Fluox

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fluoxetine hydrochloride 22.36mg equivalent to fluoxetine 20 mg;  

Available from:

Viatris Limited

INN (International Name):

Fluoxetine hydrochloride 22.36 mg (equivalent to fluoxetine 20 mg)

Dosage:

20 mg

Pharmaceutical form:

Capsule

Composition:

Active: Fluoxetine hydrochloride 22.36mg equivalent to fluoxetine 20 mg   Excipient: Acid yellow 17 Brilliant blue FCF Colloidal silicon dioxide Erythrosine Gelatin Indigo carmine Lactose monohydrate Magnesium stearate Maize starch Purified talc Sodium laurilsulfate Titanium dioxide   Water

Units in package:

Blister pack, PVC/PVdC/Al, 30 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Union Quimico Farmaceutica SA (Uquifa SA)

Therapeutic indications:

- Depression and its associated anxiety

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 30 capsules - 36 months from date of manufacture stored at or below 25°C. ex Alphapharm Pty Ltd 48 months from date of manufacture stored at or below 25°C. ex McDermott Laboratories t/a Gerard Laboratories - Blister pack, PVC/PVdC/Al - 84 capsules - 36 months from date of manufacture stored at or below 25°C. ex Alphapharm - Blister pack, PVC/PVdC/Al - 90 capsules - 36 months from date of manufacture stored at or below 25°C. ex Alphapharm Pty Ltd 48 months from date of manufacture stored at or below 25°C. ex McDermott Laboratories t/a Gerard Laboratories

Authorization date:

1998-10-21

Patient Information leaflet

Page 1 of 6
NEW ZEALAND CONSUMER MEDICINE INFORMATION
FLUOX
_FLUOXETINE HYDROCHLORIDE CAPSULES 20 MG _
_FLUOXETINE HYDROCHLORIDE DISPERSIBLE TABLETS 20 MG _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking FLUOX.
This leaflet answers some common
questions about FLUOX.
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 taking FLUOX
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 THE
MEDICINE. You may need to read it
again.
WHAT FLUOX IS USED
FOR
FLUOX is used to treat depression
and the anxiety associated with
depression, in adults. This 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.
FLUOX is also used to treat bulimia
nervosa (eating disorder) and
obsessive-compulsive disorder
(OCD).
FLUOX may also be used to treat
pre-menstrual dysphoric disorder
(PMDD), a severe form of
premenstrual syndrome (PMS).
Your FLUOX capsules or
dispersible tablets contain fluoxetine
hydrochloride. They belong to a
group of medicines known as
selective serotonin reuptake
inhibitors (SSRIs).
SSRIs are thought to work by their
action on brain chemicals called
amines which are involved in
controlling mood.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
There is no evidence that FLUOX is
addictive.
The use of this medicine in children
and adolescents under the age of
18 years is not recommended.
BEFORE YOU TAKE
FLUOX
_WHEN YO

Summary of Product characteristics

Page 1 of 15
NEW ZEALAND DATA SHEET
FLUOX
1. PRODUCT NAME
FLUOX, fluoxetine hydrochloride, capsules.
FLUOX, fluoxetine hydrochloride, dispersible tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_CAPSULES _
Each capsule contains fluoxetine hydrochloride equivalent to 20 mg
fluoxetine.
Excipient with known effect:
Lactose
Colloidal anhydrous silica, maize starch and gelatin (contains
sulfites).
For the full list of excipients, see section 6.1.
_DISPERSIBLE TABLETS _
Each dispersible tablet contains fluoxetine hydrochloride equivalent
to 20 mg fluoxetine.
Excipient with known effect:
Saccharin sodium.
Microcrystalline cellulose, maize starch, crospovidone, saccharin
sodium and peppermint powder
(contains sulfites).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
FLUOX 20 mg capsules are presented as size 3, hard gelatin capsules
with a light green opaque
body and a purple opaque cap, printed in black ink "FL20" on the body
and "
α
" on the cap.
FLUOX 20 mg dispersible tablets are 12.6 x 6 mm oval, normal convex,
white tablets, debossed "FL"
breakline "20" on one side and "G" on the other. The tablet can be
divided into equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
In adults 18 years of age and over:
•
Depression and its associated anxiety
•
Bulimia nervosa
Page 2 of 15
•
Obsessive-Compulsive disorder
•
Premenstrual dysphoric disorder - a severe form of PMS
Diagnosis of PMDD: The essential features of PMDD are clear and
established cyclicity of symptoms
(occurring during the last week of the luteal phase in most menstrual
cycles) such as depressed
mood, anxiety, affective lability, and physical symptoms such as
breast tenderness or swelling,
headaches, joint or muscle pain, bloating, and weight gain. PMDD is a
severe clinical entity and is
distinguished from the broader premenstrual syndrome by the intensity
of its symptoms (particularly
mood symptoms) and the extent to which it interferes with social
and/or occupational function.
_4.2 _
_DOSE AND METHOD