NAXYN 500 MG

Patient leaflet in accordance with the Pharmacists’ Regulations

(Preparations) - 1986

This medicine is dispensed with a doctor’s prescription only

NAXYN

®

500 mg

Tablets

Composition

Each tablet contains:

Naproxen 500 mg

For information on inactive ingredients and allergens: see section 2 “Important

information

about

some

this

medicine’s

ingredients”

section

“Additional information”.

Read the entire leaflet carefully before you start using this medicine.

This leaflet contains concise information about this medicine. If you have any

further questions, consult your doctor or pharmacist.

This medicine has been prescribed to treat 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?

For relief of signs and symptoms of rheumatic diseases, arthritis, joint

disorders, tendon inflammation, musculoskeletal disorders and relief of back

pain and menstrual pain.

Therapeutic group: Nonsteroidal anti-inflammatory drugs (NSAIDs).

2.

Before using this medicine

Do not use this medicine if:

You are sensitive (allergic) to naproxen, naproxen sodium or to any of the

other ingredients in this medicine, see section 2 “Important information

about some of this medicine’s ingredients” and section 6 “Additional

information”.

You are sensitive (allergic) to aspirin, another medicine of the nonsteroidal

anti-inflammatory drugs class (NSAIDs) or any other analgesic (such as

ibuprofen or diclofenac).

You have now or have ever had any problems with your stomach or gut

(intestine), such as an ulcers or bleeding.

You have previously experienced bleeding or perforation in your stomach

while taking NSAIDs.

You have severe kidney, liver or heart problems.

You are in the last three months of pregnancy.

Special warnings about using this medicine

If you have heart problems, have had in the past a stroke or think that you

might be at risk of such conditions (for example, if you have high blood

pressure, diabetes, high cholesterol levels or if you are a smoker), you should

consult your doctor or pharmacist regarding the treatment.

Before using NAXYN 500 mg, tell your doctor if you have:

Asthma or allergies (such as allergic rhinitis) or have had in the past swelling

of the face, lips, eyes or tongue.

A feeling of weakness (possibly because of an illness) or you are an elderly

person.

Lumps (polyps) in the nose or you sneeze a lot or have a runny, blocked,

or itchy nose (rhinitis).

Problems with the kidneys or liver.

Blood coagulation problems.

Problems with the blood vessels (arteries) anywhere in the body.

Too much lipids in the blood (hyperlipidemia).

An autoimmune disease, such as systemic lupus erythematosus (SLE,

causing joint pain, skin rashes and fever) and colitis or Crohn’s disease

(conditions causing inflammation of the bowel, abdominal pain, diarrhea,

vomiting and weight loss).

If any of the above conditions apply to you, or if you are not sure, consult your

doctor or pharmacist before using the medicine.

Drug interactions

If you are taking, or have recently taken, other medicines, including non-

prescription medicines and nutritional supplements, tell the doctor or

pharmacist. Particularly if you are taking:

Other analgesics, like aspirin, ibuprofen, diclofenac and paracetamol.

Medicines to prevent blood clotting, like aspirin/ acetylsalicylic acid, warfarin,

heparin or clopidogrel.

A hydantoin (for epilepsy), like phenytoin.

Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide

and sulfonamide antibiotics (for infections).

A sulfonylurea (for diabetes), like glimepiride or glipizide.

ACE inhibitors or other medicines for hypertension like cilazapril, enalapril

or propranolol.

Angiotensin-2 receptor blockers, like candesartan, eprosartan or losartan.

Diuretics (for high blood pressure), like furosemide.

Cardiac glycosides (for heart problems), like digoxin.

Steroids (for swelling and inflammation), like hydrocortisone, prednisolone

and dexamethasone.

Quinolone antibiotics (for infections), like ciprofloxacin or moxifloxacin.

Certain medicines for mental health problems like lithium or SSRIs like

fluoxetine

citalopram.

Probenecid (for gout).

Methotrexate (used to treat skin problems, arthritis or cancer).

