MEDICATION GUIDE

Levetiracetam Oral Solution, USP

Read t his Me dicati on G ui de be fore y ou sta rt ta ki ng Levetiracetam Oral Solution, USP a nd ea ch ti me you get a r e fill. The re m ay be new i nformati o n. This i n f ormati on does not ta ke t he place of tal k i ng to y our healt hca re pr o vi der a bout your me dical c o nditi on or t reat me nt.

Wh at is the m o st imp or tant in form ati on I sh ould kn ow ab out Levetiracetam Oral Solution, USP?

Like other an tiepilep tic dr u g s, Levetiracetam Oral Solution, USP m ay c au se suicid al th ou g h ts or ac ti ons in a very sm all number of pe ople, ab out 1 in 500 pe ople taking i t.

C all a he al thc are pr ovider r i ght aw ay if you h ave any of the se s ymp to m s, e speci ally if they are new, w or se, or w or ry you:

• t houghts a b out s uici de or d yi ng

• atte mpts to c ommit s uici de

• new or w or se de pre ssi on

• new or w or se a nxiety

• feeli ng a gitated or re stle ss

• pa nic attac ks

• t rouble slee pi ng (i n s omnia)

• new or w or se i r rita bility

• acti ng a ggre ssi ve, be i ng a n g r y, or vi ole nt

• acti ng on da ng e rous i m p ul ses

• an e xt re me i n c rea se in acti v ity a nd tal ki ng (m a nia)

• ot her u nu s ual c h a nges in b e ha vi or or m o od

Do n ot s top Levetiracetam Oral Solution, USP wi th out fir st talking to a he al thc are pr ovide r.

• St oppi ng Levetiracetam Oral Solution, USP s udde n ly can c a u se se ri ous pr o ble m s. St oppi ng a seiz ure me dici ne su dde n ly can c a u se seiz ures t hat will not st op ( stat us e pile ptic u s ).

• S uici dal t hou g hts or acti ons can be ca u sed by t h i ngs ot her t han me dici ne s. If y ou h a ve suici dal t hou g hts or acti on s, y o ur healt hca re provi d er may c heck for ot her ca u se s.

How c an I w atch for e arly symp toms of suic id al th ou gh ts and ac ti on s?

• Pay atte nti on to a ny c h a nge s, e s pecially s udden c ha nge s, in mo o d, b e ha vi or s, t h ou g ht s, or feeli ng s.

• Keep all foll ow - up vi sits wi th yo ur healt hc a re p r ovi der as sc he dule d.

• Call your healt hca re pr o vi d er between vi sits as nee de d, e specially if you a re w o r ried a bo ut s ympt om s.

Wh at is Levetiracetam Oral Solution, USP?

Levetiracetam Oral Solution, USPis a pre sc ri pti on m e dici ne ta k en by m o uth t hat is u sed with ot her me dici nes to t reat:

• pa rtial on set seiz ures in pe ople 4 years of a ge a nd ol d er with e pile p sy

• myocl onic seiz ures in pe ople 12 ye a rs of a ge a nd ol der wi th j uve nile m yocl o nic e pile p sy

• pri ma ry ge ne ralized t oni c-c l onic seiz ures in pe o ple 6 yea rs of a ge a nd ol der with ce rtain t ypes of g e ne ralized e pile p s y.

It is not kno wn if Levetiracetam Oral Solution, USP is sa fe or e ffe cti ve in c hil dren u n der 1 mon th of a ge.

Be fore ta ki ng yo ur me dici ne, ma ke s ure y ou ha ve recei v ed t he c orrect me dici ne. C o m pa re t he na me a bove with t he na me on y our bottle a nd t he a ppea ra nce of y our m e dici ne with t he de sc ri p ti on of Levetiracetam Oral Solution, USP p r ovi d ed bel ow. Tell yo ur pha rmaci st i mme diately if y ou t hi nk y ou ha ve be en gi v en t he w r o ng m e dici ne.

Levetiracetam Oral Solution, USPis a clea r, c ol orle ss, gr a pe -fla v o red li qui d.

Who should not take Levetiracetam Oral solution ?

Do not take Levetiracetam oral solution if you are allergic to levetiracetam.

Wh at sh ould I tell my he al thc are pr ovider be fore s tar ti ng Levetiracetam Oral Solution, USP?

