CIALIS 5 TABLET

Land: Zuid-Afrika

Taal: Engels

Bron: South African Health Products Regulatory Authority (SAHPRA)

Beschikbaar vanaf:

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

Dosering:

See ingredients

farmaceutische vorm:

TABLET

Samenstelling:

EACH TABLET CONTAINS TADALAFIL 5,0 mg

Autorisatie-status:

Registered

Autorisatie datum:

2010-02-08

Productkenmerken

Page 1 of 13
Eli Lilly (S.A.) (Pty) Ltd
Cialis 5
Each film-coated tablet contains 5 mg tadalafil
Approval Date: 05 May 2022
TA4462_ZA_PI-v02_FTC
PROFESSIONAL INFORMATION
SCHEDULING STATUS:
Schedule 4
PROPRIETARY NAME AND DOSAGE FORM:
CIALIS 5 (Tablets)
COMPOSITION:
Each CIALIS 5 film-coated tablet contains 5 mg tadalafil.
CIALIS
film-coated
tablets
contain
the
following
inactive
ingredients:
Lactose
monohydrate,
croscarmellose sodium, hydroxypropylcellulose, microcrystalline
cellulose, sodium laurylsulphate,
magnesium stearate, hypromellose, triacetin, titanium dioxide (E171),
iron oxide (E172) and talc.
PHARMACOLOGICAL CLASSIFICATION:
A 7.1.5 Vasodilators – peripheral
PHARMACOLOGICAL ACTION:
Tadalafil improves impaired erectile function by increasing blood flow
to the penis, in response to
sexual stimulation.
PHARMACODYNAMICS:
Tadalafil is a
selective, reversible inhibitor of
cyclic guanosine monophosphate (cGMP)-specific
phosphodiesterase type 5 (PDE5). When sexual stimulation causes the
local release of nitric oxide,
inhibition of PDE5 by tadalafil produces increased levels of cGMP in
the corpus cavernosum. This
results in smooth muscle relaxation and inflow of blood into the
penile tissues, thereby producing an
erection. Tadalafil has no effect in the absence of sexual
stimulation.
Page 2 of 13
Eli Lilly (S.A.) (Pty) Ltd
Cialis 5
Each film-coated tablet contains 5 mg tadalafil
Approval Date: 05 May 2022
TA4462_ZA_PI-v02_FTC
Tadalafil at doses of 2,5; 5 and 10 mg taken once a day has been
evaluated in 3 clinical studies
involving 853 patients of various ages (range 21-82 years) and
ethnicities, with erectile dysfunction
of various severities (mild, moderate, severe) and etiologies. In the
two primary efficacy studies of
general populations, 76 and 85% of patients reported that tadalafil 5
mg taken once a day improved
their erections as compared to 29 and 30% with placebo. Also, patients
with erectile dysfunction in
all severity categories reported improved erections while taking
tadalafil once a day. In the