VEDAFIL sildenafil (as citrate) 100 mg film-coated tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

sildenafil citrate, Quantity: 140.483 mg (Equivalent: sildenafil, Qty 100 mg)

Verfügbar ab:

Alphapharm Pty Ltd

INN (Internationale Bezeichnung):

Sildenafil citrate

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; microcrystalline cellulose; purified water; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake

Verabreichungsweg:

Oral

Einheiten im Paket:

1, 4, 8, 12

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

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

Produktbesonderheiten:

Visual Identification: Blue, film-coated, round biconvex tablets debossed with 'M' on one side and 'SL over 100' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2013-05-20

Gebrauchsinformation

VEDAFIL
®
_sildenafil (as citrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VEDAFIL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking VEDAFIL against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT VEDAFIL IS USED
FOR
The name of your medicine is
VEDAFIL. It contains the active
ingredient called sildenafil citrate.
VEDAFIL 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.
VEDAFIL 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.
VEDAFIL will work only if you are
sexually excited.
VEDAFIL will not increase your sex
drive.
VEDAFIL is not for use in women.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY VEDAFIL
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
VEDAFIL
BECAUSE SEXUAL ACTIVITY
MAY PLACE A STRAIN ON
YOUR HEART, YOUR DOCTOR
WILL NEED TO CHECK
WHETHER YOU ARE FIT
ENOUGH TO TAKE VEDAFIL.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE VEDAFIL IF
YOU ARE TAKING ANY
NITRATE OR NITRITE
MEDICATIONS, USED TO
TREAT ANGINA (CHEST PAIN)
OR OTHER HEART
CONDITIONS. IT MAY LEAD
TO A SEVER DROP IN YOUR
BLOOD PRESSURE, WHICH
MAY BE DIFFICULT TO
TREAT.
Nitrate medicines include:
•
glyceryl trinitrate (also called
nitroglycerin).
•
tablets; such as Anginine,
Lycinate, Nitrostat, Imdur
Durules, Monodur durules,
Sorbidin, Isordil, Corangin,
ISMO 20, Imtrate, Duride,
Isomonit, Ikorel and S

Fachinformation

AUSTRALIAN PRODUCT INFORMATION
VEDAFIL
®
_Sildenafil (as citrate) film coated tablets _
1
NAME OF THE MEDICINE
Sildenafil (as citrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sildenafil citrate is an orally active selective inhibitor of cGMP -
specific PDE5 (phosphodiesterase type 5)
which is the predominant PDE isoenzyme in human corpora cavernosa.
VEDAFIL film coated tablets contain 25, 50 or 100 mg sildenafil (as
citrate) as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
_ _
3
PHARMACEUTICAL FORM
VEDAFIL (Sildenafil (as citrate))
25 mg tablets
:
Blue film-coated, round biconvex tablets debossed with ‘M’ on one
side and ‘SL over 25’ on other side.
VEDAFIL (Sildenafil (as citrate))
50 mg tablets
:
Blue film-coated, round biconvex tablets debossed with ‘M’ on one
side and ‘SL over 50’ on other side.
VEDAFIL (Sildenafil (as citrate))
100 mg tablets
:
Blue film-coated, round biconvex tablets debossed with ‘M’ on one
side and ‘SL over 100’ on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VEDAFIL is indicated for the treatment of erectile dysfunction in
adult males.
VEDAFIL is not indicated for use by women.
4.2
DOSE AND METHOD OF ADMINISTRATION
Sildenafil citrate tablets 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.
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 (Clcr <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