PICO - SALAX ORANGE

Israel - English - Ministry of Health

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Active ingredient:
CITRIC ACID ANHYDROUS; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Available from:
FERRING PHARMACEUTICALS LTD
ATC code:
A09AB04
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
SODIUM PICOSULFATE 10 MG; CITRIC ACID ANHYDROUS 12 G; MAGNESIUM OXIDE 3.5 G
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
FERRING GmbH ,GERMANY
Therapeutic group:
CITRIC ACID
Therapeutic area:
CITRIC ACID
Therapeutic indications:
To clean the bowel Prior to X-ray examination, endoscopy or surgery.
Authorization number:
144 04 32928 00
Authorization date:
2015-07-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

18-09-2019

1986 - ו"משתה )םירישכת( םיחקורה תונקת יפל ןכרצל ןולע דבלב אפור םשרמ יפ לע תקוושמ הפורתה הייתשל הסימת תנכהל הקבא ,'גנרוא סקלס-וקיפ הייתשל הסימת תנכהל הקבא ,ירבנרק סקלס-וקיפ .הדידמ תיפכו הקבא תויקש יתש הליכמ הפורתה תזירא :תחא תיקשב םיליעפה םירמוחה

Sodium picosulfate, 10 mg

ג"מ 10 ,טאפלוסוקיפ םוידוס

Magnesium oxide, light 3.5 g

םרג 3.5 טייל ,דיסקוא םויזנגמ

Citric acid, anhydrous 12 g

םרג 12 סורדיהנא ,תירטיצ הצמוח קלח לע בושח עדימ" 2 ףיעס האר – םיליעפ יתלב םירמוח ."ףסונ עדימ" 6 ףיעסו "הפורתה לש םיביכרמהמ הז ןולע .הפורתב שמתשת םרטב ופוס דע ןולעה תא ןויעב ארק לא הנפ ,תופסונ תולאש ךל שי םא .הפורתה לע יתיצמת עדימ ליכמ .חקורה לא וא אפורה הלולע איה .םירחאל התוא ריבעת לא .ךרובע המשרנ וז הפורת .המוד יאופרה םבצמ יכ ךל הארנ םא וליפא םהל קיזהל

1

.

?הפורתה תדעוימ המל וא היפוקסודנא ,ןגטנר תקידב ינפל יעמה ןויקינל שמשמ סקלס-וקיפ .חותינ .יעמ ןקורמ ,לשלשמ :תיטיופרת הצובק

2

.

הפורתב שומישה ינפל :םא הפורתב שמתשהל ןיא

םיביכרמהמ דחא לכל וא םיליעפה םירמוחל )יגרלא( שיגר ךנה יתלבה םיביכרמה תמישרל( הפורתה הליכמ רשא םיפסונה .(6 ףיעס האר ,םיליעפ

.תואקהו תוליחבמ עגרכ לבוס ךנה

תונקורתה תלוכי( gastric retention ארקנש בצממ לבוס ךנה .(הביקה לש תתחפומ

.)םייעמב וא הביקב םיביכ( לוכיעה תכרעמב םיביכמ לבוס ךנה

.לוכיעה תכרעמב תובקנתה וא המיסחמ לבוס ךנה

תקלד :ןוגכ ,ןטבב תיגרוריכ תוברעתה שרודה בצממ לבוס ךנה .ןתפסותב הפירח

תויתעונת רסוח וא םייעמ תמיסח( ileus ארקנה בצממ לבוס ךנה וא )יעמה ןפודל קזנ( toxic colitis ,(םייעמה לש תילאמרונ .)סגה יעמה לש הפירח תובחרתה( toxic megacolon

.תוילכב הרומח היעבמ לבוס ךנה

.תיביכ סיטילוק וא ןהורק :ןוגכ הליעפ תיתקלד יעמ תלחמ ךל שי

.םדב םויזנגמ לש תוהובג תומר ךל שיש אפורה ידי לע ךל רמאנ

לבוס ךנה יכ ןכתיי וא הקזח אמצ תשוחת שיגרמ ךנה .הרומח תושבייתהמ

.רירש קוריפמ לבוס ךנה יכ אפורה ידי לע ךל רמאנ

.בל תקיפס יאמ לבוס ךנה יכ אפורה ידי לע ךל רמאנ .ענמיהל וא עגפיהל לולע יעמה תלוכת רבעמ ,הלא םיבצמב וא תושיגר ,ןטב באכ ,לושלש ,האקה ,הליחב םיללוכ םינימסתה .םוחו קילוקמ האצותכ באכ ,תוחיפנ הפורתב שומישל תועגונה תודחוימ תורהזא רפס ,ירבנרק סקלס-וקיפ וא 'גנרוא סקלס-וקיפב לופיטה ינפל :םא אפורל

.יתיילכה דוקפתב תוערפה וא בל תלחממ לבוס ךנה

יעמה לש תיביכ תקלד ןוגכ ,תיתקלד יעמ תלחמ לש עקר ךל שי .ןהורק תלחמ וא סגה

.לוכיעה תכרעמב חותינ הנורחאל תרבע

התא יכ אדוול שי .תיזיפ שלח וא שישק ,םינש 18-מ תוחפ ןב התא .לופיטה ךלהמב םיטילורטקלאו םילזונ לש תקפסמ תומכ התוש

.יעמ חותינ ינפל הפורתב שמתשהל דמוע ךנה תא תחקל ךרטצתש ןכתיי ,תומדקומ רקוב תועשב ךלש הקידבה םא .ךלש הנישל עירפהל לולע הזו הלילה ךלהמב הפורתה לש היינשה הנמה :תויתפורת ןיב תובוגת/תויצקרטניא ללוכ תורחא תופורת ,הנורחאל תחקל םא וא ,חקול התא םא .חקורל וא אפורל ךכ לע רפס ,הנוזת יפסותו םשרמ אלל תופורת :חקורה וא אפורה תא עדייל שי דחוימב

.ןי ִ בּוּס ןוגכ ,חפנ ירצוי םילשלשמ םירישכתב שמתשמ ךנה םא

הפה ךרד תונתינה תופורת לש ןתגיפס ןפוא לע עיפשמ סקלס-וקיפ םשרמ תופורת לטונ ךנה םא ,ןכל .תונתשהל היושע ןתעפשה ןכ לעו תולולג :ןוגכ ,עובק סיסב לע תומשרנ ןה םא דחוימב ,הפה ךרד ןתמב ןימאליצינפ ,לזרב ,הקיטויביטנא ,תרכוס דגנ תופורת ,ןויריה תעינמל םייתעש תוחפל לוטיל שי ולא תופורת ,תויטפליפא יטנא תופורת וא .סקלס-וקיפ לש ןתמ רחאל תועש 6-מ תוחפ אלו ינפל

