SILCAP 50 sildenafil (as citrate) 50 mg capsule blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

sildenafil citrate, Quantity: 70.24 mg (Equivalent: sildenafil, Qty 50 mg)

Disponível em:

iX Biopharma Pty Ltd

Forma farmacêutica:

Capsule

Composição:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; sunset yellow FCF; lactose monohydrate; tartrazine; titanium dioxide; Gelatin; silicon dioxide; sodium lauryl sulfate

Via de administração:

Oral

Unidades em pacote:

12, 8, 4

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Sildenafil is indicated for the treatment of erectile dysfunction in adult males. ,Sildenafil is not indicated for use by women.

Resumo do produto:

Visual Identification: SILCAP 50 mg capsules are yellow opaque/yellow opaque size 2 hard gelatin capsules with no markings.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

2018-07-31

Folheto informativo - Bula

Silcap Consumer Medicine Information v1.0 010818
Page 1 of 4
SILCAP
_sildenafil (as citrate) _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Silcap.
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 Silcap
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 SILCAP IS
USED FOR
Silcap is used to treat erectile
dysfunction, more commonly
known as impotence, in men. This
is when a man cannot get, or keep,
a hard erect penis suitable for
sexual activity.
Silcap belongs to a group of
medicines called
phosphodiesterase type 5
inhibitors.
It works by relaxing the blood
vessels in your penis when you
are sexually excited. This allows
blood to flow into your penis,
allowing you to get an erection in
the natural way.
Silcap will work only if you
are sexually excited.
Silcap will not increase your
sex drive.
Silcap is not for use in women.
This medicine is available only
with a doctor's prescription.
BEFORE YOU
TAKE SILCAP
WHEN YOU MUST NOT TAKE IT
YOU MUST NOT TAKE SILCAP
IF YOU ARE TAKING NITRATES
OR NITRITE MEDICATIONS. IT
MAY LEAD TO A SEVERE DROP
IN YOUR BLOOD PRESSURE,
WHICH MAY BE DIFFICULT TO
TREAT.
BECAUSE SEXUAL ACTIVITY MAY
PLACE A STRAIN ON YOUR HEART,
YOUR DOCTOR WILL NEED TO
CHECK WHETHER YOU ARE FIT
ENOUGH TO TAKE SILCAP.
DO NOT TAKE SILCAP IF YOU ARE BEING
TREATED FOR ANGINA (CHEST PAIN) OR
OTHER HEART CONDITIONS WITH
MEDICINES CALLED NITRATES.
Nitrate medicines include glyceryl
trinitrate (also called
nitroglycerin). Common trade
names for glyceryl trinitrate
tablets include Anginine and
Lycinate.
Common trade names for glyceryl
trinitrate patches include Nitro-
Dur, Transiderm-Nitro, N

Características técnicas

_Sildenafil (as citrate) 25 mg and 50 mg capsules _
_Product Information _
_iX Biopharma Pty Ltd _
Sildenafil capsule PI v2.0 260221
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
SILCAP (SILDENAFIL) CAPSULES
1
NAME OF THE MEDICINE
Sildenafil (as citrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Silcap 25 mg capsules are clear/clear size 2 hard gelatin capsules
with no markings.
Silcap 50 mg capsules are yellow opaque/yellow opaque size 2 hard
gelatin capsules with no
markings.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sildenafil is indicated for the treatment of erectile dysfunction in
adult males. Sildenafil is not
indicated for use by women.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Sildenafil capsules are for oral administration.
USE IN ADULTS
The recommended dose is 50 mg taken as needed approximately one hour
before sexual
activity. Based on the efficacy and toleration, the dose may be
increased to 100 mg or
decreased
to
25
mg.
The
maximum
recommended
dose
is
100
mg.
The
maximum
recommended dosing frequency is once per day.
USE IN CHILDREN
Sildenafil is not indicated for use in children.
DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT
The dosing recommendations for USE IN ADULTS should be followed for
patients with mild to
moderate renal impairment (Cl
cr
= 30-80 mL/min).
Since
sildenafil
clearance
is
reduced
in
patients
with
severe
renal
impairment
(Cl
cr
<30 mL/min) a 25 mg starting dose should be considered. Based on
efficacy and toleration,
the dose may be increased to 50 mg and 100 mg.
DOSAGE ADJUSTMENT IN HEPATIC IMPAIRMENT
Since sildenafil clearance is reduced in patients with hepatic
impairment (e.g., cirrhosis) a
25 mg starting dose should be considered. Based on efficacy and
toleration, the dose may be
increased to 50 mg and 100 mg.
DOSAGE ADJUSTMENT IN THE ELDERLY
_Sildenafil (as citrate) 25 mg and 50 mg capsules _
_Product Information _
_iX Biopharma Pty Ltd _