NAXYN 250 MG

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
NAPROXEN 250 MG
Available from:
TEVA PHARMACEUTICAL INDUST.LTD
ATC code:
M01AE02
Pharmaceutical form:
TABLETS
Administration route:
PER OS
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD
Therapeutic group:
NAPROXEN
Therapeutic indications:
- Relief of the signs and symptoms of rheumatic diseases including osteoarthritis, ankylosing spondylitis of rheumatoid arthritis, both in the treatment of acute flares and in the long-term management of the disease. - Juvenile Rheumatoid Arthritis. - Periarticular and Musculoskeletal Disorders.- Relief of pain in bursitis, tendinitis, synovitis, tenosynovitis and lumbago. - Relief of pain, swelling, tenderness and fever in acute gouty arthritis. - Relief of symptoms of primary dysmenorrhea.
Authorization number:
038512298000
Authorization date:
2009-05-01

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Patient Information leaflet Patient Information leaflet - Arabic

25-01-2021

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25-01-2021

NAXYN Tablets 12.01.2012 SY

עעבקנהזןולעטמרופ " רשואוקדבנונכותותואירבהדרשמי

םיחקורהתונקתיפלןכרצלןולע ) םירישכת ( שתה מ " ו - 1986

אפורםשרמבתבייחוזהפורת

ארק / שמתשתםרטבופוסדעןולעהתאןויעבי / הפורתבי

ןיסקנ ® ןיסקנ ®

250 מ " ג 500 מ " ג

תוילבט תוילבט

בכרה

הליכמהילבטלכ :

Naproxen 250 mg Naproxen 500 mg

םיליעפיתלבםיביכרמ :

Lactose monohydrate, starch, povidone,

magnesium stearate, Col. D & C Yellow

No.10, Col. FD & C Yellow No.6.

Lactose monohydrate , starch, povidone, magnesium

stearate, hydroxypropylmethylcellulose/hypromellose,

macrogol/PEG 400, macrogol/PEG 6000, Col. D&C

yellow No.10,Col. FD&C yellow No.6

הליכמהילבטלכ 71.11 מ " זוטקלג הליכמהילבטלכ 138.83 מ " זוטקלג

תיטיופרתהצובק

םידיאורטסםניאשתוקלדידגונ . םיבאכךכשמ .

תיאופרתוליעפ

תויטמוארתולחמלשםימוטפמיסוםינמיסלעהלקהל ) תוינורגש ( , םיקרפתוקלד , תוערפהותויקרפמתוערפה

רירשתכרעמב - דלש . הלקה כב תסוויבא .

רישכתבשמתשהלןיאיתמ ?

בךניהרשאכהפורתבישמתשתלא הלשןורחאהשילש הקינמואןוירה .

תושיגרהעודיםאהפורתבשמתשהלןיא ל - Naproxen , Naproxen sodium וא יביכרממדחאל רישכתה .

ןיריפסאלתושיגרהעודיםארישכתבשמתשהלןיא , םירישכתוםיטליצילס וקלדידגונ םידיאורטסםניאשת חא םיר

וא םוחתדרוהלוםיבאכךוכישלתורחאתופורתל , וא המטסאינמיסתחתפםא , תלזנ , ףאבםיפילופ , רועהתוחפנתה

החירפוא , לבוסךניהםא / ת תלבסוא ןוירסרתואהביקביקמ , יעמבואהביקבםומיד , םיימעפמרתויתלבסםא

יטפפביקמ , ואיתביקבוקינואםומיד דבכבהרומחהלחממלבוסךניהםא , הילכב ) הזילאידאלל ( בלבוא , םאוא

תא / דמועה / בלחותינהנורחאלתרבעוארובעלת .

םיפקעמחותינביחותינםורטבאכבלופיטלהפורתבשמתשהלןיא .(coronary artery bypass graft–

CABG )

תלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא

לופיטה בךניהםא - 6 ןוירהלשםינושארהםישדוחה ,

ןוירהתננכתמ , ןוירהבךניהשתבשוח , תוירופילופיטתרבועואןוירהלסנכיהלהסנמ , לבוסךניהםא / תלבסואת

רבעב דוקפיתביוקילמ : המישנהתכרעמ ) המטסאןוגכ , ףאבםיפילופ תלזנוא ( , דבכה , הילכה / ןתשהתכרעמ , תכרעמ

לוכיעה ) סוקלואןוגכ תברצוא ( , םדהתכרעמוא ) וכוהשירקןוגכ '( , םדבתוהובגםינמושתומרמ , תולחמ

סופולןוגכתוינומיאוטוא , סגהיעמהתקלד ) colitis ( ןהורקתלחמוא , תויגרלאמ , תוחפנתהמרבעבתלבסםא

םינפה , םייתפשה , ה ואםייניע ה ןושל , שיגרמךניה / ךניהםאואהשלוחה רגובמ / ת .

לבוסךנהםא / םוחתדרוהלואםיבאכךוכישלתופורתתליטנבקעיאוולתועפותמרבעבתלבסואת .

לבוסךניהםא / תויעבמת םדהילכב , ב בל םדץחלרתימוא , ץבשלןוכיסבךניהואץבשךלהיהםא ) ךניהשהרקמב

לבוס / הובגםדץחלמת , תרכס , ןשעמךניהםאואתוהובגלורטסלוכתומר / ת ( , הנפ / אפורלי .