וא/ו םימה ןזאמ לע עיפשהל תויושעש םשרמ תופורת לטונ ךנה םא תקלד ידגונ ,םידיאורטס ,תונתשמ תופורת :ןוגכ ,םיטילורטקלאה לופיטל תופורת ,ןיסקוגיד ,םויתיל ,)NASIDs( םידיאורטס םניאש .םייטוכיספ-יטנאו ןיפזמברק ,ןואכידב הקנהו ןויריה שי תורהל הסנמ וא ןויריהב תאש תבשוח ,הקינימ וא ןויריהב תא םא .הפורתב שומישה ינפל חקורה וא אפורה םע ץעייתהל תונוכמב שומישו הגיהנ שמתשהל וא גוהנל ךלש תלוכיה לע העפשה ןיא סקלס-וקיפל רחאל ןותנ ןמז לכב םיתורישל השיג ךל שיש אדו אנא ךא ,תונוכמב .תשלחנ התעפשהש דע ,הנמ לכ הפורתה לש םיביכרמהמ קלח לע בושח עדימ

ץעוויהל שי .ןגלשא םרגילימ 195 הליכמ סקלס-וקיפ לש תיקש לכ לע רומשל ךל רמאנש וא ,תוילכב תויעב ךל שי םא אפורה םע .ןגלשאה תומר תניחבמ תרקובמ הטאיד

רסמנ םא .זוטקל הליכמ זופת םעטב 'גנרוא סקלס-וקיפ הפורתה תוברל םימיוסמ םירכוסל תוליבס-יא לעב ךנה יכ אפורה ידי לע ךל .הפורתה תליטנ םרט ומע ץעוויהו אפורל הנפ אנא ,זוטקל

3

.

?הפורתב שמתשת דציכ קודבל ךילע .אפורה תוארוהל םאתהב דימת רישכתב שמתשהל שי לופיטה ןפואו ןונימל עגונב חוטב ךניא םא חקורה וא אפורה םע .דבלב אפורה ידי-לע ועבקי לופיטה ןפואו ןונימה .רישכתב .תצלמומה הנמה לע רובעל ןיא הפורתה תנכה ןפוא 150-כ הליכמה האלמ אל סוכב תיקשה תלוכת תא בברע :םירגובמ םימעפל .הסימתה תא התשו תוקד 3- 2 ךשמל בברע .םירק םימ ל"מ איהש דע ןיתמהל שי הזכ הרקמב .םמחתהל הלולע הסימתה .תותשל ידכ קיפסמ ררקתת :םידלי :הדידמ תיפכ םע הנמה תדידמל

תיקשהמ הקבאה םע תיפכה תא אלמ

ןיכסה בג םע תיפכה תא חטש

)הקבא 'רג 4( "האלמ תיפכ" איה הדידמה תיפכב הרתונש הקבא :הליכמש םימ סוכל הקבאה תא רבעה

הקבא לש תחא תיפכל םימ ל"מ 50 ךרעב

הקבא לש תויפכ יתשל םימ ל"מ 100 ךרעב

תוקד 3- 2 ךשמב סוכה תלוכת תא בברע

הסימתה תא תותשל ךדליל ןת

שי הזכ הרקמב .בוברעה ןמזב םמחתהל הלולע הסימתה םימעפל ררקתת הסימתהש דע ןיתמהל

.תיקשב הרתונש הקבאה תא ךילשהל שי :אפורמ תרחא הארוה רדעהב לבוקמ ןונימ :9 ליג לעמ םידליו )םישישק ללוכ( םירגובמ תיקשו הקידבה ינפל תועש 18 דע 10 הנושאר תיקש לוטיל ץלמומ הנושארה תיקשה תליטנ רחאל .הקידבה ינפל תועש 6 דע 4 היינש םילזונ לש )סוכל ל"מ 250-כ( תואלמ תוסוכ 5 תוחפל תותשל שי תבב םילזונה לכ תא תותשל אלו םימ קר תותשל אל בושח .םילולצ תליטנ רחאל .תועש רפסמ ךשמב הייתשה תא רזפל אלא ,תחא ל"מ 250-כ( תואלמ תוסוכ 3 תוחפל תותשל שי ,היינשה תיקשה תא תותשל אלו םימ קר תותשל אל בושח .םילולצ םילזונ לש )סוכל .תועש רפסמ ךשמב הייתשה תא רזפל אלא ,תחא תבב םילזונה לכ םיקרמ ,םילק תואקשמ ,םילולצ תוריפ יצימ ןווגמ םיללוכ םילולצ םילזונ !םימ קר תותשל ןיא .)תפצק וא היוס ,בלח ילב( הפק ,הת ,םילולצ .הקידבה ינפל םייתעש דע םילולצ םילזונ תותשל רתומ :(9 ליגל תחתמ( םידליל ןונימ .הלעמ םירגובמ ןונימב תויחנהה תא ארק םידליב הפורתה תליטנ ינמזל

