VIAGRA 25 MG

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
SILDENAFIL AS CITRATE
Available from:
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
ATC code:
G04BE03
Pharmaceutical form:
FILM COATED TABLETS
Composition:
SILDENAFIL AS CITRATE 25 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
FAREVA AMBOISE, FRANCE
Therapeutic group:
SILDENAFIL
Therapeutic area:
SILDENAFIL
Therapeutic indications:
Treatment of erectile dysfunction.
Authorization number:
111 36 29459 00
Authorization date:
2013-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

04-10-2020

88xxxxx

.םדב

הרגאיווה זוכיר תא תולעהל תולולע ןהש ןוויכמ )ריונוטיר .רתויב ךומנה ןונימה תא ךל םושרי אפורהש ןכתיי

רתיב לופיטל( ןיצוזסקוד ומכ אפלא ימסוח תצובקמ תופורת ששחמ - )תינומרעה תטולב לש הלדגהב לופיטל וא םד ץחל לולע

הרגאיו םע וז הפורת לש בוליש .םד ץחלב הדיריל םד ץחלמ םרגנה ,תרוחרחס וא רורחס לש השוחתל םורגל ךלהמב תורקל לולע בורל .רהמ םידמענ וא םיבשייתמשכ ךומנ תא ךל םושרי אפורהש ןכתיי .

הרגאיו תליטנ רחאל תועש 4 .רתויב ךומנה ןונימה ןוזמו הפורתב שומיש החורא רחאל םלוא ,החורא אלל וא םע הפורתה תא לוטיל ןתינ .בכעתהל הלולע הפורתה תעפשה תליחת הדבכ לוהוכלא תכירצו הפורתב שומיש לבקל ידכ ;הפקז תעפוהב תינמז עירפהל הלולע לוהוכלא תכירצ תומכב לוהוכלא ךורצל אל ץלמומ ,הפורתהמ תילאמיסקמ תלעות .הפורתה תליטנ ינפל הבר הקנהו ןויריה .םישנב שומישל תדעוימ הניא וז הפורת תונוכמב שומישו הגיהנ ךילע .הייארה לע עיפשהלו תרוחרחסל םורגל הלולע

הרגאיו ליעפמ וא גהונ התאש ינפל הפורתל ביגמ התא דציכ בל םישל .תונוכמ הפורתה לש םיביכרמהמ קלח לע בושח עדימ שיגר התא יכ אפורה י"ע ךל רמאנ םא .זוטקל הליכמ הפורתה ינפל אפורה םע רשק רוציל שי ,זוטקל ומכ םימייוסמ םירכוסל

הרגאיווב שומישה ?הפורתב שמתשת דציכ .3 ךילע .אפורה תוארוהל םאתהב דימת רישכתב שמתשהל שי ןפואלו ןונימל עגונב חוטב ךניא םא חקורה וא אפורה םע קודבל .רישכתב שומישה לבוקמה ןונימה .דבלב אפורה ידי לע ועבקי לופיטה ןפואו ןונימה .ןימ יסחי םויק ינפל העשכ תחא הילבט :אוה ללכ ךרדב .תצלמומה הנמה לע רובעל ןיא .םויב תחא הילבטמ רתוי לוטיל ןיא ןמזה .דבלב ינימ יוריג לש בצמב הפקז לבקל ךל רוזעת

הרגאיו כ"דבו םדאל םדאמ הנתשמ דובעל ליחתהל הפורתל חקול וב ךורא ןמז הפורתל חקול יכ הלגתש ןכתיי .העש - העש יצחכ חקול .הדבכ החורא םע תחקלנ םא דובעל ליחתהל רתוי םע ץעייתה ךרובע ידמ הקזח וא השלח הפורתה יכ שח התא םא .חקורה וא אפורה הפקזה םא וא הפקז לבקל ךל תרזוע הניא

הרגאיו םא ןימ יסחי תמלשהל דמעמ ןמז קיפסמ הקיזחמ הניא תלבקתמש .אפורה םע ץעייתה ,םיאלמ התומלשב הפורתה תא עולבל שי .סועלל וא תוצחל ,שותכל רוסא .םימ טעמ םע הנפ ,הפורתה ןמ דלי עלב תועטב םא וא רתי תנמ תלטנ םא .ךתיא הפורתה תזירא אבהו םילוח תיב לש ןוימ רדחל דימ יאוולה תועפותב הפרחהמ לובסתש ןכתיי ,רתי ןונימ תלטנ םא .הפורתה תוליעי תא תולעמ ןניא ג"מ 100 ל לעמ תונמ .ןתרמוחבו םעפ לכב הנמהו תיוותה קודב !ךשוחב תופורת לוטיל ןיא .םהל קוקז ךניה םא םייפקשמ בכרה .הפורת לטונ ךניהש ץעוויה ,הפורתב שומישל עגונב תופסונ תולאש ךל שי םא .חקורב וא אפורב יאוול תועפות .4 יאוול תועפותל םורגל לולע

הרגאיווב שומישה ,הפורת לכב ומכ ,יאוולה תועפות תמישר ארקמל להבית לא .םישמתשמהמ קלחב .ןהמ תחא ףאמ לובסת אלש ןכתיי תולק ללכ ךרדב ןה

הרגאיו םע שומישב וחוודש יאוולה תועפות .רצק ןמז תוכשמנו תונותמ דע :לש הרקמב אפורל דימ תונפלו שומישה תא קיספהל שי

ךותמ 1 דע לע עיפשהל היושע( החיכש אל – תיגרלא הבוגת ,המישנב םיימואתפ םיפוצפצ םיללוכ םינימסתה ;)שיא 100 ,םינפה ,םייפעפעה לש תוחפנתה ,תרוחרחס וא םושנל ישוק .ןורגה וא םייתפשה

הז םא ;חיכש אל – ןימ יסחי םויק רחאל וא ךלהמב הזח באכ יצח תחונתב תבשל שי ,ןימ יסחי םויק רחאל וא ךלהמב הרוק באכב לופיטל םיטארטינ לוטיל ןיא .עגריהל תוסנלו הבישי .הזחה

שומיש רחאל החווד םיבאכב הוולמ םימעפלו תכשוממ הפקז תכשמנה הפקז הווח התא םא .)הרידנ תוחיכש(

הרגאיווב .תידיימ אפורל תונפל ךילע ,תועש 4-מ רתוי

עיפשהל יושע( רידנ ,הייאר דוביא וא הייארב תימואתפ הדירי .תידיימ אפורל תונפל שי ;)שיא 1,000 ךותמ 1 דע לע

םייושע םינימסתה – )הרידנ תוחיכש( הפירח תירוע הבוגת ,הפב תויחופלש ,רועה לש תוחפנתהו ףירח ףוליק לולכל .םוחו םייניעה ביבס ,ןימה ירביאב

.)הרידנ תוחיכש( םיסוכרפ וא םיפקתה תופסונ יאוול תועפות 1 -מ רתוי לע עיפשהל תויושע( דואמ תוחיכש יאוול תועפות :)שיא 10 ךותמ .שאר באכ 10 ךותמ 1 דע לע עיפשהל תויושע( תוחיכש יאוול תועפות :)שיא שדוג ,לוכיעה תכרעמב תוערפה ,םינפב תוימומדא ,תורוחרחס ילג ,הליחב ,הייארב תוערפה ,הייאר שוטשט ,םיעבצ תייאר ,ףאב .)ןוילעה ףוגה קלחב םוח לש תימואתפ השוחת( םוח ךותמ 1 דע לע עיפשהל תויושע( תוחיכש ןניאש יאוול תועפות :)שיא 100 ,רואל תושיגר ,תומודא םייניע ,םייניעב באכ/יוריג ,החירפ ,תואקה וא תוריהמ בל תוקיפד ,תועמוד םייניע ,הייאר תוריהב ,רוא יקזבה הדירי ,תוינונשי ,םירירש באכ ,ךומנ םד ץחל ,םד ץחל רתי ,תוקזח ,הפב שבוי ,םיינזואב םילוצלצ ,)וגיטרו( רורחס ,עגמ תשוחתב םינימסת( ףאב ימינפה יופיצב תקלד ,םימוסח וא םישודג םיסוניס סקולפיר ,הנוילע ןטב באכ ,)ףאב שדוגו תויושטעתה ,ןוניצ םיללוכ םד תוחכונ ,תופייע תשוחת ,)תברצ םיללוכ םינימסת( טשוו-הביק .םוח תשוחת ,ףאהמ םומיד ,םייפגב באכ ,ןתשב 1,000 ךותמ 1 דע לע עיפשהל תויושע( תורידנ יאוול תועפות :)שיא תימואתפ הדירי ,בלה בצקב תוערפה ,בל ףקתה ,ץבש ,ןופליע םיקלחל םד תמירזב תינמז הדירי ,העימש דוביא וא העימשב דצהמ םומיד ,הפב השוחת רסוח ,ןורגב תורציה תשגרה ,חומב

