SPEDRA avanafil 50 mg tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

avanafil, Quantity: 50 mg

Boleh didapati daripada:

A Menarini Australia Pty Ltd

INN (Nama Antarabangsa):

avanafil

Borang farmaseutikal:

Tablet, uncoated

Komposisi:

Excipient Ingredients: magnesium stearate; mannitol; fumaric acid; calcium carbonate; hyprolose; iron oxide yellow

Laluan pentadbiran:

Oral

Unit dalam pakej:

8, 4, 12, 1, 2

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Treatment of erectile dysfunction in adult males.

Ringkasan produk:

Visual Identification: The 50 mg tablets are pale yellow, oval tablets debossed with 50 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status kebenaran:

Licence status A

Tarikh kebenaran:

2016-04-06

Risalah maklumat

SPEDRA
®
_avanafil_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SPEDRA.
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 SPEDRA
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 SPEDRA IS USED
FOR
SPEDRA is used to treat erectile
dysfunction, more commonly known
as impotence, in adult men. This is
when a man cannot get, or keep, a
hard erect penis suitable for sexual
activity.
SPEDRA belongs to a group of
medicines called phosphodiesterase
type 5 inhibitors.
SPEDRA contains the active
ingredient avanafil which works by
relaxing the blood vessels in your
penis. This increases the blood flow
into your penis, helping it stay hard
and erect when you get sexually
aroused. SPEDRA does not cure your
condition.
It is important to note that SPEDRA
only works if you are sexually
aroused. SPEDRA will not increase
your sex drive.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU TAKE
SPEDRA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SPEDRA IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing avanafil
•
any of the ingredients listed at the
end of this leaflet.
Some symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing
•
rash, itching or hives on the skin.
DO NOT TAKE SPEDRA IF YOU ARE
TAKING NITRATE MEDICINES WHICH
INCLUDE:
•
glyceryl trinitrate (also called
nitroglycerin)
•
nicorandil
•
sodium nitroprusside
•
isosorbide mononitrate
•
isosorbide dinitrate
•
amyl nitrite (also known as
poppers, amyl or rush).
SPEDRA has

Ciri produk

AUSTRALIAN PRODUCT INFORMATION –
SPEDRA
® (AVANAFIL)
SPEDRA PI version A3.0
Page 1 of 22
1. NAME OF THE MEDICINE
Avanafil
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SPEDRA tablets contain 50 mg, 100 mg and 200 mg of avanafil.
SPEDRA
tablets
contain
the
following
inactive
ingredients:
mannitol,
fumaric
acid,
hyprolose, calcium carbonate, magnesium stearate and iron oxide
yellow.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
SPEDRA avanafil 50 mg tablets are pale yellow, oval tablets debossed
with ‘50’ on one
side.
SPEDRA avanafil 100 mg tablets are pale yellow, oval tablets debossed
with ‘100’ on one
side.
SPEDRA avanafil 200 mg tablets are pale yellow, oval tablets debossed
with ‘200’ on one
side.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
4.2
DOSE AND METHOD OF ADMINISTRATION
Use in adult men
The recommended dose is 100 mg taken as needed approximately 15-30
minutes before
sexual activity. Based on individual efficacy and tolerability, the
dose may be increased to a
maximum dose of 200 mg or decreased to 50 mg. The lowest dose that
provides benefit
should be used and the additional efficacy of the 200 mg dose could be
limited. The
maximum recommended dosing frequency is once per day. SPEDRA is
intended for use
prior to anticipated sexual activity. In order for SPEDRA to be
effective, sexual stimulation
is required.
SPEDRA may be taken with or without food. If SPEDRA is taken with
food, the onset of
activity may be delayed compared to the fasted state.
In those patients who are stable on alpha-blocker therapy, SPEDRA
should be initiated at
the lowest dose of 50 mg (see section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS
FOR USE, Concomitant use with alpha blockers). _ _
SPEDRA PI version A3.0
Page 2 of 22
Use in Elderly (≥ 65 years old)
Dose adjustments are not required in elderly patients. However, it
should be considered
that co-morbidities increase with age.
Patients with Renal impairment
Dose ad