.הפורתה תזיראב תקפוסמ הדידמ תיפכ

הווש( האלמ תחא הדידמ תיפכ :הנושאר הנמ :םייתנש דע הנש ליג ךרע הווש( האלמ תחא הדידמ תיפכ :היינש הנמ .)תיקש עברל ךרע .)תיקש עברל יצחל ךרע הווש( תואלמ הדידמ תויפכ יתש :הנושאר הנמ :םינש 4- 2 ליג .)תיקש יצחל ךרע הווש( תואלמ הדידמ תויפכ יתש :היינש הנמ .)תיקש רבסומש יפכ ןיכהל שי( תחא תיקש :הנושאר הנמ :םינש 9- 4 ליג ךרע הווש( תואלמ הדידמ תויפכ יתש :היינש הנמ .)"םירגובמ" קרפב .)תיקש יצחל .םירגובמ ןונימ האר :הלעמו 9 ליג ?לופיטה תחלצהל עייסל לכות דציכ .אפורה ידי-לע ץלמוהש לופיטה תא םילשהל ךילע עגר לכב וליחתיש תוילזונו תופוכת םייעמ תולועפל םינכומ תויהל שי םיתורישל השיג ךל שיש אדו אנא .סקלס-וקיפ לש הנמ תליטנ רחאל .תושלחנ תועפשההש דע ,הנמ לכ רחאל ןותנ ןמז לכב דע סקלס-וקיפ םע לופיטה ךרואל םילולצ םילזונ הברה תותשל שי האלמ סוכ תותשל תוסנל שי ,יללכ ןפואב .תוקיספמ םייעמה תולועפש .אמצ התאש םעפ לכ םילולצ םילזונ לש )סוכל ל"מ 250-כ( םיקרמ ,םילק תואקשמ ,םילולצ תוריפ יצימ ןווגמ םיללוכ םילולצ םילזונ !םימ קר התשת לא .)תפצק וא היוס ,בלח ילב( הפק ,הת ,םילולצ ךכב היולת םילוחה תיבב רובעל דמוע התאש הקידבה תחלצה םייעמה לש בוט ןוקירל עיגת אל םא .רשפאה לככ יקנ היהי יעמהש הנוזתה תוארוה לע דיפקהל ךילע .הקידבה לע רוזחל ךרטצתש ןכתיי .אפורה ידי לע ךל ונתינש ,הפורתה ןמ דלי עלב תועטב םא וא רתוי הובג ןונימ תועטב תלטנ םא תזירא תא אבהו בורק םילוח-תיב לש ןוימ רדחל וא אפורל דימ הנפ .ךתיא הפורתה .הלופכ הנמ לוטיל ןיא ,דעוימה ןמזב הפורתה תא לוטיל תחכש םא .אפורב ץעוויהו ליגרה ןמזב האבה הנמה תא חק םעפ לכב הנמהו תיוותה תא קודב !ךשוחב תופורת לוטיל ןיא .םהל קוקז ךנה םא םייפקשמ בכרה .הפורת לטונ ךנהש אפורב ץעוויה ,הפורתב שומישל עגונב תופסונ תולאש ךל שי םא .חקורב וא

4

.

יאוול תועפות יאוול תועפותל םורגל לולע סקלס-וקיפב שומישה ,הפורת לכב ומכ .יאוולה תועפות תמישר ארקמל להבית לא .םישמתשמהמ קלחב .ןהמ תחא ףאמ לובסת אלש ןכתיי דיעהל םילולעה םיכשוממו םיפירח ןטב יבאכ לע םידדוב םיחוויד ויה תובוגת לע םידדוב םיחווידו ,ףוחד יאופר לופיט שרודה רומח בצמ לע .המישנ יישקל ליבוהל תולולעש תורומח תויגרלא .קדה יעמב םילק םיביכ לש םידדוב םירקמ וחווד תונפל שי ךשוממו רומח ןטב באכ וא תיגרלא הבוגת לש הרקמב !דימ אפורל 10- 1-ב תועיפומש תועפות - )common( תוחיכש יאוול תועפות 100 ךותמ םישמתשמ

.שאר יבאכ

.הליחב

.תעבטה יפב באכ תועיפומש תועפות - )uncommon( תוחיכש ןניאש יאוול תועפות 1000 ךותמ םישמתשמ 10- 1-ב

.דרג וא/ו החירפ

תושבייתה לש בצמל איבהל םילולעה םיפירח םילושלשו תואקה םילזונה תא םילשמ וניא לפוטמה םאב לובלבו שאר יבאכב הוולמה .ודבאש םיחלמהו

.ןטב יבאכ

.תואקה

)הימלקופיה וא הימרתנופיה( םדב ןגלשא וא ןרתנ לש תוכומנ תומר ילוחב םיתיעל וחווד םיסוכרפ יפקתה .םיסוכרפ יפקתה ילב וא םע .היספליפא (העבקנ םרט ןתוחיכשש תועפות) העודי הניא ןתוחיכשש יאוול תועפות

ןונגנממ קלח םה לושלש וא םייעמה לש תרבגומ תויתעונת תיתייעבל תכפוה יעמה תויתעונת םא ךא ,הפורתה לש תוליעפה .אפורל תונפל שי ,הגאד ךל תמרוג וא וא הרימחמ יאוולה תועפותמ תחא םא ,יאוול תעפות העיפוה םא ץעייתהל ךילע ,ןולעב הניוצ אלש יאוול תעפותמ לבוס התא רשאכ .אפורה םע יאוול תועפות חוויד הציחל תועצמאב תואירבה דרשמל יאוול תועפות לע חוודל ןתינ אצמנש "יתפורת לופיט בקע יאוול תועפות לע חוויד" רושיקה לע הנפמה (www.health.gov.il) תואירבה דרשמ רתא לש תיבה ףדב :רושיקל הסינכ י"ע וא יאוול תועפות לע חווידל ןווקמה ספוטל

https://sideeffects.health.gov.il

5

.

?הפורתה תא ןסחאל ךיא

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

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

.תירוקמה הזיראב ןסחאל שי .25°C לע הלועה הרוטרפמטב ןסחאל ןיא

6

.

ףסונ עדימ :םג הליכמ הפורתה םיליעפה םירמוחה לע ףסונ :'גנרוא סקלס-וקיפ

Potassium

hydrogen

carbonate,

granular,

saccharin

sodium, orange flavor which contains arabic gum (acacia

gum E414), lactose (lactose foodstuffs), ascorbic acid

E300, butylated hydroxyanisole E320.

:ירבנרק סקלס-וקיפ

Potassium

bicarbonate,

saccharin

sodium,

cranberry

flavor S/D.

הזיראה ןכות המו הפורתה תיארנ דציכ יתש הליכמ הזירא לכ .הייתשל הסימת תנכהל הקבא ונה סקלס-וקיפ םרג 4 הליכמ האלמ הדידמ תיפכ .הדידמ תיפכו הקבא םע תויקש .הקבא .הינמרג ,GmbH גנירפ :ותבותכו ןרציה םש הטישה 'חר ,מ"עב סלקיטואצמרפ גנירפ :ותבותכו םושירה לעב םש .3088900 הירסיק ,היישעת קראפ ,8 .2019 ילויב תואירבה דרשמ י"ע רשואו קדבנ הז ןולע :תואירבה דרשמב יתכלממה תופורתה סקנפב הפורתה םושיר 'סמ 144-04-32928 :'גנרוא סקלס-וקיפ 157-91-35155 :ירבנרק סקלס-וקיפ הפורתה ךא ,רכז ןושלב חסונ הז ןולע האירקה תלקהו תוטשפה םשל .םינימה ינשל תדעוימ

Patient leaflet in accordance with the Pharmacists’

Regulations (Preparations) - 1986

The dispensing of this medicine requires a doctor’s

prescription

Pico-Salax Orange, Powder for preparation

of an oral solution

Pico-Salax Cranberry, Powder for

preparation of an oral solution

This medicine package contains two sachets of powder

and a measuring spoon.

