LOVAN LIQUID fluoxetine 20mg/5mL (as hydrochloride) oral liquid bottle

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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LOVAN
_Fluoxetine hydrochloride _
1
NAME OF THE MEDICINE
Fluoxetine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LOVAN CAPSULE
Each Lovan capsule contains fluoxetine hydrochloride equivalent to 20
mg (64.7

moles) of fluoxetine.
LOVAN TAB
Each Lovan Tab contains fluoxetine hydrochloride equivalent to 20 mg
(64.7

moles) of fluoxetine.
Excipients with known effect: saccharin.
LOVAN LIQUID
Lovan Liquid contains fluoxetine hydrochloride equivalent to 20 mg/5
mL (64.7 µmoles) of fluoxetine.
Excipients with known effect: benzoates and sugars .
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Lovan 20 mg
:
Bright green capsules printed 20 in black ink on the cap.
Lovan Tab 20 mg
:
White oval dispersible tablet marked 4400 on one side and scored on
the reverse.
Lovan Liquid 20
mg/5 mL
:
Clear, colourless, mint flavoured oral solution. Available in bottles
of 35 mL, 70
mL or 140 mL.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lovan 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 and relationships with others.
4.2
DOSE AND METHOD OF ADMINISTRATION
Lovan – PRODUCT INFORMATION
2
Lovan capsules should be swallowed whole.
Lovan