Nitoman 25 mg Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Tetrabenazine

Pieejams no:

Valeant Pharma Poland sp. z o.o.

ATĶ kods:

N07XX; N07XX06

SNN (starptautisko nepatentēto nosaukumu):

Tetrabenazine

Deva:

25 milligram(s)

Zāļu forma:

Tablet

Ārstniecības joma:

Other nervous system drugs; tetrabenazine

Autorizācija statuss:

Marketed

Autorizācija datums:

2011-07-15

Lietošanas instrukcija

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
NITOMAN
®
25 MG TABLETS
TETRABENAZINE
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 of the side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. (See section 4).
WHAT IS IN THIS LEAFLET:
1.
What Nitoman is and what it is used for
2.
What you need to know before you take Nitoman
3.
How to take Nitoman
4.
Possible side effects
5.
How to store Nitoman
6.
Contents of the pack and other information
1.
WHAT NITOMAN IS AND WHAT IT IS USED FOR
Nitoman contains a substance called tetrabenazine. This affects some
of the chemicals that are
released by the nerves in the brain which helps to control jerky and
irregular movements of the body
(called chorea).
Nitoman is used for the treatment of jerky, irregular uncontrollable
movements that can be caused by
conditions such as Huntington’s chorea, senile chorea, and
hemiballismus.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITOMAN
Before you start taking Nitoman, please read the information given
below. If you think that any of
this information applies to you, or you are not sure, please tell your
doctor, nurse or pharmacist:
DO NOT TAKE NITOMAN :

If you are allergic to tetrabenazine or any of the other ingredients
of this medicine (listed in
section 6).

If you are actively suicidal (feel like killing yourself).

If you have been diagnosed as having depression that has been
untreated or difficult to
treat.

If you are breast-feeding.

If you are taking antidepressants which belong to the group of
medicines called
monoamine oxidase inhibitors or MAOIs, or have taken them at any t

Produkta apraksts

HealthProductsRegulatoryAuthority
27February2019
CRN008QWT
Page1of10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nitoman25mgTablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontains25mgofTetrabenazine.
Excipients:ContainsLactoseMonohydrate64mg
For thefull listof excipients,seesection6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellowish-buff,circular,bevel-edgedtabletshaving‘CL25’imprintedononefaceandasinglescorelineontheother.
Thetabletcanbedividedintoequalhalves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Inthecontrolofdisordersofmovementassociatedwithorganicdiseaseofthecentralnervoussystem,suchasHuntington's
chorea,hemiballismusandsenilechorea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Properdosingoftetrabenazineinvolvescarefultitrationoftherapytodetermineanindividualiseddoseforeachpatient.When
firstprescribed,tetrabenazinetherapyshouldbetitratedslowlyoverseveralweekstoallowtheidentificationofadosefor
chronicusethatreduceschoreaandiswelltolerated.
Dosageandadministrationarevariableandonlyaguideisgiven.Startingdosesshouldbe12.5mgto25mgperdayand
shouldbetitratedupslowlyevery4to7daystoallowidentificationofadosethatisefficaciousandwelltolerated.After
titrationisinitiated,thetotaldailydoseshouldbegivenintwotothreedivideddoses.Titrationcanbeupto200mgperday
ordose-limitingadverseevents,whicheverhappensfirst.Iftheadverseeventdoesnotresolve,afterdosereduction,