Vedafil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sildenafil citrate 35.121mg equivalent to Sildenafil 25 mg;  

Available from:

Viatris Limited

INN (International Name):

Sildenafil citrate 35.121 mg (equivalent to Sildenafil 25 mg)

Dosage:

25 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Sildenafil citrate 35.121mg equivalent to Sildenafil 25 mg   Excipient: Calcium hydrogen phosphate Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry blue 03K80846 Purified water  

Units in package:

Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer, 1 tablet

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

VEDAFIL is indicated for the treatment of erectile dysfunction in males

Product summary:

Package - Contents - Shelf Life: Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer - 1 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer - 4 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer - 8 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2009-07-14

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
VEDAFIL
®
_SILDENAFIL CITRATE 25 MG, 50 MG AND 100 MG _
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 risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
VEDAFIL against the benefits they
expect it will have for you.
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 VEDAFIL IS
USED FOR
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 contains the active
ingredient sildenafil citrate, which
belongs to a group of medicines
called phosphodiesterase type 5
(PDE5) 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.
This medicine is available with a
doctor’s prescription or from a
trained pharmacist without a
doctor’s prescription if you meet
certain criteria.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
VEDAFIL is not to be used in
women or in children.
BEFORE YOU
TAKE VEDAFIL
YOU MUST NOT TAKE VEDAFIL 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 OR PHARMACIST WILL NEED TO
CHECK WHETHER YOU ARE FIT ENOUGH
TO TAKE VEDAFIL.
_WHEN YOU MUST NOT _
_TAKE IT_
DO NOT TAKE VEDAFIL IF:

you have an allergy to
o
any medicine containing
sildenafil citrate
o
any of the ingredients
listed a

Summary of Product characteristics

Page 1 of 14
NEW ZEALAND DATA SHEET
VEDAFIL
®
1. PRODUCT NAME
Vedafil, 25 mg, 50 mg and 100 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 25 mg, 50 mg or 100 mg of sildenafil.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
VEDAFIL 25 mg tablets are blue, film-coated, round biconvex tablets
debossed with ‘M’ on
one side and ‘SL over 25’ on other side.
VEDAFIL 50 mg tablets are blue, film-coated, round biconvex tablets
debossed with ‘M’
on
one side and ‘SL over 50’ on other side.
VEDAFIL 100 mg tablets are blue, film-coated, round biconvex tablets
debossed with ‘M’
on
one side and ‘SL over 100’ on other side.
Do not halve tablet. Dose equivalence when the tablet is divided has
not been established.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
VEDAFIL is indicated for the treatment of erectile dysfunction in
adult males.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ADULTS_
The recommended starting dose is 50 mg taken approximately one hour
before sexual activity.
Based on 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. If sildenafil is taken with food, the onset of activity
may be delayed compared to the
fasted state (see section 5.2).
Page 2 of 14
_SPECIAL POPULATIONS_
DOSAGE ADJUSTMENT IN THE ELDERLY
Since sildenafil clearance is reduced in elderly patients, a first
dose of 25 mg should be
considered. Based on efficacy and toleration, the dose may be
increased to 50 mg and 100 mg.
DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT
The dosing recommendations for adults should be followed for patients
with mild to moderate renal
impairment (CrCl = 30-80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (CrCl
<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