נפרוקסן סודיום SP

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

25-11-2020

מרכיב פעיל:
NAPROXEN SODIUM
זמין מ:
TREE OF LIFE PHARMA LTD
קוד ATC:
M01AE02
טופס פרצבטיות:
טבליה
הרכב:
NAPROXEN SODIUM 275 MG
מסלול נתינה (של תרופות):
פומי
סוג מרשם:
אין צורך במרשם
תוצרת:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
קבוצה תרפויטית:
NAPROXEN
איזור תרפויטי:
NAPROXEN
סממני תרפויטית:
Mild and moderate analgesic. Fever reduction. non-steroidal anti-inflammatory for the treatment of rheumatic inflammations, tendinitis and muscoloskeletal inflammations. Treatment of primary dysmenorrhea.
מספר אישור:
140 34 31895 00
תאריך אישור:
2014-02-28

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

17-08-2016

עלון מידע עלון מידע - ערבית

25-11-2020

±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©†ÌÈÁ˜Â¯‰†˙Â˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ

˙ÂÈÏ·Ë SP †ÌÂÈ„ÂÒ†ÔҘ¯Ù

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Naproxen Sodium 275 mg †∫ÏÈÚÙ‰†¯ÓÂÁ‰†∫‰ÏÈÎÓ†‰ÈϷˆÏΆ† ∫·Î¯‰

Microcrystalline Cellulose, Povidone, †††††††††††††∫ÌÈÏÈÚÙ†È˙Ï·†ÌȯÓÂÁ

Magnesium Stearate, Methocel E5 (HPMC),Titanium Dioxide,

Polyethylene Glycol 400, FD&CYellow No. 6Aluminium Lake.

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103308011 12/09B

PATIENT PACKAGE INSERT INACCORDANCE WITH

THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

NAPROXEN SODIUM SP

Tablets

Read this package insert carefully in its entirety before using this medicine

Composition:Each tablet contains:

Active ingredient:Naproxen Sodium 275 mg

Inactive ingredients: Microcrystalline Cellulose, Povidone, Magnesium

Stearate, Methocel E5 (HPMC),Titanium Dioxide, Polyethylene Glycol

400, FD&CYellow No. 6Aluminium Lake.

Each tablet contains 25 mg sodium.

Therapeutic group:Nonsteroidal anti-inflammatory drugs.

Therapeutic activity:Nonsteroidal anti-inflammatory for the treatment of

rheumatic inflammations, tendinitis and skeletal muscle inflammation.

Analgesic for mild to moderate pain, for the treatment of menstrual pain

and antipyretic.

This medicine is indicated for: Treatment of headache, tooth pain, muscle

ache, back ache, rheumatic pain, menstrual pain and fever reduction.

When should the preparation not be used?

Do not use this medicine if you are pregnant or breast-feeding.

Do not use this medicine if you are sensitive to any of its ingredients, or

to aspirin, salicylates and to other nonsteroidal anti-inflammatory drugs.

Do not use this medicine if in the past you had an allergic reaction to

any analgesic preparation.

Do not use this medicine if you haverecently undergone or if you are

about to undergo heart surgery.

Do not take this medicine concomitantly with other nonsteroidal anti-

inflammatory drugs.

Do not use this medicine if you are suffering, or have suffered in the

past, from ischemic heart disease or any other heart disease, from

cerebral stroke or from any type of mini-stroke in the heart or brain.

Do not use in children under 12 years of age.

Do not take this medicine without consulting a doctor before

starting treatment:

If you are suffering, or have suffered in the past, from impaired function

of the respiratory system (e.g. asthma), the vascular system, the liver, the

urinary system, from nasal polyps (as a result of using aspirin or other

nonsteroidal anti-inflammatory drugs);from digestive disturbances,such

as:heartburn, abdominal pain or peptic ulcer, coagulation disorders,

hypertension, heart and kidney diseases;if you take diuretics;if you are

above60 years of age;if taking a medicine from this group or any other

analgesic preparation caused severe side effects in the past.

If your salt intake is restricted (each tablet contains 25 mg sodium).

How will this medicine affect your daily life?

Use of this medicine may impair alertness and therefore caution should

be exercised when engaging in activities such as driving a car, operating

dangerous machinery and in any other activity which requires alertness.

Adolescents over the age of 12 should be cautioned against engaging

in activities such as bicycle riding, playing near roads and the like.

This medicine may cause a special sensitivity when the patient is exposed

to the sun (and excessive suntanning); therefore, avoid exposure to the

sun and take appropriate precautions (long clothing, a hat, protective

creams, etc.).If you consume 3 or morealcoholic beverages a day,

consult a doctor whether you should use this medicine or use another

medicine for pain relief or reducing fever, since naproxen sodium may

cause stomach bleeding.

