Avigra

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Sildenafil citrate 140.45mg equivalent to 100 mg sildenafil;  

Disponible desde:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Designación común internacional (DCI):

Sildenafil citrate 140.45 mg (= 100 mg sildenafil)

Dosis:

100 mg

formulario farmacéutico:

Film coated tablet

Composición:

Active: Sildenafil citrate 140.45mg equivalent to 100 mg sildenafil   Excipient: Calcium hydrogen phosphate Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry blue OY-LS-20921 Opadry clear YS-2-19114-A Purified water

Unidades en paquete:

Blister pack, PVC/Al, 1 tablet

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Pfizer Ireland Pharmaceuticals

indicaciones terapéuticas:

Indicated for the treatment of erectile dysfunction in adult males.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PCTFE (Aclar)/Al or PVC/Al - 1 tablets - 5 years from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PCTFE (Aclar)/Al or PVC/Al - 4 tablets - 5 years from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PCTFE (Aclar)/Al or PVC/Al - 8 tablets - 5 years from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PCTFE (Aclar)/Al or PVC/Al - 12 tablets - 5 years from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 4 tablets - 5 years from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 8 tablets - 5 years from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 12 tablets - 5 years from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 24 tablets - 5 years from date of manufacture stored at or below 30°C

Fecha de autorización:

2010-07-09

Información para el usuario

AVIGRA
®
_sildenafil (as citrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Avigra.
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
Avigra against the benefits it is
expected to have for you.
Avigra should be used only 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 AVIGRA IS USED
FOR
Avigra 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.
Avigra 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.
Avigra will work only if you are
sexually excited.
Avigra will not increase your sex
drive.
Avigra is not for use in women.
This medicine is available only with
a doctor's prescription or from a
pharmacist trained to supply
sildenafil without a doctor's
prescription.
BEFORE YOU TAKE
AVIGRA
_WHEN YOU MUST NOT TAKE IT _
YOU MUST NOT TAKE
AVIGRA IF YOU ARE TAKING
NITRATES OR NITRITE
MEDICATIONS. 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 AVIGRA.
DO NOT TAKE AVIGRA IF YOU ARE BEING
TREATED FOR ANGINA (CHEST PAIN) OR
OTHER HEART CONDITIONS WITH CERTAIN
MEDICINES CALLED NITRATES.
Nitrate medicines include glyceryl
trinitrate (also called nitroglycerin).
Common trade names for glyceryl
trinitrate tablets include Anginine,
and Lycinate.
A common trade name for glyceryl
trini

Ficha técnica

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
AVIGRA

25 mg, 50 mg and 100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg tablet contains 25 mg sildenafil citrate
Each 50 mg tablet contains 50 mg sildenafil citrate
Each 100 mg tablet contains 100 mg sildenafil citrate
EXCIPIENTS WITH KNOWN EFFECT
•
Lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
AVIGRA 25 mg tablets are blue film-coated, rounded diamond-shaped
tablets, marked
PFIZER on one side and VGR 25 on the other.
AVIGRA 50 mg tablets are blue film-coated, rounded diamond-shaped
tablets, marked
PFIZER on one side and VGR 50 on the other.
AVIGRA 100 mg tablets are blue film-coated, rounded diamond-shaped
tablets, marked
PFIZER on one side and VGR 100 on the other.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS _ _
AVIGRA is indicated for the treatment of erectile dysfunction in adult
males.
4.2 DOSE AND METHOD OF ADMINISTRATION
AVIGRA tablets are for oral administration.
DOSE
USE IN 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 AVIGRA is taken with food, the onset of activity
may be delayed compared
to the fasted state (see section 5.2).
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Page 2 of 15
USE IN CHILDREN
AVIGRA is not indicated for use in children.
DOSE ADJUSTMENTSDOSAGE 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 Use in Adults should be followed for
patients with mild to
moderate renal impairment (Clcr = 30–80 mL/min).
Since
sildenafil
clearance
is
reduce