AURO-CITALOPRAM 40 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Aurogen South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS CITALOPRAM HYDROBROMIDE EQUIVALENT TO CITALOPRAM 40,0 mg

Authorization status:

Registered

Authorization date:

2014-03-08

Patient Information leaflet

_APPLICANT/PHCR: _AUROGEN SOUTH AFRICA (PTY) LTD
_PRODUCT PROPRIETARY NAME_: AURO-CITALOPRAM 10 MG / 40 MG
_DOSAGE FORM AND STRENGTH: _TABLET 10 MG / 40 MG
AURO-CITALOPRAM 10 AND 40 MG
PAGE 1 OF 9
_(Citalopram 10 and 40 mg, Film-coated tablet) _
APPROVED PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
AURO-CITALOPRAM.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your
pharmacist.
- AURO-CITALOPRAM 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.
S5
AURO-CITALOPRAM 10 MG (Tablet)
AURO-CITALOPRAM 40 MG (Tablet)
Citalopram hydrobromide
1.
WHAT AURO-CITALOPRAM CONTAINS
The active substance is citalopram.
AURO-CITALOPRAM 10 MG:
Each film-coated tablet contains citalopram hydrobromide corresponding
to 10 mg of citalopram.
AURO-CITALOPRAM 40 MG:
Each film-coated tablet contains citalopram hydrobromide corresponding
to 40 mg of citalopram.
The other ingredients are cellulose microcrystalline, copovidone,
croscarmellose sodium, lactose
monohydrate, magnesium stearate and maize starch. The coating material
contains
hypromellose, macrogol 400 and titanium dioxide (C.I number: 77891). _
_
2.
WHAT AURO-CITALOPRAM IS USED FOR
AURO-CITALOPRAM belongs to a group of antidepressants called selective
serotonin reuptake
inhibitors (SSRIs). AURO-CITALOPRAM is used for the treatment of
depression and when you
feel better, to help prevent these symptoms recurring. AURO-CITALOPRAM
is also used to treat
other mental conditions such as obsessive-compulsive disorder (an
anxiety disorder where a
_APPLICANT/PHCR: _AUROGEN SOUTH AFRICA (PTY) LTD
_PRODUCT PROPRIETARY NAME_: AURO-CITALOPRAM 10 MG / 40 MG
_DOSAGE FORM AND STRENGTH: _TABLET 10 MG / 40 MG
AURO-CITALOPRAM 10 AND 40 MG
PAGE 2 OF 9
_(Citalopram 10 and 40 mg, Film-coated tablet) _
person has recurrent and unwanted thoughts called obsessions and/or
repetitive behaviour call

Summary of Product characteristics

_APPLICANT/PHCR: _AUROGEN SOUTH AFRICA (PTY) LTD
_PRODUCT PROPRIETARY NAME_: AURO-CITALOPRAM 10 MG / 40 MG
_DOSAGE FORM AND STRENGTH: _TABLET 10 MG / 40 MG
AURO-CITALOPRAM 10 AND 40 MG
PAGE 1 OF 9
_(Citalopram 10 and 40 mg, Film-coated tablet) _
APPROVED PROFESSIONAL INFORMATION
SCHEDULING STATUS
S5
PROPRIETARY NAME AND DOSAGE FORM
AURO-CITALOPRAM 10 mg (Tablet)
AURO-CITALOPRAM 40 mg (Tablet)
COMPOSITION
AURO-CITALOPRAM 10 MG:
Each film-coated tablet contains Citalopram Hydrobromide corresponding
to 10 mg of citalopram.
AURO-CITALOPRAM 40 MG:
Each film-coated tablet contains Citalopram Hydrobromide corresponding
to 40 mg of citalopram.
PHARMACOLOGICAL CLASSIFICATION
A 1.2 Psychoanaleptics (antidepressants).
PHARMACOLOGICAL ACTION
Citalopram is a bicyclic phthallane derivative with antidepressant
effect. Its effect is linked to the
selective
inhibition
of specific serotonin (5-HT) reuptake. Citalopram,
primarily through
its (S)-
enantiomer, blocks 5-HT reuptake, leading to potentiation of
serotonergic activity in the central nervous
system (CNS). Neither citalopram nor its metabolites have an effect on
noradrenaline, dopamine and
GABA reuptake. Citalopram also has little or no antidopaminergic,
antiadrenergic, antiserotonergic,
anthistaminergic
or
anticholinergic
properties.
PHARMACOKINETICS:
Oral bioavailability is about 80 % with maximum plasma levels being
reached in 4 hours (range 1 to 6
hours). Volume of distribution is about 14 L/kg (range 9 to 17 L/kg).
Time to reach steady state
concentration is 1 to 2 weeks. Protein binding is about 80 %.
Elimination half-life is 36 hours (range
28- 42 hours). Citalopram undergoes hepatic metabolism primarily
involving the cytochrome P450
(CYP3A4) and 2C19 (CYP2C19) isoenzymes and to a small extent
cytochrome P450 2D6 (CYP2D6)
_APPLICANT/PHCR: _AUROGEN SOUTH AFRICA (PTY) LTD
_PRODUCT PROPRIETARY NAME_: AURO-CITALOPRAM 10 MG / 40 MG
_DOSAGE FORM AND STRENGTH: _TABLET 10 MG / 40 MG
AURO-CITALOPRAM 10 AND 40 MG
PAGE 2 OF 9
_(Citalopram 10 and 40 mg, Film-coated tablet) _
iso