The active ingredients of one sachet:

Sodium picosulfate, 10 mg

Magnesium oxide, light 3.5 g

Citric acid, anhydrous 12 g

Inactive ingredients - See section 2 ‘Important information

about some of this medicine’s ingredients’ and Section 6

‘Additional Information’.

Read the entire leaflet carefully before using this

medicine. This leaflet contains concise information about

this medicine. If you have any further questions, refer to

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.

1. What is this medicine intended for?

Pico-Salax is used to clean the bowel prior to an x-ray

examination, endoscopy, or surgery.

Therapeutic group: laxative, cathartic.

2. Before using this medicine

Do not use this medicine if:

You are sensitive (allergic) to the active ingredients

or to any of the other ingredients that this medicine

contains (for a list of inactive ingredients, please see

Section 6).

You are currently suffering from nausea and vomiting.

You have a condition called gastric retention (reduced

ability of the stomach to empty).

You have ulcers in your digestive tract (in your

stomach or bowel).

You have a blockage or perforation in your digestive

tract.

You have a condition requiring abdominal surgery,

such as acute appendicitis.

You have a condition called ileus (intestinal blockage

or failure of normal bowel movements), toxic colitis

(damage to the intestinal wall), or toxic megacolon

(acute expansion of the colon).

You have a serious kidney problem.

You have an active inflammatory bowel disease such

as Crohn’s disease or ulcerative colitis.

You have been told by your doctor that you have high

levels of magnesium in your blood.

You feel extremely thirsty or you may be severely

dehydrated.

You have been told by your doctor that you have

damaged muscles that are leaking their contents to

your blood.

You have been told by your doctor that you have

heart failure.

With these conditions, the bowels’ content may be

partly or completely prevented from passing through.

Symptoms include nausea, vomiting, diarrhea, abdominal

pain, tenderness or swelling, colicky pain and fever.

Special warnings about using this medicine:

Before treatment with Pico-Salax Orange or Pico-

Salax Cranberry, tell your doctor if:

You have heart disease or a kidney function disorder.

You have a history of inflammatory bowel disease such

as ulcerative colitis or Crohn’s disease.

You have recently had surgery in your digestive tract.

You are younger than 18 years old, elderly, or physically

weak.

Make

sure

drink

sufficient

fluids

electrolytes during treatment.

You are about to use the medicine before intestinal surgery.

If your procedure is performed early in the morning, you

may need to take the second dose of the medicine during

the night, and possible sleep disturbance may occur.

Drug interactions

If you are taking or have recently taken other medicines,

including nonprescription medications and nutritional

supplements,

tell

your

doctor

or

pharmacist.

particular tell the doctor or pharmacist if:

You are using bulk-forming laxatives such as bran.

Pico-Salax affects the way oral medicines are absorbed so

their effect might change. If you are taking oral prescription

medicines, particularly if you are

prescribed

with them

regularly, such as: contraceptive pills, antidiabetics,

antibiotics, iron, penicillamine or antiepileptics, take these

medicines at least two hours before and not less than 6

hours after administration of Pico-Salax.

If you are taking prescription medicines which may affect

your water and/or electrolyte balance such as: diuretics,

steroids, nonsteroidal anti-inflammatory drugs (NSAIDs),

lithium, digoxin, antidepressants, carbamazepine and

antipsychotics.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are trying

to become pregnant or if you are breastfeeding, consult

your doctor or pharmacist before using this medicine.

Driving and using machines

Pico-Salax does not affect your ability to drive or use

machines; however, make sure to have access to a toilet

at all times after taking each dose, until its effect wears off.

Important information about some of this medicine’s

ingredients

Each sachet of Pico-Salax contains 195 mg of potassium.

Consult your doctor if you have kidney problems, or if you

have been told to keep a controlled-potassium diet.

Orange-flavored Pico-Salax Orange contains lactose.

If you have been told by your doctor that you have an

intolerance to some sugars, including lactose, please

consult your doctor before taking this medicine.

3. How to use this medicine?

Always use the medicine according to your doctor’s

instructions. Check with the doctor or pharmacist if you are

not sure regarding the dosage and manner of treatment

with the medicine. Only your doctor will determine your

dose and how you should take this medicine.

Do not exceed the recommended dose.

How to prepare the medicine

Adults: Mix the content of the sachet into a partially filled

cup containing about 150 ml of cold water. Stir for 2-3

minutes and drink the solution. Sometimes the solution

may get warm. If this happens, wait until it cools down

sufficiently to drink it.

Children:

To measure a dose with the measuring spoon:

Fill the spoon with powder from the sachet

Pass the flat back of a knife across the top of the spoon

The powder left in the measuring spoon is one spoonful

(4 g of powder)

Pure the powder in a cup of water that contains:

About 50 ml of water for one spoonful of powder

About 100 ml of water for two spoonfuls of powder

Stir the content in the cup for 2-3 minutes.

Give you child the solution to drink.

Sometimes the solution may warm up while you mix it. If

this happens, wait until the solution cools down

Throw away the remaining powder from the sachet.

Standard dosage in the absence of other instruction

from the doctor:

Adults (including elderly) and children above the age

of 9:

It is recommended to take the first sachet 10 to 18 hours

before the procedure and the second sachet 4 to 6 hours

before the procedure. After taking the first sachet, drink at

least 5 full glasses (about 250 ml per glass) of clear liquids.

It is important not to drink only water and not to drink all

the liquids simultaneously, but to spread the drinks over

several hours. After taking the second sachet, drink at least

3 full glasses (about 250 ml per glass) of clear liquids. It is

important not to drink only water and not to drink all the liquids

simultaneously, but to spread the drinks over several hours.

Clear liquids include a variety of clear fruit juices, soft

drinks, clear soups, tea, coffee (without milk, soy or cream).

