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

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

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

Предлага се от:

AVALLON PHARMACEUTICALS PTY LTD

INN (Международно Name):

Sildenafil citrate

Лекарствена форма:

Tablet, uncoated

Композиция:

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

Начин на приложение:

Oral

Броя в опаковка:

4 tablets, 12 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

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

Каталог на резюме:

Visual Identification: light blue round slightly dotted tablets, with cross breaking notch and embossment "100"; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

2017-06-07

Листовка

NOUMED SILDENAFIL
1
NOUMED SILDENAFIL
_sildenafil citrate tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
SILDENAFIL.
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 NOUMED
SILDENAFIL 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.
NOUMED SILDENAFIL will work
only if you are sexually excited. It
will not increase your sex drive.
NOUMED SILDENAFIL 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
NOUMED SILDENAFIL
YOU MUST NOT TAKE NOUMED
SILDENAFIL IF YOU ARE TAKING
ANY NITRATE MEDICATION. 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 NOUMED
SILDENAFIL.
_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 the other ingre

Данни за продукта

Product Information - Australia
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION – NOUMED
SILDENAFIL TABLETS
(SILDENAFIL CITRATE)
1. NAME OF THE MEDICINE
Sildenafil citrate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sildenafil citrate is an off-white, crystalline powder. Its aqueous
solubility is equivalent to 2.6 mg sildenafil per
millilitre at 25

C.
In addition to sildenafil citrate, each NOUMED SILDENAFIL tablet
contains the following inactive ingredients:
microcrystalline
cellulose,
calcium
hydrogen
phosphate,
copovidone,
croscarmellose
sodium,
magnesium
stearate, saccharin sodium and indigo carmine aluminium lake.
3. PHARMACEUTICAL FORM
NOUMED SILDENAFIL 25 mg tablets: Light blue round slightly dotted
tablets with breaking notch and embossment
“25”.
NOUMED SILDENAFIL 50 mg tablets: Light blue round slightly dotted
tablets with cross breaking notch and
embossment “50”.
NOUMED SILDENAFIL 100 mg tablets: Light blue round slightly dotted
tablets with cross breaking notch and
embossment “100”.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NOUMED SILDENAFIL is indicated for the treatment of erectile
dysfunction in adult males.
NOUMED SILDENAFIL is not indicated for use by women.
4.2 DOSE AND METHOD OF ADMINISTRATION
NOUMED SILDENAFIL tablets are for oral administration.
NOUMED SILDENAFIL tablets have a breaking notch and may be broken if
necessary.
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:
_USE IN THE ELDERLY _
Since sildenafil clearance is reduced in elderly patients, an initial
dose of 25 mg should be considered. Based on
efficacy and toleration, the dose may be increased to 50 mg and 100
mg.
_USE IN PATIENTS WITH RENAL IMPAIRMENT _
The dosing recommendations for ‘USE IN ADULTS’ should be followed
for patients w