ANAPROX 550 Naproxen sodium 550mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

naproxen sodium, Quantity: 550 mg

Tilgjengelig fra:

Atnahs Pharma Australia Pty Ltd

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: magnesium stearate; povidone; purified water; purified talc; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 8000; indigo carmine

Administreringsrute:

Oral

Enheter i pakken:

50 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

ANAPROX is indicated as an analgesic in acute migraine attacks, for the treatment of gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and for the relief of acute and/or chronic pain states in which there is an inflammatory component.

Produkt oppsummering:

Visual Identification: Oblong dark blue film coated tablets engraved NPS 550 on one face and a break-line on both sides; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

1998-11-03

Informasjon til brukeren

ANAPROX
®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ANAPROX?
ANAPROX contains the active ingredient naproxen sodium. ANAPROX is
used to relieve pain and reduces inflammation (swelling,
redness and soreness) that may occur with different types of
arthritis, in muscle and bone injuries, after setting broken or
dislocated
bones, with menstrual cramps (period pain), due to migraine headache,
following surgery, or due to dental pain, migraines, after
surgery, or dental pain. For more information, see Section 1. Why am I
using ANAPROX? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ANAPROX?
Do not use if you have ever had an allergic reaction to naproxen
sodium, aspirin or any other NSAID medicines, or any of the
ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU
HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER
MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING. For more information, see Section 2. What
should I know before I use ANAPROX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ANAPROX and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE ANAPROX?
•
Take ANAPROX exactly as your doctor has prescribed. Your doctor will
tell you how many ANAPROX tablets to take each day.
More instructions can be found in Section 4. How do I use ANAPROX? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ANAPROX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ANAPROX.
•
Tell your doctor if you get an infection while using ANAPROX.
•
Tell your doctor if you feel the tablets are not helping your
condition.
•
Call your doctor straight away if you become pregnant while taking
ANAPROX.
THINGS YOU
SHOULD NOT DO
•
Do not give ANAPROX to anyone e

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION – ANAPROX
® 550
(NAPROXEN SODIUM)
1. NAME OF THE MEDICINE
Naproxen sodium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ANAPROX 550 is available as a film-coated tablet containing 550 mg of
naproxen sodium.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
List of excipients with known effect: each film-coated tablet contains
50 mg of sodium.
3. PHARMACEUTICAL FORM
Film-coated tablet.
ANAPROX 550 is supplied as an oblong, dark blue film-coated tablet
engraved "NPS 550" on one side, with
a break-line on both faces.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ANAPROX 550 is indicated as an analgesic in acute migraine attacks,
for the treatment of gout, rheumatoid
arthritis, osteoarthritis, ankylosing spondylitis and for the relief
of acute and/or chronic pain states in which
there is an inflammatory component.
4.2 DOSE AND METHOD OF ADMINISTRATION
After assessing the risk/benefit ration in each individual patient,
the lowest effective dose for the shortest
possible duration should be used.
ACUTE MIGRAINE HEADACHE
The recommended dose is 825 mg at the first symptom of an impending
headache. An additional 275 mg to
550 mg dose can be given at least an hour after the initial dose, if
necessary. The total daily dose should not
exceed 1375 mg.
ACUTE PAIN STATES WITH AN INFLAMMATORY COMPONENT
The recommended dose is 550 mg initially followed by 275 mg every six
to eight hours as required. The total
daily dose should not exceed 1375 mg.
RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, ANKYLOSING SPONDYLITIS AND
CHRONIC PAIN STATES WITH AN
INFLAMMATORY COMPONENT
The dosage range of naproxen sodium is 550 mg to 1100 mg daily in two
divided doses. The starting dose
should not be less than 550 mg daily. The dose may be increased
gradually up to 1100 mg daily, depending
on the needs of the patient.
Patients on long term treatment should be reviewed regularly with
regards to efficacy, risk factors and
ongoing need for treatment.
PREGNANCY
See Section 4.6 FERTILITY, PREGNANCY AND