ךלשםויםויהייחלעהפורתהעיפשתךיא ?

תונרעבםוגפללולעוזהפורתבשומישה תרוחרחסלםורגלו , תופייעואהיארבשוטשט , הגיהנבתוריהזבייחמןכלעו

בכרב , לכבותונכוסמתונוכמתלעפהב תונרעתבייחמהתוליעפ . םידלילרשאב ליגלעמ 12 , לעהביכרמםריהזהלשי

תברקבםיקחשממואםיינפו המודכושיבכה .

תונייתותשלןיא הפורתהםעלופיטהתפוקתבםיפירחתואקשמוא .

שמשלהפישחםעתדחוימתושיגרלםורגלהלולעוזהפורת , לע - ןכ ענמיהלשי שמשלהפישחמ ףוזשמו

רבגומ גואדלו המיאתמהנגהל שמשהמ ) םיכוראםידגב , עבוכ , וכוהנגהתוחשמ ' .(

תורהזא

NAXYN Tablets 12.01.2012 SY

ןיסקנןוגכתופורת הנטקהילעלתורושקתויהלתולולע ץבשואבליפקתהלןוכיסב הביקבםומידלו . וניהןוכיסה

ךשוממלופיטבואםיהובגםינונימברקיעב . הובגןונימלוטילןיאןכלע / אפורההחנהשהזמךשוממןמזךשמל .

דחוימבהביקבםימומידלםורגלהלולעהזרישכתתליטנ םא :

תרבע תא ליג 60 .

לטונךניה / םידיאורטסםניאשתקלדידגונתצובקמתורחאתופורתת .

ךרוצךניה / ת 3 וא םוילםיילוהוכלאתואקשמרתוי .

תכשוממהפוקתלואץלמומהמהובגןונימבהזרישכתתליטנ , ריבגהלהלולע בלףקתהואיחומץבשלןוכיסהתא .

אתועפותלםורגלהלולעוזהפורת ןוגכתויגרל :

תירועהחירפ , דרג , יחופלש ו רועבת , םינפבתוחיפנ , המישנרצוק , המטסא , םלה ) קוש .(

קספה / הנפושומישהי / אפורלי , מרתויךשמנםוחהםא - 3 מרתויםיכשמנםיבאכהםאואםימי - 10 םימי .

זוטקללםישיגרהםישנאלצאהיגרלאלםורגללולעוזוטקלליכמרישכתה .

טתפוקתב םדתוקידבךורעלשיוזהפורתבךשוממלופי , ןתש , דוקפת י תוילכודבכ .

שיגרךניהםא / יהשלכהפורתלואוהשלכןוזמלה , הפורתהתליטנינפלאפורלךכלעעידוהלךילע .

דמועךניהםא / חותינרובעלת ) ילטנדללוכ ( וזהפורתתליטנלעאפורלחוודלשי .

התליטנינפלאפורלעידוהלךילע ךניהםאהפורת לבוס / ךניהםאואםוהיזמת לבקמ / והיזללגבלופיטת ם .

דמועךניהםאאפורלחוודלךילע / תויתדבעמתוקידברובעלת , תואצותלעירפהללולעוזהפורתבלופיטורחאמ .

שיגרמךניהםאאפורלחוודלךילע / והיארהתוכיאבהערפהואוהשלכיונישה / העימשהוא .

רתןיבתובוגת תויתפו

לטונךניהםא / תפסונהפורתת , הנוזתיפסותואאפורםשרמאללתשכרשתופורתללוכ לופיטההתעהזתרמגםאוא

תרחאהפורתב , עונמלידכלפטמהאפורלחוודלךילע יאואםינוכיס - תויתפורתןיבתובוגתמםיעבונהתוליעי , דחוימב

תואבהתוצובקהמתופורתיבגל : דגנתופורת תשירק םד ) ןוגכ : ןירפרו , לרגודיפולקואןירפה ( , םינתשמ ) ןוגכ :

דימסורופ ( , ןוגכםירחאםיבאכיככשמ ןיריפסא , םיטליצילס , ןפורפוביא , קאנפולקיד , םירישכתוא ידגונ תקלד

םידיאורטסםניא , לומטצאראפ , םויתילןוגכשפנהתואירבבתויעבלתומיוסמתופורת , ואןיטסקואולפ

םרפולאטיצ , רת םדץחלתדרוהלתופו לירפזליצןוגכ , לולונרפורפואלירפלנא , תולחמבלופיטלתופורת בל , דיצנבורפ

ןודגשל ( , טסקרטותמ ) ןטרסל , ןוגכרועתויעבוםיקרפתוקלד ו תחפסל ( , תצובקמתרכסדגנתופורת האירואלינופלוס

ןוגכ : דיזיפילגואדיריפמילג ( , וסומילורקט ןירופסולקיצ ) תולתשהל רועבתויעבלוא ( , ןיאוטנדיה ) ןיאוטינפןוגכ

תותיועל ( , תיאורפלוהצמוח ) היספליפאל ( וא תופורת ידימאנופלוס תו ) גכ דיזאיתורולכורדיהןו , דימלוזאטצא ,

דימאפדניא תוקיטויביטנאו ( , ןידובודיז ) ימוהיזבלופיטל HIV ( , טסירפפימ ו ן ) הלפהתיירשהל ( , םידיזוקילג

םילאידרק ) לתויעבל ב ( ןיסקוגידןוגכ , םידיאורטס ) ןוגכ : ןוזיטרוקורדיה , ןוזאטמסקדוןולוזינדרפ ( , תוקיטויביטנא

ניוקהתצובקמ ןיצסקולפורפיצןוגכםינילו ןיצסקולפיסקומוא , הצמוחירתוס , טפלרקוס , ןימאריטסלוכ .

