The format of this leaflet was determined by the
Ministry of Health and its content has been checked
and approved on December 2013
Patient leaflet in accordance with the pharmacists'
regulations (preparations) 1986
This medicine is to be supplied upon
physician’s prescription only
Nuedexta Capsules
Each tablet contains: Dextromethorphan
hydrobromide 20 mg and Quinidine sulfate 10 mg
Inactive ingredients: See section 6 “Additional
information” in this leaflet.
Read the entire leaflet carefully before you start
using this medicine. This leaflet contains summary
information about this medicine. If you have any further
questions, refer to the physician or the pharmacist.
This medicine has been prescribed for treating your
illness. Do not pass it on to others. It may harm them,
even if it seems to you that their illness is similar.
The medicine is not intended for children and
adolescents under the age of 18.
1. What is this medicine intended for?
Nuedexta is intended for the treatment of Pseudo
Bulbar Affect (PBA). A secondary effect to a variety
of neurological disorders, unrelated to each other,
characterized by involuntary, sudden and frequent
events of crying and/or laughing. PBA events are
characterized by their occurrence being unrelated to
the underlying mental state of the patient.
Therapeutic group: Medicinal products acting on the
nervous system.
2.Before using this medicine
Do not use this medicine:
• If you are allergic (hyper sensitive) to the active
ingredients or to any of the other ingredients
that this medicine contains (See section 6).
• In certain cases of cardiovascular disorders
and in patients with heart failure.
• If you have previously suffered from
thrombocytopenia due to the use of Nuedexta,
quinine, mefloquine or quinidine, hepatitis,
bone marrow suppression or lupus-like
symptoms.
• In combination with medicines containing
quinidine, quinine, mefloquine.
• In combination with monoamine oxidase
inhibitors or if you have taken medicines of the
monoamine oxidase inhibitor class within 14
days of preceding treatment. In addition, you
should wait 14 days after completion of the
treatment with Nuedexta prior to beginning
treatment with medicines of the monoamine
oxidase inhibitor class.
Do not use Nuedexta with medicines affecting the
heart (prolonging QT) and medicines metabolized
in the liver by the CYP2D6 enzyme, such as
thioridazine, pimozide.
Special warnings regarding to the use of the
medicine
Stop the treatment immediately if you develop
thrombocytopenia (a significant reduction in the
number of platelets, possible symptoms of which are:
dizziness, chills, fever, nausea and vomiting), which
may cause life threatening bleeding events, unless it is
clearly unrelated to the medicine.
Do not resume treatment if you have been previously
diagnosed with sensitivity to the medicine or with
thrombocytopenia due to using the medicine.
Hepatitis has been reported in patients treated with
quinidine (one of the ingredients of Nuedexta), and it
is manifested by fever, thrombocytopenia or additional
signs of hypersensitivity.
In certain cases (such as cardiovascular disorders),
you may be required to undergo an ECG follow up.
The medicine may cause dizziness. Beware of falls,
especially if you suffer from motor disorders while
walking or have a history of falls.
If used with agents of the selective serotonin reuptake
inhibitor (SSRI) class (such as fluoxetine) or tricyclic
antidepressants (such as clomipramine or imipramine),
“serotonin syndrome” may develop (activity resulting
from excessive level of serotonin in the central nervous
system), which causes changes in the mental state,
hypertension, restlessness, involuntary muscle
movements, hyperthermia, enhanced reflexes,
excessive sweating, tremor.
Pay attention to exacerbation of myasthenia gravis
(severe muscle weakness).
Before using this medicine, tell your physician if:
• You are pregnant or breastfeeding
• You suffer, or have suffered in the past from - Cardiovascular disorders
- Liver disorders
- Disorders of the kidney/ urinary system
- Nervous system disorders
• You suffer from motor disorders while walking or
have a history of falls
• You suffer from myasthenia gravis (severe muscle
weakness)
If you are taking or have recently taken other
medicines including non­- prescription medicines
and food supplements, tell the physician or the
pharmacist. Especially inform the physician or the
pharmacist if you are taking:
• Antidepressants of the selective serotonin
reuptake inhibitor (SSRI) class, such as fluoxetine,
paroxetine or tricyclic antidepressants (TCA),
such as clomipramine, imipramine or desipramine
(See “Special warnings regarding to the use of the
medicine”)
• Digoxin
• Atazanavir, clarithromycin, indinavir, itraconazole,
ketoconazole, nefazodone, nelfinavir, ritonavir,
saquinavir, telithromycin, amprenavir, aprepitant
• Diltiazem, erythromycin, fluconazole,
fosamprenavir, grapefruit juice, verapamil
• Codeine, hydrocodone
Using the medicine and food
Nuedexta may be taken regardless of food.
Using the medicine and alcohol consumption
Caution is required when drinking alcohol while taking
the medicine in combination with medicines affecting
the central nervous system.
Pregnancy and breastfeeding
Do not use the medicine without consulting a
physician prior to beginning treatment if you are
pregnant, or breastfeeding.
There is no information regarding the effect of
Nuedexta on fetal development in humans or possible
passage of the medicine into the breast milk.
