NICOTINELL GUM 4 MG (MINT )

ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה

ןכדועמ(

05.2013

:ךיראת

08.2016

:תילגנאב םירישכת םש

Nicotinell Gum 2 mg (Fruit); Nicotinell Gum 2 mg (Mint);

Nicotinell Gum 4 mg (Fruit); Nicotinell Gum 4 mg (Mint)

:םושירה ירפסמ

Nicotinell Gum 2 mg (Fruit): 115-78-29638-21; 115-78-29638-22

Nicotinell Gum 2 mg (Mint): 115-78-29638-23; 115-78-29638-24

Nicotinell Gum 4 mg (Fruit): 115-79-29639-21; 115-79-29639-22

Nicotinell Gum 4 mg (Mint): 115-79-29639-23; 115-79-29639-24

:םושירה לעב םש )לארשי( ןיילקתימסוסקלג

מ"עב

! דבלב תורמחהה טורפל דעוימ הז ספוט

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

הפורתב שומישה ינפל

הפורתב שומישל תועגונה תודחוימ תורהזא

אפורל רפס קיטסמ ליטוקינב שומישה ינפל םא

יוקילמ רבעב תלבס וא לבוס ךניה םא :דוקפתב

תקועת( םד ילכ וא/ו בלה תלבס םא ,הזח ץחל רתי ,בל בצקב תורידס יא ,בל ףקתהמ ילכ תולחמ ,םייפגב םד תמירזב תויעב,םד תטולב ,ןתשה תכרעמ/הילכה ,דבכה ) ,םד תטולבב לודיג ,)דיאורית ( סירתה

תרתוי תויעבמ ,תרכסמ ,)המוטיצמורכואפ( הילכה ,הפה ללחב תקלד ,טשווה תקלדמ ,םיינישב

( לוכיעה תכרעמ תוערפה ,)סוקלוא ןוגכ .תילאנומרוה תכרעמב

וללכש תויגרלא תובוגתמ רבעב תלבס םא ןורגו םינפ ,םייתפשה לש תוחפנתה

angioedema

תצצקעמ רוע תחירפמ וא )

urticaria

ןשעמ ךנה ם

ינפל אפורל ךכ לע חוודל שי .וז הפורתב לופיטה תלחתה

הפורתל וא והשלכ ןוזמל שיגר ךניה םא

תליטנ ינפל אפורל ךכ לע עידוהל ךילע ,יהשל .הפורתה

שי וז הפורתב לופיטה תפוקתב ,תרכס ילוחב .רתוי ההובג תופיכתב רכוסה תומר תא רטנל שמתשהל ןיא

םירחא םירישכתב תינמז וב .ןיטוקינ םיליכמה

הלוח ךניה םא

וא ףירח וא בצוימ אל בצמב בל יחומ עוריא תרבע םא

למגיהל יוצר אלל תלשכנ הלימגה םא לבא ,ןיטוקינ ףילחת רישכתב שומיש לוקשל לוכי אפורה

הפורתב שומישל תועגונה תודחוימ תורהזא

יטוקינב שומישה ינפל

נ

םא אפורל רפס קיטסמ ל

לבוס ךנה הרמחה ,בל ףקתה( בל תלחממ )בלה בצקב תוערפה ,הזחב באכב

רקובמ וניאש הובג םד ץחלמ לבוס ךנה

ורחאל תלבס ץבשמ הנ

הילכב וא דבכב הרומח הלחממ לבוס ךנה

הביקב ביכמ רבעב תלבס וא לבוס ךנה

תוכשמתמ לוכיע תוערפהמ לבוס ךנה

לבוס ךנה ןורג באכמ

רומח

ללחב תקלדמ וא הפה

חקול התא םא" ףיעס האר( תרכוסמ לבוס ךנה )"...תורחא תופורת הנורחאל תחקל וא

ירתה תטולב לש רתי תוליעפמ לבוס ךנה

)דיאורית(

מ לבוס ךנה הילכה תרתוי תטולבב לודיג )המוטיצומורכואפ(

זוטקורפל תוליבס יאמ לבוס ךנה

תלד תטאידב ךנה

ןרתנ

תורחא תופורת לטונ ךנה התא םא" ףיעס האר( )"...תורחא תופורת הנורחאל תחקל וא חקול

)הקנהו ןויריה ףיעס יאר( הקינמ וא ןוירהב ךניה

במ םילבוס רשא םישנא םישנא ןכו תסלב תויע ישוק תווחל םילולע תובתות םייניש םיביכרמה ,הז ישוקמ לבוס ךנה םא .קיטסמה תסיעלב לש תרחא ןתמ תרוצב שמתשת יכ ץלמומ תוילמרדסנרט תוקבדמ ןוגכ ןיטוקינ ףילחת לניטוקינ(

