Apo-Sildenafil 50mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sildenafil (sildenafil citrate)

Available from:

Apotex Inc.

ATC code:

G04BE03

INN (International Name):

sildenafil (sildenafil citrate)

Dosage:

50mg

Pharmaceutical form:

tablets

Units in package:

(4/1x4/) blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-03-25

Patient Information leaflet

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
PR
APO-SILDENAFIL
(SILDENAFIL CITRATE TABLETS)
THIS LEAFLET IS PART III OF A THREE-PART "PRODUCT MONOGRAPH"
PUBLISHED WHEN APO-SILDENAFIL WAS APPROVED FOR SALE IN
CANADA AND IS DESIGNED SPECIFICALLY FOR CONSUMERS. THIS
LEAFLET IS A SUMMARY AND WILL NOT TELL YOU EVERYTHING ABOUT
APO-SILDENAFIL. CONTACT YOUR DOCTOR OR PHARMACIST IF YOU
HAVE ANY QUESTIONS ABOUT THE DRUG.
ABOUT THIS MEDICATION
WHAT THE MEDICATION IS USED FOR:
APO-SILDENAFIL is a treatment for erectile dysfunction in male
adults. This is when a man cannot achieve or maintain a hard,
erected penis for satisfactory sexual activity.
It is important to note that APO-SILDENAFIL works only with
sexual stimulation. APO-SILDENAFIL alone does not increase
your sex drive.
WHAT IT DOES:
APO-SILDENAFIL belongs to a class of medicine called
phosphodiesterase type 5 (PDE5) inhibitors. Following
sexual stimulation, APO-SILDENAFIL works by helping to relax
the blood vessels in your penis by allowing blood to flow into your
penis. This results in improved erectile function.
WHEN IT SHOULD NOT BE USED:
·
If you are taking any medicines containing nitrates in any form
(oral, sublingual [under the tongue], skin patch, or by inhalation
[spray]). Although APO-SILDENAFIL is used occasionally,
nitrates must never be used. Nitrates are found in many
prescription medicines that are used in the treatment of angina
pectoris (chest pain due to heart disease), such as nitroglycerin,
isosorbide mononitrate, or isosorbide dinitrate. If you do not
understand what nitrates are, or are unsure about whether a
medication you are taking is a “nitrate”, ask your doctor or
pharmacist.
IF YOU TAKE APO-SILDENAFIL WITH NITRATE-CONTAINING
MEDICINES OR ANY OTHER NITRATES (E.G., AMYL NITRITE
“POPPERS”), YOUR BLOOD PRESSURE COULD SUDDENLY DROP TO
A LIFE-THREATENING LEVEL. YOU COULD GET DIZZY, FAINT, OR EVEN
HAVE A HEART ATTACK OR STROKE.
·
If you have ever had an allergic reaction to sildenafil citrate or
the nonmedicinal ingredients

Summary of Product characteristics

APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page 1 of 28
1. NAME OF THE MEDICINAL PRODUCT
APO-SILDENAFIL Tablets 25 mg and 50 mg
(Sildenafil Citrate Tablets 25 mg and 50 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPONENT
FUNCTION
% W/W
MG/TABLET
25 MG
50 MG CORE TABLET
Sildenafil Citrate
Active
36.84
35.0*
70.0**
Microcrystalline Cellulose NF
PH 102
Filler
60.82
57.78
115.56
Magnesium Stearate NF
Lubricant
1.71
1.625
3.25
Croscarmellose Sodium NF
Disintegrant
0.526
0.5
1.0
Colloidal Silicon Dioxide NF
Glident
0.105
0.1
0.2
TOTAL CORE TABLET WEIGHT
100
95.0
190.0
FILM COATING
Hydroxypropyl Cellulose NF
TYPE LF
Film coating agent
4.0
0.8
1.6
Hydroxypropyl Methylcellulose
2910 USP E5
Film coating agent
1.0
0.2
0.4
Polyethylene Glycol 8000 NF
Solubiliser
2.0
0.4
0.8
Titanium Dioxide USP
Opacifier
3.5
0.7
1.4
Indigotine AL Lake 12-14%
(Blue #2)
Colouring agent
0.5
0.1
0.2
Purified Water USP***
Carrier
89
--
--
TOTAL FILM-COATING SOLUTION
100
20
40
TOTAL FILM-COATING SOLUTION (EXCLUDING WATER)
11
2.2
4.4
TOTAL FILM COATED TABLET WEIGHT
--
97.2
194.4
* 35 mg Sildenafil Citrate is equivalent to 25 mg Sildenafil
** 70 mg Sildenafil Citrate is equivalent to 50 mg Sildenafil
*** Purified water, used in coating solution, is removed during the
drying process
3. PHARMACEUTICAL FORM
Tablets
APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page 2 of 28
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION (WHERE APPROPRIATE DOSAGE
ADJUSTMENTS IN SPECIFIC PATIENT GROUP SHOULD BE STATED)
DOSING CONSIDERATIONS
The following factors are associated with increased plasma levels
(AUC) of sildenafil:
•
age 65 years or over (40%)
•
hepatic impairment (e.g. cirrhosis: 84%)
•
severe renal impairment (e.g. creatinine clearance <30 mL/min: 100%)
•
concomitant use