol or any of the ingredients in COPAXONE. See the end of this leaflet for a complete list of the ingredients in COPAXONE. What should I tell my doctor before using COPAXONE? Before you use COPAXONE, tell your doctor if you: UÊ>ÀiÊ«Ài}˜>˜ÌʜÀÊ«>˜Ê̜ÊLiVœ“iÊ«Ài}˜>˜Ì°ÊÌʈÃʘœÌʎ˜œÜ˜ÊˆvÊ COPAXONE will harm your unborn baby. UÊ>ÀiÊ LÀi>ÃÌvii`ˆ˜}Ê œÀÊ «>˜Ê ÌœÊ LÀi>ÃÌvii`°Ê ÌÊ ˆÃÊ ˜œÌÊ Ž˜œÜ˜Ê ˆvÊ COPAXONE passes into your breast milk. Talk to your doctor about the best way to feed your baby while using COPAXONE. Tell your doctor about all the medicines you take]ʈ˜VÕ`ˆ˜}Ê «ÀiÃVÀˆ«Ìˆœ˜Ê >˜`Ê œÛiÀ‡Ì…i‡VœÕ˜ÌiÀÊ “i`ˆVˆ˜iÃ]Ê ÛˆÌ>“ˆ˜Ã]Ê >˜`Ê herbal supplements. "*8" Ê “>ÞÊ >vviVÌÊ Ì…iÊ Ü>ÞÊ œÌ…iÀÊ “i`ˆVˆ˜iÃÊ ÜœÀŽ]Ê >˜`Ê other medicines may affect how COPAXONE works. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine. How should I use COPAXONE? UÊœÀÊ`iÌ>ˆi`ʈ˜ÃÌÀÕV̈œ˜Ã]ÊÃiiÊ̅iÊFull Prescribing Information for complete information on how to use COPAXONE. UÊ9œÕÀÊ`œV̜ÀÊ܈ÊÌiÊޜÕʅœÜʓÕV…Ê "*8" Ê̜ÊÕÃiÊ>˜`Ê when to use it. UÊ "*8" ʈÃÊ}ˆÛi˜ÊLÞʈ˜iV̈œ˜Ê՘`iÀÊޜÕÀÊΈ˜Ê­ÃÕLVÕÌ>˜i- ously). UÊ1ÃiÊ "*8" ÊiÝ>V̏ÞÊ>ÃÊޜÕÀÊ`œV̜ÀÊÌiÃÊޜÕÊ̜ÊÕÃiÊˆÌ°Ê UÊ-ˆ˜ViÊiÛiÀÞÊLœ`ÞÊÌÞ«iʈÃÊ`ˆvviÀi˜Ì]ÊÌ>ŽÊ܈̅ÊޜÕÀÊ`œV̜ÀÊ>LœÕÌÊ Ì…iʈ˜iV̈œ˜Ê>Ài>ÃÊ̅>ÌÊ>ÀiÊLiÃÌÊvœÀÊÞœÕ°Ê UÊ9œÕÊŜՏ`ÊÀiViˆÛiÊޜÕÀÊwÀÃÌÊ`œÃiʜvÊ "*8" Ê܈̅Ê>Ê`œV̜ÀÊ or nurse present. This might be at your doctor’s office or with a visiting home health nurse who will teach you how to give ޜÕÀÊ "*8" ʈ˜iV̈œ˜Ã° What are the possible side effects of COPAXONE? COPAXONE may cause serious side effects, including: UÊPost-Injection Reactions. Serious side effects may happen