Ciclosporin or tacrolimus (for skin problems or after an organ transplant).

Zidovudine (to treat AIDS and HIV infections).

Mifepristone (to terminate pregnancy or to induce labor if the baby has died).

If you are taking any of the above medicines or if you are not sure, consult your

doctor or pharmacist before using the medicine.

Using this medicine and food

Swallow the tablets with a glass of water. Take the medicine with or after a

meal.

Pregnancy, breastfeeding and fertility

Do not take NAXYN 500 mg if you are in the last three months of pregnancy,

since it can harm your baby.

If you are pregnant or breastfeeding, think you are pregnant or are planning

to become pregnant, ask your doctor or pharmacist for advice before taking

this medicine.

NAXYN 500 mg may make it more difficult to become pregnant. You should

tell your doctor if you are planning to become pregnant or if you have

difficulties becoming pregnant.

Driving and using machines

NAXYN 500 mg may cause tiredness, drowsiness, dizziness, problems with

vision and balance, depression or difficulties sleeping. Tell your doctor if you

experience any of these effects and do not drive or use any tools or machines.

Important information about some of this medicine’s ingredients

The medicine contains a sugar called lactose. If you have been told by

your doctor that you have intolerance to certain sugars, consult your doctor

before taking this medicine.

The medicine contains a dye called FD&C Yellow No. 6 (Sunset yellow FCF

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

3.

How to use this medicine?

Always use this medicine according to your doctor’s instructions. Check with

your doctor or pharmacist if you are not sure about your dose or about how

to take this medicine.

Only your doctor will determine your dose and how you should take this

medicine.

This medicine is usually not intended for children below the age of 12 years.

Do not exceed the recommended dose.

Manner of use:

Swallow the tablets with a glass of water.

Take the medicine with or after a meal.

There is no information regarding crushing and chewing. Do not split the

tablet since there is no score line in the tablet.

Medicines such as NAXYN may be associated with a small increase in the

risk of heart attack (myocardial infarction) or stroke. The risk increases with

higher doses and prolonged treatment.

Do not exceed (take more than) the

recommended dose or duration of treatment.

Consult your doctor if you are

not sure.

You should make sure that you drink enough during the treatment with NAXYN

500 mg. This is particularly important for patients who have kidney problems.

During the treatment with NAXYN 500 mg your doctor may want to see you

to check that you are receiving the right dose for you and check for any side

effects. This is particularly important for elderly patients.

If you have accidentally taken a higher dosage, if you have taken an

overdose or if a child has accidentally swallowed the medicine, immediately

contact a doctor or proceed to a hospital emergency room and bring the

package of the medicine with you.

Adhere to the treatment as recommended by the doctor.

If you forgot to take this medicine

If you forgot to take a dose, skip the forgotten dose and take the next dose

as you usually do.

Do not take a double dose to compensate for the forgotten dose.

Do not take medicines in the dark! Check the label and the dose each time

you take a medicine. Wear glasses if you need them.

If you have any further questions about using this medicine, consult your

doctor or pharmacist.

4.

Side effects

Like with all medicines, using NAXYN 500 mg may cause side effects in

some users. Do not be alarmed by this list of side effects. You may not

suffer from any of them.

Medicines such as NAXYN may be associated with a small increase in the risk

of heart attack (myocardial infarction) or stroke.

Important side effects to look out for:

Stop taking this medicine and consult your doctor immediately if any of

the following effects appears. You may need urgent medical treatment:

Serious stomach or bowel problems,

signs include:

Bleeding from the stomach, seen as vomit with blood in it, or bits that look

like coffee grounds.

Bleeding from the anus, seen as black sticky stool or bloody diarrhea.

Ulcers or holes forming in the stomach or bowel. Signs include abdominal

tenderness, abdominal pain, fever, nausea or vomiting.

Pancreas problems. Signs include severe abdominal pain spreading to the

back.

