Consumer Brief Summary Information
NUEDEXTA® (new-DEX-tuh)
(generic name = dextromethorphan hydrobromide and
quinidine sulfate) Capsules
Read this patient information carefully before you start taking NUEDEXTA.
This sheet does not replace talking with your doctor. If you have any
questions, ask your doctor or pharmacist.
What is NUEDEXTA?
s;;; .5%$%84!;IS;A;PRESCRIPTION;MEDICINE;APPROVED;TO;TREAT;PSEUDOBULBAR;
affect (PBA).
s;;; 0"!;IS;A;MEDICAL;CONDITION;THAT;CAN;OCCUR;IN;PATIENTS;WITH;CERTAIN;NERVOUS;
system diseases or brain injuries, and causes sudden, frequent, and
involuntary episodes of crying and/or laughing.
s;;; .5%$%84!;CAN;HELP;TO;REDUCE;INVOLUNTAR Y;EPISODES;OF;CRYING;AND;OR;
laughing.
You should not take NUEDEXTA if you…
s;;; !RE;TAKING;OTHER;DRUGS;THAT;CONTAIN;QUINIDINE;;QUININE;;OR;MEmOQUINE;
s;;; (AVE;A;HISTORY;OF;HYPERSENSITIVITY;REACTIONS;TO;QUINIDINE;;QUININE;;OR;
MEmOQUINE;;
s;;; !RE;TAKING;DRUGS;THAT;INTERACT;WITH;.5%$%84!;AND;CAUSE;CHANGES;IN;HEART;
rhythm (such as thioridazine or pimozide).
s;;; !RE;TAKING;;OR;HAVE;TAKEN;;DRUGS;CALLED;MONOAMINE;OXIDASE;INHIBITORS;
(MAOIs) in the past 14 days. Wait at least 14 days after stopping
NUEDEXTA before you start taking an MAOI.
s;;; (AVE;EVER;HAD;LOW;WHITE;BLOOD;CELL;COUNTS;;HEPATITIS;;OR;A;DISEASE;
called lupus.
s;;; (AVE;EVER;BEEN;ALLERGIC;TO;DEXTROMETHORPHAN;;COMMONLY;FOUND;IN;SOME;
cough medicines).
s;;; /R;YOUR;FAMILY;HAVE;CERTAIN;HEART;PROBLEMS;INCLUDING;HEART;FAILURE;;AN;
abnormal heart rhythm (such as QTc prolongation), history of arrhythmia,
or complete AV (heart) block without a pacemaker.
NUEDEXTA may cause the following serious side effects:
s;;; !LLERGIC;REACTIONS;WITH;LIGHTHEADEDNESS;;CHILLS;;FEVER;;NAUSEA;;OR;VOMITING;;
Discontinue NUEDEXTA if these occur.
s;;; (EPATITIS;HAS;BEEN;SEEN;IN;PATIENTS;TAKING;QUINIDINE;;AN;INGREDIENT;IN;
NUEDEXTA. Discontinue if this occurs.
s;;; *OR;IRREGULAR;HEARTBEATS;;)F;YOU;HAVE;CERTAIN;HEART;CONDITIONS;OR;
are taking certain medicines, your doctor may test your heart rhythm
(heartbeats) before you start NUEDEXTA. Stop NUEDEXTA and tell your
doctor immediately if you feel faint or pass out.
s;;; )F;YOU;TAKE;ANTIDEPRESSANTS;KNOWN;AS;332)S;OR;TRICYCLICS;;YOU;MAY;HAVE;
confusion, high blood pressure, fever, restlessness, sweating, and
shivering. Tell your doctor if you experience any of these side effects.
s;;; 4ELL;YOUR;DOCTOR;IF;YOU;HAVE;EVER;BEEN;DIAGNOSED;WITH;MYASTHENIA;GRAVIS;;
Taking NUEDEXTA along with other medicines.
NUEDEXTA and certain other medicines can interact, causing serious side
effects, and may affect the way NUEDEXTA or these other medicines work:
s;;; 332)S;AND;TRICYCLIC;ANTIDEPRESSANTS;;9OUR;DOCTOR;MAY;ADJUST;THE;DOSE;OF;
these medicines if used together with NUEDEXTA.
s;;; )F;YOU;ARE;TAKING;CERTAIN;MEDICINES;;YOUR;DOCTOR;MAY;TEST;YOUR;HEART;
rhythm (heartbeats) before you start NUEDEXTA.
s;;; $IGOXIN;
s;;; !LCOHOL;;,IMIT;ALCOHOL;INTAKE;WHILE;TAKING;.5%$%84!;
These are not the only medicines that may cause problems when you take
NUEDEXTA. Be sure to tell your doctor about all medicines, supplements,
and vitamins that you take before starting NUEDEXTA. Before starting a
new medicine, remind your doctor if you are taking NUEDEXTA.