Do not drink only water!

You may drink clear liquids up to two hours before the

procedure

Dosage for children (below the age of 9):

For times of medication intake in children, read the

instructions for adult dosage above.

Measuring spoon is supplied in the medicine package.

Age of 1 to 2 years: First dose: one full measuring

spoon )equivalent to 1/4 sachet(. Second dose: one full

measuring spoon (equivalent to 1/4 sachet).

Age 2-4 years: First dose: two full measuring spoons

(equivalent

sachet(.

Second

dose:

full

measuring spoons (equivalent to 1/2 sachet).

years:

First

dose:

sachet

)prepare

explained in the “Adults” section(. Second dose: two full

measuring spoons (equivalent to 1/2 sachet).

Age 9 and up: see adult dosage.

How can you contribute to the success of the treatment?

Complete the course of treatment as recommended by

your doctor.

Prepare yourself for frequent and loose bowel movements

any time after taking a dose of Pico-Salax. Please make

sure you have access to a toilet at all times after taking

each dose, until the effect wears off.

You should drink a lot of clear liquids during treatment

with Pico-Salax until your bowel movements stop. In

general, try to drink a full cup (about 250 ml per glass) of

a clear liquid every time you feel thirsty.

Clear liquids include a variety of clear fruit juices, soft

drinks, clear soups, tea, coffee (without milk, soy or

cream). Do not drink only water!

The success of the procedure you are about to undergo

at the hospital depends on your bowel being as clear as

possible. If you do not achieve adequate emptying of your

bowel you may need to repeat the procedure. Be careful

to follow your doctor’s instructions about nutrition.

If you have accidentally taken a higher dose or if a child

has accidentally swallowed some of the medicine, go

immediately to a doctor or a nearby hospital emergency

room and bring the medicine package with you.

If you forget to take the medicine at the scheduled

time, do not take a double dose. Take the next dose at the

regular time and consult your doctor.

Do not take medicines in the dark! Check the label

and dose each time you take the medicine. Wear

glasses if you need them.

If you have further questions regarding the use of this

medicine, consult your doctor or pharmacist.

4. Side effects

Like all medicines, taking Pico-Salax may cause side

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

side effects. You may not experience any of them.

There have been isolated cases of severe and prolonged

abdominal pain which may indicate a serious condition and

require urgent medical care, and isolated cases of severe

allergic reactions which may lead to difficulty breathing.

There are reports of isolated cases of mild intestinal ulcers.

In case of an allergic reaction or a severe abdominal pain

that lasts for a while consult your doctor immediately!

Common side effects (affect 1-10 in 100 users)

Headache.

Nausea.

Pain in the anus.

Uncommon side effects (affect 1-10 in 1000 users)

Rash and/or itching.

Vomiting

severe

diarrhea

which

lead

dehydration with headache and confusion if the patient

does not restore the lost fluids and salts.

Abdominal pain.

Vomiting.

levels

sodium

potassium

blood

(hyponatremia or hypokalemia) with or without fits. fits

have been occasionally reported in epileptic patients.

Side effects of unknown frequency (the frequency of

these effects has not been established yet)

Increased bowel movements or diarrhea are part of

how this medicine works. However, if bowel movements

become

troublesome

causes

concern,

should contact your doctor.

If a side effect appears, if any of the side effects

worsens or if you experience any side effect not

mentioned in this leaflet, consult your doctor.

Reporting side effects

You can report side effects to the Ministry of Health (MoH)

by following the link ‘Reporting Side Effects of Medication’

on the MoH home page (www.health.gov.il) which links to

an online form for reporting side effects, or by following

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

5. How to store the medicine?

Prevent poisoning! To prevent poisoning, keep this, and

all other medicines, in a closed place out of reach and

sight of children and/or infants. Do not induce vomiting

unless explicitly instructed to do so by a doctor.

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

date) appearing on the package. The expiry date refers

to the last day of that month.

Storage conditions

Do not store at a temperature above 25°C. Store in the

original package.

6. Additional information

In addition to the active ingredients this medicine

also contains:

Pico-Salax Orange:

Potassium

hydrogen

carbonate,

granular,

saccharin

sodium, orange flavor which contains arabic gum (acacia

gum E414), lactose (lactose foodstuffs), ascorbic acid

E300, butylated hydroxyanisole E320.

Pico-Salax Cranberry:

Potassium

bicarbonate,

saccharin

sodium,

cranberry

flavor S/D.

What does the medicine look like and what are the

contents of the package

Pico-Salax is a powder for preparing an oral solution. Each

package contains two sachets with powder and a measuring

spoon. A full measuring spoon contains 4 g of powder.

Name

and

address

of

the

manufacturer:

Ferring

GmbH, Germany.

Name and address of the registration holder: Ferring

Pharmaceuticals Ltd., 8 Hashita Street, Industrial Park

Caesarea 3088900.

This leaflet was reviewed and approved by the Ministry of

Health in July 2019.

Medicine registration number in the National Medicines

Registry of the Ministry of Health:

Pico-Salax Orange: 144-04-32928

Pico-Salax Cranberry: 157-91-35155

1.

NAME OF THE MEDICINAL PRODUCT

PICO - SALAX Orange

PICO - SALAX Cranberry

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains the following active ingredients:

Sodium picosulfate

10.0mg

Magnesium oxide, light

3.5g

Citric acid, anhydrous

12.0g

Each sachet also contains:

Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg) potassium]

Lactose (as a component of the orange flavour)

For full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Powder for oral solution in sachet.

White crystalline powder.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

To clean the bowel prior to X-ray examination or endoscopy or surgery.

4.2 Posology and method of administration

Adults (including the elderly):

The two PICOLAX sachets are taken dependent on the planned time of the

procedure:

The first reconstituted sachet is taken 10 to 18 hours before the

procedure, followed by at least five 250 ml drinks of clear liquids,

spread over several hours

The second reconstituted sachet is taken 4 to 6 hours before the

procedure, followed by at least three 250 ml drinks of clear liquids,

spread over several hours

Clear liquids may be consumed until 2 hours before the time of the

procedure

Special populations

Limited data is available for treatment of patients with low body weight (BMI

less than 18). The rehydration regimen above has not been tested in such

individuals and therefore monitoring of their hydration status is required and

the regimen may need to be altered appropriately (see section 4.4).

