MEDICATION GUIDE Levofloxacin (lee-voe-flox-a-sin) Tablets, USP 250 mg Tablets, 500 mg Tablets, and 750 mg Tablets

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1 MEDICATION GUIDE Levflxacin (lee-ve-flox-a-sin) Tablets, USP 250 mg Tablets, 500 mg Tablets, and 750 mg Tablets Read this Medicatin Guide befre yu start taking levflxacin tablets and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut levflxacin tablets? Levflxacin tablets, a flurquinlne antibitic, can cause serius side effects. Sme f these serius side effects can happen at same time and culd result in death. If yu have any f the fllwing serius side effects while yu take levflxacin tablets, yu shuld stp taking levflxacin tablets immediately and get medical help right away. 1. Tendn rupture r swelling f the tendn (tendinitis). Tendn prblems can happen in peple f all ages wh take levflxacin tablets. Tendns are tugh crds f tissue that cnnect muscles t bnes. Sme tendn prblems include pain, swelling, tears, and swelling f tendns including the back f the ankle (Achilles), shulder, hand, r ther tendn sites. The risk f getting tendn prblems while yu take levflxacin tablets is higher if yu: are ver 60 years f age are taking sterids (crticsterids) have had a kidney, heart r lung transplant. Tendn prblems can happen in peple wh d nt have the abve risk factrs when they take levflxacin tablets. Other reasns that can increase yur risk f tendn prblems can include: physical activity r exercise kidney failure tendn prblems in the past, such as in peple with rheumatid arthritis (RA).

2 Stp taking levflxacin tablets immediately and get medical help right away at the first sign f tendn pain, swelling r inflammatin. Avid exercise and using the affected area. The mst cmmn area f pain and swelling is the Achilles tendn at the back f yur ankle. This can als happen with ther tendns. Talk t yur healthcare prvider abut the risk f tendn rupture with cntinued use f levflxacin tablets. Yu may need a different antibitic that is nt a flurquinlne t treat yur infectin. Tendn rupture can happen while yu are taking r after yu have finished taking levflxacin tablets. Tendn ruptures can happen within hurs r days f taking levflxacin tablets and have happened up t several mnths after peple have finished taking their flurquinlne. Stp taking levflxacin tablets immediately and get medical help right away if yu get any f the fllwing signs r symptms f a tendn rupture: hear r feel a snap r pp in a tendn area bruising right after an injury in a tendn area unable t mve the affected area r bear weight 2. Changes in sensatin and pssible nerve damage (Peripheral Neurpathy). Damage t the nerves in arms, hands, legs, r feet can happen in peple wh take flurquinlnes, including levflxacin. Stp taking levflxacin tablets immediately and talk t yur healthcare prvider right away if yu get any f the fllwing symptms f peripheral neurpathy in yur arms, hands, legs, r feet: pain numbness burning weakness tingling The nerve damage may be permanent. 3. Central Nervus System (CNS) effects. Seizures have been reprted in peple wh take flurquinlne antibacterial medicines, including levflxacin. Tell yur healthcare prvider if yu have a histry f seizures befre yu start taking levflxacin tablets. CNS side effects may happen as sn as after taking the first dse f levflxacin tablet. Stp taking levflxacin tablets immediately and talk t yur healthcare prvider right away if yu get any f these side effects, r ther changes in md r behavir: seizures truble sleeping hear vices, see things, r sense nightmares things that are nt there (hallucinatins)

3 feel restlessness feel lightheaded r dizzy tremrs feel mre suspicius (parania) feel anxius r nervus feel anxius r nervus cnfusin suicidal thughts r acts depressin headaches that will nt g away, with r withut blurred visin 4. Wrsening f myasthenia gravis (a prblem that causes muscle weakness). Flurquinlnes like levflxacin may cause wrsening f myasthenia gravis symptms, including muscle weakness and breathing prblems. Tell yur healthcare prvider if yu have a histry f myasthenia gravis befre yu start taking levflxacin. Call yur healthcare prvider right away if yu have any wrsening muscle weakness r breathing prblems. What are levflxacin tablets? Levflxacin tablets are a flurquinlne antibitic medicine used in adults age 18 years r lder, t treat certain infectins caused by certain germs called bacteria. These bacterial infectins include: nscmial pneumnia cmmunity acquired pneumnia acute sinus infectin acute wrsening f chrnic brnchitis skin infectins, cmplicated and uncmplicated chrnic prstate infectin urinary tract infectins, cmplicated and uncmplicated acute kidney infectin (pyelnephritis) inhalatinal anthrax plague Studies f levflxacin tablets fr use in the treatment f plague and anthrax were dne in animals nly, because plague and anthrax culd nt be studied in peple. Levflxacin tablets shuld nt be used in patients with uncmplicated urinary tract infectins, acute bacterial exacerbatin f chrnic brnchitis, r acute bacterial sinusitis if there are ther treatment ptins available. Levflxacin tablets are als used t treat children wh are 6 mnths f age r lder and may have breathed in anthrax germs, have plague, r been expsed t plague germs. It is nt knwn if levflxacin tablets are safe and effective in children under 6 mnths f age.