Warnings:Do not use this medicine frequently without consulting a doctor.

During prolonged treatment with this medicine blood, liver and kidney

function tests should be performed.It is important that you use the lowest

dose that controls your pain and do not take the preparation longer than

it is necessary,as the risk of a heart attack or stroke may increase after

prolonged treatment, especially with high dosages.Taking this medicine

may cause stomach bleeding, especially if you are over 60 years of age,

if you are taking other nonsteroidal anti-inflammatory drugs, if you consume

more than three alcoholic drinks a day.Taking this medicine at a higher

dosage than that recommended or for a period longer than 10 days may

increase the risk of cerebral stroke,heart attack and stomach bleeding.

skin blisters, swelling of the face, shortness of breath, worsening of asthma,

shock.Stop using the medicine and refer to your doctor if fever lasts for

more than 3 days or if pain persists more than 10 days.If you are sensitive

to any type of food or medicine, inform your doctor before commencing

treatment with this medicine.If you are about to undergo surgery (including

dental), inform your doctor that you are taking this medicine.Before

undergoing laboratory tests inform your doctor, since treatment with this

medicine may interfere with the results.Before starting treatment inform

your doctor if you are being treated for any bacterial infection.Your doctor

should be informed of any hearing or visual disturbances.

Drug interactions:If you are taking another drug concomitantly or if you

have just finished treatment with another medicine, inform the attending

doctor, in order to prevent hazards or lack of efficacy arising from drug

interactions.This is especially important for medicines belonging to the

following groups: anticoagulants, diuretics, aspirin, salicylates or other

nonsteroidal anti-inflammatory drugs, lithium (antidepressant),

antihypertensives and heart medications such as beta-blockers

(propranolol), probenecid (for gout), methotrexate (for cancer and psoriasis),

antidiabetic drugs from the sulfonylurea group, cyclosporin (in transplants),

hydantoins (e.g. phenytoin for convulsions), sulfonamides (for infections)

and valproic acid (anticonvulsant).

Side effects:In addition to the desired effect of the medicine, adverse

reactions may occur during the course of treatment, for example: constipation,

nausea/vomiting, drowsiness, headache, dizziness, mild heartburn, mild

abdominal pain and sensitivity to the sun (see above).Antacids may be

used in order to reduce the side effects in the digestive system.

In the event these effects worsen, refer to the doctor (see also below).

Side effects that requirespecial attention:

If you experience fainting, bloody vomit, bloody or black stools - stop

treatment and refer to your doctor immediately.Fever, severe heartburn,

swelling of the face, lips, feet or hands, severe abdominal pain,

hypersensitivity (skin rash or irritation, shortness of breath or difficulty

breathing, swelling around the eyes), buzzing in the ears, reduction in

urine volume, mouth sores, nasal bleeding, hearing and visual disturbances

(see “Warnings”) - (rare): stop treatment and refer to your doctor.

In the event that you experience side effects not mentioned in this leaflet,

or if there is a change in your general health, consult your doctor immediately.

Recommended dosage unless otherwise prescribed by your doctor:

Adults and children over the age of 12: One tablet every 12 hours, as

needed, or an initial dose of 2 tablets per 24 hours.

Do not exceed a total daily dose of 2 tablets.

Over the age of 65: Up to 1.5 tablets per 24 hours.

Do not exceed the recommended dose.

Takethe lowest dose that achieves the treatment objective.

This medicine is generally not recommended for children under the

age of 12 years.

Directions for use:Do not chew! Swallow the medicine with a glass of

water.Take this medicine with or after a meal.

Avoidpoisoning!This medicine, and all other medicines, must be stored

in a safe place out of the reach of children and/or infants, to avoid poisoning.

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

the medicine, proceed immediately to a hospital emergency room and

bring the package of the medicine with you.

Donotinducevomiting unless explicitly instructed to do so by a doctor!

Donottakemedicinesinthedark! Check the label and the doseeach

time you take your medicine. Wear glasses if you need them.

Storage:Store in a cool and dry place (below 25 o C).Even if kept in their

original container and stored as recommended, medicines may be kept

for a limited period only. Please note the expiry date of the medicine! In

case of doubt, consult the pharmacist who dispensed the medicine to you.

Do not store different medications in the same package.

License number:140.34.31895.00

Version updated to 13/12/09

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

its content was checked and approved.

Distributed only by: Super-Pharm (ISRAEL) Ltd.,

P.O.B 2171, Hertzlia 46725.

Manufacturer:Trima Israel Pharmaceutical Products Maabarot Ltd.,

Kibbutz Maabarot

License holder:Tree of Life Pharma Ltd.,

Operating company 513071621, P.O.B 7735, Petach-Tikva 49170.

103308011 12/09B

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