FLUOXETINE RBX fluoxetine (as hydrochloride) 20mg capsules

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Fluoxetine hydrochloride

Disponible desde:

Generic Health Pty Ltd

Designación común internacional (DCI):

Fluoxetine hydrochloride

Información para el usuario

_ _
Fluoxetine RBX CMI V1 Nov 2010
1 of 4
FLUOXETINE RBX CAPSULES
FLUOXETINE (AS HYDROCHLORIDE) 20 MG
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fluoxetine RBX. It
does not contain all the available
information. It does not take the place
of talking with your doctor or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Fluoxetine RBX against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT FLUOXETINE RBX IS USED FOR
Fluoxetine RBX is used to treat:

depression

obsessive compulsive disorder
(OCD)

premenstrual dysphoric disorder
(PMDD)
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY FLUOXETINE
RBX HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Fluoxetine RBX for another reason.
Fluoxetine belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs). SSRIs are
thought to work by their action on
brain chemicals called amines which
are involved in controlling mood.
Fluoxetine RBX is available only with a
doctor's prescription.
Fluoxetine RBX is not recommended
for use in children and adolescents
under 18 years of age.
BEFORE YOU TAKE FLUOXETINE RBX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FLUOXETINE RBX IF YOU
ARE ALLERGIC TO

ANY MEDICINES CONTAINING
FLUOXETINE

ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE FLUOXETINE RBX IF YOU
ARE TAKING ANOTHER MEDICINE FOR
DEPRESSION CALLED A MONOAMINE
OXIDASE INHIBITOR (MAOI) OR HAVE
BEEN TAKING A MAOI WITHIN THE LAST
14 DAYS. CHECK WITH YOUR DOCTOR OR
PHARMACIST IF YOU ARE UNSURE AS TO
WHETHER OR NOT YOU ARE TAKING A
MAOI.
If

Ficha técnica

Fluoxetine RBX PI V1 Nov 2010
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FLUOXETINE RBX
NAME OF THE MEDICINE
Fluoxetine hydrochloride
Fluoxetine hydrochloride is an antidepressant for oral administration.
It is designated (±)-
_N_
-
methyl-3-phenyl-3-[(

,

,

-trifluoro-
_p_
-tolyl)-oxy]-propylamine hydrochloride, and has the
empirical formula of C
17
H
18
F
3
NO HCl. Its molecular weight is 345.79. The CAS number for
fluoxetine hydrochloride is 59333-67-4.
DESCRIPTION
Fluoxetine hydrochloride is a white to off-white crystalline solid
with a solubility of 14 mg/mL
in water.
Each capsule contains fluoxetine hydrochloride equivalent to 20 mg
(64.7

moles) of fluoxetine.
It also contains pregelatinised maize starch, gelatin, sodium lauryl
sulphate, Brilliant Blue FCF,
titanium dioxide, quinoline yellow and Allura Red AC.
PHARMACOLOGY
_Pharmacodynamics: _
The antidepressant and antiobsessional action of fluoxetine is
presumed to
be linked to its inhibition of CNS neuronal uptake of serotonin.
Studies at clinically relevant
doses in man have demonstrated that fluoxetine blocks the uptake of
serotonin, but not of
noradrenaline, into human platelets. Studies in animals also suggest
that fluoxetine is a much
more potent uptake inhibitor of serotonin than of noradrenaline.
Antagonism of muscarinic, histaminergic, and

1
-adrenergic receptors has been hypothesised to
be associated with various anticholinergic, sedative, and
cardiovascular effects of classical
tricyclic antidepressant drugs. Fluoxetine binds to these and other
membrane receptors from
brain tissue much less potently
_in vitro_
than do the tricyclic drugs.
_Pharmacokinetics_
_Absorption: _
In man, following a single oral 40 mg dose, peak plasma concentrations
of
fluoxetine from 15 to 55 ng/mL are observed after 6 to 8 hours.
Fluoxetine is 80 to 95%
absorbed following oral administration. There is a linear dose
proportionality for the absorption
of fluoxetine over the therapeutic dose range.
Food does not appear to affect the systemic bioavailability of
fluoxetine, although it