SILDENAFIL SANDOZ sildenafil (as citrate) 100 mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

sildenafil citrate, Quantity: 140.4 mg (Equivalent: sildenafil, Qty 100 mg)

Dostopno od:

Sandoz Pty Ltd

INN (mednarodno ime):

Sildenafil citrate

Farmacevtska oblika:

Tablet, uncoated

Sestava:

Excipient Ingredients: microcrystalline cellulose; copovidone; croscarmellose sodium; saccharin sodium; indigo carmine aluminium lake; calcium hydrogen phosphate; magnesium stearate

Pot uporabe:

Oral

Enote v paketu:

4 tablets, 12 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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

Povzetek izdelek:

Visual Identification: light blue round slightly dotted tablets, with cross breaking notch and debossment 100; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2009-05-05

Navodilo za uporabo

SILDENAFIL SANDOZ
1
SILDENAFIL SANDOZ
_sildenafil citrate tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sildenafil Sandoz.
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 this medicine
against the benefits they expect it
will have for you.
It should only be used 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 SILDENAFIL
SANDOZ IS USED FOR
This medicine 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.
It contains the active ingredient
sildenafil. Sildenafil 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.
Sildenafil Sandoz will work only if
you are sexually excited. It will not
increase your sex drive.
Sildenafil Sandoz is not for use in
women.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
SILDENAFIL SANDOZ
YOU MUST NOT TAKE SILDENAFIL
SANDOZ IF YOU ARE TAKING ANY
NITRATES OR NITRITE MEDICATIONS. IT
MAY LEAD TO A SEVERE DROP IN 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 SILDENAFIL
SANDOZ.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
sildenafil, the active ingredient,
or to any of th

Lastnosti izdelka

190604-Sildenafil Sandoz-pi
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
SILDENAFIL SANDOZ TABLETS SILDENAFIL (AS CITRATE)
1.
NAME OF THE MEDICINE
Sildenafil (as citrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sildenafil Sandoz 25 mg tablets contains 25 mg Sildenafil (as
citrate).
Each Sildenafil Sandoz 50 mg tablets contains 50 mg Sildenafil (as
citrate).
Each Sildenafil Sandoz 100 mg tablets contains 100 mg Sildenafil (as
citrate).
Sildenafil citrate is an off-white, crystalline powder. Its aqueous
solubility is equivalent to 2.6
mg sildenafil per millilitre at 25
°
C.
For the full list of excipients, see Section 6.1 List of excipients.
_Not all presentations may be marketed in Australia. _
3.
PHARMACEUTICAL FORM
Sildenafil Sandoz 25 mg tablets: Light blue round slightly dotted
tablets with breaking notch
and embossment “25”.
Sildenafil Sandoz 50 mg tablets: Light blue round slightly dotted
tablets with cross breaking
notch and embossment “50”.
Sildenafil Sandoz 100 mg tablets: Light blue round slightly dotted
tablets with cross breaking
notch and embossment “100”.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Sildenafil Sandoz is indicated for the treatment of erectile
dysfunction in adult males.
Sildenafil Sandoz is not indicated for use by women.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
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 _
Sildenafil Sandoz is not indicated for use in children.
190604-Sildenafil Sandoz-pi
Page 2 of 16
METHOD OF ADMINISTRATION
Sildenafil Sandoz tablets are for oral administration. Sildenafil
Sandoz tablets have a breaking
notch and may be broken if necessary.
DOSAGE ADJUSTMENT IN:

renal impairment
The dosing recommendations for ‘Use in adults’ should be followed
for p