VIAGRA 50MG TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

SILDENAFIL CITRATE

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

SILDENAFIL CITRATE

Unit dalam pakej:

4Tablet Tablets; 1Tablet Tablets

Dikeluarkan oleh:

Fareva Amboise

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
VIAGRA
®
TABLETS
Sildenafil Citrate (50 mg, 100 mg)
1
WHAT IS IN THIS LEAFLET:
1.
What VIAGRA is used for
2.
How VIAGRA works
3.
Before you use VIAGRA
4.
How to use VIAGRA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
VIAGRA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT VIAGRA IS USED FOR
VIAGRA is a treatment for
adult men with erectile
dysfunction, sometimes known
as impotence. This is when a
man cannot get, or keep a hard,
erect penis suitable for sexual
activity.
HOW VIAGRA WORKS
VIAGRA contains the active
substance sildenafil, which
belongs to a group of
medicines called
phosphodiesterase type 5
inhibitors. It works by helping
to relax the blood vessels in
your penis, allowing blood to
flow into your penis when you
get sexually excited. VIAGRA
will only help you to get an
erection if you are sexually
stimulated.
BEFORE YOU USE VIAGRA
-
_When you must not use it_
-
If you are taking medicines
containing nitrates, nitrites
or nitric oxide donors.
-
If you are allergic
(hypersensitive) to
sildenafil or any of the
other ingredients of
VIAGRA.
-
If you are taking riociguat.
This medicine is used to
treat pulmonary arterial
hypertension (i.e., high
blood pressure in the
lungs) and chronic
thromboembolic
pulmonary hypertension
(i.e., high blood pressure in
the lungs caused by blood
clots).
_Pregnancy and lactation_
VIAGRA is not indicated for
use by women.
Ask your doctor or
pharmacist for advice before
taking any medicine.
-
_Before you start to use it_
Tell your doctor
-
If you have sickle cell
anaemia (an abnormality of
red blood cells), leukaemia
(cancer of blood cells),
multiple myeloma (cancer
of bone marrow) or any
disease or deformity of
your penis. These
conditions may require
special care when taking
medicines for erectile
dysfunction.
-
If you have problems with
your heart. Your doctor
should carefully check
whether your heart can
take the additional strain of
hav

Ciri produk

1
VIAGRA
®
50MG & 100MG
Sildenafil Citrate
1.
NAME OF THE MEDICINAL PRODUCT
VIAGRA
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VIAGRA 50 mg: Each tablet contains sildenafil citrate equivalent to 50
mg sildenafil.
VIAGRA 100 mg: Each tablet contains sildenafil citrate equivalent to
100 mg sildenafil.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, rounded-diamond
shaped film-coated tablets equivalent to
50 mg
and
100 mg
of
sildenafil for oral administration, marked “PFIZER” on one side
and “VGR 50”, or “VGR 100”
on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil is indicated for the treatment of erectile dysfunction,
which is the inability to achieve
or maintain a penile erection sufficient for satisfactory sexual
performance.
In order for sildenafil to be effective, sexual stimulation is
required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sildenafil tablets are for oral administration.
USE IN ADULTS
For most patients, the recommended dose is 50 mg taken, as needed,
approximately 1 hour
before sexual activity. Based on effectiveness and toleration, the
dose may be increased to a
maximum recommended dose of 100 mg or decreased to 25 mg. The maximum
recommended
daily dose is 100 mg. The maximum recommended dosing frequency is once
per day.
USE IN PATIENTS WITH IMPAIRED RENAL FUNCTION
Dosage adjustments are not required in patients with mild to moderate
renal impairment
(creatinine clearance = 30 - 80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (creatinine
clearance <30 mL/min), a 25 mg dose should be considered.
USE IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION
Since sildenafil clearance is reduced in patients with hepatic
impairment (e.g., cirrhosis), a
25 mg dose should be considered.
USE IN PATIENTS USING OTHER MEDICATIONS
2
Given the extent of the interaction with patients receiving
concomitant therapy with ritonavir
(see section 4.5), it is recommended not to exceed a maximum single
dose of 25 mg