Nuedexta
dextromethorphan hydrobromide, quinidine sulfate
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet.
What NUEDEXTA is and what it is used for
What you need to know before you take NUEDEXTA
How to take NUEDEXTA
Possible side effects
How to store NUEDEXTA
Contents of the pack and other information
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Dextromethorphan acts on the brain.
Quinidine increases the amount of dextromethorphan in your body, by blocking the breakdown of dextromethorphan by the liver.
NUEDEXTA can help reduce how often you have episodes of PBA.
if you are allergic to dextromethorphan, quinidine or any of the other ingredients of this medicine (listed in section 6).
if you have a history of low levels of blood cells caused by quinidine, quinine or mefloquine (this can cause a tendency to bleed or bruise more easily than normal)
if you have a history of a liver disease (hepatitis) caused by quinidine
if you have a history of a condition called lupus-like syndrome caused by quinidine (this can cause joint pains, skin rash, excessive skin sensitivity to sun and overall feeling of sickness).
if you are already taking medicines containing quinidine, quinine, or mefloquine. These are medicines used to treat malaria or heart rhythm problems.
if you have a heart problem called “complete heart block” or “long QT syndrome” or have had a problem with your heart called “torsades de pointes”.
if you take a medicine called thioridazine, which is used for mental illness but can also affect the heart.
if you are taking, or have taken during the last two weeks, certain medicines for depression called monoamine oxidase inhibitors (MAOIs), such as phenelzine and moclobemide.
Please ask your doctor if you are not sure, if any of the above applies to you.
TalktoyourdoctorbeforeandaftertakingNUEDEXTAif:
you or a family member currently have or have ever had any heart disease or problems. This medicine may cause changes in heart rhythm. If you have certain heart problems or are currently taking certain other medicines, NUEDEXTA may not be appropriate for you, or your doctor
may want to monitor your heart activity when you start NUEDEXTA.
you experience symptoms such as palpitations or fainting, which may be a sign of heart problems.
you develop symptoms of an allergic reaction such as swelling of the throat or tongue, difficulty breathing, dizziness, fever, rash, or hives after taking this medicine.
you experience symptoms such as bruising, bleeding under the skin, nosebleeds and/or bleeding gums, as this may be a sign of low levels of blood cells called platelets (thrombocytopenia).
you experience symptoms, such as yellowing of the skin or eyes, dark urine, nausea or vomiting, loss of appetite, abdominal pain, and fever, as this may be a sign of drug-induced
hepatitis (liver inflammation).
you have a condition called myasthenia gravis (an autoimmune neuromuscular disease that causes muscle weakness and fatigability).
you have problems with your liver or kidney. Depending on the severity of your problems, your doctor may carefully consider whether this medicine is suitable for you and monitor you more closely for potential side effects.
you have a tendency to have falls. This medicine may cause dizziness and your doctor might need to discuss appropriate precautions to reduce the risk of falls.
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you have had at any time a serious condition called “serotonin syndrome”, which can be caused by certain medicines e.g. antidepressants. Symptoms of serotonin syndrome include agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature,
excessive sweating, shivering, and tremor.
you have a history of drug abuse. Your doctor will monitor you closely for signs of NUEDEXTA misuse or abuse.
NUEDEXTA should not be used in children and adolescents below the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It isveryimportanttotellyourdoctorifyouaretakinganyofthemedicineslistedbelow,asthese medicinesshouldneverbetakenwhileyouaretakingNUEDEXTA:
medicines containing quinidine, quinine, or mefloquine. These are medicines used to treat malaria or heart rhythm problems,
thioridazine, a medicine used in the treatment of schizophrenia and psychosis, that may affect the heart,
certain medicines for depression, called monoamine oxidase inhibitors (MAOIs- for example phenelzine and moklobemide). Do not take NUEDEXTA if you have taken these
antidepressants during the last two weeks and allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
Pleasetellyourdoctorifyouaretakinganyofthefollowingmedicines,asyourdoctorwillclosely monitoryouforside effects.:
medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
medicines used to treat HIV infection and AIDS, such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, amprenavir, fosamprenavir
medicines used to treat bacterial infections, including tuberculosis, containing clarithromycin, telithromycin, erythromycin and rifampicin
medicines used to treat various heart conditions, such as diltiazem, verapamil, digoxin, flecainide and beta-blockers (such as metoprolol)
medicines used to prevent nausea and vomiting during chemotherapy and after surgery, such as aprepitant
certain medicines used to treat depression, including nortriptyline, desipramine, paroxetine imipramine and amitriptyline, nefazodone
St John's wort, a herbal medicine used to treat depression
medicines used to treat schizophrenia and other psychotic disorders, such as haloperidol, perphenazine, aripiprazole and chlorpromazine
certain medicines used to prevent blood clots in patients with heart conditions and at risk of stroke, such as ticagrelor and dabigatran-etexilate
tamoxifen, used to treat or prevent some cancers
atomoxetine, used to treat attention-deficit hyperactivity disorder (ADHD)
medicines to reduce pain and/or cough, such as codeine and hydrocodone
medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and phenobarbital
Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicine or NUEDEXTA.
Medicinal product no longer authorised
You should not drink grapefruit juice or eat grapefruits while you are taking NUEDEXTA as this can increase the likelihood of serious side effects.
Take care if you consume alcohol while you are taking NUEDEXTA as might increase the risk of side effects such as dizziness and sleepiness.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, or if
you are not using reliable contraception, ask your doctor for advice before taking this medicine.
As NUEDEXTA may cause harm to your unborn baby, its use is not recommended when you are pregnant or if you are a women of childbearing potential not using contraception. Your doctor will discuss with you the risks and benefits of using this medicine in these situations.