םע ךכ לע ץעייתה .תוינסכל וא ) .חקורה וא אפורה

שי הקינמ וא ןוירהב ךנה םא אפורב ץעוויהל תופורתב שומישה ינפל

אלל ןשעל קיספהל ץלמומ ןוירהב ךניה םא .תוירגיסל ףילחתכ ןיטוקינ ירישכתב שומיש ןיטוקינ

.רבועב עוגפל לולע איהש הרוצ לכב יפ לע קר השעי הז רישכתב ןוירהב שומישה אפורמ הארוה

:הקנהו ןוירה

:ןוירה

םינוכיסב הוולמ ןוירהה ךלהמב ןושיע

תוערפה ןוגכ רבוע תדיל וא תמדקומ הדיל ,הדילה ינפל רבועה תלידגב רתויב הליעיה הדיחיה ךרדה הניה ןושיע תקספה .תמ לככ .ךקונית תואירב תאו ךתואירב תא רפשל ידכ .בטוי ךכ ,רתוי םדקומ קספוי ןושיעהש

לופיט אלל ןושיעה תקספה תצלמומ ןוירהב ךניה םא .ןיטוקינ יפילחתב א ,םלוא ,רשפאתמ וניא רבדהו תיסינ ם רבועל ןוכיסה ךכש ןוויכ ,ןיטוקינ יפילחתב שמתשהל ןתינ

.ןשעל םיכישממ םא הפוצמהמ רתוי ךומנ חתפתמה

תושעיהל הכירצ ןיטוקינ יפילחתב שמתשהל הטלחהה קיספהל הרטמב ,ןוירהה לש ןתינש לככ םדקומ בלשב כ רחאל שומישה תא

.םישדוח

:הקנה

הל ףידע ןתינש ןיטוקינ יפילחת םניהש םירישכתב שמתש .)תוילמרדסנרט תוקבדמ אל( ןיגוריסל לוטיל

תנמ לע ,רישכתה תא תלטונ תאש ינפל דימ קינהל יסנ רתויב הנטקה ןיטוקינה תומכ תא לבקי קוניתהש חיטבהל לע ןיטוקינ יפילחתב שמתשהל הכירצ תא םא .תירשפאה תומכ ,ןשעל קיספהל ךל רוזעל תנמ ןכתיש ןיטוקינה רשאמ הקיזמ תוחפו תיתועמשמ הנטק ,לבקי קוניתהש .ןושיעהמ ןשעה תפיאש

