MOLIPAXIN 50 mg CAPSULE CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS TRAZODONE HYDROCHLORIDE 50 mg

Authorization status:

Registered

Authorization date:

1983-03-04

Patient Information leaflet

PAGE 1 OF 13
PATIENT INFORMATION LEAFLET
1
SCHEDULING STATUS: S5
2
3
PROPRIETARY NAME AND DOSAGE FORM:
4
MOLIPAXIN 50 mg Capsules
5
MOLIPAXIN 100 mg Capsules
6
7
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MOLIPAXIN:
8

Keep this leaflet. You may need to read it again.
9

If you have further questions, please ask your doctor or your
pharmacist.
10

MOLIPAXIN has been prescribed for you personally and you should not
share your medicine
11
with other people. It may harm them, even if their symptoms are the
same as yours.
12
13
WHAT MOLIPAXIN CONTAINS:
14
Each Molipaxin 50 mg Capsule contains 50 mg of the active substance,
trazodone hydrochloride.
15
Each
Molipaxin
100
mg
Capsule
contains
100
mg
of
the
active
substance,
trazodone
16
hydrochloride.
17
Other ingredients include lactose monohydrate, magnesium stearate,
gelatin, erythrosine E127,
18
indigo carmine E132, titanium dioxide E171, yellow iron oxide E172 and
ink 0619 (S-1-20952).
19
The 100 mg Molipaxin Capsules also contain Red Iron Oxide (E172).
20
Contains sugar (lactose).
21
22
WHAT MOLIPAXIN IS USED FOR:
23
Molipaxin belongs to a group of medicines called antidepressants. It
is used to treat depression
24
and depression associated with anxiety.
25
PAGE 2 OF 13
26
BEFORE TAKING MOLIPAXIN:
27
DO NOT TAKE MOLIPAXIN:
28

if you are hypersensitive (allergic) to trazodone hydrochloride, or
any of the other ingredients
29
of MOLIPAXIN (see WHAT MOLIPAXIN CONTAINS). Signs of an allergic
reaction can
30
include: a rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue
31

if you are taking any other psychotropic medicines of which you have
not informed your
32
doctor
33

if you are taking a monoamine oxidase inhibitor (MAOI) or if you have
taken them in the last 2
34
weeks.
You should not receive MAOIs within one week of stopping MOLIPAXIN
35

if you have recently had a heart attack
36

if you are a heavy drinker or are taking sleeping tablets.
37
38
TAKE SPECIAL CARE WITH MOLIPAXIN:
39
Molipax

Summary of Product characteristics

PAGE 1 OF 16
PROFESSIONAL INFORMATION
SCHEDULING STATUS:
1
2
PROPRIETARY NAME AND DOSAGE FORM:
3
MOLIPAXIN 50 mg Capsules
4
MOLIPAXIN 100 mg Capsules
5
6
COMPOSITION:
7
MOLIPAXIN 50 mg capsule: trazodone hydrochloride 50 mg.
8
MOLIPAXIN 100 mg capsule: trazodone hydrochloride 100 mg.
9
Other ingredients include lactose monohydrate, magnesium stearate,
gelatin, erythrosine E127,
10
indigo carmine E132, titanium dioxide E171 and yellow iron oxide E172,
ink 0619 (S-1-20952).
11
The 100 mg MOLIPAXIN capsules also contain Red Iron Oxide (E172).
12
Contains sugar (lactose).
13
14
PHARMACOLOGICAL CLASSIFICATION:
15
A 1.2 Psychoanaleptics (antidepressants)
16
17
PHARMACOLOGICAL ACTION:
18
PHARMACODYNAMIC PROPERTIES
19
Trazodone hydrochloride is a triazolopyridine derivative chemically
unrelated to known tricyclic,
20
tetracyclic
and
other
antidepressant
agents.
It
has
negligible
effect
on
norepinephrine
21
(noradrenaline) re-uptake mechanisms. Whilst the mode of action of
MOLIPAXIN is not known
22
precisely, its antidepressant activity may concern norepinephric
potentiation by mechanisms other
23
than uptake blockade. A central antiserotonin effect may account for
the anxiety reducing
24
properties of trazodone.
25
S5
PAGE 2 OF 16
Trazodone hydrochloride is an anxiolytic/antidepressant, psychotropic
agent.
26
PHARMACOKINETIC PROPERTIES:
27
Trazodone is rapidly absorbed from the gastrointestinal tract and
extensively metabolised in the
28
liver. Paths of metabolism of trazodone include n-oxidation and
hydroxylation. Trazodone is
29
metabolised
to
its
active
metabolite
m-chlorophenylpiperazine
via
the
cytochrome
P450
30
isoenzyme CYP3A4.
31
Trazodone is excreted in the urine almost entirely in the form of its
metabolites, either in free or in
32
conjugated form. The elimination of trazodone is biphasic, with a
terminal elimination half-life of 5
33
to 13 hours. Trazodone is excreted in breast milk.
34
There was an approximate two-fold increase in terminal phase half-life
and significantly higher
35
plasma concentrations of