יאוולתועפות

הפורתהלשהיוצרהתוליעפלףסונב , עיפוהלתולולעהבשומישהןמזב ות תועפ ןוגכיאוול :

לוכיעהתכרעמ : תברצ , לוכיעתויעב , ןטבבאכ , הלחמואהליחבתשגרה , תוריצע , לושלש , םיזג .

םד : םינבלהםדהיאתרפסמבםייונישואהימנאןוגכםדבתויעב .

תוישפנתויעב : תומולחהיסופדבםייונישואהנישבישוק , ןואכיד , לובלב , תויזה .

כרעמ ת םיבצעה : שארבאכ , םיסוכרפ , תוינונשיואתרוחרחסתשגרה , שוחתרסוחואתוריקדוםיצוצקע ה ואםיידיב

םיילגרב , זוכירבואןורכזבישוק .

םיינזואוםייניע : היארבםייוניש , םייניעבאכ , העימשדוביאוםיינזואבםיפוצפצללוכהעימשבםייוניש , תרוחרחס

לקשמהיווישבתויעבלםורגלהלולעה .

רוזחמובל םדה : םיידיהתוחפנתה , ה םיילגר וא תופכ ה םיילגר ) תקצב ( , תויהללולע הוולמ ב הזחבאכ , תופייע , רצוק

המישנ ) יבבללשכ ( , תויצטיפלפ ) בלתוקיפד ( , הובגםדץחלואבלהבצקבהטאה , רזבתויעב י קזנואףוגלםדהתמ

םדהילכל - עלולכלםילולעםינמיס י י תופ , ןופליעתשגרה , מישנרצוק ה , יללכבאכ .

הזח : המישנרצוקללוכהמישנבישוק , לועישואםיפוצפצ , תוחפנתה בתקלדוא תואיר .

רעישורוע : םדואתללוכהתירועהחירפ , תלרח – תדרגמהחירפ , םינפהוףוגהלעתויחופלשוםינועצפ , תורובח , דורג ,

העזה , שמשלרועהתושיגר ) האר / ' " : יםויהייחלעהפורתהעיפשתךיא ךלשםו (" רעישדוביאוא .

ןתש : הילכבתויעבואןתשבםד .

תונוש : אמצ , םוח , הבוטאלתיללכהשוחתותופייעתשגרה , באכ / הפבביכ , שבאכ יר השלוחואםיר . ישוקןכתי

ןוירהלהסינכב ) האר / י " : לופיטתלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא (" , סופול : םיללוכםינמיס

וח ם , החירפ , םיקרפמבוהילכבתויעב .

תדחוימתוסחייתהתובייחמהתועפות

לוכיעהתכרעמ : הביקבםומיד ) תוימדתואקה הפקיריגרגכםיארנהםיקיקלחםע ( , תעבטהיפמםומיד ) האוצ /

רוחשואימדלושלש ( , םייעמבואהביקבבוקינואביק ) עאטבתמ " י יגרןטב ש ה , ןטביבאכ , םוח , הליחבתשגרה וא

הלחמ ( , בלבלבתויעב ) עאטבתמ " בגהרוזאלםיטשפתמהןטביבאכי ( , סגהיעמהתקלדלשהרמחה

Ulcerative colitis ( ןהורקתלחמוא ) טבתמ א באככ , לושלש , לקשמדוביאותואקה .(

תללוכההרומחתיגרלאהבוגת : ןורגהלשתימואתפתוחפנתה , ה םינפ , ה ואםיידי ה םיילגר , העילביישק , שק המישניי ,

םלה ) קוש ( , המטסא , הזחבץחל , החירפ רועבתוימומדאוא , דורגואתויחופלש .

ירפ הח הרומחתירוע : תוריהמבתחתפתמההרומחהחירפםיללוכםינמיס , רועהףוליקואתויחופלשםע , תויחופלש

הפב , םייניעבואןורגב . םוח , שארבאכ , לועיש וא מזותואבשחרתהלםילולעףוגבאכ ן . רועהלעתויחופלשןכומכ

תועורזברקיעבםיארנהשמשלהפישחב , פב וםינ ב םיידי .

דבכתויעב : םייניעהוארועהתבהצה , תופייעתשגרה , ןובאתדוביא , הלחמואהליחבתשגרה , תוערפהותרוויחהאוצ

תוארנה םדתוקידבב .

בלףקתה : וראווצהרוזאלטשפתהללולעההזחבבאכםיללוכםינמיס לאמשעורזלתדרלוםייפתכה .

ץבש : השוחתרסוחוםירירשתשלוחםיללוכםינמיס – ףוגהלשדחאדצבןכתי . חירתשוחתבימואתפיוניש , םעט ,

היארואהעימש , לובלב .