שומישה ינפל אפורב ץעוויהל שי הקינמ וא ןוירהב ךניה םא .תופורתה

-

הפורתה לש םיביכרמהמ קלח לע בושח עדימ

לוטיברוס ידי לע ךל רמאנ םא : ךלש אפורה

יכ סמ םירכוסל תוליבס יא ךל שי רשק רוצ ,םימיו אפורה םע

ךלש

הדיחי לכ .הפורתה תליטנ ינפל כ הליכמ לניטוקינ קיטסמ לש

םרג .זוטקורפל רוקמ וניה לוטיברוס .לוטיברוס

ןרתנ

לניטוקינ לש הדיחי לכ

הליכמ קיטסמ ג"מ

11.5

)ןרתנ( םוידוס ג"מ

לניטוקינ לש הדיחי לכ

הליכמ קיטסמ ג"מ

11.52

םוידוס ג"מ

)ןרתנ(

לע תחקלנ הפורתה רשאכ ךכל תעדה תא תתל שי .ןרתנ תרקובמ הטאידב םיאצמנה םילפוטמ ידי

:ןאולוט יסקורדיה דטייליטוב רשא קיטסמב ביכרמ .הפה תירירב ימוקמ יוריגל םורגל לולע

שמתשת דציכ ?הפורתב

רתוי הובג ןונימ תועטב תלטנ םא

תינמז וב תודיחי רפסמ תסעל םא

םא וא קיטסמ תסיעל ידכ ךות תנשיע

םימוטפמיסה ,קור לש רתי תשרפה ,תוליחב : תויהל םילוכי

רתוי הובג ןונימ תועטב תלטנ םא

.הרומח הלערהל ליבוהל לולע דלי ידי לע ןיטוקינ לוכיע

םימוטפמיסה םיללוכ ןיטוקינ לש רתי ןונימ לש םייללכה

,שאר באכ ,העזה ,םילושלש ,ןטב יבאכ הרקמב .העימשה תלוכיב העיגפ ,תרוחרחס תונפלו תידיימ שומישה קיספהל ךילע הז .. .חקור וא אפורל

ןיא ,שורדה ןמזב וז הפורת לוטיל תחכש םא ןמזב האבה הנמה תא חק .הלופכ הנמ לוטיל ....אפורב ץעוויהו ליגרה

השלוח העזה ,

,קור לש רתי תשרפה , הבירצ תשוחת ןורגב

,שאר באכ הערפה ,ןטב יבאכ ,םילושלש ,הליחב העימשב היארבו

בלה תומיעפב הערפה

המישנ רצוק

םדה תמירזב תוערפה

םיקיטסמ לניטוקינ לוטיל תחכש םא

קיטסמה תא סעל תחא הדיחימ רתוי סעלת לא .ךכל קקזנ התא רשאכ קר תינמז וב

וא

מ רתוי

לש תודיחי

מ רתוי וא םויל ג"מ

לש תודיחי

.םויל ג"מ

יאוול תועפות

קיטסמ לניטוקינב שומישה ,הפורת לכב ומכ קלחב יאוול תועפותל םורגל לולע תמישר ארקמל להבית לא .םישמתשמהמ תחא ףאמ לובסת אלו ןכתי .יאוולה תועפות .ןהמ

חוימ תוסחייתה תובייחמה תועפות :תד

תושיגר ,'וכו תומיתסב ,םיינישב ,הפב העיגפ ,)תוחיפנ ,החירפ( תיללכ וא תימוקמ [ רתי םיינישל תוקבדיה ,תורידס אל בל תוקיפד י/הנפו לופיטה תא י/קספה :)תורידנ( תובתות .אפורל

,שאר יבאכ :דאמ תובורק םיתיעל תועיפומ ,תוליחב ,םיקוהיש ,לוכיעה תכרעמב תועפות בו הפב תקלד תסלה ירירשב םיבאכ ,ןורג

תואקה ,תורוחרחס :תוחיכש םיתיעל תועיפומ

בל תוקיפד :תוחיכש ןניאש יאוול תועפות רועב םדואו

תיגרלא הבוגת :תורידנ יאוול תועפות

בצקב תוערפה :דואמ תורידנ יאוול תועפות בלה

לק יוריג ,הפב שבוי :ןוגכ תופסונ יאוול תועפות פה ,רבגומ ןובאית ,ןורגב ,קור לש רתי תשר ךילהתמ תועבונה תועפות ,לושלש ,תברצ ,רתי תונרע ,הדרח ,ןואכיד :ןושיעמ הלימגה .תונבצע ,הניש ידודנ

יאוול תועפות ה/שיגרמ ךניה ובש הרקמ לכב יוניש לח םא וא ,הז ןולעב וניוצ אלש אפורה םע ץעייתהל ךילע ,תיללכה ךתשגרהב .דימ

ותמ תחא םא רשאכ וא ,הרימחמ יאוולה תועפ ,ןולעב הרכזוה אלש יאוול תעפותמ לבוס התא .אפורה םע ץעייתהל ךילע

םורגל לולע קיטסמ לניטוקינב שומישה ,הפורת לכב ומכ ארקמל להבית לא .םישמתשמהמ קלחב יאוול תועפותל .ןהמ תחא ףאמ לובסת אלו ןכתי .יאוולה תועפות תמישר

שומישה תא קיספהל שי

התא םא אפורל דימ תונפלו תווהל תולולע רשא ,תואבה תועפותהמ תחאמ לבוס :תיגרלא הבוגת לש םינמיס