Patient leaflet in accordance with the Pharmacists’

Regulations (Preparations) - 1986

This medicine is dispensed with a doctor’s prescription

only

Viagra

®

25 mg

Viagra

®

50 mg

Viagra

®

100 mg

Film-coated tablets

Each tablet contains:

sildenafil )as citrate( 25 mg, 50 mg, 100 mg

For a list of inactive ingredients and allergens: see section 2

under “Important information about some of this medicine’s

ingredients” and section 6 “Further information”.

Read the entire leaflet carefully before using this

medicine. This leaflet contains concise information about

this medicine. If you have any further questions, consult

your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass

it on to others. It may harm them, even if it seems to you

that their medical condition is similar to yours.

This medicine is intended for adults over the age of 18

and is not intended for women.

1. WHAT IS THIS MEDICINE INTENDED FOR?

For treatment of impotence - erectile dysfunction.

Therapeutic group:

PDE5 enzyme inhibitor, causes dilation of blood vessels,

thereby improving the blood flow into the penis during

sexual stimulation.

2. BEFORE USING THE MEDICINE

Do not use this medicine if:

you are sensitive (allergic) to the active ingredient

or to any of the other ingredients contained in the

medicine.

you are intermittently or regularly taking organic

nitrates,

organic

nitrites

nitric

oxide

donors,

such as amyl nitrite, in any form )such as certain

medicines for treating angina pectoris).

concomitantly

taking

guanylate

cyclase

stimulators, such as riociguat )for treating pulmonary

hypertension).

you suffer from a severe heart or liver disease.

you have recently had a stroke or a heart attack, or

if you suffer from low blood pressure.

you suffer from a certain rare inherited eye disease

(such as retinitis pigmentosa).

you suffer or have suffered in the past from vision

loss

non-arteritic

anterior

ischemic

optic

neuropathy (NAION).

Special warnings regarding use of the medicine

Before treatment with Viagra

®

, tell your doctor if:

you suffer from sickle cell anemia (a disease of red

blood cells(, multiple myeloma )cancer of the bone

marrow) or leukemia (cancer of the blood cells).

you suffer from penis deformity or Peyronie’s Disease

(scoliosis of the penis).

you have problems with your heart. Your doctor will

check whether your heart can bear the additional

strain associated with sexual intercourse.

you suffer from a stomach ulcer, or a bleeding problem

(such as hemophilia).

you experience a sudden decrease or loss of vision;

stop the treatment and contact your doctor immediately.

Do not take Viagra

if you do not suffer from impotence

(erectile dysfunction).

Do not take Viagra

if you are a woman.

Patients with kidney or liver diseases

If you have a kidney or liver disease, your doctor may

decide on a lower dose for you.

Children and adolescents

The medicine is not intended for use under the age

of 18.

Tests and follow-up

Before taking the medicine, the patient must undergo a

comprehensive medical examination to ensure that the

treatment is suitable for him and that he does not suffer

from cardiovascular problems )heart and blood vessels(,

since sexual activity in itself involves a certain degree of

cardiac effort.

Drug interactions

A person who has taken Viagra

and requires any

medical

treatment

must

immediately

report

attending medical team that he has taken this medicine,

in order to prevent a situation in which he will be treated

with nitrates or other vasodilators.

If you are taking or have recently taken, other

medicines,

including

nonprescription

medicines

and

dietary

supplements,

tell

your

doctor

or

pharmacist. Particularly if you are taking:

Viagra

in combination with other medicines, especially

medicines intended to treat chest pain )angina pectoris(,

may be harmful. In the event of a medical emergency,

you should inform your doctor,

nurse or pharmacist that

you have taken Viagra

when you took it. Do not use

Viagra

in combination with

other medicines unless your

doctor tells you that you can.

Do not use Viagra

if you are taking the following medicines:

Medicines called nitrates, as the combination with

these types of medicines may lead to a dangerous

decrease in your blood pressure. Consult your doctor

if you are taking any of these medicines, which are

usually used for the treatment of angina pectoris

(chest pain).

Medicines called nitric oxide donors such as amyl

nitrite,

this

combination

also

lead

dangerous decrease in your blood pressure.

Other

medicines

treating

impotence

(erectile

dysfunction( – the combination with Viagra

is forbidden.

Riociguat

other

medicines

treatment

pulmonary hypertension - the combination with Viagra

is forbidden.

Other medicines:

Cimetidine )to reduce stomach acidity(, ketoconazole

)antifungal(, erythromycin )antibiotic(.

HIV protease inhibitors for the treatment of AIDS (such

as saquinavir, ritonavir( since they may increase the

concentration of Viagra

in the blood. Your doctor

may prescribe you the lowest dose.

Medicines

alpha-blockers

group

such

doxazosin

(for

treatment

hypertension

prostate enlargement( – due to the concern of a

decrease

blood

pressure.

Combination

this

medicine with Viagra

may cause light-headedness

or dizziness, which is caused by low blood pressure

upon sitting or standing up quickly. This is most likely

to happen within 4 hours after taking Viagra

. Your

doctor may prescribe you the lowest dose.

Using this medicine and food

medicine

taken

with

without

food.

However, the onset of action of the medicine may be

delayed after a heavy meal.

Using this medicine and alcohol consumption

Alcohol consumption may temporarily impair erectile

function. To achieve the maximal effect of the medicine,

you are advised not to drink excessive amounts of

alcohol before taking the medicine.

Pregnancy and breastfeeding

This medicine is not intended for women.

Driving and using machines

Viagra

may cause dizziness and affect vision. You

must pay attention to how you react to the medicine

before you drive or operate machines.

Important

information

about

some

of

this

medicine’s ingredients

The medicine contains lactose. If you have been told by

your doctor that you are sensitive to certain sugars, such

as lactose, contact your doctor before using Viagra

3. HOW TO USE THIS MEDICINE?

Always use this medicine according to your doctor’s

instructions. Check with the doctor or pharmacist if you

are uncertain about the dosage and treatment regimen

of the medicine.

The dosage and treatment regimen will be determined

by your doctor only. The standard dosage is usually:

one tablet about an hour before sexual intercourse.

Do not take more than one tablet per day. Do not

exceed the recommended dose.

Viagra

will help you to get an erection only if you are

sexually stimulated. The time it takes for the medicine

to start working varies from person to person, and it

normally takes about half an hour to one hour. You may

find that it takes for the medicine longer to start working

if you take it with a heavy meal.

If you feel that the medicine is too weak or too strong for

you, consult your doctor or pharmacist.

If Viagra

does not help you to get an erection, or if the

erection achieved does not last long enough for you to

complete full sexual intercourse, consult your doctor.

Do not crush, split or chew. Swallow the medicine whole

with some water.

If you have taken an overdose, or if a child has

accidentally swallowed some medicine, immediately

go to a hospital emergency room and bring the medicine

package with you.

If you have taken an overdose, you may experience an

exacerbation in side effects and their severity. Doses

above 100 mg do not increase the efficacy of the

medicine.

Do

not

take

medicines

in

the

dark!

Check

the

label and dose each time you take medicine. Wear

glasses if you need them.

If you have any further questions about using this

medicine, consult your doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Viagra

may cause side

effects in some users. Do not be alarmed by this list of

side effects; you may not experience any of them.

The side effects reported in association with the use

of Viagra

are usually mild to moderate and last for a

short time period.

