PATIENT INFORMATION. effective for the treatment of the flu in people with long-time (chronic) heart problems or breathing problems.

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1 PATIENT INFORMATION capsules, fr ral use fr ral suspensin What is TAMIFLU? TAMIFLU is a prescriptin medicine used t: treat the flu (influenza) in peple 2 weeks f age and lder wh have had flu symptms fr n mre than tw days. prevent the flu in peple wh are 1 year f age and lder. It is nt knwn if TAMIFLU is: effective in peple wh start treatment after 2 days f develping flu symptms. effective fr the treatment f the flu in peple with lng-time (chrnic) heart prblems r breathing prblems. effective fr the treatment r preventin f flu in peple wh have weakened immune systems (immuncmprmised) safe and effective fr the treatment f the flu in children less than 2 weeks f age. safe and effective in the preventin f the flu in children less than 1 year f age. TAMIFLU des nt treat r prevent illness that is caused by infectins ther than the influenza virus. TAMIFLU des nt prevent bacterial infectins that may happen with the flu. TAMIFLU is nt recmmended fr peple with end-stage renal disease (ESRD) wh are nt receiving dialysis. TAMIFLU des nt take the place f receiving a flu vaccinatin. Talk t yur healthcare prvider abut when yu shuld receive an annual flu vaccinatin. Wh shuld nt take TAMIFLU? D nt take TAMIFLU if yu are allergic t seltamivir phsphate r any f the ingredients in TAMIFLU. See the end f this leaflet fr a cmplete list f ingredients in TAMIFLU. 1

2 What shuld I tell my healthcare prvider befre taking TAMIFLU? Befre yu take TAMIFLU, tell yur healthcare prvider if yu: have prblems swallwing TAMIFLU capsules have kidney prblems have a histry f fructse (fruit sugar) intlerance. TAMIFLU cntains srbitl and may cause stmach upset and diarrhea in peple wh are fructse intlerant. have any ther medical cnditins are pregnant r plan t becme pregnant. Available infrmatin indicate that TAMIFLU des nt increase the risk f birth defects. are breastfeeding r plan t breastfeed. TAMIFLU can pass int breast milk in small amunts. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin r ver-the-cunter medicines, vitamins, and herbal supplements. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider and pharmacist when yu get a new medicine. Hw shuld I take TAMIFLU? Take TAMIFLU exactly as yur healthcare prvider tells yu t. Take TAMIFLU with fd r withut fd. There is less chance f stmach upset if yu take TAMIFLU with fd. If yu miss a dse f TAMIFLU, take it as sn as yu remember. If it is 2 hurs r less befre yur next dse, d nt take the missed dse. Take yur next dse f TAMIFLU at yur scheduled time. D nt take 2 dses at the same time. If TAMIFLU fr ral suspensin is nt available r yu cannt swallw TAMIFLU capsules, yur healthcare prvider r pharmacist may instruct yu t pen TAMIFLU capsules and mix the capsules cntents with sweetened liquids such as chclate syrup (regular r sugar-free), crn syrup, caramel tpping, r light brwn sugar (disslved in water). If yur healthcare prvider r pharmacist has instructed yu t take TAMIFLU fr ral suspensin r pen yur TAMIFLU capsules, read the detailed Instructins fr Use at the end f this leaflet. Ask yur pharmacist if yu have any questins.