Pediatric population:

A measuring spoon is provided with the product. It is recommended that a

narrow flat edge, for example the back of a knife blade, is drawn across the top

of a heaped measuring spoon to obtain a flat surface of the measure. This will give ¼ of a sachet

(4 g powder) per spoonful.

For the timing of dosing in children, refer to the instructions given for adults

1 - 2 years: first dose is 1 spoonful, second dose is 1 spoonful

2 - 4 years: first dose is 2 spoonfuls, second dose is 2 spoonfuls

4 - 9 years: first dose is 1 sachet, second dose is 2 spoonfuls

9 years and above: adult dose

Method of administration: Oral

Directions for reconstitution

Reconstitute the contents of one sachet in a cup of water (approximately 150ml). Stir

for 2-3 minutes, the solution should now become an off-white, cloudy liquid with a

faint odour of orange/cranberry. Drink the solution. If it becomes hot, wait until it

cools sufficiently to drink.

Directions for reconstitution (Pediatric population)

Reconstitute the required amount of powder in a cup containing approximately

50 ml water per spoonful. Stir for 2-3 minutes, the solution should now

become an off-white, cloudy liquid with a faint odour of orange/cranberry. Drink the

solution. If it has become warm, wait until it cools sufficiently to drink.

Discard the remaining contents of the sachet.

For directions on reconstitution of the full sachet for children of 4-9 years,

refer to the instructions given for adults.

A low residue diet is recommended on the day prior to the procedure. A clear liquid diet

is recommended on the day of the procedure. To avoid dehydration it is important to

follow the liquid intake recommendation as advocated together with the PICOLAX

dosing whilst the effects of PICOLAX persist (see section 4.2,

Posology

). Apart from

the liquid intake together with the treatment regimen (PICOLAX + additional liquids), a

normal, thirst driven intake of clear liquids is recommended.

Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup,

tea, coffee (without milk, soy or cream) and water. Do not drink only water.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section

Congestive cardiac failure

Gastric retention

Gastro-intestinal ulceration

Toxic colitis

Toxic megacolon

Ileus

Nausea and vomiting

Acute surgical abdominal conditions such as acute appendicitis

Known or suspected gastro-intestinal obstruction or perforation.

Severe dehydration

Rhabdomyolysis

Hypermagnesemia

Active inflammatory bowel disease

In patients with severely reduced renal function, accumulation of magnesium in

plasma may occur. Another preparation should be used in such cases.

4.4 Special warnings and special precautions for use

Because a clinically relevant benefit of bowel cleansing prior to elective, open

colorectal surgery could not be proven, bowel cleansers should only be administered

before bowel surgery if clearly needed. The risks of the treatment should be carefully

weighed against possible benefits and needs depending on surgical procedures

performed.

An insufficient or excessive oral intake of water and electrolytes could create

clinically significant, deficiencies, particularly in less fit patients. In this

regard patients with low body weight, children, the elderly, debilitated

individuals and patients at risk of hypokalaemia or hyponatremia may need

particular attention. Prompt corrective action should be taken to restore

fluid/electrolyte balance in patients with signs or symptoms of hypokalaemia

or hyponatremia.

Drinking only water to replace the fluid losses may lead to electrolyte imbalance.

Care should also be taken in patients with recent gastro-intestinal surgery, renal

impairment, heart disease or inflammatory bowel disease.

Use with caution in patients on drugs that might affect water and/or electrolyte balance

e.g. diuretics, corticosteroids, lithium (see 4.5).

PICO SALAX may modify the absorption of regularly prescribed oral medication and

should be used with caution e.g. there have been isolated reports of seizures in patients

on antiepileptics, with previously controlled epilepsy (see 4.5 and 4.8).

The period of bowel cleansing should not exceed 24 hours because longer preparation

may increase the risk of water and electrolyte imbalance.

For an early time of the day procedure it may be required to take the second

dose during the night and possible sleep disturbance may occur.

This medicine contains 5 mmol (or 195 mg) potassium per sachet. This should be taken

into consideration by patients with reduced kidney function or patients on a controlled

potassium diet.

This medicine contains lactose as a component of the orange flavour. Patients with rare

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

galactose malabsorption should not take this medicine.

PICO SALAX should not be used as a routine laxative.

4.5 Interaction with other medicinal products and other forms of interaction

As a purgative, PICO SALAX increases the gastrointestinal transit rate. The

absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives,

anti-diabetics, antibiotics) may therefore be modified during the treatment period (see

4.4). Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and

penicillamine, should be taken at least 2 hours before and not less than 6 hours after

administration of PICO SALAX to avoid chelation with magnesium.

The efficacy of PICO SALAX is lowered by bulk-forming laxatives.

Care should be taken with patients already receiving drugs which may be associated

with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is

a particular risk i.e. cardiac glycosides). Caution is also advised when PICO SALAX is

used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic

antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and

carbamazepine as these drugs may increase the risk of water retention and/or electrolyte

imbalance.

4.6 Fertility, Pregnancy and lactation

Pregnancy.

For PICO SALAX no clinical data on exposed pregnancy are available. Studies in

animals have shown reproductive toxicity (see section 5.3). As picosulfate is a stimulant

laxative, for safety measure, it is preferable to avoid the use of PICO SALAX during

pregnancy.

Fertility

There are no data on the effect of PICOSALAX on fertility in humans. Male and female rat

fertility was not affected by oral doses of sodium picosulfate up to 100 mg/kg (see section

5.3).

Breastfeeding.

There is no experience with the use of PICO SALAX in nursing mothers. However, due

to the pharmacokinetic properties of the active ingredients, treatment with PICO

SALAX may be considered for females who are breastfeeding.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

The most frequent adverse reactions seen in clinical trials are nausea, headache and

vomiting.

MedDRA Organ

Class

Common (≥1/100 to

≤1/10)

Uncommon

((≥1/1000 to ≤1/100)

Not known

(cannot be

estimated from

the available

data)

Immune system

disorder

Anaphylactic reaction,

hypersensitivity

Metabolism and

nutrition disorders

Hyponatraemia and

hypokalaemia

Nervous system

disorders

Headache

Epilepsy, grand mal

convulsion,

convulsions,

confusional state

Gastrointestinal

disorders

Nausea and

proctalgia

Vomiting, abdominal

pain, aphthoid ileal

ulcers*

Diarrhoea, faecal

incontinence

Skin and

subcutaneous tissue

disorders

Rash (including

erythematous and

maculo-papular rash,

urticaria, purpura)

*Isolated cases of mild reversible aphthoid ileal ulcers have been reported.