Driving and using machines
Use of this medicine may cause dizziness, which
may affect the ability to drive and operate dangerous
machines. Do not drive or operate machines if you
have experienced these side effects.
Important information on some of the ingredients
of the medicine
This medicine contains lactose. If you are sensitive to
lactose, consult the physician.
Each capsule contains 126.80 mg lactose.
3.How should you use the medicine?
Always use according to the physician's instructions.
You should check with the physician or the pharmacist
if you are unsure. The dosage and treatment will be
determined only by the physician.
The recommended dose is: One capsule daily by
mouth for the first 7 days of the treatment.
From the eighth day of treatment, take 1 capsule every
12 hours. Do not take more than 2 capsules over a
period of 24 hours. Ensure an estimated interval of 12
hours between the doses.
Swallow the medicine with water.
There is no information regarding opening and
dispersing the capsule.
If you forgot to take the medicine at the scheduled
time, do not take a double dose. Take the next dose at
the usual time and consult the physician.
If you accidently have taken a higher dosage you
might experience nausea, dizziness and headache.
Heart rhythm disorders and reduced blood pressure.
You may experience vomiting, diarrhea, tinnitus (buzz
or ringing in the ears), hearing loss, vertigo (dizziness),
blurred vision, diplopia (double vision), photophobia,
headaches, confusion, hallucinations. In addition,
lightheadedness, coma, respiratory depression,
seizures, tachycardia, excessive emotionality,
psychosis (mental disorders), ataxia (lack of muscle
control), nystagmus (involuntary eye movements),
dystonia (prolonged muscle contraction), changes in
muscle reflexes.
If you have taken an overdose, or if a child has
accidentally swallowed the medicine, refer immediately
to a physician or to a hospital emergency room and
bring the medicine package with you.
If you stop taking the medicine, discuss the
consequences with the physician.
Do not take medicines in the dark! Check the label and
the dose each time you take a medicine. Wear glasses
if you need them.
4.Side effects
As with any medicine, use of Nuedexta may cause side
effects in some of the users. Do not be alarmed by
reading the list of side effects. You may not experience
any of them.
5.How to store the medicine?
• Avoid poisoning! This medicine and any other
medicine should be kept in a closed place out of
the reach of children and/or infants in order to
avoid poisoning. Do not induce vomiting without
an explicit instruction from the physician.
• Do not use the medicine after the expiry date (exp.
date) appearing on the package. The expiry date
refers to the last day of that month.
• Storage condition: Store at a temperature below
25˚C.
• Do not use the medicine for more than one month
after package opening.
• Store in the original package.
6.Additional information
• In addition to the active ingredients the medicine
also contains:
Croscarmellose sodium, Microcrystalline cellulose
PH-302, Lactose monohydrate 310, Colloidal
silicon dioxide, Magnesium stearate (non bovine).
• Each capsule contains 126.80 mg lactose.
• What does the medicine look like and what is the
content of the package:
A red – brick gelatin capsule, “DMQ/20-10” is
imprinted on the capsule in white ink.
The package contains 60 capsules.
• License holder: Medison Pharma Ltd., 10
Hashiloach St., P.O.B 7090
Petach Tikva
• Manufacturer: Patheon Inc. Whitby, Ontario L1N
5Z5, Canada
• This leaflet was checked and approved by the
Ministry of Health in: 12/13
• Registration number of the medicine in the
National Drug Registry of the Ministry of Health:
149-88-33554-00
Side effects requiring treatment discontinuation
In cases of thrombocytopenia (significant reduction of
platelet number), hypersensitivity, hepatitis, “serotonin
syndrome” (activity resulting from excessive level of
serotonin in the central nervous system), heart rhythm
disorders (see ”Special warnings regarding to the use
of the medicine” section).
Frequently occurring side effects
- Muscle spasms, respiratory failure, abdominal
pain, muscle weakness, dizziness, fall and muscle
contractions.
- Diarrhea, dizziness.
- Cough, vomiting, muscle weakness, peripheral
edema, urinary tract infection, flu.
- Increase in the level of gamma glutamyl
transferase (GGT) enzyme (used for evaluation of
liver function), flatulence.
Side effects of unknown frequency
Effects related to the medicine ingredient
dextromethorphan
- Somnolence, dizziness, irritability or restlessness,
nausea, vomiting and abdominal pain.
Effects related to the medicine ingredient quinidine
- Nausea, vomiting, diarrhea, headaches, tinnitus
(ringing in the ears), hearing loss, vertigo, reduced
hearing, dizziness, blurred vision, diplopia (double
vision), photophobia (increased sensitivity to light),
confusion and delirium.
- Convulsions, apprehension and ataxia.
- Depression, pupil dilation, color perception
disorder, night blindness, optic nerve inflammation,
reduced visual field, photosensitivity, keratopathy
(a band of calcium deposit across the cornea), and
abnormal skin pigmentation.
Uncommonly occurring side effects
Acute psychotic reactions
If any of the side effects gets worse, or when you suffer
from a side effect not mentioned in the leaflet, you
should consult the physician.
DOR-20503-0114-06
Eng