TEVATIAPINE XR quetiapine (as fumarate) 50 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quetiapine fumarate, Quantity: 57.5 mg

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

Quetiapine fumarate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; microcrystalline cellulose; sodium citrate; magnesium stearate; titanium dioxide; macrogol 400; iron oxide yellow; iron oxide red; iron oxide black; polysorbate 80

Administration route:

Oral

Units in package:

60 modified release tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Quetiapine Modified Release Tablets are indicated for:,Bipolar Disorder ? maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder ? treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate,Efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.,Schizophrenia Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy,Major Depressive Disorder Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies,Generalised Anxiety Disorder Treatment of generalised anxiety disorder (GAD)

Product summary:

Visual Identification: Quetiapine 50 mg Modified Release Tablets: Brown, biconvex oblong film-coated tablets, debossed 'Q50' on one side, plain on the other. Packed in blisters.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-07-14

Patient Information leaflet

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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 TEVATIAPINE XR?
TEVATIAPINE XR contains the active ingredient quetiapine fumarate.
TEVATIAPINE XR is used to help correct chemical
imbalances in the brain. It is used to treat conditions such as:
Bipolar disorder, recurrent major depressive disorder, generalised
anxiety disorder and schizophrenia. For more information, see Section
1. Why am I using TEVATIAPINE XR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TEVATIAPINE XR?
Do not use if you have ever had an allergic reaction to quetiapine 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 ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TEVATIAPINE XR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TEVATIAPINE XR 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 TEVATIAPINE XR?
•
Your doctor will tell you how many tablets you will need to take each
day and how long you need to take it. This depends on
your condition and whether or not you are taking any other medicines.
•
TEVATIAPINE XR should be taken once a day, at approximately the same
time each day. It should be swallowed whole with a
full glass of water. Do not split, chew or crush the tablets. It
should be taken without food.
More instructions can be found in Section 4. How do I use TEVATIAPINE
XR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TEVATIAPINE XR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TEVATIAPINE XR.
•
Call your doctor straight away if you have any suicidal thoughts or
ment

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION – TEVATIAPINE XR
(QUETIAPINE FUMARATE) MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TEVATIAPINE XR 50 mg, 150 mg, 200 mg, 300 mg and 400 mg tablet
contains quetiapine
fumarate equivalent to 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of
quetiapine free base
respectively.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablet, modified release.
TEVATIAPINE XR modified
release tablets 50 mg:
Brown, biconvex oblong film-coated tablets debossed “Q50” on one
side, plain on the other, in blister packs [PVC/Aclar] of 60s
TEVATIAPINE XR modified
release tablets 150 mg:
White, biconvex oblong film-coated tablets debossed “Q150” on one
side, plain on the other, in blister packs [PVC/Aclar] of 60s
TEVATIAPINE XR modified
release tablets 200 mg:
Yellow, biconvex oblong film-coated tablets debossed “Q200” on one
side, plain on the other, in blister packs [PVC/Aclar] of 60s
TEVATIAPINE XR modified
release tablets 300 mg:
Light yellow, biconvex oblong film-coated tablets debossed “Q300”
on one side, plain on the other, in blister packs [PVC/Aclar] of 60s
TEVATIAPINE XR modified
release tablets 400 mg:
White, biconvex oblong film-coated tablets debossed “Q400” on one
side, plain on the other, in blister packs [PVC/Aclar] of 60s
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Quetiapine modified release tablets are indicated for:
BIPOLAR DISORDER
•
Maintenance treatment of bipolar I disorder, as monotherapy or in
combination with lithium
or sodium valproate, for the prevention of relapse/recurrence of
manic, depressive or mixed
episodes
•
Treatment of depressive episodes associated with bipolar disorder (see
Section 4.2 DOSE
AND METHOD OF ADMINISTRATION)
•
Treatment of acute mania associated with bipolar I disorder as
monotherapy or in
combination with lithium or sodium valproate
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2
Efficacy of quetiapine modified release tablets in th