Worsening of ulcerative colitis or Crohn’s disease, manifested as pain,

diarrhea, vomiting and weight loss.

Allergic reactions,

signs include:

Sudden swelling of the throat, face, hands or feet.

Difficulty breathing, tightness in the chest.

Skin rashes, blisters or itching.

Severe skin rashes,

signs include:

A severe rash that develops quickly, with blisters or peeling of the skin and

possibly blisters in the mouth, throat or eyes. Fever, headache, cough and

body aches may appear at the same time.

Blistering of skin due to exposure to sunlight (porphyria cutanea tarda) seen

mainly on arms, face and hands.

Liver problems,

signs include:

Yellowing of the skin or the white parts of the eyes (jaundice).

Feeling tired, loss of appetite, nausea or vomiting and pale colored stools

(hepatitis), and problems shown in blood tests (including hepatitis).

Heart attack, signs include:

Chest pain which may spread to the neck, shoulders and down the left arm.

Stroke,

signs include:

Muscle weakness and numbness. These sensations may appear only on

one side of the body.

A sudden change in the sense of smell, taste, hearing or vision, confusion.

Meningitis,

signs include:

Fever, nausea or vomiting, a stiff neck, headache, sensitivity to bright light

and confusion (especially in people with autoimmune diseases such as

systemic lupus erythematosus).

If you notice any of the serious side effects listed above, stop taking NAXYN

500 mg and consult your doctor immediately.

Other possible side effects:

Stomach and bowels

Heartburn, indigestion, abdominal pain, nausea or vomiting, constipation,

diarrhea, gas.

Blood

Blood problems, like anemia or changes in the number of white blood cells.

Mental illnesses

Difficulty sleeping or changes in the pattern of dreaming.

Depression.

Confusion or seeing and possibly hearing things that are not real (hallucinations).

Nervous system

Headache.

Fits or seizures, feeling dizzy or sleepy.

Sensation of pricking or numbness of your hands and feet.

Difficulties with memory or concentration.

Eyes and ears

Changes to your sight, eye pain.

Changes to your hearing, including ringing in the ears (tinnitus) and hearing

loss.

Dizziness that causes balance problems.

Heart and circulation

Swelling of the hands, feet or legs (edema), may be accompanied by chest

pain, tiredness, and shortness of breath (heart failure).

Feeling of your heart pounding (palpitations). Slow heart beat or high blood

pressure.

Problems with the way the heart pumps blood around the body or damage to

the blood vessels. signs may include tiredness, shortness of breath, feeling

faint and general pain.

Chest

Difficulties breathing, including shortness of breath, wheezing or coughing.

Pneumonia or swelling of your lungs.

Skin and hair

Skin rashes including redness, hives, pimples and blisters on the body and

face.

Bruising, itching, sweating, skin being more sensitive to the sun or hair loss.

Urinary

Blood in the urine or kidney problems.

Other

Thirst, fever, feeling tired or generally unwell.

A sore mouth or mouth ulcers.

Muscle pain or weakness.

Problems for women in getting pregnant.

‘Systemic lupus erythematosus’ (SLE). Signs include fever, rash, kidney

problems and joint pain.

If you experience any side effect, if any side effect gets worse, or if you

experience a side effect not mentioned in this leaflet, consult your doctor.

Reporting side effects

Side effects can be reported to the Ministry of Health by clicking on the link

“Reporting side effects following drug treatment” found on the Ministry of

Health homepage (www.health.gov.il) that directs you to the online form for

reporting side effects, or by entering the link: https://sideeffects.health.gov.il

5.

How to store the medicine?

Avoid poisoning! This medicine, and any other medicine, should be kept in

a closed place out of the reach and sight of children and/or infants in order

to avoid poisoning. Do not induce vomiting unless explicitly instructed to do

so by the doctor.

Do not use the medicine after the expiry date (exp. date) that appears on the

package. The expiry date refers to the last day of that month.

Store in a dry place below 25°C.

