FLUOTEX 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

1
FLUOTEX
20MG CAPSULES
_fluoxetine hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Fluotex. 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
Fluotex 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 FLUOTEX IS USED FOR
Fluotex is used to treat:
•
depression
•
obsessive compulsive
disorder (OCD)
•
premenstrual
dysphoric disorder
(PMDD)
ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS
ABOUT WHY FLUOTEX HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed Fluotex for
another reason.
Fluotex 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.
Fluotex is available only
with a doctor's
prescription.
Fluotex is not
recommended for use in
children and adolescents
under 18 years of age.
BEFORE YOU TAKE FLUOTEX
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE FLUOTEX 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 FLUOTEX 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 Fluotex
while you are taking a
MAOI, you may
experience shaking
(tremor), shivering,
muscle stiffness, fever,
rap

Summary of Product characteristics

1
AUSTRALIAN
PRODUCT
INFORMATION
–
FLUOTEX
(FLUOXETINE
HYDROCHLORIDE) CAPSULES
1
NAME OF THE MEDICINE
Fluoxetine Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each FLUOTEX capsule contains fluoxetine hydrochloride equivalent to
20 mg of fluoxetine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FLUOTEX 20MG CAPSULES: 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.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
_*FLUOTEX is only available as a 20 mg capsule and therefore only
appropriate for use in patients _
_prescribed ≥ 20 mg of fluoxetine. For patients requiring treatment
with lower strengths of fluoxetine, _
_fluoxetine dispersible tablets are available from other brands.
FLUOTEX 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/day s