השוחת ,הייארה תודחב הדירי ,הלופכ הייאר ,ןיעה לש ירוחאה םינטק םיקיקלח תייאר ,ףעפעב וא ןיעב תוחיפנ ,ןיעב הליגר אל עבצ יוניש ,םינושיא תבחרה ,תורוא ביבס הליה תייאר ,תודוקנ וא ,ףאב שבוי ,ערזה לזונב םד תוחכונ ,ןיפהמ םומיד ,ןיעה ןבולב .תונבצע ,ףאה ךותב תוחיפנ :קווישה רחאל וחוודש תופסונ יאוול תועפות ,בור .תורידנ םיתיעל חווד ימואתפ תוומ ,הביצי אל הזח תקועת תויעבמ ולבס וללה תועפותהמ ולבס רשא םירבגה לכ אל ךא רישי רשק םייק םא עובקל ןתינ אל .וז הפורת תליטנ ינפל תויבבל .הפורתב שומישל וללה תועפותה ןיב הרימחמ יאוולה תועפותמ תחא םא ,יאוול תעפות העיפוה םא ךילע ,ןולעב הניוצ אלש יאוול תעפותמ לבוס התא רשאכ וא .אפורה םע ץעייתהל הציחל תועצמאב תואירבה דרשמל יאוול תועפות לע חוודל ןתינ אצמנש "יתפורת לופיט בקע יאוול תועפות לע חוויד" רושיקה לע (www.health.gov.il( תואירבה דרשמ רתא לש תיבה ףדב :רושיקל הסינכ י"ע וא ,יאוול תועפות לע חווידל ןווקמה ספוטל הנפמה

https://sideeffects.health.gov.il

?הפורתה תא ןסחאל ךיא .5

םוקמב רומשל שי תרחא הפורת לכו וז הפורת !הלערה ענמ לעו תוקונית וא/ו םידלי לש םתייאר חווטו םדי גשיהל ץוחמ רוגס תשרופמ הארוה אלל האקהל םורגת לא .הלערה ענמת ךכ ידי .אפורהמ

(exp. date) הגופתה ךיראת ירחא הפורתב שמתשהל ןיא ןורחאה םויל סחייתמ הגופתה ךיראת .הזיראה יבג לע עיפומה .שדוח ותוא לש

.שבי םוקמב 30°C מ הכומנה הרוטרפמטב ןסחאל שי

Stop taking this medicine and contact your doctor

immediately in case of:

An allergic reaction – uncommon )may affect up to

1 in

people(;

the symptoms

include

sudden

wheeziness, difficulty breathing or dizziness, swelling

of the eyelids, face, lips or throat.

Chest pains during or after sexual intercourse –

uncommon; if this happens to you during or after

sexual intercourse, get in a semi-sitting position and

try to relax. Do not take nitrates to treat chest pain.

Prolonged and sometimes painful erection has been

reported after using Viagra

(a rare side effect). If you

experience an erection which lasts for more than 4

hours, contact a doctor immediately.

A sudden decrease or loss of vision, rare )may affect

up to 1 in 1,000 people(; contact a doctor immediately.

A severe skin reaction (a rare side effect) - the symptoms

may include severe peeling and swelling of the skin,

blisters in the mouth, genitals, around the eyes and fever.

Fits or seizures (a rare side effect).

Additional side effects

Very common side effects (may affect more than 1

in 10 people):

Headache.

Common side effects (may affect up to 1 in 10 people):

Dizziness,

redness

face,

gastrointestinal

disturbances, nasal congestion, seeing colors, blurred

vision,

vision

disturbances,

nausea,

flushes

sudden feeling of heat in the upper body).

Uncommon side effects (may affect up to 1 in 100 people):

Vomiting, rash, eye irritation/pain, red eyes, sensitivity

to light, seeing flashes of light, visual brightness, watery

eyes, rapid or pounding heartbeat, hypertension, low

blood

pressure,

muscle

pain,

sleepiness,

reduced

sense of touch, vertigo, ringing in the ears, dry mouth,

blocked or congested sinuses, inflammation of the

lining of the nose )symptoms include common cold,

sneezing and nasal congestion(, upper abdominal pain,

gastro-esophageal reflux disease (symptoms include

heartburn(, feeling tired, presence of blood in urine,

pain in the extremities, nosebleed, feeling hot.

Rare side effects )may affect up to 1 in 1,000 people(:

Fainting,

stroke,

heart

attack,

heart

rate

disorders,

temporary decrease in blood flow to parts of the brain,

feeling of constriction of the throat, numb mouth, bleeding

at the back of the eye, double vision, reduced visual acuity,

abnormal sensation in the eye, swelling of the eye or eyelid,

seeing small particles or spots, seeing halos around lights,

dilation of the pupils, discoloration of the white of the eye,

penile bleeding, presence of blood in semen, dry nose,

swelling of the inside of the nose, irritability.

Side effects based on post-marketing reports:

Unstable angina and sudden death have been reported

rarely. Most, but not all, of the men who experienced

these side effects suffered from heart problems before

taking

this

medicine.

impossible

determine

whether these effects were directly related to the use

of the medicine.

If you experience any side effect, if any side effect

gets worse, or if you experience a side effect not

mentioned in this leaflet, consult your doctor.

You can report side effects to the Ministry of Health by

following the link ‘Reporting Side Effects of Drug Treatment’

on the Ministry of Health home page (www.health.gov.il)

which links to an online form for reporting side effects or by

using the link: https://sideeffects.health.gov.il

5. HOW TO STORE THE MEDICINE?

Prevent poisoning! This and any other medicine should

be kept in a closed place, out of the reach and sight of

children and/or infants to avoid poisoning. Do not induce

vomiting unless explicitly instructed to do so by a doctor.

Do not use the medicine after the expiry date (exp.

date) which is stated on the package. The expiry date

refers to the last day of that month.

Store below 30˚C in a dry place.

6. FURTHER INFORMATION

In addition to the active ingredient, this medicine

also contains:

microcrystalline cellulose, calcium hydrogen phosphate

)anhydrous(, croscarmellose sodium, magnesium stearate.

The coating contains:

hypromellose, lactose monohydrate, titanium dioxide,

glycerol triacetate, indigo carmine aluminum lake

What the medicine looks like and contents of the pack:

Viagra

25 mg: blue diamond-shaped film-coated tablet

with the word “Pfizer” imprinted on one side and “VGR

25” on the other side.

Viagra

50 mg: blue diamond-shaped film-coated tablet

with the word “Pfizer” imprinted on one side and “VGR

50” on the other side.

Viagra

blue

diamond-shaped

film-coated

tablet with the word “Pfizer” imprinted on one side and

“VGR 100” on the other side.

Marketed in package containing 2, 4, 8 film-coated tablets.

Not all pack sizes may be marketed.

Registration holder and address:

Pfizer PFE Pharmaceuticals Israel Ltd., 9 Shenkar St.,

Herzliya Pituach 46725

Manufacturer’s name and address: Fareva Amboise,

Poce-sur-Cisse, France.

Registration numbers of the medicine in the National

Drug Registry of the Ministry of Health:

Viagra

25 mg: 111.36.29459

Viagra

50 mg: 111.37.29460

Viagra

100 mg: 111.38.29461

Revised in 06/2020.

