Nuedexta
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
26-11-2014
Valmisteyhteenveto
(SPC)
26-11-2014
Julkisesta arviointikertomuksesta
(PAR)
02-07-2013
Aktiivinen ainesosa:
dextromethorphan, quinidine
Saatavilla:
Jenson Pharmaceutical Services Limited
ATC-koodi:
N07XX59
INN (Kansainvälinen yleisnimi):
dextromethorphan hydrobromide, quinidine sulfate
Terapeuttinen ryhmä:
Other nervous system drugs
Terapeuttinen alue:
Neurobehavioral Manifestations
Käyttöaiheet:
Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.
Tuoteyhteenveto:
Revision: 2
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2013-06-24
Pakkausseloste
48
B. PACKAGE LEAFLET
Medicinal product no longer authorised
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUEDEXTA 15 MG/9 MG HARD CAPSULES
NUEDEXTA 23 MG/9 MG HARD CAPSULES
dextromethorphan / quinidine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 IS IN THIS LEAFLET
1.
What NUEDEXTA is and what it is used for
2.
What you need to know before you take NUEDEXTA
3.
How to take NUEDEXTA
4.
Possible side effects
5.
How to store NUEDEXTA
6.
Contents of the pack and other information
1.
WHAT NUEDEXTA IS AND WHAT IT IS USED FOR
NUEDEXTA IS a combination of two active substances:
Dextromethorphan acts on the brain.
Quinidine increases the amount of dextromethorphan in your body, by
blocking the breakdown
of dextromethorphan by the liver.
NUEDEXTA IS USED FOR the treatment of pseudobulbar affect (PBA) in
adults. PBA is a neurological
condition characterized by involuntary and uncontrollable episodes of
laughing and/or crying, which
don’t match your emotional state or mood.
NUEDEXTA can help reduce how often you have episodes of PBA.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUEDEXTA
DO NOT TAKE NUEDEXTA
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
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
NUEDEXTA 15 mg/9 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dextromethorphan hydrobromide monohydrate,
equivalent to 15.41 mg
dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69
mg quinidine.
Excipient with known effect:
Each hard capsule contains 119.1 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in
white ink on the capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar
affect (PBA) in adults (see
section 4.4). Efficacy has only been studied in patients with
underlying Amyotrophic Lateral Sclerosis
or Multiple Sclerosis (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is NUEDEXTA 15 mg/9 mg once daily. The
recommended dose
titration schedule is outlined below:
Week 1 (day 1-7):
The patient should take one NUEDEXTA 15 mg/9 mg capsule once daily, in
the morning, for
the initial 7 days.
Weeks 2-4 (day 8-28):
The patient should take one NUEDEXTA 15 mg/9 mg capsule, two times per
day, one in the
morning and one in the evening, 12-hours apart, for 21 days.
From Week 4 on:
If the clinical response with NUEDEXTA 15 mg/9 mg is adequate, the
dose taken in weeks 2-4
should be continued.
Medicinal product no longer authorised
3
If the clinical response with NUEDEXTA 15 mg/9 mg is inadequate,
NUEDEXTA 23 mg/9 mg
should be prescribed, taken two times per day, one in the morning and
one in the evening, 12
hours apart.
The maximum daily dose from week 4 onwards is NUEDEXTA 23 mg/9 mg,
twice daily.
In case a dose is missed, patients should not take an additional dose,
but take the prescribed next dose
at the usual time. No more than 2 capsules should be taken in any
24-hour period, wit
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