AJENAFIL 25 MG CHEWABLE TABLET

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

SILDENAFIL CITRATE

Διαθέσιμο από:

AJ RESEARCH & PHARMA SDN. BHD.

INN (Διεθνής Όνομα):

SILDENAFIL CITRATE

Μονάδες σε πακέτο:

4tablet Tablets

Κατασκευάζεται από:

GENEPHARM S.A

Φύλλο οδηγιών χρήσης

_Consumer Medication Information Leaflet (RiMUP) _
1
AJENAFIL CHEAWABLE TABLET
Sildenafil Citrate 25mg, 50mg and 100mg
WHAT IS IN THIS LEAFLET
1.
What Ajenafil Chewable
Tablet is used for
2.
How Ajenafil Chewable
Tablet it works
3.
Before you use Ajenafil
Chewable Tablet
4.
How to use Ajenafil
Chewable Tablet
5.
While you are using
Ajenafil Chewable Tablet
6.
Side Effect
7.
Storage and Disposal
Ajenafil Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT AJENAFIL CHEWABLE
TABLET IS USED FOR:
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 AJENAFIL CHEWABLE
TABLET WORKS:
Ajenafil contains the active
substance sildenafil which
belongs to a group of
medicines called
phosphodiesterase type 5
(PDE5) 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.
Ajenafil will only help you to
get an erection if you are
sexually stimulated.
BEFORE YOU USE AJENAFIL
CHEWABLE TABLET:
_When you must not use it: _

Hypersensitivity to the active
substance or to any of the
excipients.

Sexual activity is inadvisable.

Have loss of vision in one
eye because of Non-Arteritic
Anterior Ischaemic Optic
Neuropathy (NAION).

Severe hepatic impairment,
hypotension (blood pressure
<90/50 mmHg), recent
history of stroke or
myocardial infarction and
known hereditary
degenerative retinal disorders
such as
_retinitis pigmentosa._
_Before you start to use it: _
Tell your healthcare provider
about all the medicines you
take,
including prescription
and over-the-counter
medicines, vitamins,
and herbal supplements.
_Taking other medicines _
Tell your healthcare provider
if you take any of the
following:

CYP3A4 inhibitor such as
Ketoconazole,erythromycin
and cimetidine.

Medicines called HIV
protease inhibitors, such as
ritonavir, saquinavir

Antacid such as magnesium

Αρχείο Π.Χ.Π.

Proposed Package Insert
Brand or Product Name
Ajenafil Chewable Tablet 25 mg
Ajenafil Chewable Tablet 50 mg
Ajenafil Chewable Tablet 100 mg Name and Strength
Each chewable tablet 25 mg sildenafil formed in situ from 35.15 mg sildenafil citrate
Each chewable tablet 50 mg sildenafil formed in situ from 70.24 mg sildenafil citrate
Each chewable tablet 100 mg sildenafil formed in situ from 140.48 mg sildenafil citrate
Product Description
25 mg: White, triangular, with a side of 7.3 mm, biconvex, embossed with “25” on one side.
50 mg: White, triangular, with a side of 8.8 mm, biconvex, embossed with “50” on one side.
100 mg : White, triangular, with a side of 11.8 mm, biconvex, embossed with “100” on one side.
Pharmacodynamics/ Pharmacokinetics
Pha rmacotherapeutic group: Selective Phosphodiesterase -5 (PDE -5) Inhibitor
ATC -code: G04B E03
Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i.e. with sexual
stimulation, it restores impaired erectile function by increasing blood flow to the penis.
The physiological mechanism responsible for erection of the penis involves the release of nitric
oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide then activates the
enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate
(cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of
blood.
Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in
the corpus cavernosum, where PDE5 is responsible for degradation of cGMP. Sildenafil has a
peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human
corpus cavernosum but potently enhances the relaxant eff ect of NO on this tissue. When the
NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil
results in increased corpus cavernosum levels of cGMP. Therefore sexual stimulation is required in
order for sildenafil to produce its in