KETIPINOR 25 MG FILM-COATED TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

QUETIAPINE FUMARATE

Available from:

ORION PHARMA (MY) SDN. BHD.

INN (International Name):

QUETIAPINE FUMARATE

Units in package:

60Tablet Tablets; 100Tablet Tablets; 10Tablet Tablets

Manufactured by:

ORION CORP

Patient Information leaflet

KETIPINOR FILM-COATED TABLET
Quetiapine (25mg, 100mg, 200mg)
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What Ketipinor is used
for
2.
Ho
w Ketipinor works
3.
Before you use Ketipinor
4.
Ho
w to use Ketipinor
5.
While you are using it
6.
Side e
ffects
7.
Storage and Disposal of Ketipinor
8.
Pr
oduct Descriptio
n
9.
Man
ufacturer and Prod
uct
Registration Holder
10.
Date of Revision
WHAT KETIPINOR IS USED FOR
Ketipinor can be used to treat several
illnesses, such as:
-
_acute mania episode_
(where yo
u
may feel very
excited,
elated,
ag
itated, enthusiastic or hyperactiv
e
or
have poor judgment including
being aggressive or disruptive)
_ass_
_ociated with bipolar_
_disorder_
(extreme mood swings ranging from
episodes of depression to ma
nia)
-
_Schi_
_zophrenia_
: where you may h
ear
or feel thi
ngs that are not ther
e,
b
elieve things that are not true
or
f
eel unusually suspicious, anxious
,
co
nfused, guilty, tense or depressed.
HOW KETIPINOR WORKS
Ketipinor contains a substance called
quetiapine. It belongs to a group of
medicines called antipsychotics. Illnesses
that affect the brain, such as psychotic
disorders may be caused by lack of
certain chemicals in the brain. Ketipinor
helps to put right this imbalance of
chemicals in certain parts of the brain –
mainly dopamine and serotonin.
BEFORE YOU USE KETIPINOR
-_ Wh_
_en you must not us_
_e it_
Do no
t take Ketipinor
-
if you are allergic (hypersensitiv
e) to
quetiapine or any of the other
ingredients of Ketipinor (see section
PRODUCT DESCRIPTION
)
-
if
you are taking any of th
e
following medicines:

some medicines for human
immunodeficiency virus (HIV)

azole me
dicines (for fungal
in
fections
)

erythrom
ycin or clarithromy
cin
(fo
r infections
)

nefaz
odone (for depression).
-
_Before you start to us_
_e it_
Talk
to your doctor before taking
Ketipinor if:

you, or someone in your family
,
have
or have had any heart
problems, for exam
ple heart
rhythm problems or if you are
t
aking any medicines that may

Summary of Product characteristics

133547-4
1. NAME OF THE MEDICINAL PRODUCT
KETIPINOR 25 MG FILM-COATED TABLET
KETIPINOR 100 MG FILM-COATED TABLET
KETIPINOR 200 MG FILM-COATED TABLET
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg tablet: Each fi lm-coated tablet contains quetiapine fumarate
equivalent to quetiapine 25 mg.
100 mg tablet: Each fi lm-coated tablet contains quetiapine fumarate
equivalent to quetiapine 100 mg.
200 mg tablet: Each fi lm-coated tablet contains quetiapine fumarate
equivalent to quetiapine 200 mg.
3. PHARMACEUTICAL DOSAGE FORM
Film-coated tablet.
25 mg tablet: Brown/dark pink, round, convex, fi lm-coated tablet,
diameter 6 mm.
100 mg tablet: Light yellow, round, convex, fi lm-coated tablet,
diameter 8 mm.
200 mg tablet: White, round, convex, fi lm-coated tablet, diameter 11
mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of schizophrenia
•
Treatment of acute manic episodes associated with bipolar 1 disorder,
as either monotherapy or adjunct
to lithium or divalproex.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Ketipinor can be administered with or without food.
Usual dose: Ketipinor should generally be administered with an initial
dose of 25 mg twice daily, with
increases in increments of 25 – 50 mg twice or thrice daily on the 2
nd
and 3
rd
day, as tolerated, to a target
range of 300 – 400 mg daily by the 4
th
day, given twice or thrice daily.
Further dosage adjustments, if indicated, should generally occur at
intervals of not less than 2 days, as steady
state for Ketipinor would not be achieved for approximately 1 – 2
days in the typical patient. When dosage
adjustments are necessary, dose increments/decrements of 25 – 50 mg
twice daily are recommended.
Antipsychotic effi cacy was demonstrated in a dose range of 150 –
750 mg/day. Although it has been
reported that doses more than 300 mg/day were not more effi cacious
than 300 mg/day dose, in some
cases, doses in the range of 400 – 500 mg/day appeared to be needed.
The safety of doses more than 800
mg/day has not been established.
Mainte