חומהםורקתקל : םוחםיללוכםינמיס , הלחמואהליחבתשגרה , ראווצבתושקונ , שארבאכ , לתושיגר ריהברוא

לובלבו ) מב סופולןוגכתוינומיאוטואתולחמבםילוחהםישנאבדחוי ( .

הלעמונייוצשיאוולהתועפותתאשיגרמךניהםא קספה / הנפולופיטהי / אפורלי דימ !

שיגרמךניהובשהרקמלכב / הזןולעבוניוצאלשיאוולתועפותה , תיללכהךתשגרהביונישלחםאוא , ךילע

NAXYN Tablets 12.01.2012 SY

ץעייתהל דימאפורהםע .

ןונימ

רת תדעוימהניאוזהפו ללכךרדב ליגלתחתמםידליל 12 םינש .

דבלבאפורהתוארוהיפל .

תצלמומההנמהלערובעלןיא .

עץלמומהלופיטהךשממואץלמומהןונימהמהובגהןונימבהפורתהתאלוטילןיא " אפורהי .

בוצקןמזבוזהפורתלוטילתחכשםא , גלד / לוטוהנמהתליטנלעי / תאילט ה הנמ ןמזבהאבה ; ןיאןפואםושבךא

דחיבתונמיתשלוטיל !

שומישהןפוא

םימסוכםעתוילבטהעולבל .

החוראהירחאואםעהפורתהתאלוטילשי .

תוילבט 250 מ " ג :

סועללןיא שותכלוא , הייצחהוקבהילבטהתאתוצחלןתינ .

תוילבט 500 מ " ג :

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* לכותדציכ / לופיטהתחלצהלעייסלי ? *

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עץלמוהשלופיטהתאםילשהלךילע " אפורהי .

םעתוצעייתהאללהפורתבלופיטהתאקיספהלןיאךתואירבבצמברופישלחםאםג אפורה .

ענמ / י הלערה !

וםידלילשםדיגשיהלץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת / ענמתךכידילעותוקוניתוא

הלערה .

הפורתהןמדליעלבתועטבםאוארתיתנמתלטנםא , הנפ / י םילוחתיבלשןוימרדחלדימ , אבהו / י הפורתהתזירא

ךתיא .

םורגתלא / י האקהל רוהאלל אפורהמתשרופמהא !

ךתלחמבלופיטלהמשרנוזהפורת ; רחאהלוחב ) ת ( , קיזהלהלולעאיה .

ןתיתלא / י ךיבורקלוזהפורת , ךירכמואךינכש .

ךשוחבתופורתלוטילןיא : קודב / הנמהותיוותהי םעפלכב לטונךניהש / הפורתת . בכרה / ךניהםאםייפקשמי

קוקז / םהלה .

הנסחה

בוזהפורתרומשלשי םוקמ שבי , לתחתמ - C ° 25 .

הזיראהיאנתיפלםג / םיצלמומההנסחה , דבלבתלבגומהפוקתלתורמשנתופורת . לשהגופתהךיראתלבלםישלאנ

רישכתה ! קפסלשהרקמלכב , הפורתהתאךלקפיסשחקורבץעוויהלךילע .

הזיראהתואבתונושתופורתןסחאלןיא .

הפורתהםושירסמ

ןיסקנ 250 מ " ג : 038 51 22980 00

ןיסקנ 500 מ " ג : 055 98 20619 00

עבתויטבצמרפתוישעתעבט " מ ,

" ד 3190 , חתפ - הוקת

NAXYN 500mg HS/MF 09/2019 Notification

SUMMARY OF PRODUCT CHARACTERISTICS

NAXYN 500 mg

Tablets

1.

NAME OF THE MEDICINAL PRODUCT

Naxyn 500 mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 500mg naproxen

For full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Yellow, round biconvex coated tablets.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Relief of the signs and symptoms of rheumatic diseases including osteoarthritis

ankylosing spondylitis of Rheumatoid arthritis both in the treatment of acute flares

and in the long-term management of the disease.

Juvenile Rheumatoid Arthritis.

Periarticular and musculoskeletal disorders.

Relief of pain in bursitis, tendinitis, synovitis, tenosynovitis and lumbago.

Relief of pain, swelling, tenderness and fever in acute gouty Arthritis.

Relief of symptoms of primary dysmenorrhea.

4.2

Posology and method of administration

Rheumatic Diseases

The recommended daily dosage is 500 or 1000 mg taken as a single dose in the

morning or in the evening. Alternatively, 250 or 500 mg may be taken twice daily at

12-hour intervals, morning and evening.

In patients who tolerate lower doses well and have no history of gastrointestinal

disease, the dose may be increased to 1500 mg/day for flare-ups or acute

exacerbations of disease, for no longer than two weeks. Increased gastrointestinal side

effects have been reported with these higher doses.

NAXYN 500mg HS/MF 09/2019 Notification

Juvenile Rheumatoid Arthritis

In children over 5 years of age: the recommended dosage is 10 mg/kg body weight

per day, taken in 2 doses at 12-hour intervals.

Periarticular and Musculoskeletal Disorders

500 mg initially, followed thereafter by 250 mg at 8-12 hour intervals.

Acute Gouty Arthritis

750 mg initially followed 8 hours later by 500 mg and thereafter by 250 mg 8-hourly,

until the attack has passed.

Primary Dysmenorrhea

500 mg at the onset of menstrual pain, followed by 250 mg every 6 hours until

symptoms have subsided, up to a total of 1250 mg daily.

