LILLY-FLUOXETINE 20 CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Eli Lilly (S.A.) (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

CAPSULE FLUOXETINE HYDROCHLORIDE 22,36 MG

Authorization status:

Registered

Authorization date:

1997-01-10

Patient Information leaflet

ELI LILLY (SA) (PTY) LTD
PRODUCT NAME: Lilly-Fluoxetine 20
DOSAGE FORM; STRENGTH: Capsule; Fluoxetine 20
mg
DATE: 17 January 2022
REFERENCE:
PU3105_ZA_PIL_v01_MTC
Page
1
of
17
APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
LILLY-FLUOXETINE 20 (20 mg capsules)
Fluoxetine
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
LILLY-FLUOXETINE 20
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
LILLY-FLUOXETINE 20
has been prescribed for you personally and you should not share
your medicine with other people. It may harm them, even if their
symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What LILLY-FLUOXETINE 20 is and what it is used for
2.
What you need to know before you take LILLY-FLUOXETINE 20
3.
How to take LILLY-FLUOXETINE 20
4.
Possible side effects
5.
How to store LILLY-FLUOXETINE 20
6.
Contents of the pack and other information
ELI LILLY (SA) (PTY) LTD
PRODUCT NAME: Lilly-Fluoxetine 20
DOSAGE FORM; STRENGTH: Capsule; Fluoxetine 20
mg
DATE: 17 January 2022
REFERENCE:
PU3105_ZA_PIL_v01_MTC
Page
2
of
17
1.
WHAT LILLY-FLUOXETINE 20
IS AND WHAT IT IS USED FOR
LILLY-FLUOXETINE 20 capsules contain the active substance fluoxetine
which is one of a
group of medicines called selective serotonin re-uptake inhibitors
(SSRI) antidepressants.
LILLY-FLUOXETINE 20 is used for the treatment of:
•
Major depressive disorder
•
Bulimia nervosa
•
Obsessive-compulsive disorder
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LILLY-FLUOXETINE 20
DO NOT TAKE
LILLY-FLUOXETINE 20
:
•
If you are hypersensitive (allergic) to fluoxetine or any of the other
ingredients of LILLY-
FLUOXETINE 20 (listed in section 6). If you develop a rash or other
allergic reactions (like
itching, swollen lips or face or shortness of breath), stop taking the
capsules straight away
and contact your doctor immediately.
•
If you suffer from severe kidney failure.
•
If you are taking linezolid, an antib

Summary of Product characteristics

ELI LILLY (S.A.) (PTY) LTD
PRODUCT NAME: Lilly-Fluoxetine 20
DOSAGE FORM AND STRENGTH: Capsules, Fluoxetine 20 mg
DATE: 17 January 2022
REFERENCE:
PU3105_ZA_PI_v01_MTC
Page 1 of 29
APPROVED PROFESSIONAL INFORMATION
SCHEDULING STATUS
S5
1.
NAME OF THE MEDICINE
LILLY-FLUOXETINE 20 (20 mg, capsules)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LILLY-FLUOXETINE 20 capsule contains fluoxetine hydrochloride
equivalent to 20 mg
fluoxetine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules.
LILLY-FLUOXETINE 20 capsule is a size 3 capsule with an opaque green
cap and an opaque
off-white body imprinted with “20”.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Major depressive episodes
Bulimia nervosa
ELI LILLY (S.A.) (PTY) LTD
PRODUCT NAME: Lilly-Fluoxetine 20
DOSAGE FORM AND STRENGTH: Capsules, Fluoxetine 20 mg
DATE: 17 January 2022
REFERENCE:
PU3105_ZA_PI_v01_MTC
Page 2 of 29
Obsessive-compulsive disorder: The obsessions or compulsions must be
experienced as intrusive,
markedly
distressing, time consuming
or
interfering significantly
with the
person's
social
or
occupational functioning.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_MAJOR DEPRESSIVE EPISODE _
Adults and elderly: A dose of 20 mg/day is recommended, preferably in
the morning.
_BULIMIA NERVOSA _
A dose of 60 mg/day is recommended.
_OBSESSIVE-COMPULSIVE DISORDER _
A dose of 20 to 60 mg/day is recommended.
The recommended dose may be increased or decreased.
LILLY-FLUOXETINE 20 capsules cannot be used for downward dose
titration.
Doses above 80 mg/day are not recommended for any indication. Upward
dose titration is advised
at intervals of several weeks due to the kinetic properties of
LILLY-FLUOXETINE 20 (see section
5.2).
LILLY-FLUOXETINE 20 may be administered with or without food.
_ _
_USAGE IN THE ELDERLY _
ELI LILLY (S.A.) (PTY) LTD
PRODUCT NAME: Lilly-Fluoxetine 20
DOSAGE FORM AND STRENGTH: Capsules, Fluoxetine 20 mg
DATE: 17 January 2022
REFERENCE:
PU3105_ZA_PI_v01_MTC
Page 3 of 29
LILLY-FLUOXETINE 20 sh