Prozac
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
Fluoxetine hydrochloride
Available from:
Eli Lilly Australia Pty Ltd
ATC code:
N06AB03
Dosage:
20 mg of fluoxetine as the active ingredient
Pharmaceutical form:
capsules and tablets
Administration route:
Oral
Units in package:
packs of 28
Class:
Medicine Registered
Therapeutic indications:
PROZAC is indicated for the treatment of: Major depression. Obsessive Compulsive Disorder. Premenstrual Dysphoric Disorder (PMDD)
Authorization status:
Registered medicine
Authorization date:
2010-06-01
Patient Information leaflet
PROZAC
®
_fluoxetine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROZAC. 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 PROZAC 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 PROZAC IS USED
FOR
PROZAC is used to treat:
•
depression
•
obsessive compulsive disorder
(OCD)
•
premenstrual dysphoric disorder
(PMDD)
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PROZAC HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
PROZAC for another reason.
PROZAC 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.
PROZAC is available only with a
doctor's prescription.
PROZAC is not recommended for
use in children and adolescents under
18 years of age.
BEFORE YOU TAKE
PROZAC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PROZAC 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 PROZAC 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 you do take PROZAC while you
are taking a MAOI, you may
experience shaking (tremor),
shivering, muscle stiffness, fever,
rapid pulse, rapid
Read the complete document
Summary of Product characteristics
prozac-pi-v9-09oct13
Page 1 of 18
PROZAC
®
Fluoxetine Hydrochloride
NAME OF THE MEDICINE
P ROZAC
®
(flu oxet in e h ydr och lor ide)
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 C17H18F3NO HCl. Its molecular weight is 345.79. The CAS number for
fluoxetine hydrochloride is 59333-67-4.
The structural formula is as follows:
DESCRIPTION
Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14mg/mL in
water.
Each PROZAC
®
capsule
contains fluoxetine hydrochloride equivalent to 20 mg (64.7 _µ_moles) of
fluoxetine. It also contains Patent Blue V CI42051, gelatin, iron oxide yellow CI77492,
dimethicone 350, maize starch, titanium dioxide and edible black ink.
Each PROZAC
®
TAB contains fluoxetine hydrochloride equivalent to 20 mg (64.7 _µ_moles) of
fluoxetine. It also contains microcrystalline cellulose, saccharin sodium, mannitol, sorbitol,
aniseed flavouring, peppermint flavouring, colloidal anhydrous silica, maize starch, sodium
stearylfumarate and crospovidone.
PROZAC
®
LIQUID contains fluoxetine hydrochloride equivalent to 20 mg/5mL (64.7 _µ_moles) of
fluoxetine. It also contains benzoic acid, sucrose, glycerol and a mint flavouring agent. _(Not _
_available in Australia) _
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
Read the complete document
