SILDANIL PHT 20 sildenafil (as citrate) 20 mg film coated tablets blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

sildenafil citrate, Quantity: 28.1 mg (Equivalent: sildenafil, Qty 20 mg)

Διαθέσιμο από:

Accord Healthcare Pty Ltd

INN (Διεθνής Όνομα):

Sildenafil citrate

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; hypromellose; calcium hydrogen phosphate; croscarmellose sodium; titanium dioxide; lactose monohydrate; triacetin

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

90 Tablets in blister pack

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Used to treat patients with pulmonary arterial hypertension classified as WHO functional classes II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. The efficacy of sildenafil Citrate 20 mg has not been evaluated in patients currently on bosentan therapy.

Περίληψη προϊόντος:

Visual Identification: White to off white, round shaped, biconvex, film coated tablets, debossed with '20' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2012-09-10

Φύλλο οδηγιών χρήσης

SILDANIL PHT 20
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2012- Page: 1 of 4
SILDANIL PHT 20
(SILDENAFIL (AS CITRATE) 20 MG FILM-COATED TABLETS)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sildanil PHT 20.
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 your taking Sildanil PHT
20 against the benefits they expect it
will have for you.
It should be used only under strict
medical supervision.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SILDANIL PHT 20 IS
USED FOR
Sildanil
PHT
20
is
used
to
treat
pulmonary
arterial
hypertension
(high
blood
pressure
in
the
blood
vessels in the lungs). Sildanil PHT
20 brings down the blood pressure
by
relaxing
these
vessels.
Sildanil
PHT
20
tablet
contain
the
active
ingredient
sildenafil
(present
as
sildenafil citrate) which belongs to a
group
of
medicines
called
phosphodiesterase type 5 inhibitors.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SILDANIL PHT
20 HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE SILDANIL
PHT 20
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE SILDANIL PHT 20 IF:
1. YOU ARE BEING TREATED FOR
ANGINA (CHEST PAIN), OR OTHER
HEART CONDITIONS, WITH CERTAIN
MEDICINES CALLED NITRATES
Nitrate
medicines
include
glyceryl
trinitrate (also called nitroglycerin).
Common tradenames include tablets;
such as Anginine and Tridil; patches
such
as
Nitro-Dur,
Nitradisc,
Transiderm-Nitro,
Nitrocor,
Nitroderm TTS and Minitran; sprays
such as Nitrolingual and injections
such as Nitronal.
Common
tradenames
for
other
nitrate
preparations
include
tablets
such
as
Imdur
Durule,
Sorbidin,
Isordil,
Carvasin,
Corangin,
ISMO
20, Imtrate, Coronex, Duride, Ikorel
and Sodium Nitroprusside.
There may be other tradenames not

Αρχείο Π.Χ.Π.

Sildanil PHT 20 (Sildenafil (as citrate) 20 mg film-coated Tablets)
Version 1.0
-2012- Page 1 of 25
PRODUCT INFORMATION
SILDANIL PHT 20
(SILDENAFIL (AS CITRATE) 20 MG FILM-COATED TABLETS)
NAME OF THE MEDICINE
Sildenafil (as citrate)
DESCRIPTION
Sildenafil 20 mg, an oral therapy for pulmonary arterial hypertension,
is the citrate salt of
sildenafil, a selective inhibitor of cyclic guanosine monophosphate
(cGMP)-specific
phosphodiesterase type-5 (PDE5).
SILDENAFIL
CITRATE
IS
1-[4-ETHOXY-3-(6,7-DIHYDRO-1-METHYL-7-OXO-3-PROPYL-1H-
PYRAZOLO[4,3-D]PYRIMIDIN-5-YL)PHENYLSULPHONYL]-4-METHYLPIPERAZINE
CITRATE.
CAS
NUMBER 171,599-83-0.
The empirical formula for sildenafil citrate is C
22
H
30
N
6
O
4
S.C
6
H
8
0
7
Sildenafil citrate has the following structural formula:-
Sildenafil citrate is an off-white, crystalline powder with a
molecular weight of 666.7. Its
aqueous solubility is equivalent to 2.6 mg sildenafil per mL at 25°C.
In addition to sildenafil citrate, each sildenafil tablet contains the
following inactive
ingredients:
microcrystalline
cellulose,
calcium
hydrogen
phosphate
anhydrous,
croscarmellose sodium, hypromellose, magnesium stearate. The
film-coating contains
opadry II complete film coating system 31K58643 white (ARTG
No.107652), which
consists of hypromellose, titanium dioxide, lactose, glycerol
triacetate.
Sildanil PHT 20 (Sildenafil (as citrate) 20 mg film-coated Tablets)
Version 1.0
-2012- Page 2 of 25
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Sildenafil is a potent and selective inhibitor of cGMP specific
phosphodiesterase type-5
(PDE5) in the smooth muscle of the pulmonary vasculature, where PDE5
is responsible
for
degradation
of
cGMP.
Sildenafil,
therefore,
increases
cGMP
within
pulmonary
vascular
smooth
muscle
cells
resulting
in
relaxation.
In
patients
with
pulmonary
hypertension, this can lead to selective vasodilation of the pulmonary
vascular bed and, to
a lesser degree, vasodilatation in the systemic circulation.
Studies
_in vitro _
have shown that sildenafil is selective for PDE5. Its effect is m