Method of administration

For oral administration.

To be taken preferably with or after food.

4.3

Contraindications

Active or history of peptic ulceration or active gastrointestinal bleeding (two or more

distinct episodes of proven ulceration or bleeding). History of gastrointestinal

bleeding or perforation, related to previous NSAIDs therapy.

Hypersensitivity to naproxen, naproxen sodium, or any of the excipients. Since the

potential exists for cross-sensitivity reactions, Naxyn should not be given to patients

in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the

syndrome of asthma, rhinitis, nasal polyps or urticaria. These reactions have the

potential of being fatal. Severe anaphylactic-like reactions to naproxen have been

reported in such patients.

Severe renal, hepatic or heart failure

Naproxen is contraindicated during the last trimester of pregnancy (see Section 4.6).

4.4

Special warnings and precautions for use

Undesirable effects may be minimised by using the lowest effective dose for the

shortest duration necessary to control symptoms (see section 4.2 and GI and

cardiovascular risks below). Patients treated with NSAIDs long-term should undergo

regular medical supervision to monitor for adverse events.

Older people and/or debilitated patients are particularly susceptible to the adverse

effects of NSAIDs, especially gastrointestinal bleeding and perforation, which may be

NAXYN 500mg HS/MF 09/2019 Notification

fatal. Prolonged use of NSAIDs in these patients is not recommended. Where

prolonged therapy is required, patients should be reviewed regularly.

The antipyretic and anti-inflammatory activities of Naxyn may reduce fever and

inflammation, thereby diminishing their utility as diagnostic signs.

Bronchospasm may be precipitated in patients suffering from, or with a history of,

bronchial asthma or allergic disease.

As with other non-steroidal anti-inflammatory drugs, elevations of one or more liver

function tests may occur. Hepatic abnormalities may be the result of hypersensitivity

rather than direct toxicity. Severe hepatic reactions, including jaundice and hepatitis

(some cases of hepatitis have been fatal) have been reported with this drug as with

other non-steroidal anti-inflammatory drugs. Cross reactivity has been reported.

Naproxen decreases platelet aggregation and prolongs bleeding time. This effect

should be kept in mind when bleeding times are determined.

Although sodium retention has not been reported in metabolic studies, it is possible

that patients with questionable or compromised cardiac function may be at a greater

risk when taking Naxyn.

Gastrointestinal bleeding, ulceration and perforation

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all

NSAIDs at anytime during treatment, with or without warning symptoms or a

previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID

doses, in patients with a history of ulcer, particularly if complicated with haemorrhage

or perforation (see section 4.3), and in older people. These patients should commence

treatment on the lowest dose available. Combination therapy with protective agents

(e.g. misoprostol or proton pump inhibitors) should be considered for these patients,

and also for patients requiring concomitant low dose aspirin, or other drugs likely to

increase gastrointestinal risk (see section 4.5).

Patients with a history of GI toxicity, particularly when older, should report any

unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages

of treatment.

Caution should be advised in patients receiving concomitant medications which could

increase the risk of ulceration or bleeding, such as oral corticosteroid, anticoagulants

such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as

aspirin (see Section 4.5).

When GI bleeding or ulceration occurs in patients receiving Naxyn, the treatment

should be withdrawn.

NAXYN 500mg HS/MF 09/2019 Notification

NSAIDs should be given with care to patients with a history of gastrointestinal

disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated

(see Section 4.8).

Renal Effects

There have been reports of impaired renal function, renal failure, acute interstitial

nephritis, haematuria, proteinuria, renal papillary necrosis and occasionally nephrotic

syndrome associated with naproxen.

Renal failure linked to reduced prostaglandin production

The administration of an NSAID may cause a dose dependent reduction in

prostaglandin formation and precipitate renal failure. Patients at greatest risk of this

reaction are those with impaired renal function, cardiac impairment, liver dysfunction,

those taking diuretics, angiotensin converting enzyme inhibitors, angiotensin-II

receptor antagonists and older people. Renal function should be monitored in these

patients (see also Section 4.3).

Use in patients with impaired renal function

As naproxen is eliminated to a large extent (95%) by urinary excretion via glomerular

filtration, it should be used with great caution in patients with impaired renal function

and the monitoring of serum creatinine and/or creatinine clearance is advised and

patients should be adequately hydrated. Naxyn is contraindicated in patients having a

baseline creatinine clearance of less than 30ml/minute.

Haemodialysis does not decrease the plasma concentration of naproxen because of the

high degree of protein binding.

Certain patients, specifically those whose renal blood flow is compromised, such as in

extracellular volume depletion, cirrhosis of the liver, sodium restriction, congestive

heart failure, and pre-existing renal disease, should have renal function assessed

before and during Naxyn therapy. Some older people in whom impaired renal

function may be expected, as well as patients using diuretics, may also fall within this

category. A reduction in daily dosage should be considered to avoid the possibility of

excessive accumulation of naproxen metabolites in these patients.

Use in patients with impaired liver function

Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the

total plasma concentration of naproxen, but the plasma concentration of unbound

naproxen is increased. The implication of this finding for Naxyn dosing is unknown

but it is prudent to use the lowest effective dose.

Haematological

Patients who have coagulation disorders or are receiving drug therapy that interferes

with haemostasis should be carefully observed if naproxencontaining products are

administered.

