VIAGRA sildenafil (as citrate) 25mg tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

sildenafil citrate, Quantity: 35.11 mg (Equivalent: sildenafil, Qty 25 mg)

Beszerezhető a:

Viatris Pty Ltd

Gyógyszerészeti forma:

Tablet, film coated

Összetétel:

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

Az alkalmazás módja:

Oral

db csomag:

4 tablets, 8 tablets, 12 tablets, 1 tablet

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

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

Termék összefoglaló:

Visual Identification: Blue rounded diamond shaped film coated tablet engraved with "VGR 25" on one side and "Pfizer" on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

1998-09-04

Betegtájékoztató

VIAGRA
®
_sildenafil (as citrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Viagra.
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 Viagra 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 VIAGRA IS USED
FOR
Viagra 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.
Viagra 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.
Viagra will work only if you are
sexually excited.
Viagra will not increase your sex
drive.
Viagra is not for use in women.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
VIAGRA
_WHEN YOU MUST NOT TAKE IT_
YOU MUST NOT TAKE
VIAGRA 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 VIAGRA.
DO NOT TAKE VIAGRA 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, Nitroderm TTS,
and Minitran.
Common trade names for glycery

Termékjellemzők

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Page 1 of 17
AUSTRALIAN PRODUCT
INFORMATION –
VIAGRA
® (SILDENAFIL CITRATE)
1.
NAME OF THE MEDICINE
Sildenafil citrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VIAGRA 25 mg tablets contain 25 mg sildenafil (as citrate).
VIAGRA 50 mg tablets contain 50 mg sildenafil (as citrate).
VIAGRA 100 mg tablets contain 100 mg sildenafil (as citrate).
EXCIPIENT(S) WITH KNOWN EFFECT
Lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
The 25 mg tablets are blue film-coated, rounded diamond-shaped
tablets, marked PFIZER on
one side and VGR 25 on the other.
The 50 mg tablets are blue film-coated, rounded diamond-shaped
tablets, marked PFIZER on
one side and VGR 50 on the other.
The 100 mg tablets are blue film-coated, rounded diamond-shaped
tablets, marked PFIZER on
one side and VGR 100 on the other
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VIAGRA is indicated for the treatment of erectile dysfunction in adult
males.
VIAGRA is not indicated for use by women.
4.2 DOSE AND METHOD OF ADMINISTRATION
VIAGRA tablets are for oral administration.
Version: ujpviagt10821
Supersedes: pfpviagt11219
Page 2 of 17
DOSAGE
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
VIAGRA is not indicated for use in children.
DOSAGE ADJUSTMENT
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
Sinc