APO-FLUOXETINE 20mg fluoxetine (as hydrochloride) 20 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluoxetine hydrochloride, Quantity: 22.35 mg (Equivalent: fluoxetine, Qty 20 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Fluoxetine hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: pregelatinised maize starch; Shellac; ethanol absolute; iron oxide black; butan-1-ol; isopropyl alcohol; propylene glycol; purified water; titanium dioxide; brilliant blue FCF; iron oxide yellow; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

PVC/PVdC/Aluminium blister pack of 28 (14'sx2) capsules in carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of Major depression. Treatment of Obsessive Compulsive Disorder. Treatment of 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 and relationships with others.

Product summary:

Visual Identification: Green/Off-white hard gelatin self locked capsules of size '2' imprinted with 'FLX' and 'MIL' on cap/body in black edible ink containing white powder.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 42 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-02-23

Patient Information leaflet

FLUOXETINE APOTEX CAPSULES
1
FLUOXETINE APOTEX
CAPSULES
_Fluoxetine (as fluoxetine hydrochloride) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about fluoxetine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Fluoxetine APOTEX. It contains the
active ingredient fluoxetine (as
fluoxetine hydrochloride).
Fluoxetine belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs).
Serotonin is one of the chemicals in
your brain which helps control your
mood. Fluoxetine and other SSRIs
are thought to help by increasing the
amount of serotonin in your brain.
Fluoxetine is used to treat:
•
depression
•
obsessive compulsive disorder
(OCD)
•
premenstrual dysphoric disorder
(PDD)
Depression is longer lasting and/or
more severe than the 'low moods'
everyone has from time to time due
to the stress of everyday life. It is
thought to be caused by a chemical
imbalance in parts of the brain. This
imbalance affects your whole body
and can cause emotional and physical
symptoms such as feeling low in
spirit, loss of interest in activities,
being unable to enjoy life, poor
appetite or overeating, disturbed
sleep, often waking up early, loss of
sex drive, lack of energy and feeling
guilty over nothing. Fluoxetine
corrects this chemical imbalance and
may help relieve the symptoms of
depression.
Check with your doctor if you need
more information about obsessive
compulsive disorder (OCD).
The symptoms of OCD vary from
patient to patient.
This medicine is not expected

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FLUOXETINE APOTEX (FLUOXETINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Fluoxetine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg fluoxetine (as hydrochloride).
For a full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Green/off-white hard gelatin, self-locked, size 2 capsule imprinted
with 'FLX' and 'MIL' on
cap/body in black edible ink, containing white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluoxetine is indicated for treatment of –
•
major depression
•
Obsessive Compulsive Disorder (OCD)
•
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 and
relationships with others.
4.2
DOSE AND METHOD OF ADMINISTRATION
_* This medicine is only available as a 20 mg capsule and therefore
only appropriate for use in _
_patients prescribed ≥ 20 mg fluoxetine. For patients requiring
treatment with lower doses of _
_fluoxetine, fluoxetine dispersible tablets are available in other
brands. _
This medicine is an antidepressant for oral administration; capsules
should be swallowed
whole.
DEPRESSION
A dose of 20 mg/day, administered in the morning, is the usual
recommended initial dose.
If no clinical improvement is observed, a dose increase may be
considered after several
weeks. Doses above 20 mg/da