VIAGRA 25 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

SILDENAFIL AS CITRATE

Διαθέσιμο από:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

G04BE03

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

SILDENAFIL AS CITRATE 25 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

FAREVA AMBOISE, FRANCE

Θεραπευτική ομάδα:

SILDENAFIL

Θεραπευτική περιοχή:

SILDENAFIL

Θεραπευτικές ενδείξεις:

Treatment of erectile dysfunction.

Ημερομηνία της άδειας:

2023-06-30

Φύλλο οδηγιών χρήσης

ةصصخملا ةيودلأا ةصاخ ،
ً
اررض ببسي دق ىرخأ ةيودأ عم ارچايڤ
ةكراشم نإ
ةلاح ثودح لاح يف .(angina pectoris ،ةيردص ةحبذ)
ردصلا ملأ جلاعل
ارچايڤ تلوانت كنأب يلديصلا وأ ة/ضرمملا
،بيبطلا علاطإ كيلع ،ةئراط ةيبط
كل ردصأ اذإ لاإ ىرخأ ةيودأ ةكراشمب
ارچايڤ لامعتسإ زوجي لا .هلوانت دعومبو
.كلذ نكمي هنأب تاميلعت بيبطلا
:ةيلاتلا ةيودلأا لوانتت تنك اذإ ارچايڤ
لامعتسإ زوجي لا
دق عونلا اذه نم ةيودأ عم ةكراشملا نلأ
،تارتنلا تارضحتسم ىمست ةيودأ
●
ةيودأ لوانتت تنك اذإ بيبطلا رشتسإ
.مدلا طغض يف ريطخ ضافخنإ ىلإ يدؤي
ملأ ،ةيردصلا ةحبذلا) ةيردصلا ةحبذلا
جلاعل ةداع لمعتست يتلا عونلا اذه نم
.(ردصلا يف
يه ةكراشملا هذه نلأ ،ليملأا تيرتن لثم
كيرتنلا ديسكأ تاحنام ىمست ةيودأ
●
.مدلا طغض يف ريطخ ضافخنإ ىلإ يدؤت دق
ً
اضيأ
فعض) يسنجلا زجعلا جلاعل (يعضوملا وأ
يومفلا ءاطعلإاب) ىرخأ ةيودأ
●
.ةعونمم ارچايڤ عم ةكراشملا ـ (باصتنلإا
ةيعولأا يف مدلا طغض عافترإ جلاعل ىرخأ
ةيودأ وأ (riociguat) تاوچيسوير
●
.ةعونمم ارچايڤ عم ةكراشملا ـ ةئرلا يف
ةيومدلا
:ةيفاضإ ةيودأ
،(تايرطفلل داضم) لوزانوكوتيك ،(ةدعملا
ةضومح ضفخل) نيديتيميس ●
.(يويح داضم) نيسيمورتيرإ
(ريڤانوتير ،ريڤانيوكاس لثم) زآيتورﭘ HIV
تاطبثم عون نم زديلإا جلاعل ةيودأ
●
رادقملا بيبطلا كل فصي نأ زئاجلا نم
.مدلا يف ارچايڤ زي

Αρχείο Π.Χ.Π.

VIAGRA LPD CC 211122
1
S
TABLET
FILM COATED
& 100 MG
MG
50
,
25 MG
®
A
VIAGR
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VIAGRA
®
25 mg
VIAGRA
®
50 mg
VIAGRA
®
100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet
contains sildenafil citrate
equivalent to 25, 50 or 100 mg of sildenafil.
Excipient with known effect
VIAGRA
®
25 mg tablets
Each tablet contains 0.9 mg lactose monohydrate
VIAGRA
®
50 mg tablets
Each tablet contains 1.7 mg lactose monohydrate
VIAGRA
®
100 mg tablets
Each tablet contains 3.5 mg lactose monohydrate
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Film coated tablet.
VIAGRA25 mg tablets
Blue, film coated, rounded diamond-shaped tablets, marked "PFIZER" on
one side and
"VGR 25" on the other.
VIAGRA50 mg tablets
Blue, film coated, rounded diamond-shaped tablets, marked "PFIZER" on
one side and
"VGR 50" on the other.
VIAGRA100 mg tablets
Blue, film coated, rounded diamond-shaped tablets, marked "PFIZER" on
one side and
"VGR 100" on the other.
VIAGRA LPD CC 211122
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIAGRA is indicated for the treatment of erectile dysfunction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Sildenafil tablets are for oral administration.
USE IN ADULTS
The recommended dose is 50 mg taken as needed approximately one hour
before sexual
activity. Based on efficacy and tolerability, the dose may be
increased to 100 mg or decreased to
25 mg. The maximum recommended dose is 100 mg. The maximum
recommended dosing frequency is once per day. If VIAGRA
®
is taken with food, the onset of
activity may be delayed compared to the fasted state (see section
5.2).
Special populations
_Elderly: _
Dosage adjustments are not required in elderly patients (
≥ 65 years old)
.
R
_enal impairment _
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 (creat