¤ The frequencies of the side effects are based on post-marketing experience.

Diarrhoea and faecal incontinence are the primary clinical effect of PICOSALAX. Isolated

cases of severe diarrhoea have been reported post-marketing.

Hyponatraemia has been reported with or without associated convulsions. In epileptic

patients, there have been isolated reports of seizure/grand mal convulsion without associated

hyponatraemia. There have been isolated reports of anaphylactoid reaction.

Reporting

suspected

adverse

reactions

after

authorization

medicinal

product

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

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic

@moh.gov.il

4.9 Overdose

Overdosage would lead to profuse diarrhoea. Treatment is by general supportive

measures and correction of fluid and electrolyte balance.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Contact Laxatives

ATC code: A06A B58

The active components of PICO SALAX are sodium picosulfate and magnesium citrate.

S odium picosulfate is a locally acting stimulant cathartic, which after bacterial cleavage

in the colon forms the active laxative compound, bis-(p-hydroxyphenyl)-pyridyl-2-

methane (BHPM), which has a dual-action with stimulation of the mucosa of both the

large intestine and of the rectum. Magnesium citrate acts as an osmotic laxative by

retaining moisture in the colon. The combined action of the two substances is of a

'washing out' effect combined with peristaltic stimulation to clear the bowel.

The product is not intended for use as a routine laxative.

Clinical efficacy and safety

The dosing regimen as described in section 4.2 Posology, and herein further

referred to as the tailored dosing regimen, was investigated and evaluated in

trial 000121 (OPTIMA) that compared the efficacy, safety and tolerability of

PICOLAX administered according to the tailored dosing regimen versus the

fixed schedule of dosing (i.e. first dose is taken before 8am and second dose is

taken 6-8 hours later on the day before procedure), called day before dosing

regimen (204 patients were randomized, 131 received tailored dosing, 73

received day before dosing).

Superiority of the tailored dosing regimen was demonstrated compared to the

day before dosing regimen in overall colon cleansing and responder status for

ascending colon cleansing. For overall colon cleansing, the tailored dosing

regimen was compared to the day before dosing regimen, based on the

treatment difference in mean total Ottawa Scale score (4.26 versus 8.19 in

mean total Ottawa scale score for tailored dosing regimen and day before

dosing regimen respectively, with a corresponding p-value <0.0001, for the

Intend to Treat (ITT) analysis set). For the responder status of the ascending

colon, the proportion of patients with an Ottawa Scale score of either 0

(excellent) or 1 (good), was compared between the tailored dosing regimen

and the day before dosing regimen. Patients randomized to the tailored dosing

regimen were observed to have a 4.05 greater chance of being a responder

with respect to ascending colon cleansing compared to patients randomized to

the day before dosing regimen.

* Absolute Risk Difference (Crude)

** Relative Risk (Crude)

5.2

Pharmacokinetic properties

Both active components are locally active in the colon, and neither are absorbed in any

detectable amounts.

5.3 Preclinical safety data

Prenatal developmental studies in rats and rabbits did not reveal any teratogenic

potential after oral dosing of sodium picosulfate, but embryotoxicity has been observed

in rats at 1000 and 10000 mg/kg/day and in rabbits at 1000 mg/kg/day. The

corresponding safety margins were 3000 to 30000 times the anticipated human dose. In

rats, daily doses of 10 mg/kg during late gestation (fetal development) and lactation

reduced body weights and survival of the offspring. Male and female rat fertility was

not affected by oral doses of sodium picosulfate up to 100 mg/kg.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients:

Pico Salax Orange:

Potassium hydrogen carbonate, granular

Sodium saccharin

Natural spray dried orange flavour which contains acacia gum (Gum Arabic E414), lactose

(Lactose Foodstuffs), ascorbic acid E300, butylated hydroxyanisole E320.

Pico Salax Cranberry:

Potassium hydrogen carbonate

Sodium saccharin

Cranberry flavor S/D

6.2

Incompatibilities

None known

6.3

Shelf life

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

Once the sachet has been opened, use immediately and discard any unused powder or

solution.

6.4

Special precautions for storage

Do not store above 25

C. Store in the original package.

6.5

Nature and contents of container

Sachet:

4 layers: paper-low density polyethylene-aluminium-thermofusible resin

Each pack contains a pair of sachets that can be separated by tearing apart the perforated strip.

In addition each pack contains measuring spoon. A full measuring spoon contains 4gr

powder.

Weight of sachet contents: 16.1g

6.6

Instructions for use, handling and disposal

None

7.

MANUFACTURER

Ferring GmbH, Germany

8.

LICENSE HOLDER

Ferring Pharmaceuticals Ltd

8, Hashita Street, Industrial Park Caesarea 3088900

ISRAEL

9.

Marketing authorization number: Pico Salax Orange: 144-04-32928-

Pico Salax Cranberry: 157-91-35155-

The format of this leaflet was determined by the Ministry of Health and its content was

checked and approved on July 2019

ילוי

אפור

חקור

דבכנ

ךשמהב רושיאל ןונימ רטשמב יוניש

ילוי

ל תואירבה דרשמ ידי לע רישכת םי

רישכת םש

PICO - SALAX Orange

PICO - SALAX Cranberry

:ליעפ רמוח

Each sachet contains the following active ingredients:

Sodium picosulfate

10.0 mg

Magnesium oxide

3.5g

Citric acid, anhydrous

12.0g

:היוותה

To clean the bowel prior to X-ray examination or endoscopy or surgery.

רוצמ םיפ

ולע םינ

.םינכדועמ

.םינמוסמ ונכדועש םיקלחה

הטמ הלבטב םיטרופמ םיירקיעה םינוכדעה

אפורל ןולעב

ןוכדעה

קרפ

Adults (including the elderly):

The two PICOLAX sachets are taken dependent on the planned

time of the procedure:

The first reconstituted sachet is taken 10 to 18 hours

before the procedure, followed by at least five 250

ml drinks of clear liquids, spread over several hours

The second reconstituted sachet is taken 4 to 6 hours

before the procedure, followed by at least three 250

ml drinks of clear liquids, spread over several hours

Clear liquids may be consumed until 2 hours before

the time of the procedure

Special populations

Limited data is available for treatment of patients with low body

weight (BMI less than 18). The rehydration regimen above has

not been tested in such individuals and therefore monitoring of

their hydration status is required and the regimen may need to be

altered appropriately (see section 4.4).

