Adcirca

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Tadalafil

Предлага се от:

Eli Lilly Australia Pty Ltd

Клас:

Medicine Registered

Листовка

ADCIRCA
®

_tadalafil_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ADCIRCA. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ADCIRCA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ADCIRCA IS
USED FOR
ADCIRCA is used in adults as a
treatment for pulmonary arterial
hypertension.
ADCIRCA belongs to a group of
medicines called phosphodiesterase
type 5 (PDE5) inhibitors which work
by helping the blood vessels around
your lungs relax, improving the flow
of blood into your lungs. The result
of this is an improved ability to do
physical activity.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ADCIRCA
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
ADCIRCA is available only with a
doctor's prescription.
ADCIRCA is not intended for use by
children under the age of 18 years.
BEFORE YOU TAKE
ADCIRCA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ADCIRCA IF YOU ARE
CURRENTLY TAKING ANY NITRATES OR
AMYL NITRITE.
Nitrates are medicines used for the
treatment of angina ("chest pain") or
other heart conditions. ADCIRCA
has been shown to increase the
effects of these medicines.
If you are taking any form of nitrate
or are unsure talk to your doctor.
DO NOT TAKE ADCIRCA:
•
IF YOU HAVE SUFFERED A HEART
ATTACK IN THE LAST 3 MONTHS
•
IF YOU HAVE VISION LOSS IN ONE EYE
BECAUSE OF NON-ARTERITIC
ANTERIOR ISCHAEMIC OPTIC
NEUROPATHY (NAION)
•
SEVERE HYPOTENSION
DO NOT TAKE ADCIRCA IF YOU HAVE
AN ALLERGY TO:
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
to

Данни за продукта

 
adcirca-pi-v1-05aug11 

Page 1 of 19 
ADCIRCA
®

(tadalafil) 

NAME OF THE MEDICINE 

ADCIRCA
®
 (tadalafil). 

Chemically, tadalafil is pyrazino[1’, 2’:1, 6]pyrido[3, 4-b]indole-1, 4-dione, 6-(1, 3-
benzodioxol-5-yl)-2, 3, 6, 7, 12, 12a-hexahydro-2-methyl-, (6R, 12aR)-. Tadalafil has the 
empirical formula C
22
H
19
N
3
O
4
 representing a molecular weight of 389.41. Tadalafil is a 
crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. The 
CAS number for tadalafil is 171596-29-5. 

Tadalafil has the following structural formula: 

DESCRIPTION 

ADCIRCA 20 mg tablets are orange, almond shaped tablets, for oral administration, marked 
"4467" on one side. The active ingredient in ADCIRCA tablets is tadalafil. ADCIRCA tablets 
also contain the following excipients: croscarmellose sodium, hydroxypropylcellulose, 
hypromellose, lactose, magnesium stearate, cellulose - microcrystalline, sodium lauryl 
sulfate, talc - purified, titanium dioxide,  glycerol triacetate, iron oxide yellowand iron oxide 
red.  

PHARMACOLOGY 

PharmacodynamicsTadalafil is a reversible inhibitor of cyclic guanosine monophosphate 
(cGMP) – specific phosphodiesterase type 5 (PDE5). Pulmonary arterial hypertension is 
associated with impaired release of nitric oxide by the vascular endothelium and consequent 
reduction of cGMP concentrations within the pulmonary vascular smooth muscle. PDE5 is the 
predominant phosphodiesterase in the pulmonary vasculature. Inhibition of PDE5 by tadalafil 
increases the concentrations of cGMP resulting in relaxation of the pulmonary vascular 
smooth muscle cell and vasodilation of the pulmonary vascular bed. 

Studies 
in vitro have shown that tadalafil inhibits PDE5 more potently than other PDEs.   
PD