NAXYN 500mg HS/MF 09/2019 Notification

Patients at high risk of bleeding or those on full anti-coagulation therapy (e.g.

dicoumarol derivatives) may be at increased risk of bleeding if given naproxen-

containing products concurrently.

Anaphylactic (anaphylactoid) reactions

Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic

(anaphylactoid) reactions may occur both in patients with and without a history of

hypersensitivity or exposure to aspirin, other non-steroidal anti-inflammatory drugs or

naproxen-containing products. They may also occur in individuals with a history of

angio-oedema, bronchospastic reactivity (e.g. asthma), rhinitis and nasal polyps.

Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.

Steroids

If steroid dosage is reduced or eliminated during therapy, the steroid dosage should be

reduced slowly and the patients must be observed closely for any evidence of adverse

effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.

Ocular effects

Studies have not shown changes in the eye attributable to naproxen administration. In

rare cases, adverse ocular disorders including papillitis, retrobulbar optic neuritis and

papilloedema, have been reported in users of NSAIDs including naproxen, although a

cause-and-effect relationship cannot be established; accordingly, patients who

develop visual disturbances during treatment with naproxen-containing products

should have an ophthalmological examination.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of

hypertension and/or mild to moderate congestive heart failure as fluid retention and

oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs

(particularly at high doses and in long term treatment) may be associated with a small

increased risk of arterial thrombotic events (for example myocardial infarction or

stroke). Although data suggest that the use of naproxen (1000mg daily) may be

associated with a lower risk, some risk cannot be excluded.

Patients with uncontrolled hypertension, congestive heart failure, established

ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease

should only be treated with naproxen after careful consideration. Similar

consideration should be made before initiating longer-term treatment of patients with

risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes

mellitus, smoking).

NAXYN 500mg HS/MF 09/2019 Notification

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue

disorders there may be an increased risk of aseptic meningitis (see Section 4.8).

Dermatological

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-

Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in

association with the use of NSAIDs (see 4.8). Patients appear to be at highest risk for

these reactions early in the course of therapy: the onset of the reactions occurring in

the majority of cases within the first month of treatment. Naxyn should be

discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of

hypersensitivity.

Combination with other NSAIDs

The combination of naproxen-containing products and other NSAIDs, including

cyclooxygenase-2 selective inhibitors, is not recommended, because of the cumulative

risks of inducing serious NSAID-related adverse events.

Excipients with known effect

Naxyn 500 mg contains colouring agent called FD&C yellow No. 6 (Sunset yellow

FCF (E 110)) which may cause allergic reactions.

Naxyn 500 mg contains lactose monohydrate. Patients with rare hereditary problems

of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

Concomitant administration of antacid or colestyramine can delay the absorption of

naproxen but does not affect its extent. Concomitant administration of food can delay

the absorption of naproxen, but does not affect its extent.

It is considered unsafe to take NSAIDs in combination with anti-coagulants such as

warfarin or heparin unless under direct medical supervision, as NSAIDs may enhance

the effects of anti-coagulants (see Section 4.4).

Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant

use of two or more NSAIDs (including aspirin) as this may increase the risk of

adverse effects (see Section 4.4).

Acetylsalicylic acid

Clinical pharmacodynamic data suggest that concomitant naproxen usage for more

than one day consecutively may inhibit the effect of low-dose acetylsalicylic acid on

platelet activity and this inhibition may persist for up to several days after stopping

naproxen therapy. The clinical relevance of this interaction is not known.

NAXYN 500mg HS/MF 09/2019 Notification

Due to the high plasma protein binding of naproxen, patients simultaneously receiving

hydantoins, anticoagulants, other NSAIDs, aspirin or a highly protein-bound

sulfonamide should be observed for signs of overdosage of these drugs. Patients

simultaneously receiving Naxyn and a hydantoin, sulfonamide or sulfonylurea should

be observed for adjustment of dose if required. No interactions have been observed in

clinical studies with naproxen and anticoagulants or sulfonylureas, but caution is

nevertheless advised since interaction has been seen with other non-steroidal agents of

this class.

Caution is advised when Naxyn is co-administered with diuretics as there can be a

decreased diuretic effect. The natriuretic effect of furosemide has been reported to be

inhibited by some drugs of this class. Diuretics can increase the risk of nephrotoxicity

of NSAIDs.

Inhibition of renal lithium clearance leading to increases in plasma lithium

concentrations has also been reported.

Naproxen and other non-steroidal anti-inflammatory drugs can reduce the

antihypertensive effect of anti-hypertensives. Concomitant use of NSAIDs with ACE

inhibitors or angiotensin-II receptor antagonists may increase the risk of renal

impairment, especially in patients with pre-existing poor renal function (See Section

4.4).

Probenecid given concurrently increases naproxen plasma levels and extends its half-

life considerably.

Caution is advised where methotrexate is given concurrently because of possible

enhancement of its toxicity, since naproxen, among other nonsteroidal anti-

inflammatory drugs, has been reported to reduce the tubular secretion of methotrexate

in an animal model.

NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac

glycoside levels when co-administered with cardiac glycosides.

As with all NSAIDs caution is advised when ciclosporin is co-administered because

of the increased risk of nephrotoxicity.

NSAIDs should not be used for 8 - 12 days after mifepristone administration as

NSAIDs can reduce the effects of mifepristone.

