Levitra

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Vardenafil 20mg (As vardenafil hydrochloride trihydrate 23.705mg)

متاح من:

Bayer New Zealand Limited

INN (الاسم الدولي):

Vardenafil 20 mg (As vardenafil hydrochloride trihydrate 23.705mg)

جرعة:

20 mg

الشكل الصيدلاني:

Film coated tablet

تركيب:

Active: Vardenafil 20mg (As vardenafil hydrochloride trihydrate 23.705mg) Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Iron oxide red Iron oxide yellow Macrogol 400 Magnesium stearate Microcrystalline cellulose Titanium dioxide

الوحدات في الحزمة:

Blister pack, 1 tablet

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Bayer AG

ملخص المنتج:

Package - Contents - Shelf Life: Blister pack, - 1 tablets - 30 months from date of manufacture stored at or below 25°C - Blister pack, - 2 tablets - 30 months from date of manufacture stored at or below 25°C - Blister pack, - 4 tablets - 30 months from date of manufacture stored at or below 25°C - Blister pack, - 6 tablets - 30 months from date of manufacture stored at or below 25°C - Blister pack, - 8 tablets - 30 months from date of manufacture stored at or below 25°C - Blister pack, - 12 tablets - 30 months from date of manufacture stored at or below 25°C

تاريخ الترخيص:

2002-01-31

نشرة المعلومات

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

خصائص المنتج

LEVITRA
Page 1 of 21
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
LEVITRA® vardenafil (as hydrochloride trihydrate) film coated
tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LEVITRA 5 mg film-coated tablets (5.926 mg of vardenafil hydrochloride
trihydrate).
LEVITRA 10 mg film-coated tablets (11.852 mg of vardenafil
hydrochloride trihydrate).
LEVITRA 20 mg film-coated tablets (23.705 mg of vardenafil
hydrochloride trihydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
4
CLINICAL PARTICULARS
4.1
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.
4.2
Dose and method of administration
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. LEVITRA 10 mg orodispersible tablet is not bioequivalent to
LEVITRA 10 mg film-coated
tablet; therefore, the orodispersible formulation should not be used
as an equivalent to LEVITRA 10
mg film-coated tablets.
The maximum recommended dose frequency is once per day.
LEVITRA can be taken with or without food.
Sexual stimulation is required for a natural response to treatment.
_Dose adjustment _
Based on efficacy and tolerability, the LEVITRA dose may be increased
to one LEVITRA 20 mg film-
coated tablet or decreased to one LEVITRA 5 mg film-coated tablet. The
maximum daily recommended
dose is one LEVITRA 20 mg film-coated tablet.
_Elderly (above 65 years) _
Dose adjustment is not required in elderly patients.
_Children (from birth to 16 years) _
LEVITRA is not indicated for use in children.
_Hepatic impairment _
No dose adjustment is needed in patients with mild hepatic impairment
(Child-Pugh A).
LEVITRA
Page 2 of 21
As vardenafil clearance is reduced in patients with moderate hepatic
impairment Ch