DOR-Via-PIL-0820

1986 – )تارضحتسم( ةلدايصلا ةمظنأ بجومب كلهتسملل ةرشن طقف ةيبط ةفصو بجومب ءاودلا ق

وس

غلم 25

TM

ارچايڨ غلم 50

TM

ارچايڨ غلم 100

TM

ارچايڨ

ة

ّ

يلطم صارقأ :ىلع صرق لك يوتحي غلم 100 ،غلم 50 ،غلم 25 )تارتيس لكش ىلع( ليفانيدليس

sildenafil (as citrate( 25 mg, 50 mg, 100 mg

ةمهم تامولعم" 2 دنبلا رظنا :ةيساسحلا تاببس

مو ةلا

عفلا ريغ داوملا ةمئاقل ."ةيفاضإ تامولعم" 6 دنبلاو ،"ءاودلا تاب

كرم نم مسق نع هذه يوتحت .ءاودلا لامعتساب ءدبلا لبق كلذو اهتياهن ىتح ن

ّ

عمتب ةرشنلا أرقا

جوت ،ةيفاضإ ةلئسأ كيدل تناك اذإ .ءاو

دلا نع ةزجوم تامولعم ىلع ةرشنلا

يلديصلا وأ بيبطلا ىلإ ادب ول ىتح ،مه

رضي دق ه

نلأ ؛نيرخلآل ه

طعت لا .كلجأ نم ءاودلا اذه ف

.مهتلاحو ةيبطلا كتلاح نيب هباشت كل .ءاسنلل ا

دع

م سيل هنكلو ،اماع 18 نس قوف نيغلابلل

دع

م ءاودلا اذه ؟ءاو

ّ

دلا اذه

ّ

دعأ

َ

مل . 1 .باصتنلاا تابارطضا - يسنجلا زجعلا جلا

عل :ةيجلاعلا ةعومجملا مدلا قفدت ن

سحي كلذبو ،ةيومدلا ةيعولأا ع

سوت ببسي ،PDE5 ميزنلإل طبثم .ةيسنجلا ةراثلإا ءانثأ يلسانتلا وضعلا ىلإ ءاودلا لامعتسا لبق . 2 :اذإ رضحتسملا لامعتسا زوجي لا

يفاضلإا تاب

كرملا نم

يلأ وأ ةلاعفلا ة

داملل )ةيجرأ( ة

يساسح كيدل تناك .ءاودلا اهيلع يوتحي يتلا

،ةيوضعلا تارتينلا تارضحتسم مظتنم لكشب وأ بوانتلاب لوانتت تنك ،ليملأا تيرتن لثم كيرتينلا ديسكلأ ةحناملا وأ ةيوضعلا تيرتنلا angina ،ةيردصلا ةحبذلا جلاعل ةيودلأا ضعب لثم( ناك لكش يأب

.(pectoris

guanylate ميزنلإا تاطشنم ةعومجم نم ءاود نمازتلاب لوانتت تنك مدلا طغض طرف جلاعل ، riociguat ( توچيكوير لثم ، cyclase .)يوئرلا

.بلقلا وأ دبكلا يف داح ضرم نم يناعت تنك

طغض نم يناعت تنك اذإ وأ ةيبلق ةبون وأ ةيغامد ةتكسل ا

رخؤم تضرعت .ضفخنم مد

ةيكبشلا باهتلا لثم( نينيعلا يف ردان نيعم يثارو ضرم نم يناعت تنك .( Retinitis pigmentosa يغابصلا

Non-arteritic

ببسب ةيؤرلا نادقف نم يضاملا يف تيناع وأ يناعت تنك

. anterior ischaemic optic neuropathy (NAION)

ءاودلا لامعتساب ةق

ّ

لعتم ة

ّ

صاخ تاريذحت :اذإ بيبطلا ربخأ ™ارچايڨب جلاعلا ءدب لبق

بيصي ضرم ،

sickle cell anemia)

يلجنملا مدلا رقف نم يناعت تنك multiple مظعلا عاخن ناطرس( ددعتم يوقن مرو ،)ءارمحلا مدلا ايلاخ .)مدلا ايلاخ ناطرس( مدلا ضاضيبا نم وأ ) myeloma

ضرم نم وأ )بيضقلا( يلسانتلا وضعلا يف بارطضا نم يناعت تنك .)بيضقلا ءانحنا( ينوريپ

ارداق كبلق ناك اذإ بيبطلا صحفي فوس كبلق يف لكاشم نم يناعت تنك .ةيسنج تاقلاع ةماقإب طونملا يفاضلإا ءبعلا ل

محت ىلع

ةقلعتم ةلكشم نم وأ ،)peptic ulcer( ةدعملا يف ةحرق نم يناعت تنك .)ايليفوميهلا لثم فيزنلاب

جلاعلا لوانت نع فقوت ؛ئجافملا رظنلا نادقف وأ رظنلا ضافخنلا تضرعت .اروف بيبطلا ىلإ هجوتو .)باصتنلاا فعض( يسنجلا زجعلا نم يناعت تنك اذإ

ارچايڨ لوانت كل زوجي لا .ةأرما تنك اذإ

ارچايڨ لوانت

كل زوجي لا دبكلا وأ ىلكلا ىضرم ةعرجب بيبطلا كل يصوي دقف ،دبكلا وأ ىلكلا يف ضرم نم يناعت تنك اذإ .رثكأ ةضفخنم نوقهارملاو لافطلأا .ةنس 18 نم لقأ هرمع ن

م ىدل لامعتسلال ا

دعم سيل ءاودلا ةعباتملاو تاصوحفلا نأ نم دكأتلل ،لاماش ايبط اصحف زاتجي نأ ج

لاعملا ىلع ،ءاودلا لوانت لبق ةيعولأاو بلقلا يف( ةيئاعو ةيبلق لكاشم نم يناعي لا هنأو ،هل مئلام جلاعلا .بلقلا دهجب ام دح ىلإ طونم يسنجلا طاشنلا نلأ ،)ةيومدلا ةيودلأا نيب تلاعافتلا مقاطلا غلبي نأ ناك ايأ يبط جلاع ىلإ جاتحيو ،

ارچايڨ لوانتي ن

م ىلع بجي .يلديصلا وأ بيبطلا ر

ِ

شتسا ،ءاودلا لامعتساب ق

ّ

لعتت ةيفاضإ ةلئسأ

َ

كيدل تناك اذإ ةيبناجلا ضارعلأا . 4 ضعب ىدل ةيبناج ا

ضارعأ

ارچايڨ لامعتسا ب

بسي نأ نكمي ،ءاود

يأ لثم .اهنم

يأ نم يناعت لا دقف ،ة

يبناجلا ضارعلأا ةمئاق ةءارق دنع عزفت لا .نيم

دختسملا ىتح ةفيفط

ارچايڨ لامعتسا دنع اهنع غلابلإا مت يتلا ةيبناجلا ضارعلأا تناك .اريصق اتقو ترمتساو ابلاغ ةلدتعم :ثودح لاح يف بيبطلا ىلإ ه

ّ

جوتلاو لامعتسلاا نع ف

ّ

قوتلا بجي

؛)صخش 100 نيب نم 1 ىتح يف رثؤي دق( عئاش ريغ - يسسحت لعف در وأ سفنتلا يف ةبوعص ،سفنتلا ءانثأ ئجافم ريفص ىلع ضارعلأا لمتشت .ةرجنحلا وأ ،نيتفشلا ،هجولا ،نينفجلا مروت ،ةخود

هذه تثدح اذإ ؛عئاش ريغ - ةيسنج تاقلاع ةماقإ دعب وأ ءانثأ ردصلا يف ملأ فصن ةيعضوب سولجلا بجي ،ةيسنج تاقلاع ةماقإ دعب وأ ءانثأ ةلاحلا .ردصلا يف مللأا جلاعل تاتارتينلا لوانت زوجي لا .ءودهلا ةلواحمو سولج

دعب ملالآاب انايحأ ابوحصم ناك يذلا لصاوتملا باصتنلاا نع غلابلإا مت نم رثكلأ لصاوتم باصتنا نم تيناع اذ

ا .)عويشلا ردان(

ارچايڨ لامعتسا

روف بيبطلا ىلإ هجوت ،تاعاس 4

1 ىتح يف رثؤي دق( ردان لكشب ،رظنلا نادقف وأ رظنلا يف ئجافم ضافخنا .اروف بيبطلا ىلإ هجوتلا بجي ؛) صخش 1,000 نيب نم

مروتو داحلا ر

شقت ضارعلأا نمضتت دق - )عويشلا ردان( داح يدلج لعف در .مسجلا ةرارح عافتراو نينيعلا لوح ،ةيلسانتلا ءاضعلأا يف ،مفلا يف تارثب ،دلجلا