As with all NSAIDs, caution should be taken when co-administering with cortico-

steroids because of the increased risk of gastrointestinal ulceration or bleeding.

Animal data indicate that NSAIDs can increase the risk of convulsions associated

with quinolone antibiotics. Patients taking quinolones may have an increased risk of

developing convulsions.

NAXYN 500mg HS/MF 09/2019 Notification

There is an increased risk of gastrointestinal bleeding (see Section 4.4) when anti-

platelet agents and selective serotonin reuptake inhibitors (SSRIs) are combined with

NSAIDs.

There is a possible risk of nephrotoxicity when NSAIDs are given with tacrolimus.

There is an increased risk of haematological toxicity when NSAIDs are given with

zidovudine. There is evidence of an increased risk of haemarthroses and haematoma

in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and

ibuprofen.

It is suggested that Naxyn therapy be temporarily discontinued 48 hours before

adrenal function tests are performed, because naproxen may artifactually interfere

with some tests for 17-ketogenic steroids. Similarly, naproxen may interfere with

some assays of urinary 5-hydroxyindoleacetic acid.

4.6

Fertility, Pregnancy and lactation

Pregnancy

Congenital abnormalities have been reported in association with NSAID

administration in man; however, these are low in frequency and do not appear to

follow any discernible pattern. As with other drugs of this type, naproxen produces

delay in parturition in animals and also affects the human foetal cardiovascular system

(closure of ductus arteriosus). Use of Naxyn in the last trimester of pregnancy is

contraindicated (see Section 4.3). NSAIDs should not be used during the first two

trimesters of pregnancy, unless the potential benefit to the patient outweighs the

potential risk to the foetus.

Labour and delivery

Naproxen containing products are not recommended in labour and delivery because,

through its prostaglandin synthesis inhibitory effect, naproxen may adversely affect

foetal circulation and inhibit contractions, with an increased bleeding tendency in both

mother and child.

Breast feeding

Naproxen has been found in the milk of lactating women. The use of Naxyn should be

avoided in patients who are breast-feeding.

Fertility

The use of naproxen, as with any drug known to inhibit cyclooxygenase/prostaglandin

synthesis, may impair fertility and is not recommended in women attempting to

conceive. In women who have difficulty conceiving or are undergoing investigation

of infertility, withdrawal of naproxen should be considered.

NAXYN 500mg HS/MF 09/2019 Notification

4.7

Effects on ability to drive and use machines

Some patients may experience drowsiness, dizziness, vertigo, insomnia, fatigue,

visual disturbances or depression with the use of Naxyn . If patients experience these

or similar undesirable effects, they should not drive or operate machinery.

4.8 Undesirable effects

The following adverse events have been reported with NSAIDs and with naproxen.

Gastrointestinal disorders: The most commonly observed adverse events are

gastrointestinal in nature. Heartburn, nausea, vomiting, constipation, diarrhoea,

flatulence, dyspepsia, abdominal discomfort and epigastric distress.

More serious reactions which may occur are gastro-intestinal bleeding, which is

sometimes fatal, particularly in older people (see section 4.4), inflammation,

ulceration, perforation, and obstruction of the upper and lower gastrointestinal tract,

melaena, haematemesis, stomatitis, exacerbation of ulcerative colitis and Crohn’s

disease (see section 4.4), oesophagitis, gastritis and pancreatitis.

Blood and lymphatic system disorders: Neutropenia, thrombocytopenia,

granulocytopenia including agranulocytosis, eosinophilia, leucopenia, aplastic

anaemia and haemolytic anaemia.

Immune system disorders: Hypersensitivity reactions have been reported following

treatment with NSAIDs in patients with, or without, a history of previous

hypersensitivity reactions to NSAIDs. These may consist of (a) nonspecific allergic

reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma,

aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders,

including rashes of various types, pruritus, urticaria, purpura, angio-oedema and more

rarely exfoliative and bullous dermatoses (including epidermal necrolysis and

erythema multiforme).

Metabolic and nutrition disorders: hyperkalaemia.

Psychiatric disorders: Insomnia, dream abnormalities, depression, confusion and

hallucinations.

Nervous system disorders: Convulsions, dizziness, headache, lightheadedness,

drowsiness, paraesthesia, retrobulbar optic neuritis, inability to concentrate and

cognitive dysfunction have been reported. Aseptic meningitis (especially in patients

with existing auto-immune disorders, such as systemic lupus erythematosus, mixed

connective tissue disease), with symptoms such as stiff neck, headache, nausea,

vomiting, fever or disorientation (see section 4.4).

Eye Disorders: Visual disturbances, corneal opacity, papillitis and papilloedema.

Ear and Labyrinth disorders: Tinnitus, hearing disturbances including impairment

and vertigo.

NAXYN 500mg HS/MF 09/2019 Notification

Cardiac disorders: Oedema, palpitations, cardiac failure and congestive heart failure

have been reported.

Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs

(particularly at high doses and in long term treatment) may be associated with a small

increased risk of arterial thrombotic events (for example myocardial infarction or

stroke) (see section 4.4).

Vascular disorders: Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders: Dyspnoea, asthma, eosinophilic

pneumonitis and pulmonary oedema.

Hepatobiliary disorders: Jaundice, fatal hepatitis and abnormal liver function tests.

