iNova TETRABENAZINE 25mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tetrabenazine, Quantity: 25 mg

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: purified talc; iron oxide yellow; maize starch; lactose monohydrate; magnesium stearate

Administration route:

Oral

Units in package:

112 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

May be useful for the control of chorea, hemiballismus, tardive and buccolingual dyskinesias and certain dystonic syndromes.

Product summary:

Visual Identification: cylindrical, biplanar tablet with bevelled edges, yellowish colour. upper face marked CL25, lower face single break bar.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-23

Patient Information leaflet

TETRABENAZINE
TABLETS
_Tetrabenazine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tetrabenazine
Tablets. It does not contain all the
available information. Reading this
leaflet does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your taking
Tetrabenazine Tablets against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING TETRABENAZINE TABLETS, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TETRABENAZINE
TABLETS ARE USED FOR
Tetrabenazine is used for the
treatment of diseases, which cause
jerky, irregular, uncontrollable
movements such as Huntington's
chorea, senile chorea and
hemiballismus.
Tetrabenazine affects some
chemicals in the brain, and by doing
so it helps to control jerky and
irregular movements.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
TETRABENAZINE TABLETS HAVE BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
Tetrabenazine Tablets for another
use.
Tetrabenazine Tablets are not
addictive.
Tetrabenazine Tablets are only
available on a doctor's prescription.
BEFORE YOU TAKE
TETRABENAZINE TABLETS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TETRABENAZINE TABLETS
IF YOU HAVE AN ALLERGY TO:
•
Any medicine containing
tetrabenazine.
•
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty breathing
•
Swelling of the face, lips, tongue
or other parts of the body
•
Rash, itching or hives on the skin.
DO NOT TAKE TETRABENAZINE TABLETS
IF YOU ARE ALSO TAKING:
•
Medicine containing reserpine.
•
Medicine containing levodopa
•
Medicine known as a monoamine
oxidase inhibitor or have taken
this medicine in the past 2 weeks.
Tetrabenazine can affect action of
these medicines.
DO NOT TAKE TETRABENAZINE TABLETS
IF YOU HAVE:
•
Parkinson's disease.
�

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – TETRABENAZINE TABLETS
1
NAME OF THE MEDICINE
Tetrabenazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg tetrabenazine.
Contains lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, uncoated.
A cylindrical, biplanar tablet with bevelled edges, yellowish colour.
upper face marked CL25, lower
face single break bar.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
May be useful for the control of chorea, hemiballismus, tardive and
buccolingual dyskinesias and
certain dystonic syndromes.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage given below is a guide only. For each patient, the dose of
tetrabenazine should be titrated to
determine the most appropriate dose. Treatment should be reassessed
periodically in the context of
the patient’s underlying condition and concomitant medications.
Adults
An initial dosage in adults of 25 mg twice a day is recommended. This
can be increased by 25 mg a day
every 3 or 4 days until the desired therapeutic effect is achieved, or
until 200 mg/day is given, or
unwanted side effects intervene.
Children
In children, 12.5 mg twice a day has been used as an initial dose with
increments of 12.5 mg every 3
to 4 days until the desired therapeutic effect is obtained, or an
upper limit of 3 mg/kg/day is reached,
or unwanted side effects intervene.
_Note._ Only very limited information on use in children is available.
Dosage may need to be reduced in patients with impaired renal or
hepatic function or in elderly
patients.
2
It is reported that if no improvement is found after 7 to 10 days at
the maximum dose then it is unlikely
that a higher dose or a longer duration of therapy will benefit the
patient.
4.3
C
ONTRAINDICATIONS
Tetrabenazine should not be given closer than one day before or in
combination with levodopa or
reserpine as it blocks the action of these drugs, particularly the
central action.
Tetrabenazine should not be administered to persons with a known
sensitivity