Sildegra 100mg tablets

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

SILDENAFIL CITRATE

Tersedia dari:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Nama Internasional):

SILDENAFIL CITRATE

Unit dalam paket:

4tablet Tablets

Diproduksi oleh:

Sandoz Private Limited

Selebaran informasi

_Consumer Medication Information Leaflet (RiMUP)_
1
SILDEGRA

Sildenafil citrate (100 mg tablets)
WHAT IS IN THIS LEAFLET
1.
What Sildegra is used for
2.
How Sildegra works
3.
Before you use Sildegra
4.
How to use Sildegra
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Sildegra
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SILDEGRA IS USED FOR
Sildegra is a treatment for 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 SILDEGRA WORKS
Sildegra 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. Sildegra will only
help you to get an erection if you are
sexually stimulated. You should not take
Sildegra if you do not have erectile
dysfunction. You should not take
Sildegra if you are a woman.
BEFORE YOU USE SILDEGRA_ _
-
_When you must not take it _
Do not take Sildegra
•
If you are allergic
(hypersensitive) to sildenafil or
any of the other ingredients of
Sildegra.
•
If you are taking medicines
containing nitrates, or nitric oxide
donors such as amyl nitrite
("poppers"). These medicines are
often given for relief of angina
pectoris (or "chest pain").
Sildegra can cause a serious
increase in the effects of these
medicines. Tell your doctor if
you are taking any of these
medicines. If you are not certain,
ask your doctor or pharmacist.
•
If you have a severe heart or liver
problem.
•
If you have recently had a stroke
or a heart attack, or if you have
low blood pressure.
•
If you have certain rare inherited
eye diseases (such as retinitis
pigmentosa).
•
If you have ever had loss of
vision because of non-arteritic
anterior ischaemic optic
neuropathy (NAION)
_ _
-
_Before you start to use it _
Tell your doctor
•
If you have sickle cell anaemia
(an abnormality of red blood
cells

Karakteristik produk

1.
NAME OF THE MEDICINAL PRODUCT
Sildegra
®
100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sildegra
®
100 mg tablets
Each tablet contains 100 mg of sildenafil (as citrate).
3.
PHARMACEUTICAL FORM
Tablet.
Sildegra
®
100 mg tablets are light blue, round, slightly dotted tablets, with
cross breaking notch on both
sides and debossment “100” on one side.
The tablet can be divided into equal quarters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil is indicated in adult men with 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
POSOLOGY
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.
If sildenafil is taken with food, the onset of activity may be delayed
compared to the fasted state (see
section 5.2).
Use in Patients with Impaired Renal Function
Dose 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
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 of sildenafil in a 48-
hour period.
A starting dose of 25 mg should be considered in patien