It is not known whether the active substances of NUEDEXTA are expressed into human milk. Your doctor will decide if you should take this medicine while breast-feeding.
NUEDEXTA may cause dizziness. If this happens to you, do not drive or use machines.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor
before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Startoftreatment(first4weeks):
Your doctor will start your treatment with NUEDEXTA 15 mg/9 mg capsules which should be taken by you as follows:
For the first seven days of treatment: one capsule per day, taken in the morning.
From the eighth day of treatment onwards: two capsules per day, one in the morning and one in the evening, 12 hours apart.
After4weeks:
Your doctor will assess you carefully. Depending on your response to the treatment, your doctor may either decide:
to continue the treatment with NUEDEXTA 15 mg/9 mg capsules, or
to give you a higher dose and to prescribe NUEDEXTA 23 mg/9 mg capsules to you.
Regardless of which strength of NUEDEXTA has been prescribed to you:
continue the treatment with: two capsules per day (one capsule every 12 hours).
Useinolderpersons
No special dose adjustment of NUEDEXTA is required in older patients.
HowtotakeNUEDEXTA
The capsule should be taken orally (by mouth) either with or without food at about the same time each day. When taking two capsules within 24 hours, you should leave about 12 hours between doses.
If you have taken more capsules than you should, speak to your doctor immediately.
Medicinal product no longer authorised
Adverse reactions observed with this medicine may occur more often or may worsen and your doctor may perform some test and monitor you more closely.
Symptoms of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, increased heart rate, hyperexcitability, and toxic psychosis. Other effects include loss of coordinated movement (ataxia), involuntary eye movements (nystagmus), over contraction of the muscles (dystonia), blurred vision, and changes in muscle reflexes. Dextromethorphan may increase the risk of serotonin syndrome (see Warnings and precautions and Possible side effects).
Symptoms of quinidine overdose include irregular heartbeat and low blood pressure, and may also include vomiting, diarrhoea, ringing in the ears, high-frequency hearing loss, vertigo, blurred vision, double vision, increased sensitivity of the eyes to light, headache, confusion, and delirium (characterised by loss of attention, poor memory, disorientation, impaired speech).
If you forget to take 1 or more capsules, you must not take a double dose to make up for the missed doses. Take your next dose at the usual time and make sure that approximately 12 hours passes
between two doses.
Do not stop taking this medicine without speaking to your doctor first, even if you begin to feel better. Stopping treatment may cause your symptoms to return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some side effects may be serious and require treatment.
Tell your doctor immediately if you experience severe symptoms including agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor. These may be a sign of a serious condition called “serotonin syndrome”.
Tell your doctor immediately if you notice any of the following:
excessive muscle stiffness (spasticity)
excessively slow or shallow breathing (respiratory depression) and/or turning blue.
The most commonly reported side effects are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
A list of all other side effects is provided below:
(may affect up to 1 in 10 people)
diarrhoea, nausea
dizziness, headache, drowsiness
fatigue
(may affect up to 1 in 100 people)
decreased appetite
anxiety
distorted sense of taste (dysgeusia), sleepiness (hypersomnia), muscle spasticity, fainting (syncope), fall
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travel or motion sickness, ringing in the ears (tinnitus)
heart problems, such as slow, fast or irregular heart beat, or altered results during an electrocardiogram (ECG – QT prolongation)
abdominal pain, constipation, dry mouth, wind (flatulence), stomach discomfort, vomiting
increased liver enzymes (GGT, AST, ALT)
rash
muscle spasms
weakness (asthenia), irritability
(may affect up to 1 in 1,000 people)
loss of appetite (anorexia)
teeth grinding (bruxism), confusion, depressed mood, depression, disorientation (e.g. difficulty sensing time, direction, and recognition of people and places), early morning awakening, reduced emotional expressiveness (flat affect), hallucination, impulsive behaviour, indifference, insomnia, restlessness, disturbed sleep
balance disorder, abnormal coordination, speech difficulties (dysarthria), movement dysfunction, pins and needles / tingling or numbness (paraesthesia), loss of feeling or function in the lower limbs (paraparesis), sedation
double vision, blurred vision
heart attack (myocardial infarction), heart palpitations
nose bleeds, throat pain, excessively slow or shallow breathing (respiratory depression), runny nose, yawning
abnormal faeces, indigestion, inflammation of the lining of the stomach (gastritis), numbness and abnormal sensation in the mouth, rectal pain, dry tongue
gall stones, increased bilirubin levels in the blood, abnormal liver function test
redness of the skin (erythema), excessive sweating (hyperhidrosis), loss of sensation or numbness of the face, night sweats
musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
abnormally frequent daytime urination
sexual dysfunction
chest discomfort, chest pain, chills, feeling hot, gait disturbance (difficulty walking), flu-like illness, fever, decreased oxygen levels in the blood
bone fractures (skeletal injury)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in AppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle, blister and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Medicinal product no longer authorised
The active substances are:
Each NUEDEXTA 15 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Each NUEDEXTA 23 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
The other ingredients are croscarmellose sodium, cellulose microcrystalline, silica colloidal, lactose monohydrate, magnesium stearate and gelatin, titanium dioxide (E171), red iron oxide (E172), printing ink (shellac glaze, propylene glycol, titanium dioxide (E171)).
Each bottle consists of high density polyethylene (HDPE) with a child resistant polypropylene cap and contains 60 hard capsules. Each bottle will be contained within a carton.
Only for NUEDEXTA 15 mg/9 mg: Blister packs consist of a PVC based clear film with aluminium foil seal and contains 13 hard capsules. Each blister is packed in a sleeve. This pack is intended to be used for the first 10 days of treatment.
Description:
NUEDEXTA 15 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
NUEDEXTA 23 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
United Kingdom
Medicinal product no longer authorised