QUETIAPINE RBX quetiapine (as fumarate) 200mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quetiapine fumarate, Quantity: 230.284 mg (Equivalent: quetiapine, Qty 200 mg)

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Quetiapine fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; povidone; sodium starch glycollate type A; magnesium stearate; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; macrogol 400

Administration route:

Oral

Units in package:

60, 20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Quetiapine RBX 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 DOSAGE AND ADMINISTRATION) = Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate Schizophrenia = Treatment of schizophrenia

Product summary:

Visual Identification: White, film-coated, round tablets debossed with 'Q5' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2011-03-11

Patient Information leaflet

QUETIAPINE RBX CMI V5
Page 1 of 12
QUETIAPINE RBX TABLETS
QUETIAPINE FUMARATE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
QUETIAPINE RBX
quetiapine tablets.
It does not contain all the available information.
It 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 you taking
QUETIAPINE RBX
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT QUETIAPINE RBX IS USED FOR
The
name of your medicine
is QUETIAPINE RBX. QUETIAPINE RBX
contains
the active ingredient
quetiapine. Quetiapine belongs to a group of
medicines called antipsychotics. It interacts with a large number of
molecules in the brain, helping to correct chemical imbalances which
may cause mental illness.
QUETIAPINE RBX IS USED TO TREAT MENTAL ILLNESSES SUCH AS:
•
Schizophrenia, an illness causing hallucinations (like hearing
unexplained voices), strange and frightening thoughts, changes in
how you act, and feelings of being lonely and confused.
•
Bipolar disorder, an illness resulting in sustained mood swings,
either feeling very high (mania) or low (depressions). During
mania, patients experience episodes of overactivity, elation or
irritability. During depression, patients may feel depressed,
guilty, lack of energy, appetite loss, and have trouble sleeping.
Your doctor may have prescribed
QUETIAPINE RBX
for another reason.
QUETIAPINE RBX CMI V5
Page 2 of 12
Ask your doctor if you have any questions about why
QUETIAPINE RBX
has
been prescribed for you.
QUETIAPINE RBX
is not addictive.
QUETIAPINE RBX
is available only with a doctor’s prescription.
BEFORE YOU TAKE QUETIAPINE RBX
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE QUETIAPINE RBX
•
IF YOU HAVE AN ALLERGY TO QUETIAPINE OR ANY OF THE INACTIVE
INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
Sympto

Summary of Product characteristics

QUETIAPINE RBX PI _V7
Page 1 of 32
PRODUCT INFORMATION
QUETIAPINE RBX
QUETIAPINE 25/100/150/200/300 MG TABLETS
NAME OF MEDICINE
Quetiapine fumarate
Structural formula:
Chemical Name:
Bis[2-(2-[4-(dibenzo[b,f][1,4]-thiazepin-11-yl)piperazin-1-yl]ethoxy)ethanol]
fumarate.
Quetiapine fumarate has no chiral centres and only one morphological
entity has been detected
throughout development.
CAS Number: 111974-72-2
DESCRIPTION
Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits
moderate pH-dependent
solubility (94.3 mg/mL to 2.37 mg/mL at pH values from 1 to 9) and
lypophilicity characteristics
(Log P) which vary with pH (0.45 in water, 1.37 at pH 5, 2.65 at pH 7
and 2.59 at pH 9).
Quetiapine fumarate displays good solid state stability, has an
aqueous solubility of 3.29 mg/mL
at 25°C and exhibits suitable tabletting properties when combined
with appropriate excipients.
Each
film-coated tablet of
QUETIAPINE RBX
contains
quetiapine fumarate equivalent to
quetiapine 25 mg, 100 mg, 150 mg, 200 mg or 300 mg, and the inactive
ingredients:
calcium
hydrogen phosphate, lactose, microcrystalline cellulose, povidone,
sodium starch glycollate type
A, magnesium stearate, hypromellose, titanium dioxide and macrogol
400. In addition, the 25
mg tablet contains iron oxide yellow, and the 100, 150, 200 and 300 mg
tablets contain purified
talc.
PHARMACOLOGY
MECHANISM OF ACTION
Quetiapine is an atypical antipsychotic agent. Quetiapine and the
human plasma metabolite,
norquetiapine, interact with a broad range of neurotransmitter
receptors. Quetiapine and
QUETIAPINE RBX PI _V7
Page 2 of 32
norquetiapine exhibit affinity for brain serotonin (5HT
2
) and dopamine D
1
and D
2
receptors; this
combination of receptor antagonism with a higher selectivity for 5HT
2
relative to D
2
receptors is
believed to contribute to the clinical antipsychotic properties and
low extrapyramidal side effects
(EPS) liability of quetiapine. Additionally, norquetiapine has high
affinity (higher than
quetiapine) for the noradrenaline transporter, 5HT
1