Do not throw any medicines via wastewater or household waste. Ask

your pharmacist how to throw away medicines you no longer use. These

measures will help protect the environment.

6.

Additional information

In addition to the active ingredient, this medicine also contains:

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)).

What the medicine looks like and contents of the pack:

Round, yellow film-coated tablets.

The tablets are packed in blisters. Each pack contains 30 tablets.

Manufacturer’s name and address:

Teva Pharmaceutical Industries Ltd., POB 3190, Petach Tikva.

The leaflet was revised in May 2020.

Registration number of the medicine in the National Drug Registry of the

Ministry of Health:

055.98.20619

يف ريغص عافترا عم ةقلاع ،غلم 500 نيسكان لثم ةنيعم ةيودلأ نوكت نأ لمتحملا نم .ةيغامد ةتكس وأ )بلقلا ةلضع ءاشتحا( ةيبلق ةبون ثودح ةروطخ :اهنم رذحلا بجي يتلا ةمهم ةيبناج ضارعأ ةيبناجلا ضارعلأا ىدحإ ترهظ اذإ بيبطلا ىلإ ا

ً

روف هجوتو ءاودلا لوانت نع فقوت :ئراط يبط جلاع ىلإ جاتحت نأ لمتحملا نم .يلي اميف ةروكذملا :ضارعلأا لمشتو ،ءاعملأا يف وأ ةدعملا يف ةريطخ لكاشم

.ةوهقلا بوبحك ودبت يتلا عطق وأ مد عم ءيق للاخ نم رهظي يذلا ،ةدعملا نم فيزن

.يومد لاهسإ وأ يطاطم دوسأ زاربك ودبي يذلا جرشلا ةحتف نم فيزن

،نطبلا يف ةيساسح ضارعلأا لمشت .ءاعملأا يف وأ ةدعملا يف بوقث ن

وكت وأ تاحرقت .ؤيقت وأ نايثغ ،ةنوخس ،نطب ملاآ

.رهظلا ىلإ دتمي يذلا ديدش نطب ملأ ضارعلأا لمشت .سايركنبلا يف لكاشم

،مللأا للاخ نم سكعني يذلا ،نورك ضرم يف وأ يحرقتلا نولوقلا باهتلا يف مقافت .نزولا نادقفو تاؤيقت ،لاهسإ :ضارعلأا لمشتو ،ة

ّ

يسسحت لعف دودر

.نيمدقلا وأ نيديلا ،هجولا يف ،ةرجنحلا يف يئاجف خافتنا

.ردصلا يف طغض ،سفنت تابوعص

.ةكح وأ تلاصيوح ،يدلج حفط تلااح :ضارعلأا لمشتو ،ةديدش يدلج حفط تلااح

نمو ،دلجلا يف تارشقت وأ تلاصيوح عم ،ةعرسب روطتي يذلا ديدش يدلج حفط نأ لمتحملا نم .نينيعلا يف وأ قلحلا يف ،مفلا يف تلاصيوح روهظ ا

ضيأ لمتحملا .مسجلا يف ملاآو لاعس ،سأر ملاآ ،ةنوخس هتاذ تقولا يف رهظت

رهظت يتلا )ةرخأتم ةيدلج ةيرفر

ب( سمشلا ةعشلأ ضرعتلا باقعأ يف ةيدلج تلاصوح .نيديلا يفو هجولا يف ،نيعارذلا يف ساسلأاب :ضارعلأا لمشتو ،دبكلا يف لكاشم

.)ناقري( نينيعلا ضايب وأ دلجلا رارفصا

،)دبكلا يف باهتلا( بحاش نولب زاربو ؤيقت وأ نايثغ ،ةيهشلا نادقف ،بعتلاب ساسحإ .)دبكلا يف باهتلا لمشي اذهو( مدلا تاصوحف يف رهظت يتلا لكاشمو :ضارعلأا لمشتو ،ةيبلق ةبون

