Apo-Fluvoxamine 50mg Tablets

Pajjiż: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

FLUVOXAMINE MALEATE

Disponibbli minn:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Isem Internazzjonali):

FLUVOXAMINE MALEATE

Unitajiet fil-pakkett:

100Tablet Tablets

Manifatturat minn:

APOTEX INC

Fuljett ta 'informazzjoni

APO-FLUVOXAMINE
Fluvoxamine maleate (50mg, 100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Apo-Fluvoxamine is used for
2.
How Apo-Fluvoxamine works
3.
Before you use Apo-Fluvoxamine
4.
How to use Apo-Fluvoxamine
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Fluvoxamine
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-FLUVOXAMINE_ _IS USED FOR
Apo-Fluvoxamine is intended for the
relief of symptoms of depression, or the
reduction of symptoms associated with
obsessive-compulsive disorder (OCD;
persistent, obsessive thoughts that make
you carry out repetitive behaviour).
HOW APO-FLUVOXAMINE_ _WORKS
Apo-Fluvoxamine contains the active
ingredient fluvoxamine. Apo-
Fluvoxamine belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs)
antidepressants.
Apo-Fluvoxamine is believed to work by
enhancing the availability of serotonin,
one of the chemical substances in the
brain. Depression and OCD have been
associated with a decrease in the flow of
serotonin between certain brain cells.
BEFORE YOU USE APO-FLUVOXAMINE_ _
-
_When you must not use it_
_ _
Do not use this product if you are
allergic to
_ _
fluvoxamine maleate, or any
other ingredients in this medication.
(See product description)
Do not take Apo-Fluvoxamine if you
are taking or have recently taken
medicines called monoamine oxidase
inhibitors (MAOIs, including
moclobemide) within the last 14 days.
Check with your doctor or pharmacist
if you are unsure as to whether or not
you are taking MAOI.
_ _
_ _
_ _
_ _
_ _
-
_Before you start to use it _
_ _
Before taking Apo-Fluoxamine your
doctor needs to know any other
medical condition that you may have
including :
•
a history of seizures
•
liver problems
•
kidney problems
•
heart problems or have had a recent
heart attack
•
diabetes
•
a history of bleeding disorders
•
a history of suicide-related events
•
a history of mania (uncontrollable
excitement tha

Karatteristiċi tal-prodott

APO‐FLUVOXAMINE
FLUVOXAMINE MALEATE TABLETS 50 MG
ANTIDEPRESSANT, ANTIOBSESSIONAL AGENT
PHARMACOLOGY
The antidepressant and antiobsessional actions of fluvoxamine
are believed to be related to its selective inhibition of presynaptic
serotonin reuptake in brain neurons.
There is minimum interference with noradrenergic processes, and
in common with several other specific inhibitors of
serotonin
uptake, fluvoxamine has very little _in vitro_ affinity for α1, α2,
β1,
dopamine
2
,
histamine
1
,
serotonin
1
,
serotonin
2
or
muscarinic
receptors.
Pharmacokinetics:
APO‐FLUVOXAMINE
is
entirely
absorbed
following oral administration. Maximum plasma concentrations
occur within 3‐8 hours of dosing.
After
a
single
dose
and
slightly
longer
(17‐22
hours)
during
repeated dosing, the mean plasma half‐life is approximately 13‐15
hours. Within 10‐14 days, steady‐state plasma levels are usually
achieved.
APO‐FLUVOXAMINE
goes
through
an
extensive
hepatic
conversion, mostly via oxidative demethylation, into at least 9
metabolites
which
are
excreted
by
the
kidneys.
The
two
key
metabolites showed insignificant pharmacological activity. _In vitro_
binding of APO‐FLUVOXAMINE to human plasma proteins is about
80%.
INDICATION
Major Depressive Episode. Obsessive
Compulsive Disorder.
RECOMMENDED DOSE
_Depression_
_ _
_Adults_: The recommended dose is 100 mg daily. Patients should
start on 50 or 100 mg, given as a single dose in the evening.
Dosage should be reviewed and adjusted if necessary within 3 to
4 weeks of initiation of therapy and thereafter as judged clinically
appropriate. Although there may be an increased potential for
undesirable effects at higher doses, if after some weeks on the
recommended dose insufficient response is seen some patients
may benefit from having their dose increased gradually up to a
maximum of 300 mg a day. Doses up to 150 mg can be given as a
single dose, preferably in the evening. It is advisable that a total
daily dose of more than 150 mg is given in 2 or 3 divided doses.
Dosage adju