What are the most common side effects of NUEDEXTA?
Thirteen percent (13%) or less of patients reported:
s;;; $IZZINESS;;)F;YOU;ARE;UNSTEADY;ON;YOUR;FEET;OR;IF;YOU;HAVE;FALLEN;BEFORE;;
be careful while taking NUEDEXTA to avoid falling.
s;;; $IARRHEA;
s;;; #OUGH
s;;; 6OMITING
s;;; 7EAKNESS
s;;; 3WELLING;OF;FEET;AND;ANKLES
s;;; )NFECTION;IN;KIDNEYS;OR;BLADDER
s;;; 3YMPTOMS;OF;THE;mU
s;;; !BNORMAL;BLOOD;TESTS;OF;HOW;YOUR;LIVER;IS;WORKING;;
s;;; 0ASSING;GAS
These are not all of the possible side effects of NUEDEXTA. Tell your
doctor if you have any side effect that bothers you or does not go away.
How should I take NUEDEXTA?
s;;; 4AKE;.5%$%84!;EXACTLY;AS;YOUR;DOCTOR;PRESCRIBES;IT;;
s;;; ∨THE;lRST;;;DAYS;;TAKE;ONE;;;;;CAPSULE;AT;THE;SAME;TIME;EVER Y;;;;HOURS;
(a total of 1 capsule each day).
s;;; /N;DAY;;;AND;EVER Y;DAY;THEREAFTER;;TAKE;ONE;;;;;CAPSULE;EVERY;;;;HOURS;
;A;TOTAL;OF;;;CAPSULES;EACH;DAY;;
s;;; $O;NOT;TAKE;MORE;THAN;;;CAPSULES;IN;A;;;;HOUR;PERIOD;
s;;; )F;YOU;MISS;A;DOSE;OF;.5%$%84!;;do not take a double dose the next time.
Just take the single capsule at the next usual time.
s;;; .5%$%84!;MAY;BE;TAKEN;WITH;OR;WITHOUT;FOOD;
If your PBA symptoms do not improve or if they get worse, contact your
healthcare provider.
Do not give NUEDEXTA to other people, even if they have the same
symptoms that you have. It may harm them. In addition, the need for
treatment should be periodically reassessed as PBA symptoms may
spontaneously improve in some patients.
Store NUEDEXTA at room temperature.
Keep NUEDEXTA and all medicines out of reach of children and pets.
What are the ingredients in NUEDEXTA?
Active ingredients:;%ACH;BRICK;RED;GELATIN;CAPSULE;HAS;;;;MILLIGRAMS;OF;
DEXTROMETHORPHAN;HYDROBROMIDE;AND;;;;MILLIGRAMS;OF;QUINIDINE;SULFATE;
Inactive ingredients: #ROSCARMELLOSE;SODIUM;;MICROCRYSTALLINE;CELLULOSE;;
colloidal silicon dioxide, lactose monohydrate, and magnesium stearate.
This page gives you the most important but not all information about
NUEDEXTA.
s;;; )F;YOU;WOULD;LIKE;TO;KNOW;MORE;;TALK;WITH;YOUR;DOCTOR;OR;HEALTHCARE;
provider.
s;;; 9OU;CAN;ASK;YOUR;DOCTOR;OR;PHARMACIST;FOR;MORE;INFORMATION;ABOUT;
NUEDEXTA that is written for healthcare providers.
s;;; )F;YOU;WANT;MORE;INFORMATION;;GO;TO;WWW;.5%$%84!;COM;OR;CALL;
;;;;;;;.5%$% 8;;;;;;;;;;;;;;;;;;
9OU;ARE;ENCOURAGED;TO;REPORT;NEGATIVE;SIDE;EFFECTS;OF;PRESCRIPTION;DRUGS;
TO;THE;&$!;;6ISIT;WWW;FDA;GOV;MEDWATCH;OR;CALL;800-FDA-1088.
Marketed by Avanir®;0HARMACEUTICALS;;)NC;;;!LISO;6IEJO;;#!;;;;;;;
1-855-4NUEDEX (468-3339)
www.NUEDEXTA.com
NUEDEXTA and AVANIR are trademarks
of Avanir Pharmaceuticals, Inc.
Ú;;;;;;!VANIR;0HARMACEUTICALS;;)NC;
2EV;;$ATE;$ECEMBER;;;;;; .5%;;;;;;!$6;;;;;