.رسيلأا عارذلا لفسأ يفو نيفتكلا ىلإ ،ةبقرلا ىلإ رشتني دق يذلا ردصلا يف ملأ :ضارعلأا لمشتو ،ةيغامد ةتكس

ةدحاو ةهج يف طقف رهظت دق سيساحلأا هذه .)ردخ( ساسحلإا مادعناو تلاضع فعض .مسجلا نم

.كابترا ،ةيؤرلا وأ عمسلا ،قوذلا ،مشلا ةساح يف يئاجف ريغت :ضارعلأا لمشتو ،اياحسلا باهتلا

ةصاخ( كابتراو عطاسلا ءوضلل ةيساسح ،عادص ،ةبقرلا بلصت ،ؤيقت وأ نايثغ ،ةنوخس .)ةيزاهجلا ةيمامحلا ةبئذلا لثم ةيتاذ ةعانم ضارمأب نيباصملا ىضرملا ىدل لوانت نع فقوت ،هلاعأ ةروكذملا ةديدشلا ةيبناجلا ضارعلأا نم دحاو روهظ تظحلا اذإ .بيبطلا ىلإ ا

روف هجوتو غلم 500 نيسكان :ةيفاضإ ةلمتحم ةيبناج ضارعأ ءاعملأاو ةدعملا

.تازاغ ،لاهسإ ،كاسمإ ،ؤيقت وأ نايثغ ،نطب ملأ ،مضه تابوعص ،ةقرح مدلا

.ءاضيبلا مدلا ايلاخ نم ددع يف تارييغت وأ مدلا رقف لثم ،مدلا يف لكاشم ةيسفن ضارمأ

.ملاحلأا طمن يف تارييغت وأ مونلا يف تابوعص

.بائتكا

.)نايذه( ةدوجوم ريغ رومأ عامس ،ا

ضيأ نكمملا نمو ،ةيؤر وأ كابترا يبصعلا زاهجلا

.عادص

.ساعنلا وأ راودلاب ساسحإ ،تاجلاتخا وأ تاجنشت

.نيمدقلا يفو نيديلا يف )ردخ( ساسحلإا مادعنا وأ زخولاب ساسحإ

.زيكرتلا يف وأ ةركاذلا يف تابوعص ناذلآاو نويعلا

.نينيعلا يف ملأ ،ةيؤرلا يف تارييغت

.عمسلا نادقفو )نينط( نينذلأا يف نينر لمشي اذهو ،عمسلا يف تارييغت

.نزاوتلا يف لكاشم ىلإ يدؤي يذلا راود ةيومدلا ةرودلاو بلقلا

بعت ،ردصلا يف ملاآب ا

بوحصم نوكي دق يذلا ،)ةمذو( نيقاسلا وأ نيمدقلا ،نيديلا خافتنا .)بلقلا يف روصق( سفنت قيضو

.عفترم مد طغض وأ ءيطب ضبن .)ناقفخ( بلقلا ضبنب ساسحإ

.ةيومدلا ةيعولأل ررض وأ مسجلا يف مدلا خضب بلقلا اهب موقي يتلا ةقيرطلا يف لكاشم .ماع ملأو ءامغلإاب ساسحإ ،سفنت قيض ،بعت ضارعلأا هذه لمشت دقو ردصلا

.لاعس وأ ،ريفص ،سفنت قيض لمشي اذهو ،سفنت تابوعص

.نيتئرلا خافتنا وأ نيتئرلا باهتلا رعشلاو دلجلا

ىلع تلاصيوحو )

