APO-QUETIAPINE XR quetiapine (as fumarate) 200mg modified release tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quetiapine fumarate

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Quetiapine fumarate

Authorization status:

Registered

Patient Information leaflet

APO-Quetiapine XR Tablet
1
APO-QUETIAPINE XR
_Contains the active ingredient Quetiapine (as fumarate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about APO-QUETIAPINE
XR. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
QUETIAPINE XR Tablet. It contains
the active ingredient quetiapine
fumarate.
It helps to correct chemical
imbalances in the brain. It is used to
treat conditions such as:
•
Bipolar disorder, an illness in
which there are sustained mood
swings either up (mania) or down
(depression). During mania,
patients experience episodes of
overactivity, elation or irritability.
During depression, patients may
feel depressed or guilty, lack
energy, lose their appetite and
have trouble sleeping.
•
Recurrent major depressive
disorder, an illness where
depression is longer lasting
and/or more severe than the "low
moods" everyone has from time
to time due to the stress of
everyday life. It is thought to be
caused by a chemical imbalance
in parts of the brain. This
imbalance affects your whole
body and can cause emotional
and physical symptoms such as
feeling low in spirit, loss of
interest in activities, being unable
to enjoy life, poor appetite or
overeating, disturbed sleep, often
waking up early, loss of sex
drive, lack of energy and feeling
guilty over nothing.
•
Generalised anxiety disorder,
where patients have excessive
anxiety and worry.
•
Schizophrenia, an illness with
disturbances in thinking, feelings
and behaviour.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
med

Summary of Product characteristics

1 APO-QUETIAPINE XR
quetiapine fumarate
PRODUCT INFORMATION
NAME OF THE MEDICINE
Quetiapine fumarate
Chemical Name:
Bis[2-(2-[4-(dibenzo[b,f][1,4]-thiazepin-11-yl)piperazin-1-yl] ethoxy)
ethanol]
fumarate.
The chemical structure of quetiapine fumarate is:
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 has
an aqueous solubility of 3.29 mg/mL at 25°C.
APO-QUETIAPINE XR 50 mg 200 mg, 300 mg and 400 mg are modified release
tablets which are
pink (50 mg), yellow (200 mg), light yellow (300 mg) or white (400 mg)
in colour. Each tablet
contains quetiapine fumarate equivalent to 50 mg, 200 mg, 300 mg or
400 mg of quetiapine free
base. The tablets also include the following excipients – lactose,
hypromellose, sodium chloride,
povidone, talc, magnesium stearate,
microcrystalline cellulose (50mg), Opadry II 85F540003 Pink
– PI no. 109248 (50mg),
Opadry 03B52117 Yellow – PI No. 106712 (200mg), Opadry 03B82929
Yellow – PI No. 106295 (300mg) and Opadry 03B58900 White- PI No.
106176 (400mg). APO-
QUETIAPINE XR tablets do not contain gluten.
2
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
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 compared to typical antipsychotics.
Quetiapine has no affinity for the
norepinephrine transporter (NET) and low affinity for the serotonin
5HT
1A
receptor, whereas
norqu