NAXYN 500 MG

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

NAPROXEN

Verfügbar ab:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC-Code:

M01AE02

Darreichungsform:

TABLETS

Zusammensetzung:

NAPROXEN 500 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapiegruppe:

NAPROXEN

Therapiebereich:

NAPROXEN

Anwendungsgebiete:

- 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.

Berechtigungsdatum:

2012-02-28

Gebrauchsinformation

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
of
this
medicine’s
ingredients”
and
section
6
“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, diabete

Fachinformation

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