PROZAC TAB fluoxetine (as hydrochloride) 20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluoxetine hydrochloride

Available from:

Eli Lilly Australia Pty Ltd

Authorization status:

Registered

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 breathing or
con

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
vA13-18Jun21
SUPERSEDES: vA12-6May20
Page 1 of 23
PROZAC (FLUOXETINE HYDROCHLORIDE) TABLETS, CAPSULES AND
ORAL LIQUIDS
1.
NAME OF THE MEDICINE
Fluoxetine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROZAC TABLETS (_NOT AVAILABLE IN AUSTRALIA_)
Fluoxetine 20 mg (present as the hydrochloride).
Excipients with known effect: Prozac tablets contain saccharin.
PROZAC CAPSULES
Fluoxetine 20 mg fluoxetine (present as the hydrochloride).
PROZAC LIQUID (_NOT AVAILABLE IN AUSTRALIA_)
Fluoxetine 20 mg/5 mL (present as the hydrochloride).
Excipients with known effect: Prozac liquid contains sugars (as
sucrose) and benzoate.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
TABLETS
PROZAC 20 mg tablets are white, elongated, scored dispersible tablets
embossed with
“4400”.
CAPSULES
PROZAC 20 mg capsules have an opaque green cap and opaque yellow body.
Imprinted with
“Lilly 3105”.
LIQUID (_NOT AVAILABLE IN AUSTRALIA_)
PROZAC Liquid is a clear, colourless, mint flavoured oral solution
(M-5120).
vA13-18Jun21
SUPERSEDES: vA12-6May20
Page 2 of 23
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROZAC is indicated for the treatment of:
Major depression.
Obsessive Compulsive Disorder.
Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria.
The essential features of PMDD, according to the Diagnostic and
Statistical Manual-4th
edition (DSM-IV) include markedly depressed mood, anxiety or tension,
affective lability and
persistent anger or irritability. Other features include decreased
interest in usual activities,
difficulty concentrating, lack of energy, change in appetite or sleep
and feeling out of control.
Physical symptoms associated with PMDD include breast tenderness,
headache, joint and
muscle pain, bloating and weight gain. These symptoms occur regularly
during the luteal
phase and remit within a few days following onset of menses; the
disturbance markedly
interferes with work or school or with usual social activities