.)عويشلا ةردان( تاجنشت وأ عرص تابون

ة

ّ

يفاضإ ةيبناج ضارعأ :)صاخشأ 10 نيب نم 1 نم رثكأ يف رثؤت دق) ادج ةعئاش ةيبناج ضارعأ .عادص :)صاخشأ 10 نيب نم 1 ىتح يف رثؤت دق( ةعئاش ةيبناج ضارعأ ةيؤر ،فنلأا ناقتحا ،يمضهلا زاهجلا يف تابارطضا ،هجولا رارمحا ،ةخود روعش( ةرارح تاجوم ،نايثغ ،ةيؤرلا يف تابارطضا ،ةيؤرلا ش

وشت ،ناولأ .)مسجلا نم يولعلا مسقلا يف ةرارحلا نم ئجافم :)صخش 100 نيب نم 1 ىتح يف رثؤت دق( ةعئاش تسيل ةيبناج ضارعأ تاضمو ،ءوضلل ةيساسح ،ءارمح نويع ،نينيعلا يف ملأ/ج

يهت ،حفط ،تاؤيقت بلق تابرض ،ةعماد نويع ،)visual brightness( يرصب عوطس ،ءوض ،تلاضعلا يف ملأ ،مدلا طغض ضافخنا ،مدلا طغض عافترا ،ةيوق وأ ةعيرس فافج ،نينذلأا يف نينط ،)vertigo( راود ،سمللاب ساسحلإا ضافخنا ،ساعن نم ةيلخادلا ةقبطلا يف باهتلا ،ةيفنلأا بويجلا يف دادسنا وأ ناقتحا ،مفلا يف نطبلا يف ملأ ،)فنلأا ناقتحاو ،لاعس ،ةلزن ىلع ضارعلأا لمتشت( فنلأا روعش ،)ةدعملا يف ةقرح ىلع ضارعلأا لمتشت( يئيرم يدعم عاجترا ،ةيولعلا .ةرارحلاب روعش ،فنلأا نم فيزن ،فارطلأا يف ملأ ،لوبلا يف مد ،بعتلاب :)صخش 1,000 نيب نم 1 ىتح يف رثؤت دق ) ةردان ةيبناج ضارعأ ئجافم ضافخنا ،بلقلا مظن يف تابارطضا ،ةيبلق ةبون ،ةيغامد ةتكس ،ءامغإ ،غامدلا يف ءازجأ ىلإ مدلا قفدت يف تقؤم ضافخنا ،عمسلا نادقف وأ عمسلا يف نم ةيفلخلا ةهجلا يف فيزن ،مفلا يف ساسحلإا صقن ،ةرجنحلا يف ق

يضتب روعش مروت ،نيعلا يف يئانثتسا روعش ،ةيؤرلا ةدح ضافخنا ،ةجودزم ةيؤر ،نيعلا

سوت ،ءاوضلأا لوح ةلاه ةيؤر ،طاقن وأ ةريغص ماسجأ ةيؤر ،نفجلا وأ نيعلا لئاس يف مد روهظ ،بيضقلا نم فيزن ،نينيعلا ضايب نول ر

يغت ،نيؤبؤبلا .ةيبصع ،فنلأا مروت ،فنلأا فافج ،ينملا :قيوستلا دعب اهنع غلابلإا مت ىرخأ ةيبناج ضارعأ مظعم . ةردان نايحأ يف ةئجافم ةافوو ،ةرقتسم ريغ ةيردص ةحبذ نع غلابلإا مت اضيأ نوناعي اوناك ،ضارعلأا هذه نم اوناع نيذلا ،مهعيمج سيل نكلو ،لاجرلا كانه تناك اذإ ددحن نأ نكمي لا .ءاودلا اذه لوانت لبقو ،اقباس ةيبلق لكاشم نم .ءاودلا لامعتساو ضارعلأا هذه نيب ةرشابم ةقلاع اذإ وأ ،ةيبناجلا ضارعلأا نم

ٌّ

يأ مقافت اذإ ،ةيبناجلا ضارعلأا دحأ رهظ اذإ .بيبطلا ةراشتسا كيلع ،ةرشنلا يف ر

َ

كذ

ُ

ي مل

ّ

يبناج ض

ِ

راع نم تيناع غلابلإا" طبار ىلع طغضلا ربع ةيبناجلا ضارعلأاب ة

حصلا ةرازو غلابإ نكمي ةيسيئرلا ةحفصلا يف دوجوملا ،"يئاودلا جلاعلا ببسب ةيبناجلا ضارعلأا نع ىلع ةرامتسا ىلإ كهجوي يذلا )www.health.gov.il( ة

حصلا ةرازو عقومل :طبارلا ىلإ لوخدلا ربع وأ ،ةيبناجلا ضارعلأا نع غلابلإل تنرتنلإا

https://sideeffects.health.gov.il

؟ءاودلا نيزخت ة

ّ

يفيك . 5

ديعب ،قلغم ناكم يف ،رخآ ءاود

لكو ،ءاودلا اذه ظفح بجي !م

مستلا ب

نجت لا .م

مستلا ب

نجتت اذكهو ،لافطلأا وأ/و دلاولأا ةيؤر لاجمو يديأ لوانتم نع .بيبطلا نم ةحيرص تاميلعت نود ؤيقتلا ببس

ىلع رهاظلا (exp. date) ةيحلاصلا ءاهتنا خيرات دعب ءاودلا لوانت عنم

.رهشلا سفن نم ريخلأا مويلا ىلإ بسن

ي ة

يحلاصلا ءاهتنا خيرات .ة

وبعلا

. فاج ناكم يفو ، 30 °C تحت ةرارح ةجردب نيزختلا بجي ةيفاضإ تامولعم .6 :ىلع ا

ً

ضيأ ءاودلا يوتحي ،ةلا

ّ

عفلا ةداملا ىلإ ةفاضإ

microcrystalline cellulose, calcium hydrogen phosphate

)anhydrous(, croscarmellose sodium, magnesium stearate.

:ىلع ءلاطلا يوتحي

hypromellose, lactose monohydrate, titanium dioxide,

glycerol triacetate, indigo carmine aluminum lake

ّ

وبعلا يوحت اذامو ءاودلا ودبي فيك هيلع ةعوبطمو قرزأ هنول ،ني

م لكش ىلع ،يلطم صرق :غلم

ارچايڨ .رخلآا بناجلا يف

"VGR 25" كلذكو دحاو بناج يف " Pfizer " ةملك هيلع ةعوبطمو قرزأ هنول ،ني

م لكش ىلع ،يلطم صرق :غلم 50

ارچايڨ .رخلآا بناجلا يف "VGR 50" كلذكو دحاو بناج يف " Pfizer " ةملك هيلع ةعوبطمو قرزأ هنول ،ني

م لكش ىلع ،يلطم صرق :غلم

ارچايڨ .رخلآا بناجلا يف "VGR 100" كلذكو دحاو بناج يف " Pfizer " ةملك

يلطم صارقأ

، 4 ، 2 نمضتت تاوبع يف ءاودلا قوسي .تا

وبعلا ماجحأ لك ق

وس

ت لا دق ،.ض.م ليئارسإ اكيتپسامراف يإ .فإ .يپ رزياف :هناونعو ليجستلا بحاص .46725 ،حاوتيپ ايلستره ،9 راكنش عراش .اسنرف ، Poce-sur-Cisse ،زاوبمأ اڤيراف :هناونعو جتنملا مسا :ةحصلا ةرازو يف يمسرلا ةيودلأا لجس يف ءاودلا ليجست ماقرأ 111.36.29459 :غلم 25

ارچايڨ 111.37.29460 :غلم 50

ارچايڨ 111.38.29461 :غلم 100

ارچايڨ

DOR-Via-PIL-0820

.06/2020 يف اهثيدحت مت

VIAGRA LPD CC 240620

2020-0062039 ;2018-0040290

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 0.919 mg lactose monohydrate

VIAGRA

50 mg tablets

Each tablet contains 1.837 mg lactose monohydrate

VIAGRA

100 mg tablets

Each tablet contains 3.675 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.

VIAGRA LPD CC 240620

2020-0062039 ;2018-0040290

VIAGRA100 mg tablets

Blue, film coated, rounded diamond-shaped tablets, marked "PFIZER" on one side and

"VGR 100" on the other.