העילב וא המישנ יישק תוחפנתה , ,הפה לש

,םינפ

,םייתפש

וא ןושל

.ןורג

רועה לש רומח דרג

וא המודא החירפ יווילב תוטילב

ושארה םימיב ןיחבהל יושע ךנה ןהב תומיוסמ תועפות םינ באכ ,תרוחרחס ןנה

םייושע ולא .הניש תוערפהו ,שאר תקספה לש רשקהב הלימג לש םימוטפמיס תויהל יושעו ןושיעה

לש תקפסמ אל הכירצ בקע םרגיהל ם .ןיטוקינ

ב תועיפומ( תוחיכש יאוול תועפות

דע

לכמ

:)םישמתשמ

.שאר באכו תרוחרחס

ןוגכ לוכיעה תכרעמב תוערפה ,םיקוהיש

,הליח םיזג ,תברצ ,תואקה , לש רבגומ רוצי ןורגהו הפה לש יוריג ,קור

ירירשב םיבאכ בקע דחוימב עיפוהל םילולע רשא תסלה תועפות הווח התא םא .תיביסנטניא הסיעל הסיעלה תקינכט רחא אלממ התא יכ אדוו ,ולא .הנוכנה

ב תועיפומ( תוחיכש ןניאש יאוול תועפות

דע

לכמ

1,000

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החירפ

המודא תירוע

)המתירא(

לש דרגו רועב תוטילב

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ב תועיפומ( תורידנ יאוול תועפות

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לכמ

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:)םישמתשמ

.תויגרלא תובוגתו בלה בצקב תוערפה

תקספהל םירושק תויהל םייושע הפב םיביכ .ךל ןתינה לופיטל אלו ןושיעה

עלו קבדיהל יושע קיטסמה עוגפל דואמ תורידנ םיתי םירחא םייניש ילופיט וא תובתות םינישב

ןיחבמ םא וא ,הרימחמ יאוולה תועפותמ תחא םא םע ץעייתהל ךילע ,ןולעב הרכזוה אלש יאוול תעפותב .חקורה וא אפורה

תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ בוהצ עקר לע

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1.

NAME OF THE MEDICINAL PRODUCT

Nicotinell Gum 2 mg (Fruit); Nicotinell Gum 2 mg (Mint);

Nicotinell Gum 4 mg (Fruit); Nicotinell Gum 4 mg (Mint)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Nicotinell Gum 2 mg (Fruit) / Nicotinell Gum 2 mg (Mint):

One piece of medicated chewing gum contains 2 mg nicotine .

Nicotinell Gum 4 mg (Fruit) / Nicotinell Gum 4 mg (Mint):

One piece of medicated chewing gum contains 4 mg nicotine .

For excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Chewing gum

Each piece of coated chewing gum is offwhite in colour and rectangular in shape

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

As an aid to smoking cessation and for the relief of nicotine withdrawal symptoms.

In smokers currently unable or not ready to stop smoking abruptly the gum may also be used as

part of a program to reduce smoking prior to stopping completely

4.2

Posology and method of administration

Adults and elderly

2 mg strength:

One piece of Nicotinell gum to be chewed when the user feels the urge to smoke. Normally, 8-12

pieces per day can be used, up to a maximum of 25 pieces per day.

The 2 mg chewing gum is recommended in smokers with a low to moderate nicotine dependency.

The 2 mg chewing gum may not be well suited to smokers with a strong or very strong nicotine

dependency.

4 mg strength:

One piece of Nicotinell gum to be chewed when the user feels the urge to smoke. Normally, 8-12

pieces per day can be used, up to a maximum of 15 pieces per day.

The 4 mg chewing gum is intended to be used by smokers with a strong or very strong nicotine

dependency and those who have previously failed to stop smoking with the aid of nicotine

replacement therapy.

The optimal dosage form is selected according to the following table:

If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower

dosage form.

The characteristics of chewing-gum as a pharmaceutical form are such that individually different

nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to

individual requirements within the stated maximum limit.

Directions for use:

1. One piece of gum should be chewed until the taste becomes strong.

2. The chewing gum should be rested between the gum and cheek.

3. When the taste fades, chewing should commence again.

4. The chewing routine should be repeated for 30 minutes.

The treatment time is individual. Normally, treatment should continue for at least 3 months.

After three months, the user should gradually cut down the number of pieces chewed each day until

they have stopped using the product.

