VASAFIL 50 sildenafil (as citrate) 50 mg tablet blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

sildenafil citrate, Quantity: 70.225 mg

থেকে পাওয়া:

Arrotex Pharmaceuticals Pty Ltd

INN (আন্তর্জাতিক নাম):

Sildenafil citrate

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; calcium hydrogen phosphate; titanium dioxide; purified talc; brilliant blue FCF aluminium lake; polyvinyl alcohol; quinoline yellow aluminium lake; macrogol 3350

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

4 tablets

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

Visual Identification: Green coloured, round shape, convex film coated tablet cross break line on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2011-06-22

তথ্য লিফলেট

VASAFIL- Consumer Medicine Information
Page 1 of 3
VASAFIL
sildenafil (as citrate)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VASAFIL.
It does not contain all of 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 VASAFIL against the benefits
they expect it will have for you.
TALK TO YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE,
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT VASAFIL IS USED
FOR
VASAFIL is used to treat erectile
dysfunction, also commonly called
impotence, in men. This is when a man
cannot get, or keep, a hard erect penis,
suitable for sexual activity.
It 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.
VASAFIL will work only if you are
sexually excited. It will not increase
your sex drive.
It is not for use in women.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE IT
YOU MUST NOT TAKE VASAFIL IF YOU
ARE TAKING ANY NITRATE
MEDICATION. 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 VASAFIL.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VASAFIL IF YOU ARE ALLERGIC
TO MEDICINES CONTAINING SILDENAFIL
CITRATE OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash, itching
or hives, swelling of the face, lips or
tongue which may cause difficulty in
swallowing or breathing, wheezing or
shortness of breath.
DO NOT TAKE VASAFIL IF YOU ARE BEING
TREATED FOR ANGINA (CHEST PAIN) OR
OTHER HEART CONDITIONS WITH C

পণ্য বৈশিষ্ট্য

1
AUSTRALIAN PRODUCT INFORMATION – VASAFIL (SILDENAFIL
CITRATE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Sildenafil citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vasafil tablets come in three strengths and contain 25 mg, 50 mg or
100 mg of sildenafil (as sildenafil
citrate).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
_VASAFIL 25_
Green coloured, round shape, convex film coated tablet break line on
one side and
plain on the other side.
_VASAFIL 50_
Green coloured, round shape, convex film coated tablet with cross
break line on one
side and plain on the other side.
_VASAFIL 100_
Green coloured, round shape, convex film coated tablet with cross
break line on one
side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sildenafil is indicated for the treatment of erectile dysfunction in
adult males.
It is not indicated for use by women.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
ADULTS
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity.
Based on efficacy and tolerance, 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.
CHILDREN
Sildenafil is not indicated for use in children.
METHOD OF ADMINISTRATION
Sildenafil tablets are for oral administration.
2
DOSAGE ADJUSTMENT
_USE IN THE ELDERLY _
Since sildenafil clearance is reduced in elderly patients, a first
dose of 25 mg should be considered.
Based on efficacy and tolerance, the dose may be increased to 50 and
100 mg.
_IMPAIRED RENAL FUNCTION _
The dosing recommendations for adults should be followed for patients
with mild to moderate renal
impairment (creatinine clearance = 30 to 80 mL/minute).
Since sildenafil clearance is reduced in patients with severe renal
impairment (creatinine clearance <
30 mL/minute) a 25 mg starting dose should be considered. Based on
efficacy and tolerance, the
dose may be increased to 50 and 100 mg.
_IMPAIRED