4 The safety and effectiveness in children treated with levflxacin tablets fr mre than 14 days is nt knwn. Wh shuld nt take levflxacin tablets? D nt take levflxacin tablets if yu have ever had a severe allergic reactin t an antibitic knwn as a flurquinlne, r if yu are allergic t levflxacin r any f the ingredients in levflxacin tablets. See the end f this leaflet fr a cmplete list f ingredients in levflxacin tablets. What shuld I tell my healthcare prvider befre taking levflxacin tablets? Befre yu take levflxacin tablets, tell yur healthcare prvider if yu: have tendn prblems; levflxacin tablets shuld nt be used in patients wh have a histry f tendn prblems. have a prblem that causes muscle weakness (myasthenia gravis); levflxacin tablets shuld nt be used in patients wh have a knwn histry f myasthenia gravis. have central nervus system prblems such as seizures (epilepsy) have nerve prblems; levflxacin tablets shuld nt be used in patients hw have a histry f a nerve prblem called peripheral neurpathy have r anyne in yur family has an irregular heartbeat, especially a cnditin called QT prlngatin. have lw bld ptassium (hypkalemia) have bne prblems have jint prblems including rheumatid arthritis (RA) have kidney prblems. Yu may need a lwer dse f levflxacin tablets if yur kidneys d nt wrk well. have liver prblems have diabetes r prblems with lw bld sugar (hypglycemia) are pregnant r plan t becme pregnant. It is nt knwn if levflxacin tablets will harm yur unbrn child. are breastfeeding r plan t breast-feed. It is nt knwn if l evflxacin passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will take levflxacin tablets r breast-feed. Yu shuld nt d bth. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. Levflxacin tablets and ther medicines can affect each ther causing side effects. Especially tell yur healthcare prvider if yu take:

5 a sterid medicine an anti-psychtic medicine a tricyclic antidepressant a water pill (diuretic) certain medicines may keep levflxacin tablets frm wrking crrectly. Take levflxacin tablets either 2 hurs befre r 2 hurs after taking these medicines r supplements: an antacid, multivitamin, r ther medicines r supplements that have magnesium, aluminum, irn, r zinc sucralfate (Carafate ) didansine (Videx, Videx EC) a bld thinner (warfarin, Cumadin, Jantven) an ral anti-diabetes medicine r insulin an NSAID (Nn-Steridal Anti-Inflammatry Drug). Many cmmn medicines fr pain relief are NSAIDs. Taking an NSAID while yu take levflxacin tablets r ther flurquinlnes may increase yur risk f central nervus system effects and seizures. thephylline (The-24, Elixphyllin, Thechrn, Uniphyl, Thelair ) a medicine t cntrl yur heart rate r rhythm (antiarrhythmics) Ask yur healthcare prvider if yu are nt sure if any f yur medicines are listed abve. Knw the medicines yu take. Keep a list f yur medicines and shw it t yur healthcare prvider and pharmacist when yu get a new medicine. Hw shuld I take levflxacin tablets? Take levflxacin tablets exactly as yur healthcare prvider tells yu t take it. Take levflxacin tablets at abut the same time each day. Drink plenty f fluids while yu take levflxacin tablets. Levflxacin tablets can be taken with r withut fd. If yu miss a dse f levflxacin tablets, take it as sn as yu remember. D nt take mre than 1 dse in 1 day. D nt skip any dses f levflxacin tablets r stp taking it, even if yu begin t feel better, until yu finish yur prescribed treatment unless: yu have tendn prblems. See What is the mst imprtant infrmatin I shuld knw abut levflxacin tablets? yu have a nerve prblem. See What are the pssible side effects f levflxacin tablets?. yu have a central nervus sytem prblem. See What are the pssible side effects f levflxacin tablets?."

6 yu have a serius allergic reactin. see What are the pssible side effects f levflxacin tablets? yur healthcare prvider tells yu t stp taking levflxacin tablets Taking all f yur levflxacin tablets dses will help make sure that all f the bacteria are killed. Taking all f yur levflxacin tablets dses will help yu lwer the chance that the bacteria will becme resistant t levflxacin tablets. If yur infectin des nt get better while yu take levflxacin tablets, it may mean that the bacteria causing yur infectin may be resistant t levflxacin tablets. If yur infectin des nt get better, call yur healthcare prvider. If yur infectin des nt get better, levflxacin tablets and ther similar antibitic medicines may nt wrk fr yu in the future. If yu take t much levflxacin tablets, call yur healthcare prvider r get medical help right away. What shuld I avid while taking levflxacin tablets? Levflxacin tablets can make yu feel dizzy and lightheaded. D nt drive, perate machinery, r d ther activities that require mental alertness r crdinatin until yu knw hw levflxacin tablets affects yu. Avid sunlamps, tanning beds, and try t limit yur time in the sun. Levflxacin tablets can make yur skin sensitive t the sun (phtsensitivity) and the light frm sunlamps and tanning beds. Yu culd get severe sunburn, blisters r swelling f yur skin. If yu get any f these symptms while yu take levflxacin tablets, call yur healthcare prvider right away. Yu shuld use a sunscreen and wear a hat and clthes that cver yur skin if yu have t be in sunlight. What are the pssible side effects f levflxacin tablets? Levflxacin tablets can cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut levflxacin tablets? Serius allergic reactins. Allergic reactins can happen in peple taking flurquinlnes, including levflxacin tablets, even after nly 1 dse. Stp taking levflxacin tablets and get emergency medical help right away if yu have any f the fllwing symptms f a severe allergic reactin: hives truble breathing r swallwing swelling f the lips, tngue, face thrat tightness, harseness rapid heartbeat faint skin rash