3 What are the pssible side effects f TAMIFLU? TAMIFLU may cause serius side effects, including: Serius skin and allergic reactins. TAMIFLU can cause serius skin and allergic reactins. Stp taking TAMIFLU and get medical help right away if yu get any f the fllwing symptms: skin rash r hives swelling f yur face, eyes, lips, tngue, r thrat yur skin blisters and peels truble breathing blisters r sres in yur muth chest pain r tightness itching Change in behavir. Peple, especially children, wh have the flu, can develp nervus system prblems and abnrmal behavir that can lead t death. During treatment with TAMIFLU, tell yur healthcare prvider right away if yu r yur child have cnfusin, speech prblems, shaky mvements, seizures, r start hearing vices r seeing things that are nt really there (hallucinatins). The mst cmmn side effects f TAMIFLU when used fr treatment f the flu include nausea, vmiting, and headache. The mst cmmn side effect f TAMIFLU when used fr preventin f the flu include nausea, vmiting, headache, and pain. Tell yur healthcare prvider if yu have any side effect that bthers yu r that des nt g away. These are nt all f the pssible side effects f TAMIFLU. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre TAMIFLU? Stre TAMIFLU capsules at rm temperature between 68 F t 77 F (20 C t 25 C). Stre TAMIFLU fr ral suspensin in the refrigeratr fr up t 17 days between 36ºF t 46ºF (2ºC t 8ºC) Stre TAMIFLU fr ral suspensin fr up t 10 days at rm temperature between 68 F t 77 F (20 C t 25 C). Safely thrw away any unused TAMIFLU that is ut f date r n lnger needed. Keep TAMIFLU and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f TAMIFLU. Medicines are smetimes prescribed fr purpses ther than thse listed in a Patient Infrmatin leaflet. D nt use TAMIFLU fr a cnditin fr which it was nt prescribed. D nt give TAMIFLU t ther peple, even if they have the same symptms yu have. It may harm them. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut TAMIFLU that is written fr health prfessinals. Fr mre infrmatin, g t

4 What are the ingredients in TAMIFLU? Active ingredient: seltamivir phsphate Inactive ingredients: TAMIFLU capsules: crscarmellse sdium, pvidne K30, pregelatinized starch, sdium stearyl fumarate, and talc 30mg capsule shell: gelatin, red irn xide, titanium dixide, and yellw irn xide 45mg capsules shell: black irn xide, gelatin, and titanium dixide 75mg capsules shell: black irn xide, gelatin, red irn xide, titanium dixide, and yellw irn xide TAMIFLU fr ral suspensin: mnsdium citrate, saccharin sdium, sdium benzate, srbitl, titanium dixide, tuttifrutti flavring, and xanthan gum. Distributed by: Genentech, Inc., A Member f the Rche Grup, 1 DNA Way, Suth San Francisc,CA Licensr: Gilead Sciences, Inc., Fster City, Califrnia, Genentech, Inc. All rights reserved This Patient Infrmatin has been apprved by the U.S. Fd and Drug Administratin. Revised 06/2016

5 INSTRUCTIONS FOR USE capsules, fr ral use fr ral suspensin Hw d I give a dse f TAMIFLU fr ral suspensin? Step 1. Shake the TAMIFLU fr ral suspensin bttle well befre each use. Step 2. Open the bttle by pushing dwnward n the child resistant bttle cap and twisting it in the directin f the arrw. Step 3. Measure the ral suspensin with an apprpriate ral dsing dispenser t be sure yu get the crrect dse. Cntact yur pharmacist if yu d nt have an apprpriate ral dsing dispenser. Step 4. Give the full cntents f ral dsing dispenser directly int the muth. Step 5. Clse the bttle with the child-resistant bttle cap after each use. Step 6. Rinse ral dsing dispenser under running tap water and allw t air dry after each use. Hw d I mix the cntents f TAMIFLU capsules with sweetened liquids, if directed by my healthcare prvider r pharmacist? Yu will need: the prescribed dse f TAMIFLU capsules a small bwl sweetened liquid, such as chclate syrup (regular r sugar-free), crn syrup, caramel tpping, r light brwn sugar (disslved in water) Step 1. Open the cntents f the prescribed dse f TAMIFLU capsules int a small bwl. Step 2. Add a small amunt f the sweetened liquid t the capsule cntents. Step 3. Stir the mixture and give the entire dse f TAMIFLU. This Instructins fr Use has been apprved by the U.S. Fd and Drug Administratin. Revised 06/2016

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