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 y 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 (creatinine

clearance < 30 mL/min), a 25 mg dose should be considered. Based on efficacy and

tolerability, the dose may be increased to 50 mg and 100 mg as necessary.

H

epatic impairment

Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis), a

25 mg dose should be considered. Base

d on efficacy and tolerability, the dose may be

increased step-wise to 50 mg and 100 mg as necessary.

Paediatric population:

VIAGRA

is not indicated for individuals below 18 years of age.

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Use in patients taking other medicinal products

With the exception of ritonavir for which co-administration with sildenafil is not advised (see

section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant

treatment with CYP3A4 inhibitors (see section 4.5).

In order to minimise the potential for developing postural hypotension, patients should be stable

on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil

at a dose of 25 mg should be considered (see sections 4.4 and 4.5).

Method of administration

For oral use.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP)

pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates,

and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is

therefore contraindicated.

The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase

stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic

hypotension (see section 4.5).

Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men

for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as

unstable angina or severe cardiac failure).

VIAGRA

is contraindicated in patients who have loss of vision in one eye because of non-

arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in

connection or not with previous PDE5 inhibitor exposure (see section 4.4).

The safety of sildenafil has not been studied in the following sub-groups of patients and its use is

therefore contraindicated: 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

(a minority of these patients have

genetic disorders of retinal phosphodiesterases)

.

4.4

Special warnings and precautions for use

A medical history and physical examination should be undertaken to diagnose erectile

dysfunction

determine potential underlying causes, before pharmacological treatment is

considered.

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Cardiovascular risk factors

Prior to initiating any treatment for erectile dysfunction, physicians should consider the

cardiovascular status of their patients, since there is a degree of cardiac risk associated

with sexual activity.

Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood

pressure (see section 5.1). . Prior to prescribing sildenafil, physicians should carefully

consider whether their patients with certain underlying conditions could be adversely

affected by such vasodilatory effects, especially in combination with sexual activity.

Patients with increased susceptibility to vasodilators include those with left ventricular

outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or

those with the rare syndrome of multiple system atrophy manifesting as severely

impaired autonomic control of blood pressure.

VIAGRA potentiates the hypotensive effect of nitrates (see section 4.3).

Serious cardiovascular events, including myocardial infarction, unstable angina, sudden

cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic

attack, hypertension and hypotension have been reported post-marketing in temporal

association with the use of VIAGRA. Most, but not all, of these patients had pre-existing

cardiovascular risk factors. Many events were reported to occur during or shortly after

sexual intercourse and a few were reported to occur shortly after the use of VIAGRA

without sexual activity. It is not possible to determine whether these events are related

directly to these factors or to other factors.

Priapism

Agents for the treatment of erectile dysfunction , including sildenafil, should be used with caution

in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or

Peyronie’s disease), or in patients who have conditions which may predispose them to priapism

(such as sickle cell anaemia, multiple myeloma or leukaemia).

Prolonged erections and priapism have been reported with sildenafil in post-marketing

experience. In the event of an erection that persists longer than 4 hours, the patient should seek

immediate medical assistance. If priapism is not treated immediately, penile tissue damage and

permanent loss of potency could result.

Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction

The safety and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other

pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or other

treatments for erectile dysfunction have not been studied. Therefore the use of such combinations

is not recommended.

Effects on vision

Cases of visual defects have been reported spontaneously in connection with the intake

of sildenafil and other PDE5 inhibitors (see section 4.8). Cases of non-arteritic anterior ischaemic

optic neuropathy, a rare condition, have been reported spontaneously and in an observational

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study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).

Patients should be advised that in the event of any sudden visual defect, they should stop taking

VIAGRA

and consult a physician immediately (see section 4.3).

Concomitant use with ritonavir

Co-administration of sildenafil with ritonavir is not advised (see section 4.5).

Concomitant use with alpha-blockers

Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the

co-administration may lead to symptomatic hypotension in a few susceptible individuals (see

section 4.5). This is most likely to occur within 4 hours post sildenafil dosing. In order to

minimise the potential for developing postural hypotension, patients should be hemodynamically

stable on alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at a

dose of 25 mg should be considered (see section 4.2). In addition, physicians should advise

patients what to do in the event of postural hypotensive symptoms.

Effect on bleeding

Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of

sodium nitroprusside

in vitro

. There is no safety information on the administration of sildenafil to

patients with bleeding disorders or active peptic ulceration. Therefore sildenafil should be

administered to these patients only after careful benefit-risk assessment.

The film coating of the tablet contains lactose. Viagra should not be administered to men with

rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose

malabsorption.

Women

VIAGRA

is not indicated for use by women.

4.5

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on sildenafil

In vitro

studies:

Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms

3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may

reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil

clearance.

In vivo

studies:

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Population pharmacokinetic analysis of clinical trial data indicated a reduction in

sildenafil clearance when co-administered with CYP3A4 inhibitors (such as

ketoconazole, erythromycin, cimetidine).

Although no increased incidence of adverse events

was observed in these patients ,when sildenafil is administered concomitantly with CYP3A4

inhibitors, a starting dose of 25 mg should be considered

Co-administration of

the HIV protease inhibitor ritonavir, which is a highly potent P450

inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a

300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma

AUC. At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/mL, compared

to approximately 5 ng/mL when sildenafil was administered alone. This is consistent with

ritonavir's marked effects on a broad range of P450 substrates. Sildenafil had no effect on

ritonavir pharmacokinetics.

Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not

advised (see section 4.4) and in any event the maximum dose of sildenafil should under no

circumstances exceed 25 mg within 48 hours.

Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state

(1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in

sildenafil Cmax and a 210% increase in sildenafil AUC. Sildenafil had no effect on saquinavir

pharmacokinetics (see section 4.2) . Stronger CYP3A4 inhibitors such as ketoconazole and

itraconazole would be expected to have greater effects.

When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate

CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in

sildenafil systemic exposure (AUC). In normal healthy male volunteers, there was no evidence of

an effect of azithromycin (500 mg daily for 3 days) on the AUC, C

, elimination rate

constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Cimetidine

(800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56%

increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to

healthy volunteers.

Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest

increases in plasma levels of sildenafil.

Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the

bioavailability of sildenafil.

Although specific interaction studies were not conducted for all medicinal products,

population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil

pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin,

phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic

antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin

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converting enzyme inhibitors, calcium channel blockers, beta- adrenoreceptor antagonists or

inducers of CYP450 metabolism (such as rifampicin, barbiturates).

In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan,

(an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg

twice a day) with sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4%

decrease in sildenafil AUC and C

, respectively. Therefore, concomitant administration of

strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma

concentrations of sildenafil.

Nicorandil is a hybrid of potassium channel activator and nitrate. Due to the nitrate component it

has the potential to result in a serious interaction with sildenafil.

Effects of sildenafil on other medicinal products

In vitro

studies:

Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and

3A4 (IC50 >150 µM). Given sildenafil peak plasma concentrations of approximately 1 µM after

recommended doses, it is unlikely that VIAGRA will alter the clearance of substrates of these

isoenzymes.

There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors

such as theophylline or dipyridamole.

In vivo

studies:

Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil

was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric

oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).

Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when

PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to

augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical

effect of the combination in the population studied. Concomitant use of riociguat with PDE5

inhibitors, including sildenafil, is

contraindicated (see section 4.3).

Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic

hypotension in a few susceptible individuals. This is most likely to occur within 4 hours post sildenafil

dosing (see sections 4.2 and 4.4).

In three specific drug-drug interaction studies, the alpha-

blocker doxazosin (4 mg and

8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to

patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In

these study populations, mean additional reductions of supine blood pressure of 7/7

mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood

pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed.

When sildenafil and doxazosin were administered simultaneously to patients stabilized on

doxazosin therapy, there were infrequent reports of patients who experienced

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symptomatic postural hypotension. These reports included dizziness and light-

headedness, but not syncope.

No significant interactions were shown when sildenafil (50mg) was co-administered with

tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.

Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl

salicylic acid (150 mg).

Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy

volunteers with mean maximum blood alcohol levels of 80 mg/dl.

Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE

inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and

centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor

blockers, showed no difference in the side effect profile in patients taking sildenafil compared to

placebo treatment. In a specific interaction study, where sildenafil (100 mg) was co-administered

with amlodipine in hypertensive patients, there was an additional reduction on supine systolic

blood pressure of 8 mmHg. The corresponding additional reduction in supine diastolic blood

pressure was 7 mmHg. These additional blood pressure reductions were of a similar magnitude to

those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).

Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease

inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.

In healthy male volunteers, sildenafil at steady state (80 mg t.i.d.) resulted in a 49.8% increase in

bosentan AUC and a 42% increase in bosentan C

(125 mg b.i.d.).

4.6

Fertility, pregnancy and lactation

VIAGRA is not indicated for use by women.

There are no adequate and well-controlled studies in pregnant or breast-feeding women.

No relevant adverse effects were found in reproduction studies in rats and rabbits

following oral administration of sildenafil.

There was no effect on sperm motility or morphology after single 100 mg oral doses of

sildenafil in healthy volunteers (see section 5.1)..

4.7

Effects on ability to drive and use machines

VIAGRA may have a minor influence

on the ability to drive and use machines.

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As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be

aware of how they react to VIAGRA, before driving or operating machinery.

4.8

Undesirable effects

Summary of the safety profile

The safety profile of

VIAGRA

is based on 9,570 patients in 74 double blind placebo-controlled

clinical studies. The most commonly reported adverse reactions in clinical studies among

sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness nausea,

hot flush, visual disturbance, cyanopsia and vision blurred

Adverse reactions from post-marketing surveillance has been gathered covering an estimated

period >10 years. Because not all adverse reactions are reported to the Marketing Authorisation

Holder and included in the safety database, the frequencies of these reactions cannot be reliably

determined.

Tabulated list of adverse reactions

In the table below all medically important adverse reactions, which occurred in clinical trials at an

incidence greater than placebo are listed by system organ class and frequency (very common

(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to

<1/1,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing

seriousness.

Table 1: Medically important adverse reactions reported at an incidence greater than

placebo in controlled clinical studies and medically important adverse reactions reported

through post-marketing surveillance

System Organ

Class

Very

common

(

1/10)

Common

(

1/100 and

<1/10)

Uncommon

(

1/1,000 and

<1/100)

Rare

(

1/10,000 and

<1/1,000)

Infections and

infestations

Rhinitis

Immune system

disorders

Hypersensitivity

Nervous system

disorders

Headache

Dizziness

Somnolence,

Hypoaesthesia

Cerebrovascular

accident,

Transient ischaemic

attack,

Seizure,

Seizure recurrence,

Syncope

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System Organ

Class

Very

common

(

1/10)

Common

(

1/100 and

<1/10)

Uncommon

(

1/1,000 and

<1/100)

Rare

(

1/10,000 and

<1/1,000)

Eye disorders

Visual colour

distortions**

Visual

disturbance,

Vision blurred

Lacrimation

disorders***

Eye pain,

Photophobia,

Photopsia,

Ocular

hyperaemia,

Visual

brightness,

Conjunctivitis

Non-arteritic

anterior ischaemic

optic neuropathy

(NAION),

Retinal vascular

occlusion,

Retinal

haemorrhage,

Arteriosclerotic

retinopathy,

Retinal disorder,

Glaucoma,

Visual field defect,

Diplopia,

Visual acuity

reduced,

Myopia,

Asthenopia,

Vitreous floaters,

Iris disorder,

Mydriasis,

Halo vision,

Eye oedema,

Eye swelling,

Eye disorder,

Conjunctival

hyperaemia,

Eye irritation,

Abnormal sensation

in eye,

Eyelid oedema,

Scleral

discoloration

Ear and

labyrinth

disorders

Vertigo,

Tinnitus

Deafness

Cardiac

disorders

Tachycardia,

Palpitations

Sudden cardiac

death,

Myocardial

infarction,

Ventricular

arrhythmia,

Atrial fibrillation,

Unstable angina

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System Organ

Class

Very

common

(

1/10)

Common

(

1/100 and

<1/10)

Uncommon

(

1/1,000 and

<1/100)

Rare

(

1/10,000 and

<1/1,000)

Vascular

disorders

Flushing,

Hot flush

Hypertension,

Hypotension

Respiratory,

thoracic and

mediastinal

disorders

Nasal

congestion

Epistaxis,

Sinus congestion

Throat tightness,

Nasal oedema,

Nasal dryness

Gastrointestinal

disorders

Nausea,

Dyspepsia

Gastro

oesophagael

reflux disease,

Vomiting,

Abdominal pain

upper,

Dry mouth

Hypoaesthesia oral

Skin and

subcutaneous

tissue disorders

Rash

Stevens-Johnson

Syndrome (SJS),

Toxic Epidermal

Necrolysis (TEN)

Musculoskeletal

and connective

tissue disorders

Myalgia,

Pain in

extremity

Renal and

urinary

disorders

Haematuria

Reproductive

system and

breast disorders

Penile

haemorrhage,

Priapism,

Haematospermia,

Erection increased

General

disorders and

administration

site conditions

Chest pain,

Fatigue,

Feeling hot

Irritability

Investigations

Heart rate

increased

*

Reported during post-marketing surveillance only

**Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia

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***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected

adverse events should be reported to the Ministry of Health according to the National Regulation

by using an online form

: https://sideeffects.health.gov.il/

4.9

Overdose

In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to

those seen at lower doses but the incidence rates and severities were increased.

Doses of 200 mg did not result in increased efficacy but the incidence of adverse

reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was

increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal

dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma

proteins and not eliminated in the urine.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction

ATC Code G04B E03

Mechanism of action

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 effect 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

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required in order for sildenafil to produce its intended beneficial pharmacological effects.

Pharmacodynamic effects

Studies

in vitro

have shown that sildenafil is selective for PDE5, which is involved in the

erection process. Its effect is more potent on PDE5 than on other known

phosphodiesterases. There is a 10-fold selectivity over PDE6 which is involved in the

phototransduction pathway in the retina. At maximum recommended doses, there is an

80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11. In

particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the

cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.

Clinical efficacy and safety

Two clinical studies were specifically designed to assess the time window after dosing

during which sildenafil could produce an erection in response to sexual stimulation. In a

penile plethysmography (RigiScan) study of fasted patients, the median time to onset for

those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25

minutes (range 12-37 minutes) on sildenafil. In a separate RigiScan study, sildenafil was

still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.

Sildenafil causes mild and transient decreases in blood pressure which, in the majority of

cases, do not translate into clinical effects. The mean maximum decreases in supine

systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg. The

corresponding change in supine diastolic blood pressure was 5.5 mmHg. These decreases

in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due

to increased cGMP levels in vascular smooth muscle. Single oral doses of sildenafil up to

100 mg in healthy volunteers produced no clinically relevant effects on ECG.

In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14

patients with severe coronary artery disease (CAD) (>70% stenosis of at least one

coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7%

and 6% respectively compared to baseline. Mean pulmonary systolic blood pressure

decreased by 9%. Sildenafil showed no effect on cardiac output, and did not impair blood

flow through the stenosed coronary arteries.

A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with

erectile dysfunction and chronic stable angina who regularly received anti-anginal

medicinal products (except nitrates). The results demonstrated no clinically relevant

differences between sildenafil and placebo in time to limiting angina.

Mild and transient differences in colour discrimination (blue/green) were detected in

some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg

dose, with no effects evident after 2 hours post-dose. The postulated mechanism for this

change in colour discrimination is related to inhibition of PDE6, which is involved in the

phototransduction cascade of the retina. Sildenafil has no effect on visual acuity or

contrast sensitivity. In a small size placebo-controlled study of patients with documented

early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg)

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demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler

grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).

There was no effect on sperm motility or morphology after single 100 mg oral doses of

sildenafil in healthy volunteers (see section 4.6).

Further information on clinical trials

In clinical trials sildenafil was administered to more than 8000 patients aged 19-87. The

following patient groups were represented: elderly (19.9%), patients with hypertension

(30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia

(19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the

prostate (3.7%), radical prostatectomy (3.3%). The following groups were not well

represented or excluded from clinical trials: patients with pelvic surgery, patients post-

radiotherapy, patients with severe renal or hepatic impairment and patients with certain

cardiovascular conditions (see section 4.3 ).

