XENAZINE 25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TETRABENAZINE

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

N07XX06

Pharmaceutical form:

TABLETS

Composition:

TETRABENAZINE 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

RECIPHARM FONTAINE, FRANCE

Therapeutic group:

TETRABENAZINE

Therapeutic area:

TETRABENAZINE

Therapeutic indications:

Movement disorders, associated with organic central nervous system conditions, e.g. Huntington's chorea, hemiballismus and senile chorea.Moderate to severe tardive dyskinesia, which is disabling and/or socially embarrassing. The condition should be persistent despite a switch to atypical antipsychotic medication and/or reduction in dosage of antipsychotic medication, when withdrawal of antipsychotic medication is not a realistic option.

Authorization date:

2014-11-30

Patient Information leaflet

Xenazine tab. PIL vr 01A
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
This medicine is dispensed by doctor
’s prescription only
XENAZINE
®
25 MG,
TABLETS
ACTIVE INGREDIENT: EACH TABLET CONTAINS: Tetrabenazine 25 mg
Inactive ingredients and allergens: see section
2, ‘Important information about some of this medicine’s
ingredients’
and section 6,
’
Additional information.
’
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have any further questions,
consult with your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar.
Xenazine 25 mg affects several chemical substances that are released
in the brain and help to control
abnormal and involuntary movements of the body.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Xenazine 25 mg is prescribed to treat diseases that cause sudden
uncontrollable abnormal movements,
such as Huntington's chorea, senile chorea, tardive dyskinesia and
hemiballismus.
THERAPEUTIC GROUP: medicines acting on the central nervous system.
2. BEFORE USING THIS MEDICINE
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING XENAZINE 25 MG, TELL YOUR DOCTOR IF:
•
You have been diagnosed with depression or have suicidal thoughts or
have attempted to commit
suicide.
•
You have had depression at any time.
•
You start showing angry or aggressive behavior.
•
You have a heart problem known as Long QT syndrome. Caution should be
exercised when using
tetrabenazine concomitantly with other medicines known to prolong QT
syndrome (listed under
‘Drug
interactions’
) and by patients with congenital QT syndromes and a history of
cardiac arrhythmias.
•
You have a recent history of chest pain or heart disease.
•
You have ever had hand tremors and jerky movements in your arms and
legs at any time, which is
known as Parkinson
’s disease

Summary of Product characteristics

Page
1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
TRADE NAME OF THE MEDICINAL PRODUCT
XENAZINE® 25 MG
2
.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg tetrabenazine.
Excipient: Each tablet also contains 64 mg of lactose monohydrate.
For a full list of excipients, see Section 6.1
.
3
.
PHARMACEUTICAL FORM
Tablet
Yellowish-buff, circular, bevel-
edged tablets with ‘CL25’ 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
Movement disorders, associated with organic central nervous system
conditions
,
e.g. Huntington's chorea, hemiballismus and senile chorea
.
Moderate to severe tardive dyskinesia, which is disabling and/or
socially
embarrassing. The condition should be persistent despite a switch to
atypical
antipsychotic medication and/or reduction in dosage of antipsychotic
medication,
when withdrawal of antipsychotic medication is not a realistic option
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets are for oral administration
.
Organic Central Nervous System Movement Disorders
Adults
Dosage and administration are variable and only a guide is given. An
initial starting
dose of 25 mg three times a day is recommended. This can be increased
by 25 mg a
day every three or four days until 200 mg a day is being given or the
limit of tolerance,
as dictated by unwanted effects, is reached, whichever is the lower
dose
.
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
.
Tardive Dyskinesia
Recommended starting dose of 12.5 mg a day, subsequently titrated
according to
response. Medication should be discontinued if there is no clear
benefit or if the side-
effects cannot be tolerated
.
The elderly
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2 of 12
No specific studies have been performed in the elderly, but
tetrabenazine has been
administered to elderly patients in standard dosage