LEVITRA 10 vardenafil 10 mg (as hydrochloride trihydrate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vardenafil hydrochloride trihydrate, Quantity: 11.852 mg (Equivalent: vardenafil, Qty 10 mg)

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; macrogol 400; hypromellose; titanium dioxide; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

6 tablets, 2 tablets, 8 tablets, 1 tablet (sample), 4 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LEVITRA is indicated for the treatment of erectile dysfunction in adult males (inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). LEVITRA is not indicated for use by women.

Product summary:

Visual Identification: Orange (light orange to grey-orange), round film coated tablet with Bayer cross on one side and "10" on the other.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2003-04-08

Patient Information leaflet

Levitra 5 10 & 20 CMI
1
LEVITRA
® 5
(LA·VEE·TRAH)
LEVITRA
® 10
(LA·VEE·TRAH)
LEVITRA
® 20
(LA·VEE·TRAH)
_vardenafil _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about Levitra.
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 Levitra
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 LEVITRA IS
USED FOR
This medicine is used to treat
erectile dysfunction.
Erectile dysfunction, also known
as impotence in adult males, is the
inability to obtain and/or maintain
a hard erect penis sufficient for
sexual activity.
Levitra tablet contains the active
ingredient
VARDENAFIL
which works
by relaxing the blood vessels in the
penis when you are sexually
aroused. This allows blood to flow
into the penis, allowing you to get
an erection.
Levitra will only work if you are
sexually aroused. It will not
increase your sex drive.
Levitra is not addictive.
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
LEVITRA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LEVITRA IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
vardenafil hydrochloride
trihydrate
•
any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
DO NOT TAKE LEVITRA IF YOU ARE
TAKING NITRATE MEDICINES WHICH
INCLUDE
:
•
glyceryl trinitrate (also called
nitroglycerine)
•
nicorandil
•
sodium nitroprusside
•
isosorbide mononitrate
•
isosorbide dinitrate

Summary of Product characteristics

200221 LEVITRA 5, 10 & 20 PI
1
AUSTRALIAN PRODUCT INFORMATION
LEVITRA
® 5, 10 AND 20 (VARDENAFIL)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Vardenafil (as hydrochloride trihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LEVITRA
5
film-coated
tablets
contain
5
mg
vardenafil
(as
5.926
mg
of
vardenafil
hydrochloride trihydrate).
LEVITRA 10 film-coated tablets contain 10 mg vardenafil (as 11.852 mg
of vardenafil
hydrochloride trihydrate).
LEVITRA 20 film-coated tablets contain 20 mg vardenafil (as 23.705 mg
of vardenafil
hydrochloride trihydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
LEVITRA 5, 10 and 20 tablets are orange film-coated round tablets
marked with the BAYER
cross on one side and the dose strength (“5”, “10” or
“20”) on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LEVITRA is indicated for the treatment of erectile dysfunction in
adult males (inability to
achieve or maintain penile erection sufficient for satisfactory sexual
performance).
LEVITRA is not indicated for use by women.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
The recommended starting dose of LEVITRA is 10 mg, taken orally 25 to
60 minutes before
sexual activity. Sexual activity can be initiated as soon as 15
minutes and as long as 4 – 5
hours after taking LEVITRA. Depending on co-morbidities and
concomitant medications, it
may be necessary to commence on a lower dose of 5 mg film-coated
tablet.
The maximum recommended dose frequency is once daily.
200221 LEVITRA 5, 10 & 20 PI
2
METHOD OF ADMINISTRATION
LEVITRA can be taken with or without food.
Sexual stimulation is required for a natural response to treatment.
DOSAGE ADJUSTMENT
Based on efficacy and tolerability, the LEVITRA dose may be increased
to 20 mg or decreased
to 5 mg. The maximum recommended dose is 20 mg once daily.
RENAL IMPAIRMENT
No dose adjustment is needed in patients with mild (CL
cr
> 50-80 mL/min), moderate (CL
cr
>
30-50 mL/min) or severe (CL
cr
< 30 mL/m