In fixed dose studies, the proportions of patients reporting that treatment improved their

erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on

placebo. In controlled clinical trials, the discontinuation rate due to sildenafil was low

and similar to placebo.

Across all trials, the proportion of patients reporting improvement on sildenafil were as

follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%),

organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic

heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%),

spinal cord injury (83%), depression (75%). The safety and efficacy of sildenafil was

maintained in long-term studies.

5.2

Pharmacokinetic properties

Absorption

Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached

within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The

mean absolute oral bioavailability is 41% (range 25-63%). After oral dosing of sildenafil

AUC and C

increase in proportion with dose over the recommended dose range (25-

100 mg).

When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in

of 60 minutes and a mean reduction in C

of 29%.

Distribution

The mean steady-state volume of distribution (V

) for sildenafil is 105 l, indicating

distribution into the tissues.

After a single oral dose of 100 mg, the mean maximum total plasma concentration of

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sildenafil is approximately 440 ng/ml (CV 40%). Since sildenafil (and its major

circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the

mean maximum free plasma concentration for sildenafil of 18 ng/ml (38 nM). Protein

binding is independent of total drug concentrations.

In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002%

(average 188 ng) of the administered dose was present in ejaculate 90 minutes after

dosing.

Biotransformation:

Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor

route) hepatic microsomal isoenzymes.

The major circulating metabolite results from N-desmethylation of sildenafil,This

metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro

potency for PDE5 approximately 50% of the parent drug.

Plasma concentrations of this metabolite are approximately 40% of those seen for

sildenafil.

The N-desmethyl metabolite is further metabolized, with a terminal half-life of

approximately 4 hours.

Elimination

The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of

3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites

predominantly in the faeces (approximately 80% of administered oral dose) and to a

lesser extent in the urine (approximately 13% of administered oral dose).

Pharmacokinetics in special patient groups:

Elderly

Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil,

resulting in approximately 90 % higher plasma concentrations of sildenafil and the active

N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45

years). Due to age-differences in plasma protein binding, the corresponding increase in

free sildenafil plasma concentration was approximately 40 %.

Renal insufficiency

In volunteers with mild to moderate renal impairment (creatinine

clearance = 30-80 mL/min) the pharmacokinetics of sildenafil were not altered after

receiving a 50 mg single oral dose.. The mean AUC and C

of the N-desmethyl

metabolite increased up to 126% and up to 73% respectively, compared to age-matched

volunteers with no renal impairment. However, due to high inter-subject variability,

these differences were not statistically significant.

In volunteers with severe renal impairment (creatinine clearance <30 mL/min) ,

sildenafil clearance was reduced, resulting in mean increases in AUC and C

of a of

VIAGRA LPD CC 240620

2020-0062039 ;2018-0040290

100% and 88% respectively compared to age-matched volunteers with no renal

impairment.

In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased

by 200 % and 79 % respectively.

Hepatic insufficiency

In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B), sildenafil

clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared

to age-matched volunteers with no hepatic impairment . The pharmacokinetics of

sildenafil in patients with severely impaired hepatic function have not been studied.

5.3

Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of

safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and

toxicity to reproduction

and development..

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablet core:

Microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose

sodium, magnesium stearate,

Film coat

hypromellose, lactose monohydrate, titanium dioxide (E171), glycerol triacetate, indigo

carmine aluminium lake (E132).

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4

Special precautions for storage

Store below 30

C, in a dry place

6.5

Nature and contents of container

VIAGRA

Tablets 25 mg: blisters in cartons of 1, 4, 8 and 12.

VIAGRA

Tablets 50 mg: blisters in cartons of 1, 4, 8 and 12.

VIAGRA LPD CC 240620

2020-0062039 ;2018-0040290

VIAGRA

Tablets 100 mg: blisters in cartons of 1, 4, 8 and 12.

Not all pack sizes may be marketed

6.6

Special precautions for disposal

No special instructions are required.

7. MANUFACTURER

FAREVA AMBOISE Poce-Sure Cisse, France

8. LICENSE HOLDER

Pfizer PFE Pharmaceuticals Israel Ltd., 9 Shenkar St., Herzliya Pituach 46725

9. LICENSE NUMBERS

VIAGRA

25 mg

111-36-29459

VIAGRA

50 mg

111-37-29460

VIAGRA

100 mg

111-38-29461

Revised in June 2020

לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה

עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור

ןכדועמ( ןכדועמ( ןכדועמ(

.102.50

.102.50

.102.50

ךיראת

26.11.2015

םושירה רפסמו תילגנאב רישכת םש

VIAGRA 25 MG 111-36-29459-00

VIAGRA 50 MG 111-37-29460-00

VIAGRA 100 MG 111-38-29461-00

םושירה לעב םש

מ"עב לארשי הקיטבצמרפ רזייפ

עוימ הז ספוט ה טורפל ד דבלב תורמחה

ב"צמ נמוסמ ובש ,ןולעה תו

תורמחהה שקובמה תו בוהצ עקר לע

.

ונמוס תורמחה רדגב םניאש םייוניש )ןולעב(

ר ןמסל שי .הנוש עבצב םוקימב םייוניש אלו יתוהמ ןכות ק .טסקטה

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

Contraindications

NA

The co-administration of PDE5

inhibitors, including sildenafil, with

guanylate cyclase stimulators, such

as riociguat, is contraindicated as it

may potentially lead to symptomatic

hypotension (see section 4.5).

Interaction with

other medicinal

products and other

forms of interaction

In vivo studies:

Sildenafil was shown to

potentiate the hypotensive

effects of acute and

chronic nitrates, therefore

use of nitric oxide donors,

organic nitrates or organic

nitrites in any form either

regularly or intermittently

with Sildenafil is

contraindicated (see

Contraindications).

….

In vivo studies:

Sildenafil was shown to potentiate

the hypotensive effects of acute and

chronic nitrates, therefore use of

nitric oxide donors, organic nitrates

or organic nitrites in any form either

regularly or intermittently with

Sildenafil is contraindicated (see

Contraindications).

Riociguat: Preclinical studies showed

additive systemic blood pressure

lowering effect when PDE5

inhibitors were combined with

riociguat. In clinical studies,

riociguat has been shown to augment

the hypotensive effects of PDE5

inhibitors. There was no evidence of

favourable clinical effect of the

combination in the population

studied. Concomitant use of riociguat

with PDE5 inhibitors, including

sildenafil, is contraindicated (see

section 4.3).

…..

ךיראתב ינורטקלא ראודב רבעוה

1116611/62

לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה

עדימ עדימ עדימ ןכרצל ןולעב )תוחיטב ןכרצל ןולעב )תוחיטב ןכרצל ןולעב )תוחיטב

ןכדועמ( ןכדועמ( ןכדועמ(

.102.50

.102.50

.102.50

)

)

)

ךיראת

26.11.2015

םושירה רפסמו תילגנאב רישכת םש

VIAGRA 25 MG 111-36-29459-00

VIAGRA 50 MG 111-37-29460-00

VIAGRA 100 MG 111-38-29461-00

:םושירה לעב םש

מ"עב לארשי הקיטבצמרפ רזייפ

ה טורפל דעוימ הז ספוט דבלב תורמחה

הה תושקובמה תורמח

ןולעב קרפ

יחכונ טסקט

שדח טסקט

רישכתב שמתשהל ןיא :םא

םיזנאה יילעפשמ תצובקמ הפורת ליבקמב לטונ ךנה

guanylate cyclase

ןוגכ(

riociguat

תודחוימ תורהזא תועגונה

ל

שומיש הפורתב

( טאוגיסואיר

riociguat

םדה ילכב הובג םד ץחלב לופיטל

האיר

הרגאיו םע בולישה

.רוסא

ב"צמ נמוסמ ובש ,ןולעה תושקובמה תורמחהה תו בוהצ עקר לע

( ונמוס תורמחה רדגב םניאש םייוניש ןולעב םוקימב םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב ) .טסקטה

ךיראתב ינורטקלא ראודב רבעוה

1116611/62

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