دعلا( بابشلا بح ،ىرش ،رارمحا لمشت يتلا يدلج حفط تلااح .هجولاو مسجلا

.رعشلا طقاستل وأ سمشلل ةيساسح رثكأ دلجلا حبصيو ،ق

رعت ،ةكح ،تامدك لوبلا زاهج

.ىلكلا يف لكاشم وأ لوبلا يف مد ىرخأ

.ديج ريغ ماع ساسحإ وأ بعتلاب ساسحإ ،ةنوخس ،شطع

.مفلا يف تاحرقت وأ مفلا يف ملأ

.فعض وأ تلاضع ملأ

.ةأرملا لمحت نأ يف لكاشم

ملأو ىلكلا يف لكاشم ،يدلج حفط ،ةنوخس ضارعلأا لمشتو .ةيزاهج ةيمامح ةبئذ .لصافم

ّ

يبناج ضراع نم تيناع اذإ وأ ،ة

ّ

يبناجلا ضارعلأا دحأ مقافت اذإ ،يبناج ضرع رهظ اذإ .بيبطلا ةراشتسا كيلع ،ةرشنلا يف روكذم ريغ

ة

ّ

يبناجلا ضارعلأا نع غيلبتلا غيلبتلا" طبارلا ىلع طغضلا للاخ نم ة

يبناج ضارعأ نع ة

حصلا ةرازو غيلبت نكمملا نم ةرازو عقوم يف ةيسيئرلا ةحفصلا ىلع دوجوملا "يئاود جلاعل ةجيتن ة

يبناج ضارعأ نع نع غيلبتلل تنرتنلإا ربع ةرامتسا ىلإ كل

وحي يذلا )www.health.gov.il( ة

حصلا .https://sideeffects.health.gov.il :طبارلا لوخد ربع وأ ،ة

يبناجلا ضارعلأا

5

.

؟ءاودلا نزخي فيك

لوانتم نع ا

ديعب ،قلغم ناكم يف ،رخآ ءاود

لكو ،ءاودلا اذه ظفح بجي !م

مستلا ب

نجت نوﺪب ؤ

يقتلا ﺐ

ﺒﺴت لا .م

مستلا ب

نجتت اذكهو ،لافطلأا وأ/و دلاولأا ةيؤر لاجمو يديأ .ﺐﻴﺒﻄلا ﻦم ةﺤيﺮص تاﻤﻴلعت

خيرات .ة

وبعلا ىلع رهاظلا )exp. date( ة

يحلاصلا ءاهتنا خيرات دعب ءاودلا لوانت عنم

.رهشلا سفن نم ريخلأا مويلا ىلإ بسني ة

يحلاصلا ءاهتنا

. 5ºC تحت ةرارح ةجرد يف ،فاج ناكم يف نيزختلا بجي

ةراشتساب مق .تيبلا يف تلامهملا ة

لس يف وأ

حصلا فرصلا هايم يف ةيودلأا ءاقلإ عنم

هذه

نإ .لامعتسلاا نمض دعت مل يتلا ةيودلأا نم ص

لختلا ةيفيك ىلإ ةبسنلاب

يلديصلا .ةئيبلا ىلع ظافحلا يف دعاستس لئاسولا

6

.

ة

ّ

يفاضإ تامولعم

:ا

ً

ضيأ ،ءاودلا يوتحي ،لا

ّ

عفلا بكرملا ىلإ ةفاضلإاب

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)).

:ة

ّ

وبعلا يوحت اذامو ءاودلا ودبي فيك .رفصأ نول تاذ ةريدتسمو ةفلغم صارقأ

صرق 30 ىلع ة

وبع لك يوتحت ،)تارتسيلب( طئارش يف ةموزرم صارقلأا :هناونعو ليجستلا بحاصو جتنملا مسا .اڤكت حاتيپ ،3190 .ب.ص ،.ض.م ةيودأ تاعانص عاڤيت . 0 0 رايأ يف ةرشنلا ريرحت

ّ

مت

:ة

ّ

حصلا ةرازو يف

ّ

يمسرلا ةيودلأا

ّ

لجس يف ءاودلا ليجست مقر

055.98.20619

لاكل

دعم ءاودلاف اذه عم .ر

كذملا ةغيصب

صنلا درو اهليهستو ةرشنلا هذه ةءارق طيسبتل .نيسنجلا

DOR-Nax-PIL-0520-05

DOR-Nax-PIL-0520-05

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