Nitoman 25 mg Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Tetrabenazine

Disponível em:

Lundbeck UK LLP

Código ATC:

N07XX; N07XX06

DCI (Denominação Comum Internacional):

Tetrabenazine

Dosagem:

25 milligram(s)

Forma farmacêutica:

Tablet

Tipo de prescrição:

Not applicable

Área terapêutica:

Other nervous system drugs; tetrabenazine

Status de autorização:

Marketed

Data de autorização:

1994-04-01

Folheto informativo - Bula

SERVICE PACKAGING
PROS NITOMAN 25 MG 112 COMP IE
607930A
Graphist: Denis Margueritte
Mockup Request Number:
BIOV0075
Item code
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170 x 428
16/08/18
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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 dia

Características técnicas

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, consideration should be given to withdrawing
tetrabenazine treatment.
If there is no improvement at the maximum dose in seven days, it is
unlikely that the compound will be of benefit to
the patient, either by increasing the dose or by extending the
duration of treatment.
_Discontinuation of Treatment with Tetrabenazine_
Discontinuation of tetrabenazine is associated with the return of
chorea (without significant worsening compared to
baseline). Other adverse reactions to sudden treatment