Treatment should be discontinued when the dose has been reduced to 1-2 pieces of gum per day.

Nicotinell gum is sugar free.

4.3

Contraindications

Hypersensitivity to nicotine or any components of the gum.

Nicotinell gum should not be used by non-smokers.

4.4

Special warnings and precautions for use

Any risks that may be associated with nicotine replacement therapy are substantially outweighed by

the well established dangers of continued smoking.

Precautions: Users should be informed that if they continue to smoke while using the gums they may

experience increased adverse effects due to the hazards of smoking, including cardiovascular effects.

Cardiovascular disease

In stable cardiovascular disease Nicotinell gum presents a lesser hazard than continuing to smoke.

However dependant smokers currently hospitalised as a result of a recent myocardial infarction,

unstable or worsening angina pectoris including Prinzmetal's angina, severe cardiac arrhythmias,

uncontrolled hypertension, or recent cerebrovascular accident who are considered to be

haemodynamically unstable should be encouraged to stop smoking with nonpharmacological

interventions (such as counselling). If this fails, Nicotinell gum may be considered but as data on

safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus

Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than

usual when nicotine replacement therapy is initiated as catecholamines released by nicotine can affect

carbohydrate metabolism.

Allergic reactions

Angioedema and urticaria have been reported.

Gastro-intestinal disease

Swallowed nicotine may exacerbate symptoms in patients suffering from active oesophagitis, oral or

pharyngeal inflammation, gastritis, or peptic ulcers and oral nicotine replacement therapy preparations

should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal and or hepatic impairment

Should be used with caution in patients with moderate to severe hepatic impairment and/or severe

renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for

increased adverse effects.

Danger in small children

Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small

children that may be fatal (please see section 4.9). Products containing nicotine should not be left

where they may be misused, handled or ingested by children. Nicotinell gum should be disposed of

with care.

Pheochromocytoma and uncontrolled hyperthyroidism

Nicotinell gum should be used with caution in patients with uncontrolled hyperthyroidism or

pheochromocytoma as nicotine causes the release of catecholamines.

Transferred dependence

Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking

Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP

1A2 (and possibly CYP 1A1). When a smoker stops, this may result in slower metabolism and a

consequential rise in blood levels of drugs such as theophylline, tacrine, olanzaprine and clozaprine.

Other warnings

People having problems with the joint of the jawbone and denture wearers may experience difficulty

in chewing the gum.

In this case, it is recommended that they use a different pharmaceutical form of nicotine replacement

therapy.

Because Nicotinell gum contains sorbitol: Patients with rare hereditary conditions of fructose

intolerance should not take this medicine.

Nicotinell 2mg Gum (Fruit) contains sweeteners including Sorbitol (powder) 208.0 mg per gum.

Nicotinell 2mg Gum (Mint) contains sweeteners including Sorbitol (powder) 207.9 mg per gum.

Nicotinell 2 mg Gum contains sodium 11.50 mg per piece of gum.

The gum base contains butylated hydroxyl toluene which may cause local irritation to mucous

membranes.

Nicotinell 4mg Gum (Fruit) contains sweeteners including Sorbitol (powder) 192.1 mg per gum.

Nicotinell 4mg Gum (Mint) contains sweeteners including Sorbitol (powder) 192.0 mg per gum.

Nicotinell 4 mg Gum contains sodium 11.52 mg per piece of gum.

The gum base contains butylated hydroxy toluene which may cause local irritation to mucous

membranes.

4.5

Interaction with other medicinal products and other forms of interaction

No information is available on interactions between Nicotinell gum and other drugs. No clinically

relevant interactions between nicotine replacement therapy and other drugs has definitely been

established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6

Fertility, pregnancy and lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the

pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the

mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used

as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by

far the best option but Nicotinell gums may be used in pregnancy as a safer alternative to smoking.

Because of the potential for nicotinefree periods, intermittent dose forms are preferable, but patches

may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if

possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to

the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in

breast milk and permit feeding when levels were at their lowest.

4.7

Effects on ability drive and use machines

There is no evidence of any risks associated with driving or operating machinery when Nicotinell gum

is used following the recommended dose.

4.8

Undesirable effects

Certain symptoms such as dizziness, headache and sleep disturbances may be related to withdrawal

symptoms in connection with smoking cessation and may be due to insufficient administration of

nicotine. Cold sores may develop in connection with smoking cessation, but any relation with the

nicotine treatment is unclear.