Àˆ}…ÌÊ >vÌiÀÊ ÞœÕÊ ˆ˜iVÌÊ "*8" Ê >ÌÊ >˜ÞÊ Ìˆ“iÊ `ÕÀˆ˜}Ê ÞœÕÀÊ course of treatment. Call your doctor right away if you have >˜ÞʜvÊ̅iÃiÊ«œÃ̇ˆ˜iV̈œ˜ÊÀi>V̈œ˜ÊÃޓ«Ìœ“Ãʈ˜VÕ`ˆ˜}\ Ê UÊÀi`˜iÃÃÊ̜ÊޜÕÀÊV…iiŽÃʜÀʜ̅iÀÊ«>ÀÌÃʜvÊ̅iÊLœ`ÞÊ­yÕň˜}® Ê UÊV…iÃÌÊ«>ˆ˜ Ê UÊv>ÃÌʅi>ÀÌÊLi>Ì Ê UÊ>˜ÝˆiÌÞ Ê UÊLÀi>̅ˆ˜}Ê«ÀœLi“ÃʜÀÊ̈}…̘iÃÃʈ˜ÊޜÕÀÊ̅Àœ>Ì Ê UÊÃÜiˆ˜}]ÊÀ>Å]ʅˆÛiÃ]ʜÀʈÌV…ˆ˜} Ê vÊޜÕʅ>ÛiÊÃޓ«Ìœ“ÃʜvÊ>Ê«œÃ̇ˆ˜iV̈œ˜ÊÀi>V̈œ˜]Ê`œÊ˜œÌÊ }ˆÛiÊޜÕÀÃivʓœÀiʈ˜iV̈œ˜ÃÊ՘̈Ê>Ê`œV̜ÀÊÌiÃÊޜÕÊ̜° UÊChest Pain.Ê9œÕÊV>˜Ê…>ÛiÊV…iÃÌÊ«>ˆ˜Ê>ÃÊ«>ÀÌʜvÊ>Ê«œÃ̇ˆ˜iV̈œ˜Ê reaction or by itself. This type of chest pain usually lasts a few minutes and can begin around 1 month after you start using COPAXONE. Call your doctor right away if you have chest pain while using COPAXONE. UÊDamage to your skin.Ê >“>}iÊ̜Ê̅iÊv>ÌÌÞÊ̈ÃÃÕiʍÕÃÌÊ՘`iÀÊ ÞœÕÀÊΈ˜½ÃÊÃÕÀv>ViÊ­ˆ«œ>ÌÀœ«…Þ®Ê>˜`]ÊÀ>ÀiÞ]Ê`i>̅ʜvÊޜÕÀÊ skin tissue (necrosis) can happen when you use COPAXONE. >“>}iÊ̜Ê̅iÊv>ÌÌÞÊ̈ÃÃÕiÊ՘`iÀÊޜÕÀÊΈ˜ÊV>˜ÊV>ÕÃiÊ>ʺ`i˜Ì»Ê >ÌÊ̅iʈ˜iV̈œ˜ÊÈÌiÊ̅>Ìʓ>ÞʘœÌÊ}œÊ>Ü>Þ°Ê9œÕÊV>˜ÊÀi`ÕViÊ ÞœÕÀÊV…>˜ViʜvÊ`iÛiœ«ˆ˜}Ê̅iÃiÊ«ÀœLi“ÃÊLÞ\ Ê UÊvœœÜˆ˜}ÊޜÕÀÊ`œV̜À½Ãʈ˜ÃÌÀÕV̈œ˜ÃÊvœÀʅœÜÊ̜ÊÕÃiÊ "*8" Ê Ê UÊV…œœÃˆ˜}Ê >Ê `ˆvviÀi˜ÌÊ ˆ˜iV̈œ˜Ê >Ài>Ê i>V…Ê ̈“iÊ ÞœÕÊ ÕÃiÊ COPAXONE. See Step 4 in the Instructions for Use, “Choose your injection area”. /…iʓœÃÌÊVœ““œ˜ÊÈ`iÊivviVÌÃʜvÊ "*8" ʈ˜VÕ`i\ UÊΈ˜Ê«ÀœLi“ÃÊ>ÌÊޜÕÀʈ˜iV̈œ˜ÊÈÌiʈ˜VÕ`ˆ˜}\ ◦ redness ◦ itching ◦ pain ◦ lumps ◦ swelling UÊÀ>Å UÊŜÀ̘iÃÃʜvÊLÀi>̅ UÊyÕň˜}Ê­Û>Ü`ˆ>̈œ˜® Tell your doctor if you have any side effect that bothers you or that does not go away. /…iÃiÊ>ÀiʘœÌÊ>Ê̅iÊ«œÃÈLiÊÈ`iÊivviVÌÃʜvÊ "*8" °ÊœÀÊ “œÀiʈ˜vœÀ“>̈œ˜]Ê>ÎÊޜÕÀÊ`œV̜ÀʜÀÊ«…>À“>VˆÃÌ° >ÊޜÕÀÊ`œV̜ÀÊvœÀʓi`ˆV>Ê>`ۈViÊ>LœÕÌÊÈ`iÊivviVÌðÊ9œÕʓ>ÞÊ Ài«œÀÌÊÈ`iÊivviVÌÃÊ̜Ê Ê>ÌÊ£‡nää‡ ‡£änn°Ê How should I store COPAXONE? UÊ-̜ÀiÊ "*8" ʈ˜Ê̅iÊÀivÀˆ}iÀ>̜ÀÊLiÌÜii˜ÊÎÈcÊ̜Ê{ÈcÊ ­Óc Ê̜Ênc ®° UÊ7…i˜ÊޜÕÊ>ÀiʘœÌÊ>LiÊ̜ÊÀivÀˆ}iÀ>ÌiÊ "*8" ]ÊޜÕʓ>ÞÊ store it for up to 1 month at room temperature between x™cÊ̜ÊnÈcÊ­£xc Ê̜ÊÎäc ®°Ê UÊ*ÀœÌiVÌÊ "*8" ÊvÀœ“ʏˆ}…ÌʜÀʅˆ}…ÊÌi“«iÀ>ÌÕÀi° UÊ œÊ˜œÌÊvÀiiâiÊ "*8" ÊÃÞÀˆ˜}iðÊvÊ>ÊÃÞÀˆ˜}iÊvÀiiâiÃ]Ê̅ÀœÜÊ it away in a sharps disposal container. See Step 13 in the Instructions for Use, “Dispose of needles and syringes”. Keep COPAXONE and all medicines out of the reach of children. General information about the safe and effective use of COPAXONE. Medicines are sometimes prescribed for purposes other than ̅œÃiʏˆÃÌi`ʈ˜Ê>Ê*>̈i˜ÌʘvœÀ“>̈œ˜Êi>yiÌ°Ê œÊ˜œÌÊÕÃiÊ "*8" Ê vœÀÊ>ÊVœ˜`ˆÌˆœ˜ÊvœÀÊ܅ˆV…ʈÌÊÜ>ÃʘœÌÊ«ÀiÃVÀˆLi`°Ê œÊ˜œÌÊ}ˆÛiÊ "*8" Ê̜ʜ̅iÀÊ«iœ«i]ÊiÛi˜ÊˆvÊ̅iÞʅ>ÛiÊ̅iÊÃ>“iÊÃޓ«Ìœ“ÃÊ as you have. It may harm them. /…ˆÃÊ*>̈i˜ÌʘvœÀ“>̈œ˜Êi>yiÌÊÃՓ“>ÀˆâiÃÊ̅iʓœÃÌʈ“«œÀÌ>˜ÌÊ information about COPAXONE. If you would like more infor- “>̈œ˜]ÊÌ>ŽÊ܈̅ÊޜÕÀÊ`œV̜À°Ê9œÕÊV>˜Ê>ÎÊޜÕÀÊ«…>À“>VˆÃÌʜÀÊ doctor for information about COPAXONE that is written for health professionals. œÀʓœÀiʈ˜vœÀ“>̈œ˜]Ê}œÊ̜ÊÜÜÜ°Vœ«>ݜ˜i°Vœ“ÊœÀÊV>Ê£‡nää‡ nnLJn£ää° What are the ingredients in COPAXONE? Active ingredient: glatiramer acetate Inactive ingredients: mannitol >ÀŽiÌi`ÊLÞ\Ê/ 6Ê iÕÀœÃVˆi˜Vi]ʘV°]Ê"ÛiÀ>˜`Ê*>ÀŽ]Ê-ÊÈÈÓ££ ˆÃÌÀˆLÕÌi`ÊLÞ\Ê/ 6Ê*…>À“>ViṎV>ÃÊ1-]ʘV°]Ê œÀ̅Ê7>iÃ]Ê *Ê£™{x{ Product of Israel /…ˆÃÊ LÀˆivÊ ÃՓ“>ÀÞÊ ˆÃÊ L>Ãi`Ê œ˜Ê "*8" Ê  ‡>««ÀœÛi`Ê «>̈i˜Ìʏ>Liˆ˜}]ÊÀiۈÃi`\Ê >˜Õ>ÀÞÊÓä£{°Ê "*‡{Î{£{