7 Skin rash may happen in peple taking levflxacin tablets, even after nly 1 dse. Stp taking levflxacin tablets at the first sign f a skin rash and immediately call yur healthcare prvider. Skin rash may be a sign f a mre serius reactin t levflxacin tablets. Liver damage (hepattxicity): Hepattxicity can happen in peple wh take levflxacin tablets. Call yur healthcare prvider right away if yu have unexplained symptms such as: nausea r vmiting stmach pain fever weakness abdminal pain r tenderness itching unusual tiredness lss f appetite light clred bwel mvements dark clred urine yellwing f yur skin r the whites f yur eyes. Stp taking levflxacin tablets and tell yur healthcare prvider right away if yu have yellwing f yur skin r white part f yur eyes, r if yu have dark urine. These can be signs f a serius reactin t levflxacin tablets (a liver prblem). Intestine infectin (Pseudmembranus clitis) Pseudmembranus clitis can happen with many antibitics, including levflxacin tablets. Call yur healthcare prvider right away if yu get watery diarrhea, diarrhea that des nt g away, r bldy stls. Yu may have stmach cramps and a fever. Pseudmembranus clitis can happen 2 r mre mnths after yu have finished yur antibitic. Serius heart rhythm changes (QT prlngatin and trsades de pintes) Tell yur healthcare prvider right away if yu have a change in yur heart beat (a fast r irregular heartbeat), r if yu faint. Levflxacin tablets may cause a rare heart prblem knwn as prlngatin f the QT interval. This cnditin can cause an abnrmal heartbeat and can be very dangerus. The chances f this happening are higher in peple:

8 wh are elderly with a family histry f prlnged QT interval with lw bld ptassium (hypkalemia) wh take certain medicines t cntrl heart rhythm (antiarrhythmics) Jint Prblems Increased chance f prblems with jints and tissues arund jints in children can happen. Tell yur child s healthcare prvider if yur child has any jint prblems during r after treatment with levflxacin tablets. Changes in bld sugar Peple wh take levflxacin tablets and ther flurquinlne medicines with ral antidiabetes medicines r with insulin can get lw bld sugar (hypglycemia) and high bld sugar (hyperglycemia). Fllw yur healthcare prvider s instructins fr hw ften t check yur bld sugar. If yu have diabetes and yu get lw bld sugar while taking levflxacin tablets, stp taking levflxacin tablets and call yur healthcare prvider right away. Yur antibitic medicine may need t be changed. Sensitivity t sunlight (phtsensitivity) See What shuld I avid while taking levflxacin tablets? The mst cmmn side effects f levflxacin tablets include: nausea headache diarrhea insmnia cnstipatin dizziness In children 6 mnths and lder wh take levflxacin tablets t treat anthrax disease r plague, vmiting is als cmmn. Levflxacin tablets may cause false-psitive urine screening results fr piates when testing is dne with sme cmmercially available kits. A psitive result shuld be cnfirmed using a mre specific test. These are nt all the pssible side effects f levflxacin tablets. Tell yur healthcare prvider abut any side effect that bthers yu r that des nt g away.

9 Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre levflxacin tablets? Stre levflxacin film-cated tablet at 20 t 25 C (68 t 77 ); excursins permitted t 15 t 30 C (59 t 86 F) [see USP Cntrlled Rm Temperature]. Keep levflxacin tablets in a tightly clsed cntainer. Keep levflxacin tablets and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f levflxacin tablets Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use levflxacin tablets fr a cnditin fr which it is nt prescribed. D nt give levflxacin tablets t ther peple, even if they have the same symptms that yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut levflxacin tablets. If yu wuld like mre infrmatin abut levflxacin tablets, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut levflxacin tablets that is written fr healthcare prfessinals. Fr mre infrmatin g t r call What are the ingredients in levflxacin tablets? Active ingredient: levflxacin, USP. Inactive ingredients: crspvidne, hyprmellse, magnesium stearate, micrcrystalline cellulse, plyethylene glycl, plysrbate 80 and titanium dixide. 250 mg & 500 mg levflxacin film-cated tablets als cntain ferric xide red and ferric xide yellw. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Trade marks are prperty f their respective wner.

10 Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad , Dist. Mehsana, INDIA. Fr: TORRENT PHARMA INC., 150 Allen Rad, Suite 102, Basking Ridge, NJ Revised: April 2018