LOVAN 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

LOVAN
_contains the active ingredient fluoxetine (hydrochloride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LOVAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking LOVAN against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT LOVAN IS USED
FOR
LOVAN is used to treat
•
depression
•
obsessive compulsive disorder
(OCD)
•
premenstrual dysphoric disorder
(PMDD).
LOVAN 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LOVAN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
LOVAN for another reason.
LOVAN is available only with a
doctor's prescription.
LOVAN is not recommended for use
in children and adolescents under 18
years of age.
BEFORE YOU TAKE
LOVAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LOVAN IF YOU ARE
ALLERGIC TO:
•
any medicines containing
fluoxetine (such as Prozac and
Zactin)
•
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 LOVAN 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 LOVAN while you are
taking a MAOI, you may experience
shaking (tremor), shivering, muscle
stiffness, fever, rapid pu

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