Skin and subcutaneous tissue disorders: Skin rashes including fixed drug eruption,

itching (pruritus), urticaria, ecchymoses, purpura, sweating.

Alopecia, erythema multiforme, Stevens Johnson syndrome, erythema nodosum,

lichen planus, pustular reaction, SLE, epidermal necrolysis, very rarely toxic

epidermal necrolysis, photosensitivity reactions (including cases in which skin

resembles porphyria cutanea tarda “pseudoporphyria”) or epidermolysis bullosa-like

reactions which may occur rarely.

If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur,

treatment should be discontinued and the patient monitored.

Musculoskeletal and connective tissue disorders: Myalgia and muscle weakness.

Renal and urinary disorders: Including, but not limited to, glomerular nephritis,

interstitial nephritis, nephrotic syndrome, haematuria, raised serum creatinine, renal

papillary necrosis and renal failure.

Reproductive system and breast disorders: Female infertility.

General disorders and administration site conditions: Thirst, pyrexia, fatigue and

malaise.

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

Symptoms

Symptoms include headache, heartburn, nausea, vomiting, epigastric pain,

gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, drowsiness,

NAXYN 500mg HS/MF 09/2019 Notification

dizziness, tinnitus, fainting. In cases of significant poisoning acute renal failure and

liver damage are possible.

Respiratory depression and coma may occur after the ingestion of NSAIDs but are

rare.

In one case of naproxen overdose, transient prolongation of the prothrombin time due

to hypothrombinaemia may have been due to selective inhibition of the synthesis of

vitamin-K dependent clotting factors.

A few patients have experienced seizures, but it is not known whether these were

naproxen-related or not. It is not known what dose of the drug would be life-

threatening.

Management

Patients should be treated symptomatically as required. Within one hour of ingestion

of a potentially toxic amount activated charcoal should be considered. Alternatively in

adults gastric lavage should be considered within one hour of ingestion of a

potentially life-threatening overdose.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic

amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam.

Other measures may be indicated by the patient’s clinical condition.

Haemodialysis does not decrease the plasma concentration of naproxen because of the

high degree of protein binding. However, haemodialysis may still be appropriate in a

patient with renal failure who has taken naproxen.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-

steroids. ATC code: M01AE02

Naproxen is a non-steroidal anti-inflammatory analgesic compound with antipyretic

properties as has been demonstrated in classical animal test systems. Naproxen

exhibits its anti-inflammatory effect even in adrenalectomised animals, indicating that

its action is not mediated through the pituitary-adrenal axis.

Naproxen inhibits prostaglandin synthetase (as do other NSAIDs). As with other

NSAIDs, however, the exact mechanism of its anti-inflammatory action is not known.

NAXYN 500mg HS/MF 09/2019 Notification

5.2 Pharmacokinetic properties

Naproxen is completely absorbed from the gastro-intestinal tract, and peak plasma

levels are reached in 2 to 4 hours. Naproxen is present in the blood mainly as

unchanged drug, extensively bound to plasma proteins. The plasma half-life is

between 12 and 15 hours, enabling a steady state to be achieved within 3 days of

initiation of therapy on a twice daily dose regimen. The degree of absorption is not

significantly affected by either foods or most antacids. Excretion is almost entirely via

the urine, mainly as conjugated naproxen, with some unchanged drug. Metabolism in

children is similar to that in adults. Chronic alcoholic liver disease reduces the total

plasma concentration of naproxen but the concentration of unbound naproxen

increases. In older people, the unbound plasma concentration of naproxen is increased

although total plasma concentration is unchanged.

5.3 Preclinical safety data

Carcinogenicity

Naproxen was administered with food to Sprague-Dawley rats for 24 months at doses

of 8, 16 and 24mg/kg/day. Naproxen was not carcinogenic in rats.

Mutagenicity

Mutagenicity was not seen in salmonella typhimurium (5 cell lines), Sachharomyces

cerevisisae (1 cell line) and mouse lymphoma tests.

Fertility

Naproxen did not affect the fertility of rats when administered orally at doses of

30mg/kg/day to males and 20mg/kg/day to females.

Teratogenicity

Naproxen was not teratogenic when administered orally at doses of 20mg/kg/day

during organogenesis to rats and rabbits.

Perinatal/Postnatal Reproduction

Oral administration of naproxen to pregnant rats at doses of 2, 10 and 20mg/kg/day

during the third trimester of pregnancy resulted in difficult labour. These are known

effects of this class of compounds and were demonstrated in pregnant rats with aspirin

and indometacin.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate, starch, povidone, magnesium stearate, hypromellose,

polyethylene glycol 400, polyethylene glycol 6000, D&C yellow No. 10, FD&C

yellow No. 6 (Sunset yellow FCF (E 110)).

NAXYN 500mg HS/MF 09/2019 Notification

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 in a dry place, below 25ºC.

6.5 Nature and contents of container

Each package contains 30 tablets in

blister pack.

6.6 Special precautions for disposal

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance

with local requirements.

7.

LICENCE HOLDER AND MANUFACTURER

Teva Pharmaceutical Industries Ltd.,

P.O.Box 3190, Petach Tikva.

8.

Registration Numbers

055.98.20619

The content of this leaflet was approved by the Ministry of Health in September 2009 and

updated according to the guidelines of the Ministry of Health in September 2019

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