TETRABENAZINE SUN tetrabenazine 25 mg tablet bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

tetrabenazine, Quantity: 25 mg

Tersedia dari:

Sun Pharma ANZ Pty Ltd

Bentuk farmasi:

Tablet, uncoated

Komposisi:

Excipient Ingredients: lactose; maize starch; purified talc; magnesium stearate; iron oxide yellow; colloidal anhydrous silica; sodium starch glycollate type A

Rute administrasi :

Oral

Unit dalam paket:

112 tablets

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

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

Ringkasan produk:

Visual Identification: Yellow, circular, flat faced bevelled edge uncoated tablet, debossed with 179 on one side and scored on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-11-28

Selebaran informasi

1
TETRABENAZINE SUN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TETRABENAZINE SUN?
TETRABENAZINE SUN contains the active ingredient Tetrabenazine.
TETRABENAZINE SUN is used for the treatment of diseases,
which cause jerky, irregular, uncontrollable movements such as
Huntington's chorea, senile chorea and hemiballismus.
For more information, see Section 1. Why am I using TETRABENAZINE SUN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE THIS MEDICINE?
Do not use if you have ever had an allergic reaction to tetrabenazine
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR PLAN TO BECOME PREGNANT.
DO NOT TAKE TETRABENAZINE SUN IF YOU ARE PREGNANT OR BREASTFEEDING.
For more information, see Section 2. What should I know before I use
this medicine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TETRABENAZINE SUN and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE THIS MEDICINE?
The usual starting dose in adults is one tablet twice a day. This may
increase to a total of 200 mg (8 tablets) a day. More
instructions can be found in Section 4. How do I use this medicine? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING THIS MEDICINE?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
this medicine.
THINGS YOU
SHOULD NOT DO
Do not take TETRABENAZINE SUN if you are also taking medicines
containing reserpine, levodopa or
monoamine oxidase inhibitor. Do not take TETRABENAZINE SUN if you
have: Parkinson's disease,
Depression, Galactose intolerance, Lapp lactase deficiency or
glucose-galactose malabsorption.
TETRABENAZINE SUN tablets contain lactose.
DRIVING OR USING
MACHINES
This medicine may cause light-headedness,

Karakteristik produk

Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
TETRABENAZINE SUN (TETRABENAZINE) TABLETS
_ _
1.
NAME OF THE MEDICINE
Tetrabenazine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg tetrabenazine.
Excipients with known effects: Contains sugars as lactose.
For the full list of excipients, see Section 6.1
LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Tablet, uncoated.
Yellow, circular, flat faced beveled edge uncoated tablet debossed
with “179” on one side and
scored on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
May
be
useful
for
the
control
of
chorea,
hemiballismus,
tardive
and
buccolingual
dyskinesias and certain dystonic syndromes.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
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.
METHOD OF ADMINISTRATION
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 ADJUSTMENT IN:
Dosage may need to be reduced in patients with impaired renal or
hepatic function or in
elderly patients. It is reported that if no improvement is found after
7 to 10 days at the
Page 2 of 10
maximum dose then it is unlikely that a higher dose or a longer
duration of therapy will
benefit the patient.
4.3.
CONTRAINDICATIONS
Tetrabenazine should not be given closer than one day before or in
combination with
levodopa or reserpine as it blo