Nicotinell gums can cause adverse reactions similar to those associated with nicotine administered by

other means (including smoking). These can be attributed to the pharmacological effects of nicotine,

which are dose dependant. Non dose-dependent adverse reactions are as follows:

Jaw muscle ache, erythema, urticaria, hypersensitivity, angioneurotic oedema and anaphylactic

reactions.

At recommended doses Nicotinell gum has not been found to cause any serious adverse effects.

Excessive consumption of Nicotinell gum by those who have not been in the habit of inhaling tobacco

smoke could possibly lead to nausea, faintness or headaches.

Increased frequency of aphthous ulcer may occur after abstinence from smoking.

Most of the side effects which are reported by patients occur generally during the first 3-4

weeks after initiation of therapy.

Nicotine from gums may sometimes cause a slight irritation of the throat and increase salivation at the

start of the treatment.

Excessive swallowing of nicotine which is released in the saliva may, at first, cause hiccups. Those

who are prone to indigestion may suffer initially from minor degrees of dyspepsia or heartburn; slower

chewing will usually overcome this problem.

The gum may stick to and in rare cases damage dentures and dental appliances.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as:

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) or

very rare

(<1/10,000),

Nervous system disorders:

Common: Headache, dizziness

Gastrointestinal disorders:

Common: Salivary hypersecretion, stomatitis,

oral pain, pharyngolaryngeal

pain, hiccups, nausea, vomiting, dyspepsia and

flatulence.

Musculoskeletal, connective and bone

disorders:

Common: Jaw muscle ache

Cardiac disorders:

Uncommon: palpitations

Rare: Atrial arrhythmia

Skin and subcutaneous tissue disorders:

Uncommon: Erythema, urticaria.

Immune system disorders:

Rare: Hypersensitivity, angioneurotic oedema and

anaphylactic reactions.

The patient may still experience nicotine dependence after smoking cessation.

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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.g

ov.il

4.9

Overdose

In overdose, symptoms corresponding to heavy smoking may be seen, however the toxicity of nicotine

cannot be directly compared with that of smoking, because tobacco smoke contains additional toxic

substances (eg. Carbon monoxide and tar).

Overdose with Nicotinell gum may only occur if many pieces are chewed simultaneously. Nicotine

toxicity after ingestion will most likely be minimized as a result of early nausea and vomiting that

occur following excessive nicotine exposure. Risk of poisoning by swallowing the gum is small. Since

the release of nicotine from the gum is slow, very little nicotine is absorbed from the stomach and

intestine, and if any is, it will be inactivated in the liver.

Chronic smokers can tolerate doses of nicotine that, in a non-smoker, would be more toxic, because of

the development of tolerance.

The acute lethal dose of nicotine in a non-tolerant man has been estimated to be 0.5 0.75 mg per kg

bodyweight,corresponding in an adult to 40-60mg.

Even small quantities of nicotine are dangerous in children, and may result in severe symptoms of

poisoning which may prove fatal. If poisoning is suspected in a child, a doctor must be consulted

immediately.

Symptoms

Symptoms of acute nicotine poisoning include nausea, vomiting, salivation, throat burn, abdominal

pain, diarrhoea, perspiration, headache, dizziness, hearing and visual disturbances and marked

weakness. In extreme cases, these symptoms may be followed by hypotension, tachycardia, cardiac

arrhythmia, dyspnoea, prostration, circulatory collapse, coma and terminal convulsions.

Treatment of overdose

Treatment of overdose should be immediate as symptoms may develop rapidly (particularly in

children). All nicotine intake should stop immediately. Emesis is usually spontaneous. Artificial

respiration with oxygen should be instituted if necessary. Consider activated charcoal, provided airway

can be protected in those presenting within 1 hour of ingestion of more than 0.2mg/kg of nicotine.

Monitor vital signs and treat symptomatically.

Toxicity

Nicotine is highly toxic by ingestion, inhalation and skin contact. The fatal dose has been estimated to

be as little as 40 mg of nicotine in an adult and just a few milligrams of nicotine have caused severe

symptoms. It can be very rapidly absorbed with CNS, neuromuscular and autonomic features. The

half-life of nicotine ranges from 24 minutes to 2 hours but symptoms may persist for up to 72 hours in

severe cases of poisoning.