Be fore ta ki ng Levetiracetam Oral Solution, USP, tell yo ur healt hc are prov i der a b out all of y o ur me dical c onditi on s, i nc l udi ng if you:

• ha ve or ha ve had de pre ssi on, mood pr o ble ms or s uici dal t h oughts or be h a vi or

• ha ve ki d ney proble ms

• a re pre g na nt or pla n ni ng to bec ome pr e gna nt. It is not k n own if Levetiracetam Oral Solution, USP will ha rm yo ur u n bo rn ba b y. Y ou a nd your healt hca re prov i der will ha ve to deci de if y ou sh ould t a ke Levetiracetam Oral Solution, USP w hile you a re pr e gna nt. If y ou bec ome pre gn a nt w hile ta ki ng Levetiracetam Oral Solution, USP, talk to yo ur healt hca re pr o vi der a bout re gi ste ri ng with t he N orth A m e rican A ntie pile ptic D rug P re g na ncy Re gi st ry. Y ou can e n roll in t h is re gi st ry by calli ng 1- 8 88 - 2 3 3-2 3 34. T he p u rpo se of t his r e gi st ry is to c ollect i nformati on a b o ut t he sa fety of Levetiracetam Oral Solution, USP a nd ot her a ntie pile ptic me dici ne dur i ng p re gn a nc y.

• a re brea st fee di n g.  Levetiracetam  c an pa ss i n to yo ur milk a nd m ay ha rm y o ur ba b y. Y ou a nd y o ur healt h ca re pr o vi der s hould di sc u ss w het her y ou sh ould ta ke Levetiracetam Oral Solution, USP or brea st -fee d; you sh o uld not do bo t h.

Tell your healt hca re prov i der a bout all t he m e dici nes y ou t a ke, i ncl ud i ng p re sc ri pti on a nd non p re sc ri pti on m e dici ne s, vi ta mi n s, a nd he rbal s uppl e me nt s. Do n ot sta rt a new me dici ne wit h out fi r st tal ki ng with yo ur healt hca re prov i de r.

K now t he me dici nes y ou ta k e. Keep a li st of t hem to s how y our healt hc a re p r ovi d er a nd p ha rmaci st each ti me you get a new me dici ne.

How sh ould I take Levetiracetam Oral Solution, USP?

Ta ke Levetiracetam Oral Solution, USP e xactly as p re sc ri be d.

• Y our healt hc a re p r ovi der will tell you h ow much Levetiracetam Oral Solution, USP to ta ke a nd w hen to ta ke it. Levetiracetam Oral Solution, USP is u s ually ta ken twice a da y. Ta ke Levetiracetam Oral Solution, USP at t he sa me ti mes each d a y.

• Y our healt hc a re p r ovi der m ay c ha n ge y o ur d o se. Do n ot c ha nge y our do se wit hout tal ki ng to y o ur healt hca re p rovi d e r.

• Ta ke Levetiracetam Oral Solution, USP with or wit h out f o od.

• If y o ur healt hc a re p r ovi d er has pre sc ri bed Levetiracetam Oral Solution, USP, be s ure to a sk y our pha rmaci st f or a me dici ne dr o pper or me dici ne c up to help y ou me a s ure t he c o r rect a mo u nt of Levetiracetam Oral Solution, USP. Do n ot u se a h o u se hold tea s p o on. A sk your pha rmaci st for i n st ructi ons on how to u se t he mea s uri ng de v ice t he ri ght wa y.

• If y ou mi ss a do se of Levetiracetam Oral Solution, USP, ta ke it as s oon as you re me m be r. If it is al mo st ti me for y our ne xt d o s e, j u st s kip t he mi ssed do se. Ta ke t he ne xt dose at your r e gular ti me. Do n ot take two d o ses at the s ame time.

• If y ou ta ke t oo mu ch Levetiracetam Oral Solution, USP, call yo ur l ocal P oi s on C ont rol Ce nter or go to t he nea re st e me rg e ncy r oom ri g ht awa y.

Wh at sh ould I avoid while taking Levetiracetam Oral Solution, USP?

Do not d ri ve, o pe rate ma c hi n e ry or do ot her da nge r ous acti vities until you k n ow how Levetiracetam Oral Solution, USP a ffects you. Levetiracetam Oral Solution, USP may ma ke you dizzy or slee py.

Wh at are the p o ssible s ide e ffec ts of Levetiracetam Oral Solution, USP?

See “ W hat is t he mo st i mporta nt i nfo r mati on I sh ould know a bout Levetiracetam Oral Solution, USP?”

Levetiracetam Oral Solution, USPc an ca u se se ri ous si de e ffect s.

