LUVOX 100 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbott Laboratories S.A. (Pty) Ltd

Dosage:

100 mg

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS FLUVOXAMINE MALEATE 100 mg

Authorization status:

Registered

Authorization date:

1995-03-08

Patient Information leaflet

ABBOTT LABORATORIES SOUTH AFRICA (PTY)
LTD
SUBMISSION DATE:
12 NOVEMBER 2021
TYPE: POST-REGISTRATION
VARIATION
LUVOX 100
APPROVAL DATE: 13 FEB 2022
CATEGORY: IA
IN
, IB
100 MG, FILM-COATED TABLETS
IMPLEMENTATION: 13 FEB 2022
CODE: C.I.0.1, C.I.0.2A,
C.I.0.3
COUNTRY CODE: ZA
REG NO.: X/1.2/60
SEQUENCE NO.: 0000
1.3.1.1 PROFESSIONAL INFORMATION
1.5.5.1
Signed:
Page 1 of 21
SCHEDULING STATUS
S5
1.
NAME OF THE MEDICINE
LUVOX 100 film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains fluvoxamine maleate 100 mg.
_Excipient with known effect: _
Contains sugar: Each tablet contains 303 mg mannitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Oval, biconvex, white, film-coated, breakable tablets, inscribed with
“S” on the one side and “313”
on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LUVOX is indicated in adults for the treatment of major depressive
episodes and for the short-term
treatment of severe, disabling obsessive-compulsive disorder, where
the obsessions or
compulsions cause marked distress, are time-consuming or significantly
interfere with social or
occupational functioning.
ABBOTT LABORATORIES SOUTH AFRICA (PTY)
LTD
SUBMISSION DATE:
12 NOVEMBER 2021
TYPE: POST-REGISTRATION
VARIATION
LUVOX 100
APPROVAL DATE: 13 FEB 2022
CATEGORY: IA
IN
, IB
100 MG, FILM-COATED TABLETS
IMPLEMENTATION: 13 FEB 2022
CODE: C.I.0.1, C.I.0.2A,
C.I.0.3
COUNTRY CODE: ZA
REG NO.: X/1.2/60
SEQUENCE NO.: 0000
1.3.1.1 PROFESSIONAL INFORMATION
1.5.5.1
Signed:
Page 2 of 21
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
MAJOR DEPRESSIVE EPISODES
The effective daily dose usually varies between 100 mg and 200 mg and
should be adjusted to the
individual response of the patient up to a maximum of 300 mg. The
minimum recommended
starting dose is 100 mg per day and can be given as a single dose,
preferably in the evening. It is
advisable that a total daily dose of more than 150 mg is given in 2 or
3 divided doses.
OBSESSIVE-CO

Summary of Product characteristics

ABBOTT LABORATORIES SOUTH AFRICA (PTY)
LTD
SUBMISSION DATE:
12 NOVEMBER 2021
TYPE: POST-REGISTRATION
VARIATION
LUVOX 100
APPROVAL DATE: 13 FEB 2022
CATEGORY: IA
IN
, IB
100 MG, FILM-COATED TABLETS
IMPLEMENTATION: 13 FEB 2022
CODE: C.I.0.1, C.I.0.2A,
C.I.0.3
COUNTRY CODE: ZA
REG NO.: X/1.2/60
SEQUENCE NO.: 0000
1.3.1.1 PROFESSIONAL INFORMATION
1.5.5.1
Signed:
Page 1 of 21
SCHEDULING STATUS
S5
1.
NAME OF THE MEDICINE
LUVOX 100 film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains fluvoxamine maleate 100 mg.
_Excipient with known effect: _
Contains sugar: Each tablet contains 303 mg mannitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Oval, biconvex, white, film-coated, breakable tablets, inscribed with
“S” on the one side and “313”
on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LUVOX is indicated in adults for the treatment of major depressive
episodes and for the short-term
treatment of severe, disabling obsessive-compulsive disorder, where
the obsessions or
compulsions cause marked distress, are time-consuming or significantly
interfere with social or
occupational functioning.
ABBOTT LABORATORIES SOUTH AFRICA (PTY)
LTD
SUBMISSION DATE:
12 NOVEMBER 2021
TYPE: POST-REGISTRATION
VARIATION
LUVOX 100
APPROVAL DATE: 13 FEB 2022
CATEGORY: IA
IN
, IB
100 MG, FILM-COATED TABLETS
IMPLEMENTATION: 13 FEB 2022
CODE: C.I.0.1, C.I.0.2A,
C.I.0.3
COUNTRY CODE: ZA
REG NO.: X/1.2/60
SEQUENCE NO.: 0000
1.3.1.1 PROFESSIONAL INFORMATION
1.5.5.1
Signed:
Page 2 of 21
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
MAJOR DEPRESSIVE EPISODES
The effective daily dose usually varies between 100 mg and 200 mg and
should be adjusted to the
individual response of the patient up to a maximum of 300 mg. The
minimum recommended
starting dose is 100 mg per day and can be given as a single dose,
preferably in the evening. It is
advisable that a total daily dose of more than 150 mg is given in 2 or
3 divided doses.
OBSESSIVE-CO