All patients who have taken a deliberate overdose should be referred for assessment.

Children and adults who have ingested 0.2 mg/kg or more nicotine, or those who are symptomatic,

should be referred for medical assessment.

Children or adults who have accidentally ingested less than 0.2 mg/kg nicotine and who have no new

symptoms since the time of ingestion do not need to be referred for medical assessment. Patients

should be advised to seek medical attention if symptoms develop.

All symptomatic children and adults following accidental transdermal patch application should be

referred for medical assessment.

Features

Early features of ingestion include burning in the mouth and throat, nausea, vomiting, confusion,

dizziness, weakness, hypersalivation, sweating and increased bronchial secretions. There may be

sympathetic features including tachycardia, tachypnoea, hypertension and agitation followed by

bradycardia, systemic hypotension and respiratory depression.

More severe poisoning leads to arrhythmias including atrial fibrillation, coma, convulsions and

respiratory and cardiac arrest. Recovery is likely if survival exceeds 2-3 hours.

Skin contact may lead to irritation followed by variable absorption depending on the length of

exposure and concentration. Systemic features may follow.

Eye contact with liquid may lead to irritation and lacrimation.

Management

General measures

Maintain a clear airway/ensure adequate ventilation. Monitor pulse and BP. Perform 12 lead ECG

and measure QRS duration and QT interval and repeat especially if the patient is symptomatic or has

taken slow release preparations.

Good neurological outcome after cardiac arrest (due to nicotine poisoning) may occur after

prolonged resuscitation. Cardiac arrest in hospital or witnessed out of hospital, with bystander CPR,

should be continued for at least 1 hour (discuss with local poisons centre).

The benefits of gastric decontamination are uncertain. Consider activated charcoal (50g adults: 1g/kg

children) provided airway can be protected in those presenting within 1 hour of ingestion of more than

0.2mg/kg of nicotine.

Asymptomatic patients who have ingested more than 0.2mg/kg of nicotine should be observed for at

least 4 hours. However, if other cardiac/cardiotoxic agents have been taken monitor for the longest

period recommended for these.

In symptomatic patients check U&Es, creatinine kinase and arterial blood gases.

Contact the local poisons information centre for specific advice.

Bradycardia

If symptomatic give IV atropine

If associated with hypotension, dobutamine or isoprenaline may be considered

Temporary pacemaker or external pacing may be required

Agitation

Agitated adults can be sedated (IV diazepam: if ineffective oral or parenteral haloperidol)

Agitated children are better managed without sedation. Exclude other causes (eg hypoxia: infection:

hypoglycaemia: raised ICP). Seek expert paediatric advice.

Hypertension

Adults: in agitated patient hypertension may settle with sedation. If hypertension persists give IV

nitrates until blood pressure controlled. Calcium antagonists are an alternative as second line therapy.

Phentolamine or sodium nitroprusside are options if there is hypertension without evidence of cardiac

ischaemia (but may cause a rapid fall in blood pressure) or alternatively IV labetalol.

Children (under 5 years): Seek expert paediatric advice.

Convulsions

Give oxygen, check blood sugar, U&Es and arterial blood gases. Correct acidbase balance and

metabolic disturbances as necessary.

A single brief convulsion does not require treatment. Otherwise control with IV diazepam or

lorazepam. If unresponsive seek advice from NPIS/NPIC or appropriate specialist.

Other points to note

A high percentage of urine screens will be positive for nicotine in both smokers and non-smokers.

Quantitative blood concentrations are not readily available. Appropriate history and recognition of

clinical finding are important.

Other treatments/measures indicated by patient's clinical condition.

On discharge patients should be advised to seek medical attention if symptoms develop.

Skin exposure

Remove soiled clothes, nicotine patches or contaminating fluid.

Wash skin with soap and water.

Treat symptoms of systemic toxicity as above.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

ATC Code: N07B A01

Pharmacotherapeutic group: Drugs used in nicotine dependence

Nicotine, the primary alkaloid in tobacco products and a naturally occurring autonomous substance, is

a nicotine receptor agonist in the peripheral and central nervous systems and has pronounced CNS and

cardiovascular effects. On consumption of tobacco products, nicotine has proven to be addictive,

resulting in craving and other withdrawal symptoms when administration is stopped. This craving and

these withdrawal symptoms include a strong urge to smoke, dysphoria, insomnia, irritability,

frustration or anger, anxiety, concentration difficulties agitation and increased appetite or weight gain.