Call your healt hca re pr o vi der ri ght away if you ha ve a ny of t he se s ympt om s:

• mood a nd b e ha vi or c ha n ges s uch as a ggre ssi on, a gitati o n, a nge r, a nxiet y, a pat hy, mo od swi ng s, de pre ssi on, h o stilit y, a nd i rrita bilit y. A few pe ople m ay get p s yc ho tic s ympt oms s uch as hall uci n ati ons ( seei ng or hea ri ng t hi ngs t hat a re really not t he r e ), del usi ons (fal se or st ra nge t h ou g hts or belie f s) a nd u n u s ual be h a vi or.

• e xt re me slee pi ne ss, ti re dne ss, a nd wea k ne ss

• proble ms with mu scle c o ord i nati on ( p roble ms wal ki ng a nd movi n g)

• allergic reactions such as swelling of the face, lips, eyes, tongue, and throat, trouble

swallowing or breathing, and hives.

• a s kin ra s h. Se ri ous s kin ra s hes can ha pp en a fter you sta rt ta ki ng Levetiracetam Oral Solution, USP. Th e re is no way to tell if a mild ra sh will bec ome a se ri ous reacti o n.

The mo st c om m on si de e f fects seen in pe o ple w ho ta ke Levetiracetam Oral Solution, USP i ncl ude:

• slee pi ne ss

• wea kne ss

• i nfecti on

• dizzi ne ss

The mo st c om m on si de e f fects seen in c hil dr en w ho t a ke Levetiracetam Oral Solution, USP i ncl u de, in a dditi on to t h o se li sted a bove:

• ti re dne ss

• acti ng a ggre ssi ve

• na sal c onge sti on

• dec rea sed a ppetite

• i rrita bility

The se si de e ffects can ha p pen at a ny ti me b ut ha p pen m ore o ften wit hin t he fi r st 4 wee ks of t reat me nt e xce pt for i nfecti o n.

Tell your healt hca re prov i der if you ha ve a ny si de e f fect t hat bot he rs y ou or t hat d oes not go awa y.

The se a re not all t he po ssi ble si de e ffects of Levetiracetam Oral Solution, USP. F or m ore i n forma ti on, a sk y our healt hca re p rov i der or pha rmaci st.

C all your d oc tor f or medic al ad vice ab out side e ffec t s. Y ou m ay rep ort side e ffec ts to FDA at 1 - 800 - FDA -10 8 8.

How sh ould I s tore Levetiracetam Oral Solution, USP?

• St ore Levetiracetam Oral Solution, USP at ro om te mpe ra t ure, 59 °F to 86°F (15°C to 30° C) aw ay from heat a nd li ght.

• Keep Levetiracetam Oral Solution, USP and all medic ines out of the re ach of children.

Gener al in form ati on ab out Levetiracetam OralSolution, USP.

Me dici nes a re s ometi mes pre sc ri bed f or p urpo ses ot h er t han t hose li sted in a Me dicati on G ui de. Do n ot u se Levetiracetam Oral Solution, USP for a c onditi on for w hich it w as not pre sc ri be d. Do n ot gi ve Levetiracetam Oral Solution, USP to ot her pe o ple, e ven if t hey ha ve t he sa me s ympt oms t hat y ou h a ve. It may ha rm t he m.

This Me dicati on G ui de s um ma rizes t he mo st i mporta nt i nf o rmati on a b out Levetiracetam Oral Solution, USP. If y ou w ould li ke more i nformati o n, talk with y our h ealt hca re pr o vi de r. Y ou can a sk your pha r maci st or healt hca re prov i der f or i n f ormati on a b out Levetiracetam Oral Solution, USP t h at is w ritten for health profe ssi onals.

Wh at are the in gredien ts of Levetiracetam Oral Solution, USP?

Levetiracetam Oral Solution, USPacti ve i ngre die nt: l e veti racetam

Inacti ve i n g re die nt s: ace s ul f a me pota ssi um, a rti ficial gr a pe fla vor, cit ric ac i d, gl yc e ri n, maltit ol s ol uti on, met hyl p a ra be n, monoa m moni um gl y c yrrhizi nate, pro p yl pa r a be n, puri fied wate r, s odi um cit rate.

Levetiracetam Oral Solution, USP d oes not c ontain lact o se or gl ut e n. Levetiracetam Oral Solution, USP does c ontain c a rb o hydrate s. T he li quid is dye -fre e.

Information on the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Rx Only

This Me dicati on G ui de has b een a pp r oved by t he US F ood a nd D r ug A dmi ni st rati on.

Manufactured by:
Lannett Company, Inc.
Carmel, NY 10512

Manufactured for:

Alembic Pharmaceuticals, Inc.
750 Route 202, Bridgewater, NJ 08807
USA

Re v. 09/19