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AUSCAP ASPEN- Consumer Medicine Information
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AUSCAP ASPEN
_fluoxetine _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AUSCAP ASPEN. 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 AUSCAP ASPEN 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 AUSCAP ASPEN
IS USED FOR
AUSCAP ASPEN is used to treat:
depression
obsessive compulsive disorder
(OCD)
premenstrual dysphoric disorder
(PMDD)
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AUSCAP
ASPEN HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
AUSCAP ASPEN for another reason.
The active ingredient in AUSCAP
ASPEN is fluoxetine hydrochloride.
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.
AUSCAP ASPEN is available only with
a doctor's prescription.
AUSCAP ASPEN is not recommended
for use in children and adolescents
under 18 years of age.
BEFORE YOU TAKE
AUSCAP ASPEN
_ _
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE AUSCAP ASPEN IF YOU
ARE ALLERGIC TO
ANY MEDICINES CONTAINING
FLUOXETINE
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms
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AUSCAP ASPEN- Product Information
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PRODUCT INFORMATION
AUSCAP ASPEN
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
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