The gum replaces part of the nicotine that would have been administrated via tobacco and reduces the

intensity of the withdrawal symptoms and smoking urge.

5.2

Pharmacokinetic properties

When the gum is chewed, nicotine is steadily released into the mouth and is rapidly absorbed through

the buccal mucosa. A proportion, by the swallowing of nicotine containing saliva, reaches the stomach

and intestine where it is inactivated.

The nicotine peak plasma mean concentration after a single dose of the 2 mg coated gum is

approximately 6.4 nanograms per ml (after 45 minutes) (average plasma concentration of nicotine

when smoking a cigarette is 15-30 nanograms per ml).

The nicotine peak plasma mean concentration after a single dose of the 4 mg coated gum is

approximately 9.3 nanograms per ml (after approximately 60 minutes) (average plasma concentration

of nicotine when smoking a cigarette is 15-30 nanograms per ml).

Nicotine is eliminated mainly via hepatic metabolism; small amounts of nicotine are eliminated in

unchanged form via the kidneys. The plasma halflife is approximately three hours. Nicotine crosses

the blood-brain barrier, the placenta and is detectable in breast milk.

5.3

Preclinical safety data

No definite conclusion can be drawn on the genotoxic activity of nicotine

in vitro

. Nicotine was

negative in

in-vivo

tests. Animal experiments have shown that nicotine induces post-implantation loss

and reduces the growth of foetuses. The results of carcinogenicity assays did not provide any clear

evidence of a tumorigenic effect of nicotine.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Nicotinell Gum 2 mg (Fruit) ; Nicotinell Gum 4 mg (Fruit):

Center: Gum Base*, Calcium Carbonate, Sorbitol (powder), Sodium Carbonate Anhydrous, Sodium

Hydrogen Carbonate, Amberlite, Glycerol, Purified Water, L-Menthol, Tutti, Saccharin, Sodium

Saccharin, Acesulfame K, Carnauba Wax, Talcum Powder.

Coat: Xylitol, Mannitol, Gelatine, Titanium dioxide, L-Menthol, Tutti, Carnauba Wax, Talc.

Nicotinell Gum 2 mg (Mint) ; Nicotinell Gum 4 mg (Mint):

Center: Gum Base*, Calcium Carbonate, Sorbitol (powder), Sodium Carbonate Anhydrous, Sodium

Hydrogen Carbonate, Amberlite, Glycerol, Purified Water, L-Menthol, Peppermint Oil**, Eucalyptus

Oil, Saccharin, Sodium Saccharin, Acesulfame K.

Coat: Xylitol, Mannitol, Gelatine, Titanium dioxide, L-Menthol, Carnauba Wax, Talc.

*Containing butylated hydroxy toluene

**Mint falvouring system composed of L-Menthol (Ph-Eur), Peppirmint oil (Ph-Eur) and Mint Oil

(Ph-Eur)

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

24 months.

6.4

Special precautions for storage

Store below 25

6.5

Nature and contents of container

The chewing gum is packed in PVC/PVdC/aluminium blisters. The blisters are packed in boxes

containing 12, 24, 48, 96 and 204 pieces of gum.

6.6

Special precautions for disposal and other handling

No special requirements.

7.

MANUFACTURER

Novartis Consumer Health Schweiz AG

6343 Risch, Switzerland

8.

MARKETING AUTHORISATION HOLDER

GSK CONSUMER HEALTHCARE ISRAEL LTD., P.O.B. 3256, Petach-Tikva

9.

MARKETING AUTHORISATION NUMBER(S)

Nicotinell Gum 2 mg (Fruit):

115-78-29638-21; 115-78-29638-22

Nicotinell Gum 2 mg (Mint):

115-78-29638-23; 115-78-29638-24

Nicotinell Gum 4 mg (Fruit):

115-79-29639-21; 115-79-29639-22

Nicotinell Gum 4 mg (Mint):

115-79-29639-23; 115-79-29639-24

The content of this leaflet was determined, checked and approved by MOH in August 2017

NicGum DR v1