4.2 Posology and

method of

administration

Pediatric population:

A measuring spoon is provided with the product. It is

recommended that a narrow flat edge, for example the back of a

knife blade, is drawn across the top of a heaped measuring spoon

to obtain a flat surface of the measure. This will give ¼ of a

sachet (4 g powder) per spoonful.

For the timing of dosing in children, refer to the instructions

given for adults

1 - 2 years: first dose is 1 spoonful, second dose is 1 spoonful

2 - 4 years: first dose is 2 spoonfuls, second dose is 2 spoonfuls

4 - 9 years: first dose is 1 sachet, second dose is 2 spoonfuls

9 years and above: adult dose

Method of administration: Oral

Directions for reconstitution

Reconstitute the contents of one sachet in a cup of water

(approximately 150ml). Stir for 2-3 minutes, the solution

should now become an off-white, cloudy liquid with a

faint odour of orange/cranberry. Drink the solution. If it

becomes hot, wait until it cools sufficiently to drink.

Directions for reconstitution (Pediatric population)

Reconstitute the required amount of powder in a cup

containing approximately

50 ml water per spoonful. Stir for 2-3 minutes, the

solution should now become an off-white, cloudy liquid

with a faint odour of orange/cranberry. Drink the

solution. If it has become warm, wait until it cools

sufficiently to drink.

Discard the remaining contents of the sachet.

For directions on reconstitution of the full sachet for

children of 4-9 years, refer to the instructions given for

adults.

For an early time of the day procedure it may be required

to take the second dose during the night and possible

sleep disturbance may occur.

4.4 Special warnings

and special

precautions for use

Clinical efficacy and safety

The dosing regimen as described in section 4.2 Posology,

and herein further referred to as the tailored dosing

regimen, was investigated and evaluated in

trial 000121 (OPTIMA) that compared the efficacy,

safety and tolerability of PICOLAX administered

according to the tailored dosing regimen versus the

fixed schedule of dosing (i.e. first dose is taken before

8am and second dose is taken 6-8 hours later on the day

before procedure), called day before dosing

regimen (204 patients were randomized, 131 received

tailored dosing, 73 received day before dosing).

5.1 Pharmacodynamic

properties

Superiority of the tailored dosing regimen was

demonstrated compared to the day before dosing regimen

in overall colon cleansing and responder status for

ascending colon cleansing. For overall colon cleansing,

the tailored dosing regimen was compared to the day

before dosing regimen, based on the

treatment difference in mean total Ottawa Scale score

(4.26 versus 8.19 in mean total Ottawa scale score for

tailored dosing regimen and day before

dosing regimen respectively, with a corresponding p-

value <0.0001, for the Intend to Treat (ITT) analysis set).

For the responder status of the ascending

colon, the proportion of patients with an Ottawa Scale

score of either 0 (excellent) or 1 (good), was compared

between the tailored dosing regimen and the day before

dosing regimen. Patients randomized to the tailored

dosing regimen were observed to have a 4.05 greater

chance of being a responder with respect to ascending

colon cleansing compared to patients randomized to

the day before dosing regimen.

ל ןולעב ןכרצ

ןוכדעה

קרפ םא

הנמה תא תחקל ךרטצתו ןכתי ,תומדקומ רקוב תועשב ךלש הקידבה היינשה

לש ךלש הנישל עירפהל לולע הזו הלילה ךלהמב הפורתה

וקיפב לופיטה ינפל

-

סקלס וקיפ וא 'גנרוא

-

סקלס :םא אפורל רפס ,ירבנרק

ןונימ

:אפורמ תרחא הארוה רדעהב לבוקמ

(םישישק ללוכ) םירגובמ

ליג לעמ םידליו

9

הנושאר תיקש לוטיל ץלמומ

דע

תיקשו הקידבה ינפל תועש הינש

דע

תועש תליטנ רחאל .הקידבה ינפל ה תיקשה הנושאר תותשל שי

תוחפל

סוכ תו

אלמ םי

לזונ לש (ל"מ םי

לולצ םילזונה לכ תא תותשל אלו םימ קר תותשל אל בושח ,םי דחא תבב אלא עש רפסמ ךשמב הייתשה תא רזפל תו

תליטנ רחאל תיקש

הינש

שי תותשל

תוחפל

סוכ תו

אלמ םי

לזונ לש (ל"מ םי

לולצ קר תותשל אל בושח ,םי דחא תבב םילזונה לכ תא תותשל אלו םימ אלא תועש רפסמ ךשמב הייתשה תא רזפל

קשמ ,םילולצ תוריפ יצימ ןווגמ ליכהל םיכירצ םילולצ םילזונ

,הת ,םילולצ םיקרמ ,םילק תו

!םימ קר תותשל ןיא .(תפצק וא היוס ,בלח ילב) הפק

רתומ

תותשל

םילזונ

םילולצ

דע

םייתעש

ינפל

הקידבה

םידליל ןונימ

ליגל תחתמ)

9

(

:

ליגל תחתמ) םידליל

9

:(

הפורתה תליטנ ינמז ב תויחנהה תא ארק םידליב ןונימ

.הלעמ םירגובמ

.הפורתה תזיראב תקפוסמ הדידמ תיפכ

:םייתנש דע הנש ליג הנמ

הנושאר

תיפכ

הדידמ

תחא

האלמ

הווש) ךרע

,(תיקש עבר הנמ

הינש

תיפכ

הדידמ

תחא

האלמ

הווש) ךרע

.(תיקש עבר

ליג

:םינש הנמ

הנושאר

יתש

תויפכ

הדידמ

תואלמ

הווש) ךרע

,(תיקש יצח הנמ

הינש

יתש

תויפכ

הדידמ

תואלמ

הווש) ךרע

.(תיקש יצח

ליג

:םינש הנמ

תחקל) תחא תיקש :הנושאר ומכ

רבסומש

קרפב

לש

,("םירגובמ" הנמ

הינש

יתש

תויפכ

הדידמ

תואלמ

הווש) ךרע

.(תיקש יצח

ליג

:הלעמו

ןונימ האר .םירגובמ

3

כ . שמתשת דצי ?הפורתב

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